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The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
September 24, 2008
08-38
___________________________________
PRODUCT
a) Cartons labeled in part:"***BANTRY BAY SEAFOODS IRELAND MUSSELS
In a Garlic Butter Sauce Heat 'n Eat***1 lb (454g) Net Weight***READY IN 5
MINUTES***Serves 2***Origin Ireland***Cooked and Frozen***Ingredients:
Mussels, Vegetable oil blend (palm oil, rapeseed oil, emulsifier: momo and
diglycerides of fatty acids, colour:beta carotene), Butter, Natural garlic flavoring,
Garlic, Parsley. This product contains Shellfish (mussels), Milk (butter). Cooking
Instructions: For best results, cook from frozen. *** Always ensure mussels are fully
opened before serving. Microwave Empty contents of pouch into a microwaveable
dish, cover and cook for 5-6 mins. Mix and serve. OR Pierce pouch and place on a
microwaveable plate, cook for 5-6 mins. Allow to stand for 1 minute. Open with
care and serve.***HACCP APPROVED, Recall # F-556-8;
b) Bantry Bay Seafodos Mussels Cooked and Frozen in Tomato & Garlic Sauce 2 lb,
Recall # F-557-8
CODE
a) Production Date: 02/29/2008; Best Before End: 08/29/2009; Batch Code: 366 08
28A2;
b) Production Date: 277 07 24A2 Best before End: 4-04-09
RECALLING FIRM/MANUFACTURER
Bantry Bay Seafoods, Bantry, Ireland, by e-mail on August 20, 2008 and September 4, 2008. Firm initiated recall is ongoing.
REASON
Frozen cooked mussels are contaminated with azaspiracid toxins.
VOLUME OF PRODUCT IN COMMERCE
18,720 one pound packages
DISTRIBUTION
FL, GA, MA, NE, NJ, PA, VA, and WA
___________________________________
PRODUCT
YourLife Liquimax Complete Nutrition Multi-Vitamin Formula, 32 oz bottles. UPC Code 7497052290, 7497023607, 7497023696, Recall # F-558-8
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leiner Health Products, Llc., Carson, CA, by press release, telephone, fax, or email on June 6, 2008.
Manufacturer: Wellington Foods, Inc., Long Beach, CA. Firm initiated recall is ongoing.
REASON
Product contains undeclared allergens – fish, tree nuts and wheat.
VOLUME OF PRODUCT IN COMMERCE
115,080 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Liquid Acidophilus labeled as "ACIDOPHILUS Balances and Supports Digestive System", "Dietary Supplement NET WT. 16 OZ.". UPC: 719985714160. Product is labeled under various brand names: 1) "Artista's ProFitness", 2) "Mother's Market & Kitchen California", 3) "Lassens Natural Foods & Vitamins", 4) "Full o-Life", 5) "New Frontiers", 6) "The Merc Community Mercantile", 7) "Strawberry Fields", 8) "The Wedge", 9) "People's Food Co-op", 10) "New Pioneer Food Co-op", 11) "Arbor Farms Market", 12) "Chamberlin's", 13) "Akin's Natural Foods Market", 14) "Sprouts Farmers Market", 15) "Moscow Food Co-op", 16) “La Montanita Co-op", 17) "Durango Natural Foods", 18) "Cranberries Fresh Foods Market", 19)"Community Food Co-op", 20) "Rainbow Natural Remedies", 21) "Town & Country Markets Inc", 22) "Nature's Garden", 23) "Back to Basics Nutrition", 24) "Ashland Food Co-op", 25) "Skagit Valley Food Co-op", 26) "MaxLife Super Nutrition", 27) "Community Food Co op", 28) "PCC", 29) "Henry's Farmers Market", 30) "Keil's", 31) "Synergize", 32)"Jimbo's...Naturally", 33) "Wild Oats Food Origins", 34) "The Mustard Seed Natural Food and Supplements", 35) "Sun Harvest Supplements", 36) "Healthway Natural Foods”, 37) "Earth Fare", 38) "Harvest Co-operative Supermarkets", 39) "Ellwood Thompson's Natural Market", 40) "Berkshire Co-op Market", 41) "Cultural Health Revolution", 42) "Three Rivers Market", 43) "Staff of Life", 44) "Organic Produce & Natural Foods", 45) "Mollie Stone's", 46) "Sacramento Natual Foods Co-op", 47) "Brattleboro Food Co-op", 48) "GreenStar Cooperative Market", 49) "Real Food Health & Nutrition", 50) "New Leaf Bloom Total Body Care", 51) "New Leaf", 52) "Karsan's Elliot's Natural Foods", 53) "COOP", 54) "Fresh to Market Natural Living", 55) "The Food Mill Inc.", 56) "Westerly Natural Market", 57) "Maui Farmers Market & Deli", 58) "Andronico's Market", 59) "Island Naturals", 60) "Enterprise Health Foods", 61) "Down to Earth All Vegetarian", 62) "California Organics", 63) "Lakeshore Natural Foods", 64) "Acidophilus Pharmacy Favorites", 64) "Healing Secrets", 65) "Berkeley Bowl Market Place", 65) "Smile Herb Shop", 66) "Davis Food Co-op", 67) "River Valley Market", 68) "Lori's natural foods", 69) "Nature's Pantry", 70) "Kea'au natural foods", 71) "Mana Foods", Recall # F-559-8
CODE
Lot #3233-B8 and Lot #2326-E8
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nexgen Pharma, Inc., Irvine, CA, by email on July 25, 2008 and by follow-up letter on July 29, 2008.
Manufacturer: Wellington Foods, Inc., Long Beach, CA. Firm initiated recall is complete.
REASON
Dietary supplement contains undeclared wheat and undeclared potassium sorbate.
VOLUME OF PRODUCT IN COMMERCE
3,504 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Comstock Premium Cherry Pie Filling or Topping in 21 oz. cans, UPC: 4125543117, Recall # F-546-8
CODE
ITEM #: 9204912 7380C22 STRW FIL OU 273109
RECALLING FIRM/MANUFACTURER
Recalling Firm: Birdseye Foods, Rochester, NY, by email on April 9, 2008.
Manufacturer: Birds Eye Foods, Inc., Fennville, MI. Firm initiated recall is complete.
REASON
Cans labeled as Cherry Pie Filling actually contain Strawberry Pie Filling.
VOLUME OF PRODUCT IN COMMERCE
2,400 cans
DISTRIBUTION
FL, GA, KY, OH, TX
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Monistat Uristat Urinary Pain Relief Tablets, (Phenazopyridine HCl) 95 mg tablets, 12 and 24 tablet blister packs; NDC 52152-149-10 - Item Code 080612, 12 ct; UPC Code 300620806120; 14 Digit GTIN/Outer Case Code 103006220806127; Item Code 080624, 24 ct; UPC Code 300620806243, 14 Digit GTIN Outer Case Code 10300620806240, Recall # D-366-2008
CODE
All lots within expiry
RECALLING FIRM/MANUFACTURER
Recalling Firm: Johnson & Johnson Consumer Products, Co., Skillman, NJ, by letters on June 17, 2008.
Manufacturer: Actavis Totowa LLC, Totowa, NJ. Firm initiated recall is ongoing.
REASON
cGMP Deviation; Lack of stability indicating methods by manufacturer.
VOLUME OF PRODUCT IN COMMERCE
27 lots
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Trifluoperazine Hydrochloride Tablets, USP, 5 mg, 100 Tablets, NDC 00781-1034-01, Recall # D-367-2008
CODE
Lot number: V06016
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc., Princeton, NJ, by letter on July 11, 2008.
Manufacturer: Sandoz, Inc., Broomfield, CO. Firm initiated recall is ongoing.
REASON
Failed Dissolution Specification (6 month stability).
VOLUME OF PRODUCT IN COMMERCE
17,799 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Tricosal Tablets, salicylate content 500 mg* (as choline magnesium trisalicylate),
100 tablets, Rx only, Recall # D-368-2008;
b) Tricosal Tablets, salicylate content 750 mg* (as choline magnesium trisalicylate),
100 tablets, Rx only, Recall # D-369-2008;
c) Tricosal Tablets, 1000 mg* (as choline magnesium trisalicylate), 100 tablets,
Rx only, Recall # D-370-2008;
d) Prenatal Plus Tablets, Multivitamin/Multimineral Supplement, Rx only,
100 tablets, Recall # D-371-2008;
e) Tri-Vitamin with Fluoride Chewable Tablets, multivitamin and fluoride supplement,
Rx only, 100 tablets, Recall # D-372-2008;
CODE
a) Lot No. 0005437A1, exp 06/08;
b) Lot No’s.: 00060616A1, exp 06/08 and 00060743A1, exp. 08/08;
c) Lot No. 00060881A1, exp. 10/08;
d) Lot No’s.: 000060530A1, exp. 06/08; 00060657A1, exp. 07/08;
00060869A2, exp. 10/08; 00060964A2, exp. 11/08; 00070010A1, exp. 01/09;
00070110A2, exp. 02/09; 00070227A1, exp. 03/09; 00070319A2, exp. 04/09;
00070446A2, exp. 05/09; 00070447A2, exp. 06/09; 00070629A1, exp. 08/09;
00070678A2, exp. 08/09; 00070747A2, exp. 09/09; 00070748A2, exp. 10/09;
e) Lot No’s: 00060617A1, exp. 07/08 and 00070479A2, exp. 6/09;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Qualitest Pharmaceuticals, Inc., Huntsville, AL, by letter beginning on June 2, 2008 and June 12, 2008.
Manufacturer: Actavis Totowa LLC, Totowa, NJ. Firm initiated recall is ongoing.
REASON
cGMP Deviation; Lack of stability indicating methods.
VOLUME OF PRODUCT IN COMMERCE
61,798 Units (Includes Recall # D-373 and D-374-2008 – Class III)
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
a) Carisoprodol, Aspirin and Codeine Phosphate, USP, 200 mg/325 mg, 16 mg,
Rx only, 100 tablets, Recall # D-373-2008;
b) Guanfacine Tablets, USP, 1 mg, 100 tablets, Rx only, Recall # D-374-2008;
CODE
a) Lot Nos.: 00005629A1, exp. 07/08; 00060713A1, exp. 08/08; 00061024A1,
exp. 11/08; 00070488A1, exp. 06/09; 00070702A1, exp. 08/09;
b) Lot Nos.: 00070012A2, exp. 01/09 and 00080042A1, exp. 01/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Qualitest Pharmaceuticals, Inc., Huntsville, AL, by letter beginning on June 2, 2008 and June 12, 2008.
Manufacturer: Actavis Totowa LLC, Totowa, NJ. Firm initiated recall is ongoing.
REASON
cGMP Deviation; Lack of stability indicating methods.
VOLUME OF PRODUCT IN COMMERCE
61,798 Units (Includes Recall # D-368; D-369; D-370; D-371 and D-372-2008 – Class II)
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0853-08
CODE
Unit: 019LG29104
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by letter dated August 23, 2007 and follow-up fax on December 5, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1398-08
CODE
Unit: 19LT42826
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by telephone and letter on March 17, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
___________________________________
PRODUCT
a) Fresh Frozen Plasma (Apheresis), Recall # B-1416-08;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1417-08;
c) Platelets Pheresis Leukocytes Reduced, Recall # B-1418-08
CODE
a) and b) Unit: 032GP36040;
c) Unit: 032GP36215
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by fax on August 12, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1492-08
CODE
Unit: 9077380
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on July 16, 2007. Firm initiated recall is complete.
REASON
Blood product, labeled leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1623-08
CODE
Unit: 6493032
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., New Brunswick, NJ, by telephone on April 11, 2007 and fax on April 26, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Source Plasma, Recall # B-1707-08
CODE
Units: 85319707, 85304710, 84808714, 84802859, 84779014, 84637994
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by fax on June 29, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had previously tested reactive for the antibody to the Hepatitis C virus (anti-HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma, Recall # B-1711-08
CODE
Units: 06MTNA6092, KP102292, 06MTNA5484, 06MTNA5424, 06MTNA5209, 06MTNA5186, KP101825, 06MTNA4984, 06MTNA4872, 06MTNA4783, 06MTNA4634, 06MTNA4478, 06MTNA4409, 06MTNA4263, 06MTNA6373, 06MTNA6135, 06MTNA3859, 06MTNA3417
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by letter on April 19, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
CA, NC
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1753-08;
b) Recovered Plasma, Recall # B-1754-08
CODE
a) and b) Unit: 1470673
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated September 8, 2006 and electronically on September 7, 206. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL, Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1819-08
CODE
Unit: V50625
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by fax on February 27, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets, Recall # B-1822-08
CODE
Unit: V97789
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone on July 6, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1826-08
CODE
Unit: 9207866
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on November 6, 2007 and follow-up letter on November 19, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Cornea, Recall # B-1876-08
CODE
Tissues: SA200711361, SA200711362
RECALLING FIRM/MANUFACTURER
San Antonio Eye Bank, San Antonio, TX, by letters on February 19, 2008. Firm initiated recall is complete.
REASON
Human tissues for transplantation, collected from a donor who was not properly evaluated for hemodilution, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
DC and MD
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1912-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1913-08;
c) Platelets, Recall # B-1914-08
CODE
a) Unit: K99290;
b) Unit: F92348;
c) Units: F92348, K99290
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by fax on May 22, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1932-08
CODE
Unit: 1421876
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on June 6, 2006 and follow-up letter on July 11, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Source Plasma, Recall # B-1961-08
CODE
Unit: KZ040275
RECALLING FIRM/MANUFACTURER
Plasma Biological Services Inc., Memphis, TN, by fax on March 18, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from donors whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1977-08
CODE
Unit: 026FF72814
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone on October 18, 2007 and follow-up letter on October 26, 2007.
Manufacturer: The American National Red Cross, Mobile, AL. Firm initiated recall is complete.
REASON
Blood product, possibly not returned to controlled storage within 30 minutes following irradiation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Recall # B-1981-08;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1982-08
CODE
a) Unit F31280;
b) Units: F31280 (split unit)
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by fax on March 12, and 13, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced which did not meet the requirements for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MI
___________________________________
PRODUCT
a) Recovered Plasma, Recall # B-1984-08;
b) Red Blood Cells, Recall # B-1985-08
CODE
a) and b) Unit: M44513
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank dba Rock River Valley BC, Rockford, IL, by fax and letter on May 27, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfekit- Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI and Austria
___________________________________
PRODUCT
Source Plasma, Recall # B-2002-08
CODE
Units: 382058444, 382058463, 382063380, 382065949, 382066116, 382067041, 382074388, 382078691, 382079617, 382079953, 382087042, 382087717
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Tuscaloosa, AL, by fax on May 7, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
NC
___________________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-2005-08;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-2006-08
CODE
a) Unit: 71X414287;
b) Unit: 71X414251
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers - Montgomery Region, Montgomery, AL, by facsimile on April, 18, 2006. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2009-08
CODE
Units: 72E30692X, 72E317724, 72E310422
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on January 2, 2008. Firm initiated recall is complete.
REASON
Blood products, processed more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2011-08
CODE
Unit: Y91147
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on January 17, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2012-08
CODE
Units: 9174272, 9171910
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 20, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO, TN
___________________________________
PRODUCT
Red Blood Cells, Recall # B-2013-08
CODE
Unit: 71R093947
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers - Montgomery Region, Montgomery, AL, by facsimile on January 18, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-2014-08;
b) Platelets Irradiated, Recall # B-2015-08
CODE
a) and b) Unit: V55939
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on June 13, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT
a) Recovered Plasma, Recall # B-2016-08;
b) Red Blood Cells, Recall # B-2017-08;
c) Platelets, Recall # B-2018-08
CODE
a), b) and c) Unit: 6268382
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by electronic mail on March 19, 2008 and by telephone on March 20, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL and Austria
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-2019-08
CODE
Unit: 9426027
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL, by telephone on June 18, 2008.
Manufacturer: LifeSource Portage Park, Chicago, IL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose wife completed the donor history form, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2021-08
CODE
Unit: 9416847
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on April 28, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2022-08
CODE
Units: 9316263, 6793544
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on April 19, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO, NJ
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2023-08
CODE
Unit: 72F376943
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone on April 27, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2024-08
CODE
Unit: 72F247684
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone on May 7, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2025-08
CODE
Unit: 72F53748X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone on April 24, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2026-08
CODE
Units: 9729605 (Part 1, 2 and 3)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on June 19, 2007 and follow-up letter dated June 27, 2007. Firm initiated recall is complete.
REASON
Blood products, with unacceptably high platelet concentrations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2027-08
CODE
Units: 9891502 (Part 1, 2 and 3)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on June 7, 2007. Firm initiated recall is complete.
REASON
Blood products, with platelet counts below the specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2028-08
CODE
Unit: 9910085 (split product)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on August 5, 2007. Firm initiated recall is complete.
REASON
Blood product, with unacceptably high platelet concentration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2029-08
CODE
Unit: 9949560
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on June 29, 2007 and follow-up letter on July 6, 2007. Firm initiated recall is complete.
REASON
Blood product, with unacceptably high platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
____________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2032-08
CODE
Unit: 019FS42136
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by fax on May 9, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
__________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2033-08
CODE
Unit: 9866218
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on July 25, 2007. Firm initiated recall is complete.
REASON
Blood product, with insufficient plasma to support the platelets as a 7-day product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2034-08
CODE
Unit: 2248474
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by telephone and fax on January 11, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2035-08
CODE
Units: 9189255 (Part 1, 2 and 3)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on January 16, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced which did meet the requirements for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2037-08
CODE
Unit: 004E16430
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by letter and fax on April 21, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2038-08
CODE
Unit: 004KK56301
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by facsimile on April 16, 2008. Firm initiated recall is complete.
REASON
Blood product, which tested negative for antibody to hepatitis B core antigen (anti-HBc), but was collected from a donor who tested repeat reactive for anti-HBc on two previous occasions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
___________________________________
PRODUCT
Sunquest Blood Bank and Blood Donor version 6.0.1 distributed with Sunquest Laboratory 6.1 and 6.2 and Sunquest Blood Bank and Blood Donor version 6.0.2 distributed with Sunquest Laboratory 6.3, Recall # B-2039-08
CODE
Sunquest Blood Bank and Blood Donor version 6.0.1 distributed with Sunquest Laboratory 6.1 and 6.2 and Sunquest Blood Bank and Blood Donor version 6.0.2 distributed with Sunquest Laboratory 6.3
RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc., Tucson, AZ, by e-mail on July 30, 2008. Firm initiated recall is ongoing.
REASON
Software, with a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
289 Clients
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2042-08
CODE
Unit: 004FJ29145
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA, by telephone on June 4, 2008 and letter on June 11, 2008.
Manufacturer: Recalling Firm: ARC Blood Services, New England Region, Bangor, ME. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ME
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-2043-08;
b) Plasma Frozen, Recall # B-2044-08
CODE
a) and b) Unit: 22FX56603
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone, fax and letters on May 9, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-2047-08
CODE
Units: 9948662 (split unit)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on April 14, 2007 and letter on April 17, 2007. Firm initiated recall is complete.
REASON
Blood products, that did not meet QC specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-2048-08;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-2049-08
CODE
a) Unit: 9949716
b) Units: 9949716 (split unit)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter dated April 18, 2007. Firm initiated recall is complete.
REASON
Blood products, that did not meet QC specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
______________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2050-08
CODE
Unit: 38Y46255
RECALLING FIRM/MANUFACTURER
American National Red Cross Indiana-Ohio Region, Fort Wayne, IN by letter or e-mail on June 14, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
______________________________________________
PRODUCT
Sunquest Blood Bank and Blood Donor version 6.0.1 distributed with Sunquest Laboratory 6.1 and 6.2; Sunquest Blood Bank and Blood Donor version 6.0.2 distributed with Sunquest Laboratory 6.3, Recall # B-2052-08
CODE
Sunquest Blood Bank and Blood Donor version 6.0.1 distributed with Sunquest Laboratory 6.1 and 6.2; Sunquest Blood Bank and Blood Donor version 6.0.2 distributed with Sunquest Laboratory 6.3
RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc, Tucson, AZ, by e-mail on August 15, 2008. Firm initiated recall is ongoing.
REASON
Software with a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
273 clients Nationwide and 12 Internationally
DISTRIBUTION
Nationwide and Internationally
________________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2053-08
CODE
Unit: 72F269781
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on May 3, 2008. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2054-08
CODE
72F269480
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on May 15, 2008. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2055-08
CODE
Unit: 72F244264
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL, by facsimile on April 26, 2008. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2056-08
CODE
Unit: 72F376906
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on April 26, 2008. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2057-08
CODE
Unit: 72F356305
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on May 1, 2008. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2058-08
CODE
Unit: 72F399133
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on May 10, 2008. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2059-08
CODE
Unit: 72F177063
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on May 7, 2008. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2060-08
CODE
Unit: 72F176969
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on May 6, 2008. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-2064-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-2065-08;
c) Platelets Leukocytes Reduced, Recall # B-2066-08
CODE
a) Unit: 019LR15614;
b) and c) Units: 019LR14400; 019LR15614
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by telephone and fax on June 11, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
TN
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-2067-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-2068-08
CODE
a) and b) Unit: 019LT41521
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by telephone and letter on June 21, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-2070-08
b) Red Blood Cells Leukocytes Reduced, Recall # B-2071-08
CODE
a) Unit: 019LE57754;
b) Units: 019LE57754; 019LE64261; 019LH18547
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by letter dated July 31, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TN, KY
****CORRECTION****
In the September 3, 2008, 08-35 Enforcement Report, Recall # B-1887-06 is incorrect, the correct recall number is B-1887-08.
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # 1879-08
CODE
Units: 2663204, 2663560, 2663539, 2663245, 2664060, 2663550, 2663321, 2663334, 2662901, 2663541, 2663224, 2663395, 2663248, 2663548, 2663582, 2662915, 2662960, 2662996, 2653881, 2662470, 2663212, 2663320, 2662951, 2662914, 2663585, 2664050, 2664065
RECALLING FIRM/MANUFACTURER
Our Lady Of The Lake Hospital, Inc, Blood Bank, Baton Rouge, LA, by fax beginning on February 23, 2007. Firm initiated recall is complete.
REASON
Blood products, that were not leukoreduced in accordance with specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Source Plasma, Recall # B-1958-08
CODE
Unit: JQ036250
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by fax on February 4, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-1959-08
CODE
Unit: JQ017594
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by fax on February 15, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-1960-08
CODE
Unit: JQ032904
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by fax on February 5, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1976-08
CODE
Units: 026FJ63749; 026FJ63774
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone on February 8, 2008. Firm initiated recall is complete.
REASON
Blood products, collected using trip scales that had no documentation of daily QC, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1977-08
CODE
Unit: 026FF72814
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone on October 18, 2007 and follow-up letter on October 26, 2007.
Manufacturer: The American National Red Cross, Mobile AL. Firm initiated recall is complete.
REASON
Blood product, possibly not returned to controlled storage within 30 minutes following irradiation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Source Plasma, Recall # B-1983-08
CODE
Unit: 363022080
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Fort Worth, TX, by fax on October 15, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
BioArchive Vapor By-Pass Assembly, accessory to the Bioarchive Device, packed in a cardboard box, Recall # B-2001-08
CODE
All assemblies in the field are affected.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Thermogenesis Corp., Rancho Cordova, CA, by letter on May 7, 2008.
Manufacturer: Gordineer Electronics, Roseville, MI. Firm initiated recall is ongoing.
REASON
Vapor Bypass Assembly, manufactured with an incorrect connector type on the Controller Box which can create the risk of electric shock, was distributed.
VOLUME OF PRODUCT IN COMMERCE
38 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Source Plasma, Recall # B-2003-08
CODE
Unit: JQ034030
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by fax on February 15, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-2004-08
CODE
Unit: JQ046927
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by fax on February 5, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
a) Recovered Plasma, Recall # B-2007-08;
b) Fresh Frozen Plasma, Recall # B-2008-08
CODE
a) Units: 72E075073, 72E086850, 72E085380, 72E078456, 72E082802, 72E292878,
72E473259, 72E312151, 72E306537, 72E306549, 72E317620, 72E317588,
72E315872, 72E30692X, 72E317724, 72E311848, 72E311824, 72E311812,
72E310410, 72E311873, 72E31185X, 72E310422, 72E317183, 72E317226,
72E317238, 72E70635X, 72E27637X, 72E710663, 72E710687, 72E709222,
72E310422;
b) Units: 72E298397, 72E313473, 72E265286, 72E276553, 72E276528, 72E313135,
72E613967, 72E305381
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on January 2, 2008. Firm initiated recall is complete.
REASON
Blood products, processed more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
39 units
DISTRIBUTION
AL and FL
___________________________________
PRODUCT
Source Plasma, Recall # B-2010-08
CODE
Unit: JQ038070
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by fax on February 15, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells, Unit: B-2020-08
CODE
Unit: 5679111
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on April 18, 2008. Firm initiated recall is complete.
REASON
Blood product, prepared without the appropriate amount of additive (ADSOL), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2030-08
CODE
Unit: 5579130
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter dated November 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a leishmania risk area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL and Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2031-08
CODE
Units: R44596, R44608, R44603, R44604
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, South Bend, IN, by interdepartmental mail and in person April 17, 2007. Firm initiated recall is complete.
REASON
Blood products, collected using a scale with unacceptable quality control results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
IN
___________________________________
PRODUCT
Recovered Plasma, Recall # B-2036-08
CODE
Unit: 004E16430
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by Logic system on April 21, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-2040-08
CODE
Unit: 004GF71112
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone on March 20, 2008 and by letter on March 21, 2008. Firm initiated recall is complete.
REASON
Blood product, stored at an unacceptable temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-2041-08
CODE
Unit: 004FJ29145
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA, by Logic on June 4, 2008.
Manufacturer: Recalling Firm: ARC Blood Services, New England Region, Bangor, ME. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2045-08
CODE
Unit: 1779013
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on June 12, 2008 and letter dated June 25, 2008. Firm initiated recall is complete.
REASON
Blood product, labeled as an AS-3 product but with no red cell preservative solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT
Recovered Plasma, Recall # B-2051-08
CODE
Unit: 38Y46255
RECALLING FIRM/MANUFACTURER
American National Red Cross Indiana-Ohio Region, Fort Wayne, IN by letter or e-mail on June 14, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25 mg per Vial, Rx NDC 58468-0080-1, Recall # B-2061-08
CODE
Lot Number: C7010C01 Exp. APR/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Genzyme, Framingham, MA, by letter dated August 21, 2008.
Manufacturer: Genzyme Ireland Ltd. Waterford, Ireland. Firm initiated recall is ongoing.
REASON
Thymoglubin, in which the product fails stability for opalescence, was distributed.
VOLUME OF PRODUCT IN COMMERCE
13,731 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Source Plasma, Recall # B-2062-08
CODE
Units: 05OWIC4533, 05OWIC5473, 05OWIC8514, 05OWIC9536, 05OWID0068 05OWIE2925, 05OWIC3489, 05OWIC5747, 05OWIC6208
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by fax on September 22, 2005.
Manufacturer: BioLife Plasma Services, LP, Oshkosh, WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor possibly at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Austria, CA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-2063-08
CODE
Unit: 019LR14400
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, electronically on June 7, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-2069-08
CODE
Units: 019LE64261; 019LH18547
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, electronically on July 31, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. Product number: 9896 002 04432. Site ID #: 506241, 500046, 521648, 522220, 520020, 533112, 533314, 533471, 533530, 535257, 535118, 535924, 540860, 541490, 539106, 547017, 547142, 549798, 547348, 550258, 553676, 553235, Recall # Z-1374-2008
CODE
SN number: 43, 49, 52, 107, 123, 131, 152, 157, 171, 179, 185, 202, 266, 333, 337, 389, 408, 446, 485, 491, 514, 515
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letters on March 22, 2008.
Manufacturer: Philips Medical Systems Ned Bv, Best, Netherlands. Firm initiated recall is ongoing.
REASON
Unexpected movement of the X-ray table may occur. These movements may lead to patient injury, e.g., an uncontrolled tilt may cause the patient to slip off.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Altaire MRI System Emergency Rundown Switch Unit (ERDU) is intended to provide the physician with physiological and clinical information obtained non-invasive and without the use of ionizing radiation, Recall # Z-1542-2008
CODE
Serial # L001-L242 (not inclusive)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, by letter on February 11, 2008.
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
REASON
The firm’s Altaire MR Scanner’s Emergency Rundown Switch Unit (ERDU), that is used to shut down the device in an emergency, was found to be defective. An ERDU failure could delay or prevent patient access leading to possible patient death or serious injury.
VOLUME OF PRODUCT IN COMMERCE
235 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices, Recall # Z-1609-2008
CODE
Lot 0610315
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Cardiac Surgery Technologies, Minneapolis, MN, by letter on February 25, 2008.
Manufacturer: Medtronic Mexico EG, Sonora, Mexico. Firm initiated recall is ongoing.
REASON
Medtronic has identified one lot #0610315 of U-Clip Removal Tools, Catalog UREM1860FW that was incorrectly assembled. The nose cone attachment, on the body of the removal tool, may not contain sufficient adhesive, which can allow the nose cone to separate from the body of the device.
VOLUME OF PRODUCT IN COMMERCE
80 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device),
Recall # Z-1653-2008;
b) ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device),
Recall # Z-1654-2008
CODE
a) ABL700 Series (902-441);
b) ABL800 Flex (902-754)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake, OH, by letter on February 28, 2008.
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
REASON
Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. This may cause the operator to perform measurements and obtain questionable results.
VOLUME OF PRODUCT IN COMMERCE
2,481 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
LIFEPAK 1000 defibrillator - portable battery powered semi-automated model that can be operated in either of three modes: Automated external defibrillator (AED), manual defibrillator and electrocardiographic (ECG) mode. The defibrillator is intended for indoor or outdoor use in a wide variety of hospital and pre-hospital settings including ground and air ambulances, physician's offices, aircraft, stadiums and specialty medical clinics. ECG monitoring is intended for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring. Affected part numbers: 320371500021 through 320371500038, 320371500043, 320371500044, 320371500046, 320371500048, 320371500050, 320371500056, 320371500058, 320371500063, and 320371500067, Recall # Z-1656-2008
CODE
Domestic: 35223068, 35267516, 35267519, 35892406, 35895430, 35242436, 35892542, 35977949, 35267533, 35267553, 35910136, 35972647, 35972648, 35972649, 35972650, 35972651, 35972652, 35972653, 35942190, 35942193, 35938673, 35223075, 35969804, 35969805, 35926650, 35926651, 35926652, 35926653, 35926654, 35926655, 35926562, 35967657, 35967658, 35967659, 35967660, 35967661, 35967664, 35967665, 35967666, 35967667, 35969810, 35969811, 35969812, 35969813, 35972478, 35972479, 35972480, 35972481, 35972482, 35904997, 35973187, 35974263, 35974264, 35974265, 35974266, 35974267, 35974268, 35969073, 35969090, 35969091, 35969092, 35969093, 35969094, 35969095, 35969096, 35969097, 35969098, 35969099, 35969100, 35969101, 35969102, 35969103, 35969104, 35969105, 35972621, 35972622, 35972623, 35972624, 35972625, 35965677, 35965678, 35965679, 35965680, 35965682, 35965684, 35965685, 35965688, 35965689, 35965690, 35967568, 35988737, 35988738, 35988739, 35988740, 35223108, 35223112, 35223114, 35220224, 35894843, 35894847, 35895509, 36126318, 35960736, 35965709, 35967427, 35967428, 35967429, 35267501, 35267536, 35267540, 35220192, 35267515, 35267555, 35267564, 35267567, 35899706, 35940395, 35988726, 35988727, 35988728, 35988729, 35988730, 35988731, 35970273, 35970274, 35267539, 35941278, 35941279, 35941281, 35937926, 35941681, 35941682, 35941683, 35941684, 35969806, 35220228, 35237266, 35240666, 35937929, 35937930, 35937931, 35989256, 35989257, 35989258, 35989259, 35267499, 35267518, 35267535, 35267537, 35267544, 35267554, 36056305, 35989250, 35989251, 35240665, 35977960, 35977961, 35977962, 35977963, 35985351, 35985352, 35937080, 35969397, 35938191, 35925967, 35925969, 35925970, 35977943, 35969809, 35973251, 35973252, 35940914, 35940915, 35940916, 35940917, 35975854, 35975855, 35937412, 35936972, 35989254, 35989209, 35989210, 35989211, 35989212, 35989214, 35989216, 35989217, 35989218, 35989219, 35989220, 35989221, 35989222, 35989223, 35984629, 35984630, 35984631, 35242411, 35910064, 35910065, 35927618, 35927625, 35220222, 35941658, 35941659, 35941660, 35220058, 35220059, 35937407, 35937079, 35969142, 35969143, 35977658, 35977659, 35220234, 35237239, 35237250, 35237254, 35237258, 35237264, 35237268, 35371825, 35894840, 35895512, 35895515, 35976917, 35976918, 35977112, 35977113, 35938844, 35985323, 35949829, 35989230, 35989231, 35989232, 35989233, 35969372, 35969373, 35969374, 35940414, 35940415, 35940416, 35240661, 35220184, 35267505, 35267532, 35267542, 35892536, 35892538, 35892539, 35895417, 35895428, 35895429, 35895507, 35985335, 35985336, 35985337, 35985338, 35985339, 35985340, 35940923, 35940924, 35940925, 35940926, 35940927, 35940928, 35940929, 35940930, 35940931, 35940932, 35940933, 35940934, 35267534, 36066526, 35476349, 35976916, 36066043, 35936912, 35936913, 35936914, 35969843, 35988243, 35988244, 35988245, 35988246, 35988247, 35988248, 35988249, 35988250, 35988251, 35988252, 35988253, 35988254, 35988255, 35988256, 35988257, 35987853, 35987854, 35987855, 35987856, 35987857, 35987858, 35987859, 35987860, 35987861, 35239096, 35938488, 35938489, 35938490, 35938491, 35938492, 35938494, 35938495, 35938496, 35938497, 35938498, 35938499, 35938500, 35938501, 35938502, 35240659, 35240660, 35240658, 35243101, 35243102, 35243104, 35243105, 35973242, 35936907, 35936908, 35936909, 35936976, 35936977, 35936978, 35936979, 35936980, 35936981, 35936982, 35989247, 35220056, 35976645, 35976646, 35976647, 35937396, 35937397, 35937398, 35937399, 35969155, 35937405, 35969361, 35969368, 35223079, 35941213, 35941214, 35242430, 35267521, 36059851, 35220225, 35220226, 35938437, 35938438, 35973138, 35220229, 35977680, 35976802, 35976814, 35967591, 35967592, 35967593, 35967594, 35967596, 35215160, 35242418, 35223091, 35215179, 35977955, 35977956, 35977957, 35977119, 35242419, 35240663, 35267541, 35215123, 35215124, 35215099, 35542818, 35542819, 35985320, 35985321, 35985322, 35984620, 35984621, 35949854, 35949855, 35976611, 35976612, 35976613, 35976614, 35987845, 35987846, 35987847, 35949843, 35892381, 35892384, 35938843, 35938845, 35938846, 35938847, 35941665, 35907652, 35975856, 35267502, 35976902, 35976906, 35976908, 35976910, 35936807, 35931716, 35931717, 35931718, 35931719, 35931722, 35931724 INTERNATIONAL: 35239067, 35239068, 35239069, 35239070, 35239072, 35239084, 35239088, 35363261, 35526920, 35526921, 35526922, 35526923, 35526924, 35526925, 35526926, 35542908, 35542909, 35508807, 35508811, 35508824, 35508832, 35508843, 35508845, 35810714, 35810715, 35810716, 35810717, 35810718, 35810719, 35810720, 35810721, 35810722, 35810723, 35363231, 35369859, 35505854, 35505855, 35505856, 35505857, 35586318, 35586901, 35586903, 35587862, 35587863, 35734627, 35734629, 35734630, 35734631, 35734619, 35734620, 35734621, 35734622, 35734632, 35935143, 35935152, 35935153, 35935155, 35935156, 35937304, 35969554, 35969555, 35969556, 35969557, 35969558, 35969559, 35969560, 35969561, 35969562, 35969563, 35508830, 35891899, 35891907, 35891908, 35891910, 35216482, 35217295, 35242374, 35242375, 35242376, 35242377, 35242378, 35242379, 35242380, 35242381, 35242382, 35242383, 35242384, 35242385, 35242386, 35242387, 35242388, 35242389, 35242390, 35242391, 35242392, 35242393, 35242394, 35242395, 35242396, 35242397, 35242398, 35242399, 35242400, 35242401, 35242403, 35242404, 35242405, 35242406, 35242407, 35242408, 35242409, 35242410, 35242412, 35242413, 35242414, 35242415, 35242416, 35242417, 35242422, 35242424, 35242425, 35242426, 35242427, 35242428, 35242429, 35242431, 35242432, 35242434, 35242435, 35242437, 35242438, 35242439, 35303872, 35303874, 35303877, 35303886, 35303887, 35303888, 35303889, 35303890, 35303891, 35303892, 35303893, 35303897, 35324247, 35324248, 35324249, 35324251, 35324252, 35324254, 35324255, 35324256, 35324257, 35324258, 35324259, 35324260, 35324261, 35324270, 35324271, 35324272, 35324273, 35324601, 35325480, 35514565, 35514566, 35514567, 35514568, 35514569, 35514570, 35514573, 35514574, 35514575, 35514576, 35514577, 35514578, 35514579, 35514580, 35514581, 35514582, 35514583, 35514584, 35514585, 35514586, 35514587, 35514588, 35514589, 35514590, 35514591, 35514592, 35514593, 35514594, 35514595, 35514596, 35514597, 35514598, 35514599, 35514600, 35521728, 35521729, 35521730, 35521731, 35521732, 35521733, 35521736, 35521739, 35521740, 35521742, 35521743, 35521744, 35521745, 35521746, 35521747, 35521748, 35521749, 35521750, 35521751, 35521752, 35521753, 35521754, 35521756, 35521757, 35509591, 35521763, 35521764, 35521765, 35521766, 35521767, 35521768, 35521769, 35521770, 35521771, 35521772, 35521773, 35521774, 35521776, 35521778, 35521779, 35521781, 35521782, 35521783, 35521784, 35501101, 35521795, 35521796, 35521797, 35521798, 35521799, 35521800, 35476379, 35476380, 35476381, 35566509, 35566512, 35566514, 35573132, 35573133, 35573134, 35573136, 35573138, 35573139, 35573141, 35573142, 35573143, 35573144, 35573145, 35573146, 35573147, 35573148, 35573149, 35573150, 35573151, 35573154, 35574103, 35242402, 35242420, 35267514, 35476348, 35225555, 35226258, 35222373, 35222364, 35225006, 35225007, 35242233, 35242236, 35226336, 35242234, 35242310, 35242314, 35242315, 35242316, 35242317, 35242318, 35245558, 35245559, 35245560, 35245561, 35246717, 35246718, 35246720, 35246723, 35246724, 35246726, 35246731, 35246733, 35246735, 35246739, 35246740, 35246741, 35246742, 35246743, 35246744, 35246745, 35246746, 35246747, 35246748, 35246749, 35246751, 35246752, 35246753, 35246754, 35246758, 35248807, 35248808, 35271234, 35271235, 35271236, 35271237, 35271238, 35271244, 35271245, 35271246, 35271247, 35271248, 35271249, 35271253, 35271254, 35271549, 35271550, 35271551, 35271552, 35271554, 35271556, 35271559, 35271560, 35271563, 35271564, 35271568, 35271569, 35271570, 35271571, 35271572, 35271573, 35271574, 35270620, 35270621, 35270622, 35270623, 35270624, 35270625, 35270626, 35272368, 35272370, 35272371, 35272372, 35272373, 35272374, 35246685, 35246686, 35246687, 35246688, 35246689, 35246690, 35246691, 35246692, 35246693, 35246699, 35246706, 35246707, 35246708, 35246709, 35272476, 35272477, 35270660, 35245554, 35245565, 35245566, 35245567, 35245570, 35270665, 35274082, 35274104, 35276145, 35276146, 35248810, 35271562, 35273796, 35273811, 35273817, 35273820, 35273821, 35273824, 35273825, 35273826, 35273828, 35273837, 35272483, 35272485, 35273752, 35273774, 35246967, 35273964, 35273967, 35276151, 35276152, 35246755, 35248809, 35190671, 35273805, 35273932, 35273934, 35273777, 35273783, 35273957, 35273958, 35273959, 35273960, 35276209, 35276066, 35274086, 35274087, 35274088, 35274089, 35274090, 35274091, 35274092, 35274093, 35274094, 35274095, 35274096, 35274098, 35293110, 35293119, 35293123, 35293127, 35293130, 35293132, 35293133, 35293134, 35293135, 35293136, 35293137, 35293138, 35296110, 35296112, 35296114, 35296116, 35296117, 35296119, 35296120, 35296122, 35296124, 35296126, 35296127, 35296128, 35296129, 35296130, 35296131, 35296132, 35296133, 35296134, 35296135, 35296136, 35296137, 35296138, 35296139, 35296141, 35296989, 35297006, 35274259, 35274261, 35274262, 35274263, 35274264, 35274265, 35274266, 35274267, 35274268, 35274269, 35274270, 35293987, 35294006, 35294165, 35294167, 35295202, 35295204, 35295205, 35295254, 35295255, 35295256, 35295257, 35295258, 35296146, 35296147, 35296148, 35296149, 35296150, 35296151, 35296152, 35296153, 35296154, 35296155, 35296156, 35296157, 35296158, 35296159, 35296160, 35296161, 35296162, 35296164, 35293818, 35293912, 35293913, 35293914, 35293955, 35293970, 35293095, 35293096, 35303935, 35292839, 35293974, 35293984, 35293986, 35293790, 35293960, 35301228, 35276067, 35296078, 35272480, 35295135, 35304482, 35304485, 35304488, 35304489, 35304492, 35304493, 35304495, 35304499, 35304500, 35304502, 35304503, 35304504, 35304505, 35304506, 35304507, 35304508, 35304512, 35304514, 35304522, 35304525, 35304526, 35304528, 35304529, 35304536, 35304537, 35304538, 35304540, 35304541, 35304542, 35304543, 35304544, 35304545, 35304550, 35304552, 35304553, 35304556, 35304557, 35304559, 35301790, 35294172, 35296072, 35296076, 35296077, 35295235, 35295236, 35293789, 35293816, 35293820, 35296063, 35294196, 35293131, 35325539, 35325540, 35325541, 35325542, 35325543, 35325544, 35325550, 35325551, 35325552, 35325553, 35325554, 35325557, 35325560, 35325561, 35325563, 35325564, 35325566, 35325571, 35325573, 35325574, 35325575, 35325576, 35325577, 35325578, 35325579, 35325580, 35325581, 35325582, 35325583, 35325584, 35325585, 35325586, 35325587, 35296030, 35327150, 35327156, 35327159, 35327160, 35327161, 35327162, 35327163, 35327170, 35327171, 35327174, 35327175, 35327177, 35327179, 35327180, 35327183, 35327185, 35327194, 35327200, 35327227, 35327228, 35327232, 35327234, 35363336, 35369584, 35369591, 35363269, 35363881, 35402318, 35402334, 35398577, 35402364, 35424290, 35424291, 35424292, 35424293, 35424294, 35424295, 35424296, 35424298, 35424300, 35424309, 35424311, 35424312, 35424313, 35412729, 35422363, 35424324, 35412744, 35428592, 35412732, 35412730, 35412731, 35412733, 35412734, 35453012, 35453032, 35453046, 35453049, 35453051, 35455626, 35372669, 35438439, 35455684, 35458604, 35469773, 35469774, 35469775, 35469776, 35469777, 35469778, 35469780, 35469782, 35469784, 35469797, 35492121, 35484768, 35494550, 35494551, 35494552, 35494554, 35494555, 35494557, 35494558, 35494561, 35494563, 35500311, 35499349, 35499351, 35499352, 35499353, 35499354, 35497109, 35499365, 35500472, 35497110, 35506699, 35508848, 35509447, 35506692, 35499357, 35499358, 35506682, 35506683, 35506684, 35506685, 35506686, 35506687, 35506688, 35506689, 35510516, 35509446, 35508847, 35515020, 35515685, 35516073, 35550674, 35550678, 35550679, 35550687, 35559432, 35559434, 35559435, 35559436, 35559438, 35560042, 35560609, 35561478, 35560140, 35560328, 35560329, 35560330, 35560331, 35560332, 35560385, 35563333, 35563658, 35560390, 35560770, 35560771, 35563607, 35563611, 35563615, 35563623, 35563640, 35563644, 35563679, 35564108, 35573044, 35573045, 35572999, 35573043, 35589210, 35501244, 35521735, 35590439, 35590441, 35239082, 35293976, 35273787, 35318768, 35274260, 35276150, 35609807, 35609808, 35609810, 35609818, 35609819, 35294182, 35611860, 35521762, 35632575, 35632576, 35632577, 35632579, 35632581, 35632585, 35633882, 35633922, 35633923, 35633924, 35633925, 35633926, 35633927, 35633928, 35633929, 35633930, 35633931, 35633932, 35633933, 35633934, 35633936, 35633939, 35633941, 35633951, 35633873, 35633875, 35633879, 35239079, 35324250, 35293981, 35294010, 35294158, 35294173, 35318765, 35637690, 35651589, 35651590, 35273785, 35328478, 35657802, 35669708, 35508837, 35664049, 35497108, 35508812, 35508817, 35508819, 35508836, 35708524, 35328467, 35521760, 35521761, 35239080, 35239085, 35267309, 35721120, 35273786, 35273788, 35326314, 35325520, 35740743, 35810724, 35810725, 35810726, 35810727, 35810728, 35810729, 35810730, 35810731, 35810732, 35810733, 35744811, 35813408, 35813404, 35905347, 35911976, 35911977, 35911978, 35911979, 35911980, 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35983499, 35983500, 35983502, 35983503, 35983504, 35983505, 35983506, 35983507, 35983508, 35983509, 35983510, 35983201, 35983202, 35983203, 35934187, 35934188, 35934189, 35934190, 35934191, 35984510, 35292353, 35398593, 35508815, 35508831, 35926986, 35984533, 35223119, 35223120, 35223123, 35223131, 35242354, 35242355, 35242356, 35242358, 35242359, 35242360, 35242361, 35242326, 35242327, 35242328, 35242329, 35242340, 35242341, 35242342, 35242343, 35242344, 35242353, 35245748, 35223125, 35267304, 35267305, 35267306, 35267308, 35267289, 35267290, 35267291, 35267292, 35267293, 35267294, 35267295, 35267297, 35267298, 35267299, 35267300, 35267302, 35267303, 35301231, 35301234, 35301791, 35301792, 35301795, 35301798, 35301801, 35301804, 35303869, 35318736, 35318737, 35318730, 35318731, 35293988, 35308660, 35308663, 35308664, 35308665, 35318754, 35318758, 35318759, 35318761, 35318763, 35318739, 35318740, 35318742, 35318745, 35318748, 35318749, 35318750, 35318751, 35318767, 35372692, 35369648, 35390603, 35402294, 35427344, 35412742, 35438423, 35438424, 35484646, 35521780, 35521755, 35521758, 35521759, 35559406, 35559408, 35559409, 35559410, 35559411, 35559412, 35559413, 35559417, 35559418, 35560673, 35560674, 35550677, 35526932, 35526934, 35526937, 35563024, 35563025, 35563330, 35550681, 35550683, 35550685, 35560593, 35563620, 35567493, 35561508, 35561524, 35572910, 35563672, 35572996, 35572988, 35572989, 35318729, 35324244, 35324245, 35590362, 35294008, 35294009, 35586912, 35573451, 35628260, 35293783, 35293787, 35293812, 35318727, 35328473, 35328475, 35632962, 35632963, 35632964, 35632965, 35632966, 35611861, 35611862, 35611863, 35611864, 35611865, 35611866, 35611867, 35611868, 35611869, 35611870, 35664105, 35664111, 35667357, 35664406, 35664419, 35664899, 35665555, 35665558, 35665562, 35508827, 35508828, 35508833, 35508835, 35508840, 35508844, 35509589, 35685323, 35239086, 35326341, 35497107, 35508814, 35508818, 35508820, 35508821, 35508825, 35508829, 35508834, 35508838, 35508839, 35508841, 35508842, 35509590, 35239081, 35239083, 35239087, 35736269, 35736339, 35736340, 35814784, 35896890, 35735644, 35894004, 35926670, 35927324, 35940426, 35953462, 35976973, 35976974, 35976975, 35976976, 35976977, 35976978, 35976979, 35976980, 35976981, 35976982, 35976983, 35976984, 35976985, 35976986, 35976987, 35983205, 35983206, 35983207, 35983208, 35983209, 35983210, 35983211, 35983212, 35983191, 35983192, 35971160, 35977158, and 35971177
RECALLING FIRM/MANUFACTURER
Physio Control, Inc., Redmond, WA, by letter on February 27, 2008. Firm initiated recall is ongoing.
REASON
Potential for the display screen to dim and eventually go blank. The risk to patient is a delay in defibrillation therapy if the defibrillator was needed in a cardiac arrest situation. Death or permanent impairment can occur if the user fails to deliver a defibrillation shock or defibrillation is delayed.
VOLUME OF PRODUCT IN COMMERCE
1,647 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
ArthroCare brand Topaz XL ArthroWand with Integrated Cable Wand, Catalog Number: AC4045-01; Sterile Surgical Device. Product is indicated for ablation and debridement of tendons in orthopedic procedures, Recall # Z-1657-2008
CODE
Lot Numbers: A603250-A, A609450-A, A610250-A, A615750-A, A616850-A, A627860-A, A627860-B, A604670-A, A615870-A, A620170-A, A623270-A, and A634670-A
RECALLING FIRM/MANUFACTURER
ArthroCare Corporation, Sunnyvale, CA, by letters dated January 31, 2008. Firm initiated recall is ongoing.
REASON
Devices for which sterility may be compromised as evidenced by punctures in the plastic tray during shipping. The risk to the patient is a potential infection subsequent to the surgical procedure.
VOLUME OF PRODUCT IN COMMERCE
2,129 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder glenoid surface for implanting a Hybrid Glenoid component. This instrument is intended to function by drilling a hole into the natural glenoid surface allowing the center boss of glenoid implant to sit within the hole, and the non-articulating surface of the glenoid implant to rest flush onto the natural glenoid surface, Recall # Z-1658-2008
CODE
Lots 44550, 110100, 171760, 211530, 211550, 767940, 820310, 820330, 827250, 853810, 866590, 919780, 919790, 919800, 968270, 980230 and 980250
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letters dated March 13, 2008. Firm initiated recall is ongoing.
REASON
The glenoid implant may not seat fully on the face of the natural glenoid due to inadequate measurement tolerances (tolerance stack-up) in the design of the cutter. Use of the instrument may lead to incomplete seating of the glenoid implant, elevating the theoretical risk of glenoid loosening, which may lead to early revision surgery. The problem may contribute to early device failure and patient injury because the stack-up tolerances could result in inadequate removal of bone from the natural glenoid surface. Long range health consequences may include: premature breakdown of cement mantle, excessive fatigue loading, the potential for early device failure and patient injury.
VOLUME OF PRODUCT IN COMMERCE
189 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) LS-232 Large 12 LeadWear Single Pack - Disposable ECG Monitoring component
intended for use as a radiofrequency signal transmitter and receiver of
electrocardiograph physiological signals which are displayed on the ECG monitors
of various manufacturers' systems that have been validated for compatibility,
Recall # Z-1659-2008;
b) LS-202 Large LeadWear Combo Pack - Disposable ECG Monitoring component
intended for use as a radiofrequency signal transmitter and receiver of
electrocardiograph physiological signals which are displayed on the ECG monitors
of various manufacturers' systems that have been validated for compatibility,
Recall # Z-1660-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
GMP Companies/Lifesync Corp., Ft Lauderdale, FL, by letter on December 14, 2007. Firm initiated recall is ongoing.
REASON
LifeSync Wireless ECG System - Intermittent failure when using LS-202 and LS-203 LeadWear in conjunction with LS-41245 and LS-41285 Adaptors. The out of box failure manifests as a V-Lead failure, leading to a possible delay in treatment based upon a delay in ECG monitoring.
VOLUME OF PRODUCT IN COMMERCE
1,344 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individual components secured within a foam insert. Catalog Number # 720-800. Laboratory In-Vitro Diagnostic Assay intended for the semi-quantitative detection of IgG antibodies to Gliadin in human serum by indirect enzyme immunoassay as an aid in the diagnosis of celiac disease, Recall # Z-1684-2008
CODE
Lot # S0207, Expiration Date: Nov. 30, 2008.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diamedix Corporation, Miami, FL, by letter on December 14, 2007.
Manufacturer: D-Tek Sa, Mons, Belgium. Firm initiated recall is ongoing.
REASON
Standards and controls in the Is-anti-Gliadin IgG Test Kits are exhibiting low activity. A drop in the O.D.s the Positive Control could potentially recover low out of range (which would invalidate the test), or false positive test results could be obtained.
VOLUME OF PRODUCT IN COMMERCE
174 Test Kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Electrode Adaptor Cable Quick-Combo System, Model 9055. The 9055 Electrode Adaptor is intended for use by trained personnel who use a Cardiac Science Automated External Defibrillator (AED) for defibrillation with Medtronic QUICK-COMBO Electrodes, Recall # Z-1714-2008
CODE
Lot numbers: 123004, 92804, 62305, 63005, 52504, 50405, 33105, 12605, 12505, 7715, 6952, 6838
RECALLING FIRM/MANUFACTURER
Cardiac Science Corporation, Bothell, WA, by letter on January 23, 2008. Firm initiated recall is complete.
REASON
Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is used.
VOLUME OF PRODUCT IN COMMERCE
63 units
DISTRIBUTION
Nationwide, Canada, Norway, Guam
___________________________________
PRODUCT
Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable Anchor, size 2 (5 metric) Braided Composite Suture, violet 36" (91cm) Size 2 (5metric) eyelet loop. Made in Switzerland; Sterile. The Lupine BR Anchor System is indicated for use in soft tissue bone fixation. Catalog Number 210711, Recall # Z-1810-2008
CODE
Lot Number 3069512
RECALLING FIRM/MANUFACTURER
Recalling Firm: DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA, by letter dated April 29, 2008.
Manufacturer: Ethicon SARL, Neuchatel, Switzerland. Firm initiated recall is complete.
REASON
Lupine BR Anchor w/Orthocord was assembled with an incorrect suture configuration. The suture loop was not assembled at the distal end of the anchor. It was only threaded through the suture hole in the anchor. Risk associated with incorrect suture configuration include premature breakage.
VOLUME OF PRODUCT IN COMMERCE
105 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Intuitive Surgical DA Vinci Surgical System, Mode; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02. The IS2000 CPG is used during cardiac ablation procedures, Recall # Z-1811-2008
CODE
Lot Number: 802011
RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc., Sunnyvale, CA, by letter on April 18, 2008. Firm initiated recall is complete.
REASON
The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize the Instrument which makes the IS2000 CPG instrument nonfunctional at all sites. Risks associated are loss of operability of the instrument, delay in surgery, and loss of dexterity.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Depuy LCS Knee - Orthopedic knee implant. Meniscal bearing insert, Sz: STD, mm thick 12 5, sterile; Depuy Orthopaedics, Inc., Warsaw, IN; REF 1178-21-025). Product is a prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing intended to to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis. It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses, Z-1812-2008
CODE
Lot: B2LE31000
RECALLING FIRM/MANUFACTURER
Depuy Orthopedics, Inc., Warsaw, IN, by letter on May 6, 2008. Firm initiated recall is complete.
REASON
Labeling Discrepancy -- Mislabeled and mis-etched as to size. Inserts were labeled and packaged as size Standard, 12.5mm Inserts but were actually a 10mm Inserts. Risks include but not limited to: a delay in the procedure while the proper component is located, and tight joint with constricted movement as a result of implantation of the wrong thickness of insert.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model number 020700 (axum/standard treatment couch) and 021756 hand controller. The device is indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated, Recall # Z-1862-2008
CODE
All models
RECALLING FIRM/MANUFACTURER
Accuray, Inc., Sunnyvale, CA, by customer advisory notice. Firm initiated recall is complete.
REASON
Couch may move unexpectedly, which may result in patient impacting the linear accelerator.
VOLUME OF PRODUCT IN COMMERCE
105 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument, non-sterile. This device is a surgical instrument used during knee arthroplasty procedures to snap or lock the polyethylene bearing surface into the retaining rail on a metal tibial plate, Recall # Z-1863-2008
CODE
Lots 60577285, 60582624, 60587308, 60603255 and 60610860
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by letter on May 16, 2008. Firm initiated recall is ongoing.
REASON
The instrument is prone to fracture during use.
VOLUME OF PRODUCT IN COMMERCE
500 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Triathlon Femoral Sizer - The Femoral sizer was developed for use with the Triathlon Total Knee Instrumentation system. It interfaces with the Modular Handled and the Femoral Stylus to facilitate sizing for a femoral component, and preparing holes to accept the corresponding 4:1 Cutting Guide. The femoral sizer is designed to prepare the femoral cuts in 3 degrees of external rotation by referencing against the posterior condyles. The Femoral sizer is set by locking it into the left or right orientation based on the femur. Catalog Number: 6541-1-603, Recall # Z-1864-2008
CODE
All lots (except lot codes NMZC01, NMYV01, NMYW03)
RECALLING FIRM/MANUFACTURER
Styker Howmedica Osteonics Corporation, Mahwah, NJ, by letters on May 27, 2005. Firm initiated recall is complete.
REASON
When attempting to position the Triathlon Femoral Sizer, the pre-setting may slip from L (left knee) to R (right knee) and vice verse intra-operatively.
VOLUME OF PRODUCT IN COMMERCE
560 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Short Barrel Sideplate, Omega + 140 degrees, 4 slots; The Omega Plus Compression Screw system consists of a series of lag screws, proximal hip side plates, supracondylar side plates, and compression screw designed to be used in the temporary stabilization of fractures of the proximal femur (intracapsular or intertrochanteric) and/or distal third of the femur (supracondylar area. These components are now made available in sterile packaging. Catalog Number: 3362-0-404, Recall # Z-1865-2008
CODE
Lot code: E00985
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp. Mahwah, NJ, by letter on January 25, 2005.
Manufacturer: Stryker Trauma AG, Selzach, Switzerland. Firm initiated recall is complete.
REASON
The packaging labeled as catalog number 3362-0-040; lot code E00985, 140 x 4 slot may contain a 5 hole slot.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Stryker Ureteral Kit, Model number 220-180-516, The ureteral kit is a ureteral
transillumination device with reusable illumination source and a fiberoptic light
ureteral catheter kit which is provided sterile for single use disposable application.
The device is intended to be used to transilluminate the ureter during laparoscopic
and open surgical procedures of the lower abdomen or pelvic areas to help the
surgeon identify the ureter, Recall # Z-1866-2008;
b) Stryker Ureteral Universal Kit, Model number 220-180-517, The ureteral kit is a
ureteral transillumination device with reusable illumination source and a fiberoptic
light ureteral catheter kit which is provided sterile for single use disposable
application. The device is intended to be used to transilluminate the ureter during
laparoscopic and open surgical procedures of the lower abdomen or pelvic areas to
help the surgeon identify the ureter, Recall # Z-1867-2008
CODE
a) Lot numbers 4023, 4105, 4158, 4360, 4524, 4585, 4740, 4862, 4880, 5070,
5211, 5328;
b) Lot numbers: 4025, 4169, 4362, 4647, 4711, 5196, 5461
RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA, by telephone and letters on May 9, 2009. Firm initiated recall is ongoing.
REASON
Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery.
VOLUME OF PRODUCT IN COMMERCE
322 kits
DISTRIBUTION
Nationwide, Australia, Canada, Scandinavia, Italy, Switzerland
___________________________________
PRODUCT
ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural. The ON-Q Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic only pain management. Recall # Z-1869-2008
CODE
Lot Number: 772166
RECALLING FIRM/MANUFACTURER
I-Flow Corporation, Lake Forest, CA, by letters on February 12, 2008. Firm initiated recall is ongoing.
REASON
The ON-Q PainBuster, REF PS6504 (lot number 772166), box may contain the wrong product, ON-Q PainBuster, REF PS6502. If the wrong product is used, patients would receive a 2 ml/hr infusion rather than a 5 ml/hr infusion, which could result in inadequate pain relief.
VOLUME OF PRODUCT IN COMMERCE
345 units
DISTRIBUTION
Internationally
___________________________________
PRODUCT
Medacta AMIS Universal Table for Leg Positioner, Model Number: 01.15.10.0172. The AMIS universal table for leg positioner and AMIS Leg Positioner are used during Anterior Minimally Invasive Surgery for hip arthroplasty. The system aids the surgical procedure by providing support and alignment of the limb, Recall # Z-1870-2008
CODE
All product of Model Number 01.15.10.0172
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medacta Usa Inc., Camarillo, CA, by letter on May 27, 2008.
Manufacturer: Medacta International SA, Strada Regina, Switzerland. Firm initiated recall is ongoing.
REASON
Medacta is issuing this Recall because improper connection of the table clamping mechanism may result in the AMIS table becoming separated from the surgical table resulting in injury to the patient.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105, 915-2832 and CP-1323. The system is used in trauma and reconstructive surgical procedures in the mid face and craniofacial skeleton. Used to support non-load bearing tissues of cranial maxillofacial anatomy, including but not limited to brow fixation, Recall # Z-1872-2008
CODE
Lot numbers: 898240, 898330, 898250, 898350, 898320, 951140, 868920, 978810
RECALLING FIRM/MANUFACTURER
Biomet Microfixation, Inc., Jacksonville, FL, by letters on March 19, 2008. Firm initiated recall is ongoing.
REASON
The outer foil pouch on the Lactosorb Plate system was not properly sealed. The product is labeled as sterile, but the lot was not sterilized. These devices are intended to be implanted into bone and are required to be sterile. A heavy bioburden would increase the potential for bone infection (osteomyelitis).
VOLUME OF PRODUCT IN COMMERCE
117 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed
by visual color comparison used for the detection of drugs of abuse. Sun Biomedical
Part Numbers: 15-2016; Recall # Z-1873-2008;
b) VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro
immunoassay test completed by visual color comparison used for the detection of
drugs of abuse. Sun Biomedical Part #: 15-2017, Recall # Z-1874-2008;
c) VisuaLine Tricyclic Antidepressants: Six Dip (COC-THC-OPI-MET-BZD-OXD);
Six Dip (COC-THC-OPI-MET-PCP-OXD); Eight DIP (COC-THC-OPI-MET-AMP-
BAR-BZD-OXD); Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA);
Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA); Ten Dip
(COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD); Ten Dip (COC-THC-
OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD); Five Dip (COC-THC-OPI-BZD-
OXD); and Six Dip (CPC-THC-OPI-MET-AMP-OXD). Sun Biomedical Part
15-2043; Part 15-2046; Part 15-2065; Part 15-2072; Part 15-2080; Part 15-2083;
Part 15-2085; Part 15-2095; and Part 15-2101. Product is intended for in vitro
immunoassay test completed by visual color comparison used for the detection
of drugs of abuse, Recall # Z-1875-2008
CODE
a) Lot number Vis-OXD-dip 07-018-1-275 or Vis OXD-Dip 07-081-257;
b) lot number: Vis-PPX Dip 07-094-1-85;
c) Lot Vis-6SP-Dip 08-021-1; Lot Vis-6SP-Dip 07-270-1; Lot Vis-8SP-Dip-07-207-2;
Lot Vis-9SP-Dip-07-106-1; Lot Vis-10 Dip 06-204-2, Vis-10 Dip 07-002-2,
Vis-10-Dip-07-231-1; Part 15-2083, lot Vis-10SP-Dip-07-311-1; Vis-10SP-Dip 07-
324-1, VIS 10SP-Dip-08-045-3; Lot Vis 10SP Dip-07-201-1, Vis-10SP-Dip 07-
263-1; Lot Vis 5SP-Dip 07-284-2; Vis 5SP-Dip -8-008-01; Lot Vis-6SP Dip-07-326-1
RECALLING FIRM/MANUFACTURER
Sun Biomedical Laboratories, Inc., Blackwood, NJ, by letters on May 29, 2008. Firm initiated recall is ongoing.
REASON
Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.
VOLUME OF PRODUCT IN COMMERCE
1,137 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
PANTA Nails, 10mm x 150 length. The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and the treatment of trauma to the hindfoot and distal tibia. The nail affords rigid, load sharing fixation that incorporates a simple nail-mounted, in-line method of compression across the arthrodesis site. Catalog number 500050ND, Recall # Z-1877-2008
CODE
Lot: E7XX
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letters on March 24, 2008.
Manufacturer: NewDeal SA, Lyon, France. Firm initiated recall is complete.
REASON
Certain PANTA Nails from one lot were incorrectly manufactured. The internal thread for certain PANTA Nails may present an insufficient depth and may not allow the engagement of the threaded part of the compression device. The risks presented include: an increase in surgery time, or the implantation of a nail less ideally suited for the patient's anatomy if no other 10 mm nail is available.
VOLUME OF PRODUCT IN COMMERCE
45 nails
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Biomet OSS Interlok IM Stem w/Screw, straight collar, 11 mm x 225 mm, TI6AL4V
alloy, sterile; REF 150490. Orthopedic implant intended as part of a replacement knee
joint, Recall # Z-1879-2008;
b) Biomet OSS Interlok IM Stem w/Screw, straight collar, 13 mm x 225 mm, TI6AL4V
alloy, sterile; REF 150491. Orthopedic implant intended as part of a replacement knee
joint, Recall # Z-1880-2008;
c) Biomet OSS Interlok IM Stem w/Screw, straight collar, 15 mm x 225 mm, TI6AL4V
alloy, sterile; REF 150492. Orthopedic implant intended as part of a replacement knee
joint, Recall # Z-1881-2008
CODE
a) Lots 564030 and 217680;
b) Lots 354050, 138040 and 067490;
c) Lots 354060 and 138050
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter on May 15, 2008. Firm initiated recall is ongoing.
REASON
Mislabeled--The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package contents.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Philips Gallileo Automatic Collimator, Part Numbers: 9896 010 00612, 9896 010 00614, 9896 010 00615. The device is a diagnostic x-ray beam-limiting device intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam, Recall # Z-1886-2008
CODE
Site numbers: 6544, 10029, 10033, 10417, 10419, 10434, 10461, 10481, 10498, 10499, 13012, 13028, 13032, 13034, 13122, 13125, 13131, 13146, 13198, 13216, 13224, 13225, 13243, 13244, 13246, 13247, 13248, 13249, 13250, 13251, 13252, 13254, 13256, 13278, 13279, 13285, 13295, 13295, 13912, 14078, 14081, 14176, 26155, 38193, 38194, 38197, 38281, 38299, 38319, 38350, 38354, 38367, 38446, 38609, 38633, 38667, 38684, 38747, 38875, 38959, 38960, 38989, 40934, 40934, 41237, 41353, 41408, 41464, 41469, 41471, 41472, 41473, 45034, 50386, 50448, 52452, 52453, 52454, 52457, 52458, 52458, 52474, 76579, 76586, 76829, 76891, 76894, 76905, 76906, 76907, 76907, 76908, 76909, 76920, 76921, 76922, 76926, 76943, 76949, 76969, 76970, 76976, 76981, 76991, 76998, 80316, 80333, 82557, 82560, 82568, 82569, 82614, 82632, 82647, 82648, 82654, 82681, 82686, 82705, 82718, 82724, 82725, 82806, 82808, 82828, 82832, 82833, 82833, 82835, 82919, 82919, 82938, 82941, 82944, 83008, 83009, 83010, 83011, 83012, 83029, 83043, 83072, 83331, 83332, 83338, 83341, 83390, 83391, 83603, 83604, 83619, 83652, 83653, 83800, 83801, 83866, 83900, 83908, 83942, 83948, 83960, 83998, 84419, 84439, 84440, 84453, 84454, 84455, 84457, 84458, 84488, 84497, 84701, 84705, 84723, 84731, 84817, 84818, 84846, 84847, 84848, 84849, 84862, 84863, 84891, 84929, 84932, 84937, 84943, 84972, 85009, 85036, 85053, 85063, 85066, 85069, 85103, 85115, 85118, 85151, 85152, 85162, 85181, 85439, 85461, 85463, 85465, 85466, 85468, 85495, 85627, 85628, 85696, 85697, 85698, 85699, 85860, 86014, 86072, 86073, 86075, 86117, 86119, 86120, 86123, 86210, 86211, 86212, 86219, 86220, 86222, 86225, 86227, 86230, 86266, 86267, 86268, 86270, 86279, 86300, 86301, 86302, 86304, 86306, 86307, 86308, 86310, 86311, 86314, 86325, 86336, 86337, 86338, 86357, 86382, 86383, 86385, 86388, 86402, 86451, 86455, 86472, 86493, 86493, 86507, 86550, 86602, 86605, 86614, 86621, 86622, 86625, 86902, 86904, 86919, 86920, 86921, 86943, 86951, 86963, 86973, 86974, 87003, 87014, 87027, 87028, 87032, 87039, 87048, 87049, 87057, 87071, 87082, 87141, 87144, 87301, 87303, 87321, 87338, 87602, 87606, 87608, 100039, 100094, 100203, 100244, 100245, 100428, 100433, 100437, 100439, 100441, 100454, 100455, 100490, 100544, 100547, 100569, 100571, 100572, 100573, 100584, 100591, 100602, 100616, 100617, 100619, 100642, 100659, 100678, 100772, 100773, 100782, 100807, 100824, 100827, 100868, 100885, 100891, 101081, 101213, 101218, 101308, 101405, 102496, 104373, 250090, 250100, 250439, 250677, 250678, 557777, 557784, 557786, 557787, 557803, 557833, 557876, 557880, 557885, 557938, 557943, 557990, 558001, 558008, 558014, 558040, 558052, 558060, 558154, 558155, 558156, 558157, 558160, 558163, 558181, 558186, 558207, 558208, 558210, 558284, 558289, 558290, 558291, 558292, 558294, 558295, 558304, 558311, 558312, 558361, X1727, 6983, 10000, 10002, 10006, 10178, 10392, 10393, 10410, 10418, 10435, 10493, 13173, 13178, 13178, 13245, 13257, 13283, 13284, 13293, 13970, 14070, 14169, 14177, 26294, 38195, 38196, 38207, 38268, 38314, 38342, 38361, 38423, 38608, 38610, 38625, 38626, 38634, 38656, 38679, 38689, 38693, 38695, 38712, 38743, 38745, 38963, 40936, 41120, 41121, 41420, 41463, 41468, 50230, 50322, 50427, 50446, 50447, 52450, 59652, 62868, 62950, 62997, 76391, 76578, 76829, 76837, 76925, 76940, 76957, 76958, 76959, 76960, 76967, 76973, 80318, 80339, 82503, 82515, 82516, 82561, 82571, 82613, 82630, 82646, 82656, 82674, 82675, 82712, 82720, 82722, 82726, 82728, 82805, 82809, 82831, 82834, 82920, 82942, 82949, 82954, 83001, 83007, 83031, 83074, 83083, 83308, 83319, 83369, 83370, 83648, 83651, 83698, 83909, 83936, 83943, 83944, 83947, 84420, 84434, 84461, 84703, 84851, 84857, 84858, 84893, 84931, 84938, 84939, 84963, 84964, 85029, 85030, 85037, 85109, 85117, 85147, 85148, 85149, 85166, 85167, 85168, 85184, 85402, 85403, 85405, 85437, 85438, 85462, 85467, 85484, 85486, 85492, 85493, 85494, 85683, 86015, 86070, 86071, 86078, 86213, 86216, 86221, 86221, 86226, 86228, 86232, 86309, 86344, 86358, 86359, 86384, 86386, 86389, 86394, 86395, 86397, 86400, 86543, 86579, 86601, 86606, 86607, 86611, 86613, 86618, 86619, 86623, 86901, 86938, 86939, 86942, 86964, 86976, 86979, 86980, 86990, 87005, 87016, 87017, 87031, 87045, 87050, 87051, 87079, 87136, 87137, 87138, 87142, 87169, 87175, 87178, 87196, 87320, 87333, 87363, 87609, 100426, 100438, 100443, 100457, 100481, 100489, 100494, 100549, 100555, 100556, 100557, 100604, 100605, 100614, 100615, 100618, 100770, 100780, 100825, 100834, 100835, 100848, 100855, 100867, 101076, 101079, 101080, 101132, 101240, 101563, 102081, 102335, 102337, 102338, 102339, 102340, 102341, 102342, 102344, 102376, 102385, 102388, 102609, 250043, 250092, 250313, 250679, 505640, 557789, 557792, 557794, 557812, 557883, 557935, 557940, 557988, 557991, 558009, 558010, 558013, 558017, 558018, 558019, 558024, 558025, 558026, 558030, 558063, 558064, 558158, 558174, 558184, 558190, 558195, 558205, 558224, 558226, 558285, 558293, 558302, 558308, 558310, 558366, 558370, 20278751, 82730, 83073, 10405, 13253, 38975, 76831, 82617, 82657, 83956, 84712, 86223, 86451, 100322, 100633, 100633, 104199
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, North America Co. Phillips, Bothell, WA, by letter on February 7, 2008.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
The collimator could fall from the x-ray stand, due to loosening screws, and strike a patient or operator underneath.
VOLUME OF PRODUCT IN COMMERCE
709 devices
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) M-Style® Mushroom Cup® Vacuum Assisted Delivery System used with hand
pump (Ref: 10007LP). Product is intended to assist a clinician in the delivery of an
infant during childbirth. Indicated for use during vaginal delivery and Cesarean
sections. Recall # Z-1887-2008;
b) M-Style® Cup with Universal Vacuum Release (UVR) used with wall suction,
Vacuum Assisted Delivery System (Ref: 10015LP). Product is intended to assist
a clinician in the delivery of an infant during childbirth. Indicated for use during
vaginal delivery and Cesarean sections. Recall # Z-1888-2008;
c) Mystic® II M-Style® Mushroom Cup Vacuum Assisted Delivery System (Ref:
10057). Product is intended to assist a clinician in the delivery of an infant during
childbirth. Indicated for use during vaginal delivery and Cesarean sections.
Recall # Z-1889-2008
CODE
a) 57860, 57861, 57864, 57866, 57868, 57870, 57872, 57873, 57874, 58113, 60728,
60729, 60730, and 60742;
b) 57816, 57817, 57852, 57853, 57854, 57855, 57856 57857, 57858, 57859, 58114,
60756, and 60757;
c) 57735, 57760, 57761, 57768, 57908, 57909, 57910, 57911, 57912, 57913, 57918,
57919, 57922, 57924, 57925, 58299, and 60815
RECALLING FIRM/MANUFACTURER
Cooper Surgical, Inc., Trumbull, CT, by letter on January 16, 2008. Firm initiated recall is ongoing.
REASON
Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/or c-section for delivery. An inability to remove the cup from the head may delay delivery and/or prevent the user from applying forceps if necessary. This may result in serious injury or death to the baby.
VOLUME OF PRODUCT IN COMMERCE
35,527 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
GE 1.5T and 3.0T Signa HDx MR System. The product is used as a diagnostic
imaging device to produce axial sagittal, coronal and oblique images, spectroscopic
images, and/or spectra, dynamic images of the internal structures and organs of the
body; 1) Model 5127452; 2) Model 2377062-61; 3) Model 2395001-2,
Recall # Z-1890-2008;
b) GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System. The product
is used as a diagnostic imaging device to produce axial sagittal, coronal and oblique
images, spectroscopic images, and/or spectra, dynamic images of the internal
structures and organs of the body. 1) Model: 5107849; 2) Model: 5107849-2; 3)
Model: M3000PT; 4) Model: M3000PW, Recall # Z-1891-2008
CODE
a) 1) 00000HDMR20228 00000276057MR7 00000275160MR0 000000HDMR2544 00000HDMR10417 00000HDMR10094 00000274383MR9 00000273832MR6 00000274385MR4 00000276073MR4 00000274359MR9 00000HDMR10273 00000273119MR8 00000DDDM10670 00000HDMR20073 00000HDMR10739 000000HDMR2451 000000HDMR2335 00000HDMR20189 000000HDMR1004 00000HDMR10489 00000HDMR10291 00000HDMR20151 00000HDMR20061 00000HDMR10743 000000HDMR2528 000000HDMR2976 00000HDMR20044 000000HDMR2773 00000HDMR20294 00000HDMR20059 00000HDMR10418 00000HDMR10831 00000HDMR20036 and 00000HDMR20056;
2) 00000008376YR6 00000007126YR6 00000007551YR5 00000007555YR6 00000006690YR2 00000007518YR4 00000008525YR8 00000005222YR5 00000007134YR0 00000008354YR3 00000005989YR9 00000007107YR6 00000008100YR0 00000007594YR5 00000006710YR8 00000008103YR4 00000007092YR0 00000007503YR6 00000007574YR7 00000006754YR6 00000007542YR4 00000008116YR6 00000008522YR5 00000006685YR2 00000007105YR0 00000008564YR7 00000005974YR1 00000005545YR9 00000006705YR8 00000006600YR1 00000007585YR3 00000005532YR7 00000008549YR8 00000007533YR3 00000007498YR9 00000005231YR6 00000006583YR9 00000005216YR7 00000007554YR9 00000009031YR6 00000006708YR2 00000007117YR5 00000007864YR2 00000007866YR7 00000007514YR3 00000008342YR8 00000005546YR7 00000007892YR3 00000007865YR9 00000006556YR5 00000006660YR5 00000007862YR6 00000009421YR9 00000007556YR4 00000008378YR2 00000008539YR9 00000006656YR3 00000005536YR8 00000008115YR8 00000008335YR2 00000052299YR0 00000006727YR2 00000006726YR4 and 00000007572YR1;
3) 00000280673MR5 00000278397MR5 00000277211MR9 00000276434MR8 00000275968MR6 00000278549MR1 00000280781MR6 00000276265MR6 00000275046MR1 00000283745MR8 00000284233MR4 00000275648MR4 00000280000MR1 00000279068MR1 00000275967MR8 00000274744MR2 00000276266MR4 00000280001MR9 00000278851MR1 00000275647MR6 00000281340MR0 00000275465MR3 and 00000282549MR5;
b) 1) 00000262460MR9 00000270245MR4 00000260692MR9 00000269581MR5 00000268123MR7 00000277574MR0 00000267973MR6 00000280302MR1 00000262803MR0 00000270974MR9 00000273229MR5 00000277190MR5 00000277189MR7 00000279752MR0 00000261198MR6 00000272433MR4 00000269437MR0 00000265177MR6 00000264407MR8 00000265173MR5 00000274998MR4 00000268011MR4 00000270383MR3 00000262459MR1 00000269326MR5 00000261064MR0 00000271248MR7 00000263970MR6 00000276409MR0 00000274835MR8 00000278722MR4 00000271120MR8 00000262456MR7 00000273459MR8 00000266821MR8 00000266071MR0 00000276491MR8 00000266066MR0 00000265061MR2 00000266754MR1 00000271234MR7 00000266343MR3 00000273365MR7 00000262299MR1 00000263879MR9 00000262793MR3 00000273341MR8 00000266822MR6 00000269340MR6 00000273230MR3 00000262800MR6 00000261678MR7 00000271246MR1 00000280388MR0 00000261205MR9 00000262666MR1 00000262673MR7 00000260480MR9 00000276591MR5 00000279460MR0 00000272533MR1 00000263974MR8 00000262667MR9 00000261066MR5 00000271124MR0 00000277955MR1 2333 00000272072MR0 00000261069MR9 00000264087MR6 00000267322MR6 00000274839MR0 00000265005MR9 00000275642MR7 00000270466MR6 00000275086MR7 00000261061MR6 00000275845MR6 00000272076MR1 00000269435MR4 00000270387MR4 00000268518MR8 00000268477MR7 00000268515MR4 00000269575MR7 00000272968MR9 00000270026MR8 00000272969MR7 00000272070MR4 00000268692MR1 00000271662MR9 00000268417MR3 00000270467MR4 00000272536MR4 00000273529MR8 00000279146MR5 00000275668MR2 and 00000260651MR5;
2) 00000279077MR2 00000282686MR5 00000283386MR1 00000283076MR8 00000279423MR8 00000278623MR4 00000278626MR7 00000279921MR1 00000276633MR5 00000273541MR3 00000274170MR0 00000274930MR7 00000281703MR9 00000281443MR2 00000281019MR0 00000275936MR3 00000279713MR2 00000273267MR5 and 00000273266MR7;
3) 00000266842MR4 00000266160MR1 00000271322MR0 00000275009MR9 00000268302MR7 00000263655MR3 00000264783MR2 00000266194MR0 00000267528MR8 00000026005MR8 00000266156MR9 00000265852MR4 00000267533MR8 000267533MR8ZZ 00000265968MR8 00000267529MR6 00000267527MR0 00000266690MR7 00000264643MR8 00000267618MR7 00000268837MR2 00000270528MR3 00000270097MR9 00000268301MR9 00000269332MR3 and 00000267860MR5;
4) 00000266270MR8 00000250462MR9 and 00000263921MR9
RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI, by letter dated September 14, 2007. Firm initiated recall is ongoing.
REASON
GE healthcare has become aware of an artifact which could affect the diagnostic capability associated with the 3.0T Propeller T2 Flair application of the 3.0T Signa HDx scanner.
VOLUME OF PRODUCT IN COMMERCE
269 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
EKOS EndoWave Infusion System consisting of a Drug Delivery Catheter and an Ultrasound Core. Labeled as Sterile, Single Use Only. The device is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, Recall # Z-1892-2008
CODE
071126006-001, 071126006-002, 071126006-003, 071126006-005, 071204008-001, 071128015-001, 071128015-002, 071128015-003, 071128015-004, 071128015-005, Item number 500-52106, expiration date 2009-10
RECALLING FIRM/MANUFACTURER
EKOS Corp., Bothell, WA, by telephone and letters on February 20, 2008. Firm initiated recall is complete.
REASON
Product mislabeled - 6 cm treatment zone catheter had been built using 50 cm treatment zone drilled tubing. Consequently, drug was delivered outside of the treatment zone.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
WA, NC, IL, OH, NY, MI, KY
___________________________________
PRODUCT
a) Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-KS,
(Distributed in the U.S.). 5 Fr. (110 cm) Pacing Catheter, 6 Fr. Introducer Sheath,
.035 inch diameter spring-wire guide, Single use. The device is indicated for use in
sampling blood for oxygen levels and measuring pressure in the right heart,
Recall # Z-1907-2008;
b) Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-IK,
(Distributed in Canada, Croatia, Dominican Republic, Honduras, New Zealand,
Russia, South Africa and Venezuela). For Export Only, 5 Fr. (110 cm) Pacing
Catheter, 6 Fr. Introducer Sheath, .035 inch diameter spring-wire guide, Single use,
Sterilized. The device is indicated for use in sampling blood for oxygen levels and
measuring pressure in the right heart, Recall # Z-1908-2008
CODE
a) Lot # RF8015919;
b) Lot # RF8015920
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International Inc., Asheboro, NC, by letter on/about April 11, 2008.
Manufacturer: Arrow International Inc, Reading, PA. Firm initiated recall is ongoing.
REASON
The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly.
VOLUME OF PRODUCT IN COMMERCE
686 kits
DISTRIBUTION
Nationwide, South Africa, Venezuela
___________________________________
PRODUCT
a) CMS-MST572 5F insertion kit with 5 cm tear away. The product is shipped 10 kits
per box and is intended for use in percutaneous procedures to introduce and position
catheters, pacing leads and other interventional devices within the coronary and
peripheral vasculature, Recall # Z-1909-2008;
b) USCT5D, Pro-PICC CT 5F x 55 cm Dual Lumen. infusion catheter insertion kit.
The product is shipped 5 units per box and is indicated for short and long term access
to the central venous system, Recall # Z-1910-2008
CODE
a) Lot #: MAPA870;
b) Lot #: MAPA880
RECALLING FIRM/MANUFACTURER
Medical Components, Inc. dba MedComp, Harleysville, PA, by letters on April 11, 2008. Firm initiated recall is ongoing.
REASON
Kit contains incorrect component.
VOLUME OF PRODUCT IN COMMERCE
350 units
DISTRIBUTION
PA, TX
___________________________________
PRODUCT
Phillips Medical Systems, SureSigns VS3 Vital Signs Monitor model numbers 863071, 863072, 863073, 863074. All four model numbers have the same user manual. The device is intended for monitoring, recording and alarming of multiple physiological parameters, Recall # Z-1911-2008
CODE
Model #’s only
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by the Field Safety Notice. Firm initiated recall is ongoing.
REASON
Some users of SureSigns VS3 Signs Monitor may have assumed that the SpO2 Non-Pulsatile and SpO2 No Sensor technical alarms were enabled when the SureSigns VS3 Vital Signs Monitor was not in Interval non-invasive blood pressure (NBP) mode. These alarms are only enabled when interval NBP mode is selected. If when monitoring SpO2, the clinician does not notice when the sensor is no longer attached, the patient is not being monitored through Spo2.This could result in delay or lack of needed therapy. The labeling provided with the monitor did not fully describe this feature.
VOLUME OF PRODUCT IN COMMERCE
7,529 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide, Rx Only, Model 3777-75, Recall # Z-1912-2008
CODE
Lot number V030733, Serial numbers V030733017, V030733018, V030733026.
RECALLING FIRM/MANUFACTURER
Medtronic Neuromodulation, Minneapolis, MN, by letter dated March 2008.
Manufacturer: Medtronic Puerto Rico Inc., Villalba Pr, PR. Firm initiated recall is ongoing.
REASON
Product contains accessory stylets that are not the correct length.
VOLUME OF PRODUCT IN COMMERCE
39 distributed (3 subject to recall, 36 already used or returned)
DISTRIBUTION
NC, FL
___________________________________
PRODUCT
AneuRx AAAdvantage stent graft and the Xcelerant Delivery System with Hydro. Product number lLXCH161685. The product is designed to treat infrarenal abdominal aortic or aorto-ilac aneurysms during an endovascular approach, Recall # Z-1918-2008
CODE
Serial numbers: V00092566, V00092567, V00092568, and V00092569
RECALLING FIRM/MANUFACTURER
Medtronic CardioVascular, Santa Rosa, CA, by letter the week of April 28, 2008. Firm initiated recall is complete.
REASON
Products may contain elevated Endotoxin (pyrogen) levels above the firm’s specifications, and the product is labeled as containing no pyrogen.
VOLUME OF PRODUCT IN COMMERCE
4 devices
DISTRIBUTION
NC, VA
___________________________________
PRODUCT
a) Esprit Ventilator, Model V1000 manufactured with Power Supply PN 1015852.
The Esprit Ventilator is a microprocessor controlled, electrically powered,
mechanical ventilator. PN 701-01000, Recall # Z-2002-2008;
b) Esprit Power Supply Snubber Board Assembly FRU, PN 1036236 The Esprit
Ventilator is a microprocessor controlled, electrically powered, mechanical
ventilator. PN 1036236, Recall # Z-2003-2008;
c) Esprit Power Supply Field Replacement Unit (FRU), PN 101 8246 The Esprit
Ventilator is a microprocessor controlled, electrically powered, mechanical
Ventilator. PN 1018246, Recall # Z-2004-2008
CODE
a) Serial Numbers: VS3007041 VS3007181 VS3007263 VS3007672 VS3007895 VS3009980 VS3007527 VS3006533 VS3006642 VS3007000 VS3007167 VS3007175 VS3007477 VS3007485 VS3007486 VS3007540 VS3007546 VS3007564 VS3007611 VS3007613 VS3007773 VS3007851 VS3008688 VS3008878 VS3007806 VS3008988 VS3009084 VS3009074 VS3009124 VS3009545 VS3009605 VS3009665 VS3009872 VS3009895 VS3009897 VS3009918 VS3009922 VS3009940 VS3010330 VS3010325 VS3010361 VS3010379 VS3010601 VS3010612 VS3010652 VS3010656 VS3010662 VS3010668 VS3010678 VS3010684 VS3010696 VS3010688 VS3010744 VS3010800 VS3010815 VS3010826 VS3010832 VS3010867 VS3010872 VS3010873 VS3010895 VS3010942 VS3005888 VS3006538 VS3006545 VS3006556 VS3006560 VS3006525 VS3006581 VS3006585 VS3006654 VS3006668 VS3006694 VS3007057 VS3007005 VS3007126 VS3007127 VS3007134 VS3007132 VS3007151 VS3007152 VS3007010 VS3001228 VS3001229 VS3001311 VS3001324 VS3001344 VS3001348 VS3001406 VS3001411 VS3001690 VS3000577 VS3000585 VS3001227 VS3001274 VS3001280 VS3001297 VS3001304 VS3001321 VS3001234 VS3001375 VS3001744 VS3001861 VS3001164 VS3001277 VS3001327 VS3001400 VS3001854 VS3000910 VS3001218 VS3001399 VS3001385 VS3009867 VS3009019 VS3009706 VS3011031 VS3011076 VS3007814 VS3010170 VS3010426 VS3010509 VS3010916 VS3010919 VS3010928 VS3010682 VS3010869 VS3010874 VS3010885 VS3005886 VS3010693 VS3010824 VS3007757 VS3008853 VS3008945 VS3008989 VS3004976 VS3005856 VS3006199 VS3006203 VS3007530 VS3000955 VS3000998 VS3001015 VS3001283 VS3001674 VS3002006 VS3002033 VS3002034 VS3002082 VS3006562 VS3007049 VS3007639 VS3007659 VS3010402 VS3010405 VS3010407 VS3010466 VS3010486 VS3010523 VS3010544 VS3010568 VS3010554 VS3010590 VS3000563 VS3007066 VS3010617 VS3008584 VS3002008 VS3001633 VS3001880 VS3001900 VS3001993 VS3001998 VS3002021 VS3002023 VS3002063 VS3002077 VS3002083 VS3002130 VS3002136 VS3002792 VS3003177 VS3007383 VS3007541 VS3007904 VS3008640 VS3008660 VS3008665 VS3008786 VS3008802 VS3008845 VS3008846 VS3008852 VS3009589 VS3009737 VS3009874 VS3009877 VS3009971 VS3010108 VS3010115 VS3010123 VS3010121 VS3010127 VS3010139 VS3010142 VS3010169 VS3010381 VS3010368 VS3010712 VS3010731 VS3010775 VS3010806 VS3010829 VS3010847 VS3010854 VS3010904 VS3010922 VS3010934 VS3010935 VS3010940 VS3010941 VS3010946 VS3010959 VS3011026 VS3011029 VS3011039 VS3011042 VS3011048 VS3011055 VS3011057 VS3011059 VS3011067 VS3008846 VS3002199 VS3002205 VS3002207 VS3000911 VS3004618 VS3004668 VS3004986 VS3005762 VS3005817 VS3005816 VS3005804 VS3005822 VS3005908 VS3006190 VS3006215 VS3006529 VS3006552 VS3006666 VS3007014 VS3007012 VS3007145 VS3007168 VS3007221 VS3007274 VS3007299 VS3007413 VS3007439 VS3007507 VS3007582 VS3007753 VS3007880 VS3007866 VS3007893 VS3007898 VS3008528 VS3009644 VS3009647 VS3009649 VS3009650 VS3010760 VS3010757 VS3010792 VS3001068 VS3004467 VS3004468 VS3004476 VS3004493 VS3004515 VS3004526 VS3004581 VS3004583 VS3004585 VS3004590 VS3004593 VS3004597 VS3004599 VS3004608 VS3004620 VS3004645 VS3004658 VS3004670 VS3004675 VS3004677 VS3004690 VS3004756 VS3004943 VS3004965 VS3004979 VS3000567 VS3000575 VS3000602 VS3000617 VS3000635 VS3000907 VS3000909 VS3000943 VS3000946 VS3000952 VS3000960 VS3000970 VS3000973 VS3001666 VS3001677 VS3001681 VS3001683 VS3001686 VS3001692 VS3001695 VS3001710 VS3001725 VS3001743 VS3002752 VS3003168 VS3003239 VS3003277 VS3003671 VS3003677 VS3003678 VS3003694 VS3003735 VS3003808 VS3004022 VS3004055 VS3004068 VS3004070 VS3004071 VS3004075 VS3004084 VS3004085 VS3004086 VS3004110 VS3004214 VS3001032 VS3001048 VS3001059 VS3001060 VS3001061 VS3001065 VS3001066 VS3001067 VS3001074 VS3001075 VS3001076 VS3001078 VS3001087 VS3001113 VS3001117 VS3001632 VS3001094 VS3001630 VS3001644 VS3001651 VS3004243 VS3004247 VS3004281 VS3004282 VS3004318 VS3004371 VS3000560 VS3000607 VS3000906 VS3000957 VS3000964 VS3001019 VS3001035 VS3001036 VS3001070 VS3001084 VS3001111 VS3001103 VS3001109 VS3001637 VS3001685 VS3001673 VS3001707 VS3001705 VS3001702 VS3001689 VS3001672 VS3001675 VS3001659 VS3001642 VS3001711 VS3001650 VS3001701 VS3001693 VS3001663 VS3001660 VS3001667 VS3001696 VS3001714 VS3003839 VS3004072 VS3004031 VS3004037 VS3004192 VS3004356 VS3004460 VS3004627 VS3004594 VS3004490 VS3004531 VS3005869 VS3007320 VS3007484 VS3008777 VS3009082 VS3009850 VS3009842 VS3009950 VS3010027 VS3010061 VS3010158 VS3010484 VS3010489 VS3010807 VS3010831 VS3010843 VS3010907 VS3010974 VS3011030 VS3010063 VS3007409 VS3009861 VS3009863 VS3010120 VS3010166 VS3010042 VS3010430 VS3010435 VS3010622 VS3010758 VS3011079 VS3007502 VS3007526 VS3009616 VS3010842 VS3009847 VS3009887 VS3009912 VS3009937 VS3010327 VS3010975 VS3003206 VS3007438 VS3008714 VS3004805 VS3006192 VS3006193 VS3006194 VS3006195 VS3006202 VS3006206 VS3006211 VS3006219 VS3006333 VS3006349 VS3006396 VS3006399 VS3006402 VS3006408 VS3006414 VS3006400 VS3006394 VS3006337 VS3006386 VS3006421 VS3006637 VS3007177 VS3007292 VS3007429 VS3009915 VS3009944 VS3010050 VS3010076 VS3010078 VS3010080 VS3010074 VS3010077 VS3010864 VS3010905 VS3009720 VS3009721 VS3009722 VS3009726 VS3000574 VS3000631 VS3000637 VS3000641 VS3000644 VS3000918 VS3000921 VS3000922 VS3000923 VS3000924 VS3000934 VS3000986 VS3000995 VS3001010 VS3001014 VS3001016 VS3001018 VS3001041 VS3001052 VS3001053 VS3001054 VS3001055 VS3001232 VS3001240 VS3001259 VS3001268 VS3001272 VS3001301 VS3001331 VS3001360 VS3001741 VS3001794 VS3002134 VS3002632 VS3002667 VS3002668 VS3002708 VS3002721 VS3002760 VS3002926 VS3003726 VS3003747 VS3003811 VS3004178 VS3004464 VS3004538 VS3004561 VS3004577 VS3004601 VS3004629 VS3004674 VS3004811 VS3004837 VS3004851 VS3004980 VS3004987 VS3001012 VS3009014 VS3009567 VS3009576 VS3007501 VS3007717 VS3006550 VS3006566 VS3006643 VS3006650 VS3006652 VS3006657 VS3007024 VS3007204 VS3007206 VS3007272 VS3007305 VS3007508 VS3007600 VS3007683 VS3008639 VS3008776 VS3008872 VS3008932 VS3008936 VS3009066 VS3009110 VS3009121 VS3009136 VS3009145 VS3009157 VS3009173 VS3009179 VS3009182 VS3009148 VS3009547 VS3009549 VS3009555 VS3009566 VS3009610 VS3009643 VS3009666 VS3009692 VS3009698 VS3009719 VS3010476 VS3010511 VS3010933 VS3011021 VS3011051 VS3007607 VS3007879 VS3007830 VS3007810 VS3007911 VS3008551 VS3008549 VS3008589 VS3008628 VS3008634 VS3008666 VS3008682 VS3008698 VS3008721 VS3008722 VS3008779 VS3008783 VS3008787 VS3008785 VS3008796 VS3008801 VS3008803 VS3008810 VS3008819 VS3008816 VS3008831 VS3008848 VS3007897 VS3008898 VS3008923 VS3008928 VS3008946 VS3008996 VS3008998 VS3009013 VS3009016 VS3009018 VS3009024 VS3009043 VS3009046 VS3009052 VS3009060 VS3009063 VS3009069 VS3009086 VS3009092 VS3009096 VS3009108 VS3009114 VS3009115 VS3009118 VS3009119 VS3009126 VS3009132 VS3009133 VS3009135 VS3009142 VS3009143 VS3009146 VS3009147 VS3009129 VS3009130 VS3009149 VS3009151 VS3009153 VS3009156 VS3009158 VS3009159 VS3009176 VS3009177 VS3009178 VS3009180 VS3009523 VS3009526 VS3009528 VS3009531 VS3009532 VS3009533 VS3009534 VS3009535 VS3009536 VS3009538 VS3009539 VS3009540 VS3009541 VS3009542 VS3009543 VS3009544 VS3009548 VS3009550 VS3009552 VS3009553 VS3009554 VS3009556 VS3009557 VS3009558 VS3009559 VS3009560 VS3009561 VS3009562 VS3009563 VS3009564 VS3009565 VS3009568 VS3009569 VS3009107 VS3009571 VS3009572 VS3009573 VS3009574 VS3009575 VS3009577 VS3009578 VS3009579 VS3009580 VS3009581 VS3009583 VS3009584 VS3009585 VS3009587 VS3009588 VS3009590 VS3009592 VS3009599 VS3009593 VS3009597 VS3009596 VS3009598 VS3009594 VS3009582 VS3009600 VS3009602 VS3009603 VS3009604 VS3009609 VS3009612 VS3009613 VS3009614 VS3009615 VS3009606 VS3009617 VS3009619 VS3009607 VS3009621 VS3009622 VS3009627 VS3009628 VS3009629 VS3009630 VS3009632 VS3009635 VS3009636 VS3009638 VS3009639 VS3009608 VS3006998 VS3007819 VS3008884 VS3011025 VS3004803 VS3004916 VS3005626 VS3005797 VS3005852 VS3005865 VS3005902 VS3005984 VS3006200 VS3006218 VS3006634 VS3007103 VS3007542 VS3007545 VS3007605 VS3007620 VS3010923 VS3011776 VS3000604 VS3000675 VS3001276 VS3001366 VS3001768 VS3002823 VS3004473 VS3004607 VS3004642 VS3004684 VS3004685 VS3004723 VS3004832 VS3004945 VS3001712 VS3002810 VS3002830 VS3003013 VS3004638 VS3005013 VS3004925 VS3007190 VS3007193 VS3009646 VS3010820 VS3000584 VS3001023 VS3001046 VS3001122 VS3001123 VS3001643 VS3001814 VS3002027 VS3006424 VS3007284 VS3009623 VS3007684 VS3010937 VS3010467 VS3010418 VS3010448 VS3010514 VS3010410 VS3010413 VS3010423 VS3010438 VS3010499 VS3010510 VS3010529 VS3010535 VS3010539 VS3010543 VS3010506 VS3010585 VS3008702 VS3008781 VS3002806 VS3003105 VS3003172 VS3003191 VS3003196 VS3003633 VS3006555 VS3006559 VS3007301 VS3007630 VS3007638 VS3007670 VS3008942 VS3008986 VS3009601 VS3009655 VS3009662 VS3009879 VS3010730 VS3010776 VS3010860 VS3010908 VS3010918 VS3010965 VS3011013 VS3011037 VS3011066 VS3011069 VS3011077 VS3010674 VS3005659 VS3011773 VS3011780 VS3011783 VS3011785 VS3011788 VS3011792 VS3011795 VS3011796 VS3011800 VS3011801 VS3011804 VS3011810 VS3004565 VS3004648 VS3004689 VS3004729 VS3004830 VS3004942 VS3004983 VS3005041 VS3004974 VS3005627 VS3005681 VS3005656 VS3005719 VS3005689 VS3005690 VS3005702 VS3005789 VS3005801 VS3005778 VS3005811 VS3005813 VS3005814 VS3005815 VS3005752 VS3004956 VS3005806 VS3005665 VS3005802 VS3005800 VS3005731 VS3005823 VS3005819 VS3005824 VS3005828 VS3005834 VS3010503 VS3010924 VS3007617 VS3010415 VS3010808 VS3010879 VS3010900 VS3010927 VS3011045 VS3010192 VS3010939 VS3011040 VS3011058 VS3011086 VS3007280 VS3009882 VS3009907 VS3010131 VS3011073 VS3011078 VS3011081 VS3011082 VS3011084 VS3010441 VS3010492 VS3010039 VS3010056 VS3010813 VS3010859 VS3010917 VS3010926 VS3011041 VS3010799 VS3010856 VS3010903 VS3009993 VS3010100 VS3010753 VS3011047 VS3009035 VS3010075 VS3010724 VS3010786 VS3010805 VS3010858 VS3010875 VS3010890 VS3010914 VS3010915 VS3010929 VS3010930 VS3010981 VS3010989 VS3010994 VS3011004 VS3011024 VS3011052 VS3011054 VS3011063 VS3011064 VS3011074 VS3007297 VS3007321 VS3011070 VS3011009 VS3011071 VS3011053 VS3011065 VS3010602 VS3010801 VS3010790 VS3010952 VS3010957 VS3010987 VS3011010 VS3011016 VS3005820 VS3005893 VS3005894 VS3005899 VS3005905 VS3005925 VS3005942 VS3007016 VS3007029 VS3007047 VS3007059 VS3007054 VS3007070 VS3007082 VS3007102 VS3007006 VS3007112 VS3007125 VS3007161 VS3007173 VS3007192 VS3007240 VS3007236 VS3007241 VS3007257 VS3007316 VS3007317 VS3007325 VS3007328 VS3007351 VS3007361 VS3007367 VS3007390 VS3007406 VS3007419 VS3007424 VS3007431 VS3007440 VS3007444 VS3007465 VS3007466 VS3007468 VS3007482 VS3007500 VS3007511 VS3007521 VS3007522 VS3007528 VS3007539 VS3007547 VS3007548 VS3007557 VS3007561 VS3007558 VS3007573 VS3007584 VS3007585 VS3007495 VS3007592 VS3007602 VS3007616 VS3007632 VS3007621 VS3007648 VS3007653 VS3007656 VS3007655 VS3007667 VS3007676 VS3007678 VS3007695 VS3007735 VS3007737 VS3007873 VS3007877 VS3007884 VS3007595 VS3007862 VS3007910 VS3007922 VS3008523 VS3007899 VS3008537 VS3008539 VS3008545 VS3008556 VS3008587 VS3008597 VS3008602 VS3007803 VS3008649 VS3008653 VS3008710 VS3008794 VS3008833 VS3008877 VS3008885 VS3008897 VS3008901 VS3008920 VS3008972 VS3008975 VS3009128 VS3009570 VS3009626 VS3009645 VS3009651 VS3009652 VS3009653 VS3009654 VS3009656 VS3009657 VS3009659 VS3009661 VS3009664 VS3009669 VS3009670 VS3009684 VS3009690 VS3009694 VS3009697 VS3009699 VS3009701 VS3009702 VS3009704 VS3009707 VS3009796 VS3009854 VS3009898 VS3009910 VS3009911 VS3009931 VS3009951 VS3009955 VS3009965 VS3009973 VS3009990 VS3009994 VS3010007 VS3010019 VS3010024 VS3010043 VS3010066 VS3010068 VS3010069 VS3010082 VS3010128 VS3010196 VS3010185 VS3010388 VS3010409 VS3010417 VS3010442 VS3010433 VS3010453 VS3010461 VS3010468 VS3010475 VS3010462 VS3010483 VS3010496 VS3010500 VS3010504 VS3010517 VS3010472 VS3010567 VS3010571 VS3010583 VS3010587 VS3010591 VS3010596 VS3010600 VS3010607 VS3010624 VS3010633 VS3010636 VS3010641 VS3010643 VS3010645 VS3010629 VS3010666 VS3010667 VS3010704 VS3010707 VS3010718 VS3010717 VS3010720 VS3010727 VS3010728 VS3010747 VS3010742 VS3010738 VS3010743 VS3010846 VS3010861 VS3010862 VS3010841 VS3010884 VS3010839 VS3003627 VS3003337 VS3003707 VS3003160 VS3001154 VS3002791 VS3002952 VS3001139 VS3001166 VS3001661 VS3001676 VS3001736 VS3001757 VS3001819 VS3001833 VS3001842 VS3001844 VS3001858 VS3001911 VS3001912 VS3001923 VS3001972 VS3002026 VS3002096 VS3002116 VS3002185 VS3002731 VS3002748 VS3002757 VS3002769 VS3002771 VS3002785 VS3002797 VS3002817 VS3002837 VS3002850 VS3002858 VS3002872 VS3002909 VS3002911 VS3002934 VS3002939 VS3002947 VS3002955 VS3002961 VS3002963 VS3002965 VS3002972 VS3002974 VS3002980 VS3003100 VS3003108 VS3003109 VS3003123 VS3003126 VS3003133 VS3003150 VS3003156 VS3003159 VS3003176 VS3003184 VS3003192 VS3003200 VS3003202 VS3003209 VS3003235 VS3003255 VS3003258 VS3003260 VS3003265 VS3003267 VS3003270 VS3003273 VS3003276 VS3003282 VS3003287 VS3003293 VS3003294 VS3003296 VS3003298 VS3003300 VS3003310 VS3003317 VS3003321 VS3003323 VS3003336 VS3003339 VS3003351 VS3003359 VS3003361 VS3003364 VS3003376 VS3003378 VS3003404 VS3003412 VS3003417 VS3003421 VS3003426 VS3003439 VS3003623 VS3003626 VS3003628 VS3003629 VS3003631 VS3003634 VS3003635 VS3003638 VS3003640 VS3003643 VS3003644 VS3003649 VS3003650 VS3003651 VS3003652 VS3003654 VS3003655 VS3003656 VS3003657 VS3003658 VS3003659 VS3003661 VS3003663 VS3003664 VS3003666 VS3003670 VS3003686 VS3003702 VS3003704 VS3003728 VS3003729 VS3003730 VS3003731 VS3003737 VS3003741 VS3003743 VS3003750 VS3003752 VS3003754 VS3003757 VS3003763 VS3003766 VS3003770 VS3003772 VS3003774 VS3003785 VS3003793 VS3003803 VS3003807 VS3003813 VS3003814 VS3003831 VS3003836 VS3003841 VS3003844 VS3003846 VS3003848 VS3003849 VS3003851 VS3003852 VS3003854 VS3003855 VS3003858 VS3003887 VS3003890 VS3003928 VS3002846 VS3002973 VS3003102 VS3003117 VS3003143 VS3003164 VS3003254 VS3003291 VS3003292 VS3003391 VS3003625 VS3003630 VS3003637 VS3003668 VS3007026 VS3004635 VS3004813 VS3005642 VS3005696 VS3005810 VS3005897 VS3005945 VS3006191 VS3006213 VS3006220 VS3006385 VS3006546 VS3006549 VS3006578 VS3006587 VS3006584 VS3007199 VS3007215 VS3007296 VS3007304 VS3007397 VS3007512 VS3007712 VS3007715 VS3007771 VS3007777 VS3007823 VS3007834 VS3007908 VS3007896 VS3008567 VS3008558 VS3008646 VS3009154 VS3009155 VS3009809 VS3009828 VS3009848 VS3010394 VS3010532 VS3010533 VS3005695 VS3005784 VS3005909 VS3006679 VS3007563 VS3008622 VS3009834 VS3010079 VS3010089 VS3010099 VS3010104 VS3010609 VS3010605 VS3010611 VS3010713 VS3010749 VS3010750 VS3010825 VS3011038 VS3011068 VS3011072 VS3007106 VS3009975 VS3010124 VS3010354 VS3007324 VS3007556 VS3008912 VS3010200 VS3010333 VS3010335 VS3010561 VS3010748 VS3011083 VS3005668 VS3005691 VS3007208 VS3008541 VS3008696 VS3010469 VS3010508 VS3010566 VS3010588 VS3010721 VS3003197 VS3005661 VS3008643 VS3008863 VS3008976 VS3009625 and VS3010733;
b) Serial Numbers: VS6500009 VS6500013 VS6500019 VS6500024 VS6500096 VS6500112 VS6500116 VS6500117 VS6500640 VS6500644 VS6500645 VS6500350 VS6500204 VS6500210 VS6500221 VS6500227 VS6500427 VS6500438 VS6500446 VS6500313 VS6500332 VS6500967 VS6500308 VS6500357 VS6500362 VS6500367 VS6500213 VS6500038 VS6500103 VS6500106 VS6500108 VS6500123 VS6500144 VS6500165 VS6500300 VS6500307 VS6500310 VS6500323 VS6500343 VS6500355 VS6500358 VS6500354 F21380F023872 F21380F023873 F21380F023874 F21380F023877 F21380F023878 F21380F023981 F21380F024067 VS6500183 VS6500043 VS6500100 VS6500145 VS6500435 VS6500451 VS6500455 VS6500457 VS6500466 VS6500467 VS6500471 VS6500483 VS6500503 VS6500508 VS6500510 VS6500512 VS6500519 VS6500528 VS6500533 VS6500541 VS6500548 VS6500037 VS6500092 VS6500111 VS6500122 VS6500129 VS6500447 VS6500535 VS6500522 VS6500551 VS6500074 F21380F023825 F21380F023836 F21380F023840 F21380F023844 F21380F023895 F21380F023896 F21380F023905 F21380F023906 F21380F023908 F21380F023912 F21380F023918 F21380F023923 F21380F023924 F21380F023927 F21380F023979 F21380F023987 F21380F024020 VS6500136 VS6500296 VS6500301 VS6500315 VS6500331 VS6500335 VS6500345 VS6500314 VS6500318 VS6500328 VS6500336 VS6500344 VS6500218 VS6500217 VS6500386 VS6500424 VS6500449 VS6500453 VS6500454 VS6500456 VS6500093 VS6500151 VS6500086 VS6500207 VS6500079 VS6500237 VS6500239 VS6500283 VS6500284 VS6500285 VS6500286 VS6500287 VS6500288 VS6500290 VS6500292 VS6500293 VS6500295 VS6500351 VS6500353 VS6500356 VS6500363 VS6500368 VS6500378 VS6500413 VS6500423 VS6500641 VS6500672 VS6500683 VS6500703 VS6500723 VS6500734 VS6500738 VS6500773 VS6500785 VS6500787 VS6500790 VS6500810 VS6500826 VS6500833 VS6500837 VS6500846 VS6500847 VS6500852 VS6500857 VS6500858 VS6500864 VS6500875 VS6500880 VS6500881 VS6500882 VS6500883 VS6500885 VS6500888 VS6500889 VS6500891 VS6500893 VS6500896 VS6500897 VS6500898 VS6500899 VS6500900 VS6500902 VS6500903 VS6500904 VS6500907 VS6500908 VS6500909 VS6500910 VS6500911 VS6500912 VS6500913 VS6500914 VS6500915 VS6500918 VS6500919 VS6500920 VS6500921 VS6500924 VS6500927 VS6500931 VS6500935 VS6500936 VS6500937 VS6500573 VS6500765 VS6500922 VS6500379 VS6500387 VS6500390 VS6500392 VS6500394 VS6500395 VS6500396 VS6500399 VS6500441 VS6500445 VS6500448 VS6500035 VS6500063 VS6500068 VS6500078 VS6500107 VS6500604 VS6500610 VS6500611 VS6500618 VS6500623 VS6500624 VS6500654 VS6500598 VS6500600 VS6500608 VS6500609 VS6500025 VS6500156 VS6500164 VS6500203 VS6500208 VS6500209 VS6500219 VS6500222 VS6500186 VS6500977 VS6500205 VS6500001 VS6500071 VS6500152 VS6500197 VS6500161 VS6500173 and VS6500184;
c) Serial Numbers: VSF5200298 VSF5200306 VSF5200312 VSF5200337 VSF5200398 VSF5200466 VSF5200628 VSF5200571 VSF5200608 VSF5200615 VSF5200329 VSF5200470 VSF5200474 VSF5200524 VSF5201550 VSF5201552 VSF5202104 VSF5202115 VSF5202826 VSF5202829 VSF5201193 VSF5201199 VSF5201202 VSF5201203 VSF5201204 VSF5202791 VSF5202793 VSF5200224 VSF5200292 VSF5200350 VSF5200351 VSF5203007 VSF5203118 VSF5203226 VSF5203704 VSF5203732 VSF5204192 VSF5204201 VSF5204209 VSF5204212 VSF5200297 VSF5200406 VSF5200340 VSF5200065 VSF5200067 VSF5200080 VSF5201108 VSF5204331 VSF5204335 VSF5204359 VSF5201082 VSF5201094 VSF5200089 VSF5200310 VSF5203769 VSF5203847 VSF5200326 VSF5201746 VSF5200303 VSF5200809 VSF5201557 VSF5200407 VSF5200551 VSF5200555 VSF5200567 VSF5200631 VSF5200638 VSF5200645 VSF5200793 VSF5200802 VSF5200824 VSF5200827 VSF5200846 VSF5203473 VSF5203622 VSF5203846 VSF5204323 VSF5203470 VSF5202787 VSF5203216 VSF5203227 VSF5203229 VSF5203232 VSF5203110 VSF5204060 VSF5204061 VSF5204068 VSF5204175 VSF5204154 VSF5200348 VSF5200359 VSF5200364 VSF5200400 VSF5200404 VSF5202388 VSF5203708 VSF5204156 VSF5203678 VSF5200357 VSF5200360 VSF5200374 VSF5200378 VSF5200388 VSF5200412 VSF5200476 VSF5200481 VSF5200508 VSF5200527 VSF5200531 VSF5200532 VSF5200533 VSF5204180 VSF5204262 VSF5204365 VSF5204367 VSF5204439 VSF5204444 VSF5204447 VSF5204451 VSF5204461 VSF5204465 VSF5204466 VSF5204467 VSF5204468 VSF5204512 VSF5204516 VSF5204517 VSF5204520 VSF5204529 VSF5201595 VSF5201710 VSF5201974 VSF5202819 VSF5202830 VSF5204437 VSF5204492 VSF5203161 VSF5203420 VSF5203810 VSF5203848 VSF5203174 VSF5203411 VSF5203677 VSF5203439 VSF5200096 VSF5200098 VSF5200100 VSF5200101 VSF5200102 VSF5200103 VSF5200104 VSF5200105 VSF5200106 VSF5200107 VSF5200108 VSF5200110 VSF5200111 VSF5200112 VSF5200114 VSF5200115 VSF5200116 VSF5200118 VSF5200119 VSF5200121 VSF5200122 VSF5200347 VSF5200855 VSF5201026 VSF5201163 VSF5201175 VSF5201505 VSF5201522 VSF5201523 VSF5201545 VSF5201547 VSF5201750 VSF5201758 VSF5202057 VSF5202116 VSF5202125 VSF5202395 VSF5203027 VSF5203426 VSF5203725 VSF5203772 VSF5203849 VSF5204063 VSF5204093 VSF5204128 VSF5204138 VSF5204141 VSF5204145 VSF5204194 VSF5204200 VSF5204307 VSF5204315 VSF5204452 VSF5204477 VSF5204482 VSF5204486 VSF5204489 VSF5204490 VSF5204519 VSF5200097 VSF5200259 VSF5200284 VSF5200377 VSF5200550 VSF5200862 VSF5200886 VSF5201002 VSF5201013 VSF5201024 VSF5201043 VSF5201044 VSF5201059 VSF5201062 VSF5201078 VSF5201153 VSF5201167 VSF5203855 VSF5204050 VSF5204178 VSF5204254 VSF5200113 VSF5200099 VSF5200109 VSF5200281 VSF5200386 VSF5200462 VSF5200480 VSF5200528 VSF5200573 VSF5200586 VSF5200831 VSF5200843 VSF5200844 VSF5200895 VSF5201011 VSF5201020 VSF5201050 VSF5201029 VSF5201063 VSF5201067 VSF5201138 VSF5201161 VSF5201168 VSF5201169 VSF5201178 VSF5201192 VSF5201158 VSF5201181 VSF5201182 VSF5201751 VSF5201997 VSF5202238 VSF5202252 VSF5202248 VSF5202255 VSF5203024 VSF5203025 VSF5203028 VSF5203179 VSF5203753 VSF5203858 VSF5204028 VSF5204179 VSF5204142 VSF5204150 VSF5204041 VSF5204252 VSF5204313 VSF5204326 VSF5203105 VSF5203422 VSF5201244 VSF5201569 VSF5202394 VSF5201240 VSF5201257 VSF5201504 VSF5202096 VSF5203047 VSF5203173 VSF5203233 VSF5203475 VSF5201510 VSF5202798 VSF5203006 VSF5203053 VSF5203183 VSF5203432 VSF5204158 VSF5204266 VSF5204357 VSF5204387 VSF5204392 VSF5204337 VSF5201260 VSF5201268 VSF5202055 VSF5203184 VSF5202124 VSF5202005 VSF5204364 VSF5204370 VSF5203987 VSF5204518 and VSF5200343
RECALLING FIRM/MANUFACTURER
Respironics California Inc., Carlsbad, CA, by letters on January 25, 2008. Firm initiated recall is ongoing.
REASON
This action is being taken to address power supply failures on the Esprit Ventilator which have occurred in some units. These failures, which were discovered through routine product monitoring, have been reported in countries that utilize an input voltage of greater than 200 volts AC. Some customers have reported a burning smell coming from the ventilator.
VOLUME OF PRODUCT IN COMMERCE
2,019 units
DISTRIBUTION
Internationally
___________________________________
PRODUCT
iReview" Software (Accessory To) iLab Ultrasound Imaging System, Model Number: H74900018010, Catalog Number: 1801; Product is manufactured and distributed by Boston Scientific Corporation, Fremont, CA The iReview" Software is provided on CD and is a computer application designed for reviewing cases recorded with firm's iLab "System, and for exporting stills or videos of those runs, Recall # Z-2006-2008
CODE
Lot Number: 74791
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Fremont, CA, by letter on May 2, 2008. Firm initiated recall is ongoing.
REASON
The firm initiated a recall of a specific iReview" Software, Ver 1.0 Kit, which was released for distribution in a non-validated format.
VOLUME OF PRODUCT IN COMMERCE
10 kits
DISTRIBUTION
FL, MI, CA, AZ, SC
___________________________________
PRODUCT
Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument available with the Phoenix Tibia Nail System. If desired, it may be used to seat the nail into the medullary canal. The Phoenix Tibial Nail System is indicated for alignment, stabilization, fixation of fractures caused by trauma or disease and the fixation of long bones that have been surgically prepared for correction of deformity and arthrodesis. Catalog number: 14-442053-00, Recall # Z-2012-2008
CODE
Lot numbers: 502398, 503684
RECALLING FIRM/MANUFACTURER
EBI, L.P., Parsippany, NJ, by letters on May 7, 2007. Firm initiated recall is ongoing.
REASON
Customer complaint received regarding the separation of the mallet handle during a medical procedure.
VOLUME OF PRODUCT IN COMMERCE
38 mallets
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Biopsy Guide Starter Kits C5-2 used with the Philips HD3 Ultrasound System
intended for diagnostic ultrasound imaging or fluid analysis of the human body.
C5-2 Part No. 989605353731, Recall # Z-2013-2008;
b) Biopsy Guide Starter Kits C7-3 used with the Philips HD3 Ultrasound System
intended for diagnostic ultrasound imaging or fluid analysis of the human body.
The C7-3 kits were not serialized. Any kits that shipped after April 3, 2008 are not
affected by this issue. Recall # Z-2014-2008;
c) Biopsy Guide Starter Kits L9-5, used with the Philips HD3 Ultrasound System
intended for diagnostic ultrasound imaging or fluid analysis of the human body;
Part No. 989605353761, Recall # Z-2015-2008
CODE
Lot #'s: 6503, 6536, 6536, 6693, 6801, 6978, 7175, 7861, 7861, 7982, 7861, 8053,
8286 and 9155. SN # ranges: 123-152, 153-167, 178-187, 168-177, 188-197,
198-207, 208-222, 223-224, 233-247, 248-251, 225-232, 252-254, 255-264 and
265-269;
b) No batch or lot numbers available. The affected C7-3 kits were distributed between
November 29, 2005 and April 3, 2008;
c) Lot #'s: 6446, 6546, 6546, 6627, 6627, 6627, 6987, 6987, 7154, 7366, 7850 and 7983.
SN # ranges: 133-162, 304-318, 319-323, 163-167, 168-177, 178-187, 188-193, 194-
197, 198-212, 213-217, 218-249 and 250-264
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, Andover, MA, by letters on June 4, 2008.
Manufacturer: Medison Company, Gangwon-Do Nam-Myeon. Firm initiated recall is ongoing.
REASON
HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use.
VOLUME OF PRODUCT IN COMMERCE
173 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Physio-Control Internal Defibrillator Handles, 1) PN: 3010901-002 for use with
LIFEPAK 12 and 20. 2) PN: 805249-014 thru 019 for use with LIFEPAK 9 and 9P,
Recall # Z-2035-2008;
b) Internal Defibrillation Electrodes: PN: 805355-10 thru 14 and 805355-020 thru -024,
Recall Z-2036-2008
CODE
a) 1) Lot Numbers: 0003, 0004, 0005, 0006, 0007, 0008, 0009, 0012, 0101, 0102, 0103, 0104, 0106, 0107, 0108, 0109, 0110, 0111, 0112, 0201, 0202, 0204, 0205, 0206, 0207, 0208, 0209, 0210, 0211, 0212, 0301, 0302, 0303, 0304, 0305, 0306, 0307, 0308, 0310, 0312, 0401, 0402, 0403, 0404, 0405, 0406, 0407, 0411, 0412, 0501, 0502, 0503, 0504, 0505, 0509, 0510, 0511, 0512, 0602, 0603, 0604, 0605, 0606, 0608, 0610, 0611, 0612, 0701, 0702, 0704, 0705, 0710, 0711, 9808, 9809, 9811, 9812, 9902, 9904, 9905, 9907, 9909, 9910, 9911, 9912;
2) Lot Numbers: 0002, 0003, 0004, 0006, 0007, 0008, 0009, 0011, 0101, 0102, 0103, 0104, 0105, 0110, 0112, 0201, 0202, 0203, 0205, 0206, 0208, 0209, 0211, 0304, 0305, 0306, 0307, 0308, 0401, 0402, 0404, 0405, 0412, 0502, 0503, 0506, 0507, 0509, 0603, 0604, 9508, 9509, 9608, 9609, 9610, 9702, 9706, 9708, 9709, 9807, 9809, 9811, 9812, 9902, 9906, 9907, 9908, 9909, 9912;
b) Lot Numbers: 0001, 0060, 0080, 0090, 0100, 0102, 0104, 0106, 0107, 0123, 0197, 0200, 0203, 0204, 0205, 0206, 0207, 0300, 0301, 0304, 0305, 0306, 0307, 0398, 0399, 0404, 0405, 0407, 0499, 0500, 0501, 0502, 0503, 0504, 0505, 0507, 0600, 0601, 0604, 0605, 0606, 0607, 0698, 0700, 0703, 0704, 0705, 0706, 0707, 0800, 0802, 0803, 0804, 0805, 0806, 0807, 0895, 0899, 0900, 0901, 0903, 0904, 0905, 0906, 0907, 1000, 1001, 1002, 1004, 1005, 1006, 1007, 1023, 1097, 1099, 1101, 1103, 1104, 1105, 1106, 1107, 1201, 1202, 1204, 1205, 1206, 1207, 1298, 1300, 1302, 1304, 1305, 1306, 1307, 1398, 1400, 1402, 1403, 1404, 1405, 1406, 1407, 1498, 1499, 1501, 1502, 1505, 1506, 1601, 1602, 1603, 1604, 1605, 1606, 1607, 1700, 1701, 1702, 1703, 1704, 1705, 1706, 1707, 1797, 1799, 1801, 1802, 1804, 1805, 1806, 1807, 1898, 1899, 1903, 1905, 1906, 1907, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2101, 2103, 2104, 2105, 2106, 2107, 2202, 2203, 2205, 2206, 2207, 2298, 2299, 2300, 2301, 2302, 2304, 2305, 2306, 2399, 2402, 2403, 2405, 2406, 2407, 2499, 2500, 2501, 2502, 2503, 2505, 2506, 2507, 2599, 2600, 2601, 2602, 2603, 2605, 2606, 2607, 2698, 2699, 2702, 2800, 2802, 2806, 2807, 2899, 2900, 2901, 2903, 2904, 2905, 2906, 2907, 2999, 3000, 3001, 3002, 3005, 3006, 3007, 3098, 3099, 3100, 3101, 3102, 3104, 3105, 3106, 3107, 3197, 3198, 3203, 3204, 3205, 3206, 03294, 3299, 3302, 3303, 3305, 3306, 3398, 3399, 3400, 3401, 3403, 3404, 3405, 3406, 3407, 3498, 3499, 3500, 3501, 3503, 3505, 3507, 3597, 3599, 3602, 3603, 3605, 3606, 3607, 3697, 3698, 3699, 3700, 3701, 3702, 3705, 3706, 3707, 3798, 3799, 3805, 3806, 3807, 3899, 3900, 3901, 3905, 3906, 3907, 3998, 4000, 4003, 4005, 4006, 4007, 4099, 4100, 4101, 4102, 4103, 4105, 4106, 4107, 4197, 4199, 4200, 4201, 4203, 4204, 4206, 4207, 4298, 4299, 4300, 4302, 4304, 4305, 4306, 4307, 4399, 4401, 4405, 4406, 4498, 4499, 4500, 4502, 4503, 4506, 4507, 4600, 4601, 4603, 4605, 4606, 4607, 4699, 4701, 4702, 4704, 4705, 4706, 4797, 4799, 4803, 4805, 4806, 4900, 4904, 4906, 4907, 4998, 5000, 5001, 5002, 5003, 5005, 5006, 5103, 5105, 5106, 5199, 5200, 5203, 5204, 5205, 5206, 5299, 5301
RECALLING FIRM/MANUFACTURER
Physio Control, Inc., Redmond, WS, by letters beginning February 5, 2008. Firm initiated recall is ongoing.
REASON
Based on testing, sterilization methods described in labeling may be ineffective and may cause damage or corrosion to the paddles or handles. If handles and/or paddles are not sterilized adequately and are used on a patient, there is a risk of infection. If handle discharge button is damaged during sterilization, defibrillation therapy may be prevented.
VOLUME OF PRODUCT IN COMMERCE
47,274 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Advantx-E is an angiographic X-Ray system, Recall # Z-2038-2008;
b) Innova 2100IQ is a Digital Fluoroscopic Imaging System that consists of an a
monoplane positioner, a vascular or cardiac table, an X-ray system and a digital
detector, Recall # Z-2039-2008;
c) Innova 3100/3100IQ is a cardiovascular Imaging System. The system consists of
an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital
detector, Recall # Z-2040-2008;
d) Innova 4100/4100IQ is a X-Ray system that consists of an a monoplane positioner,
a vascular or cardiac table, an X-ray system and a digital detector, Recall # Z-2041-
2008;
e) Innova 2000's principle system components include a C-arm, image acquisition,
processing and archiving capabilities, Recall # Z-2042-2008;
f) Innova 2121-1Q/3131-1Q is a Biplane Cardiovascular Imaging System. The Innova
Biplane systems are the first and only digital flat panel biplane system with a full
sized lateral plane to cover lateral anatomy without requiring multiple contrast
injections and radiation exposures, Recall # Z-2043-2008
CODE
a) 206598LCBI 215955LCLP 304843LCA 309655FSP4 312942EP1 318377MC1XX 405840SOIC 409772VAS5 505887CL1 507225CC101 516663EP2 574294LCA 602532LCA 609653LCA 609757CCL5 609757EP1 609757LCEP 610988EP 615443LCA 650369SV2 702731LCPLUS 706774UEP1 714670LCA 717544EP8 717763EP1 717782EP1 757398EP 760241LCV 772468LCA 773564LCA 781769NCL 818884LCA 864560SPLCA 936266LCA 954MWLCA 956994BICATH BPANGIO ECXV1407CLCV ECXV1407ELCV ECXV1407ILC OLC-ADVE VASCSOUTH 309655FSP2A 501978LAB2 918307CDLC 810326LCA 918307SHLC1 410614CV6 314525ACL1A 904739EP 843797LCA2 603669ELCV 703689LCA2 301896ANGIO2 361788LCPLUS 915670LCA 612273LCLP 617636EP BPEP 770844NFLCA 281420LAB2 918744JB5 215750LCLP 410543CATH3 904202EPA 504785LCA 303839CL4 856342LCLP 717544EP7 213977LCLP1 314768SMOL1 215823LCLP BG4549VA01 4406 2584562 1165109 082406030007T 82406030011 82406040023 82406040024 82406050008 82406050009 82406060002 82406070009 82406070011 82406090011 82406090012 82406090014 82406090015 82406090017 82406090021 82406100012 82406100013 82406100015 82406100017 82406110001 82406110003 82406120015 82406130015 82406130016 82406130017 82406140018 82406160036 82406160037 82406160038 82406160041 82406180003 82406190009 82406190011 82406190012 82406190013 82406200003 82406230009 82406230011 82406230012 82406270006 82406290001 82406300001 82406310002 82406532603 082406ATCLCV1 82406030012 82406120017 82406100014 82406020003 82406100016 82406140019 82406310004 82406090018 82406090020 82406090016 82406090019 82406040026 82406140021 82406010012 82406130018 82406060003 82406270007 519663LCP 519685LCNP 416369LCLP 514398BIPLAN CS1118VA02 UC1923XR23 EG1235VA01 EG1703VA01 FP721A02 DPN85900 YE162A29 NE185034 YE645824 YP158312 A1105902 A4160425 A9793301 M2002604 M2528706 M4212427 X2881402 A1064503 A1105901 M1076843 B1607012 M4488827 A9793306 00440VAS01 GE1006VA01 GP1046VA01 2546301ADLCV 835060023 8.30066E+13 8.3016E+12 8.30166E+12 8.30166E+13 8.30168E+13 8.30166E+13 8.3006E+13 A5375115 A5719806 A5114287 A5267808 A5687002 B5381808 A5719814 A5129811 A5332104 C5821416 YX1512 YX1513 YX1525 YX1675 YX1678 YX1681 YX1700 YX1516 YX1530 YX2222 KW1001VA02 KA1048VA01 LB1018VA01 LB1188VA01 MA1274VA01 MA1361VA01 MA1276VA01 MA1272VA01 MA1205VA01 MA1288VA01 MA1312VA01 MA1174VA01 MT1014VA01 2504649LC+ 33XVLCN544793 6622LCDLX 9926LCPLUS NG1018VA01 RTD1205 RO4165VA01 RU1047VA01 RU1086VA03 RU1175VA01 RU1379VA01 RU2076VA01 RU2400VA01 RU2580VA01 RU1205VA01 SY2035VA01 SY2026RX01 06092VAS01 34004VAS01 34107VAS01 65005VAS01 78001VAS01 01002VAS02 853060178 853060181 853060182 853060183 853060184 853060185 853060186 853060190 853060180 853060188 853060189 853060192 5982LCV 388555220VASMET YU4060VA01;
b) 2100 Q _ 505848CATH1 505848EP 318448INNOVA3 305682IN2 4105502100 410554INNOVA2 208367INNOVA 2035762100 214947MINNOVA 214947MINNOVA2 303839CL2 252384CATH1 303788CL1 4436432100 8184092100 219932DCL2 305364P2100 713794LAB1 727869CATH3 727869CCL2 727869EP5 208227CATH1 8157412100 816861KCVAI2 308865GIN1 865693CCL 865693CCL2 516562INNOVA6 516562INNOVA7 865977CCL 217383CCL2A 541732CV2 251435ICV3 239436CATH4 732776CATH4 212305CATH1 65049321 304424INNOVA 215453INNOVA21 229228INNOV21C RPINNOVA2100 303425CL3 317355INNOVA3 330363LAB3 330375LAB2 336538ARCL1 360456XCL4 405604D2100 408559INV1 410554INNOVA1 414291CL2 414649INNOVA2 417269SCLA 417347FCV4 501257VALAB1 508856IN21 516562INNOVA2A 518243LAB2 561548ET2 570476INNOVA21 573761SMC2 573815BCR2 573815BCR3 573815BCR4 574535IN21 602239CLAB2 607737CL1 610250INNOVA1 610250INNOVA3 612273INNOVA2 615284CV3 615342CV3 615446CV1 617636CL1 630856H2100 650369SV4 651582IN3 661327INNOVA1 661327INNOVA2 713375U2100 717217INN21 717544GECATH2 717544GECATH3 718470EP 727942CATH2 732324INN1 732923INN 770HMCCL1 781340IN1 781340IN3 785354HRTEP 803256PCL5 808547QCV1A 808547QCV3A 812238UN21 813615CL1 813615CL8 813615CL9 813615EP3 814452EP 815759CARDIAC1 817329BG2100 843724CL1 843724CL2 843724CL3 843724EP1 845368LAB1 845368LAB2 856853IN2100 858554INNOVA2 864255SFCL1 904597CATH 910343EP1 910671INOV21 916781INNOVA2 937208INNOVA2 954735CL2 954987CCL7 954987CCL8 973579LAB1 985898INNOVAA 985898INNOVAB CM2100 ECXV1406F FHOMEP 508335INNOVA 828213IN21 901765EP 262255INNOVA2 410337INNOVA6 573256MHC 804764CATH2 845365V13 847316INNOVA1 847316INNOVA2 910162009 910162010 910162011 910162012 910163011 910163014 010120RX44 82416100014 82416150002 82416100011 82416130026 82416010007 82416030005 82416040011 82416040012 82416040014 82416050003 82416060001 82416100009 82416100012 82416100017 82416120008 82416130016 82416130019 82416130023 82416130024 82416160007 82416180003 82416200004 82416210007 82416220010 82416120009 82416030004 82416100007 604875AINNOVA1 416480INNOVA 604682INNOVA1 604682INNOVA2 604875AINNOVA2 26814ANGI2 2664023INNOVA 2641225INNOVA CS1118VA03 HC4348XR02 PC0052XR07 PC0052XR08 507902XR01 HC0222XR35 HC4355XR06 HC4480XR05 HC1995XR03 DK1066VA02 DZ1006VA01 FEB52055 ME612436 CEE15663 C99999164 FI1017VA02 FI1017VA03 A4166952 B1650215 B5483438 M1334109 M2068110 M2569315 M2844529 M4176519 M4183841 M4200108 M4211066 M4496941 M4198195 M181374801 00060VAS02 00159VAS04 00192VAS04 00192VAS05 00234VAS01 00282VAS02 00371VAS01 00440VAS02 00440VAS03 00463VAS06 00888VAS02 01065VAS01 05208VAS02 05217VAS02 10507VAS01 H2077VAS27 H17654VAS8 828160007 600010VA01 HU1094VA01 HU1116VA01 HU1205VA01 HU1231VA10 835160017 835160018 IE1100VA02 IE1077VA01 IE1053VA01 8.3016E+12 8.3016E+13 8.30161E+13 8.30162E+13 8.30163E+13 8.30166E+13 8.30168E+13 8.30169E+13 8.30168E+13 IQ1126VA01 A5333036 A5333037 A147111802 A5125125 A5131858 A5155141 A5164510 A5219606 A5220710 A5286803 A5400910 A5605743 A5624112 A5800506 A5807919 A58080104 B5120723 C5123625 C5123626 C5323515 B5603933 A5111034 YV0054 YV0057 YV0058 YV0059 YV0060 YV0061 YV0062 YV0063 YV0064 YV0065 YV0066 YV0067 YV0068 YV0069 YV0070 YV0071 YV0072 YV0073 YV0074 YV0077 YV0080 YV0055 YV0056 850060723 KW1018VA01 KW1018VA02 KW1018VA03 LV4000VA02 LV4000VA03 LV4001VA02 MA1004VA02 644INNOVA21 83INNOVA2588441 NO1009VA03 NO1064VA03 920169006 600151VA01 600042VA03 PL1677VA01 787844INNOVACL1 787844INNOVACL2 787844INNOVACL3 PER00218 RO1108XR01 SA1011VA01 SA1054VA02 A004RX01 A020RX13 847160003 SY1001VA02 SY2005VA01 06052VAS01 20001VAS02 34009VAS06 34134VAS02 35049VAS01 58010VAS01 80002VAS01 35021VAS02 853060191;
c) 215576INNOVA1 760242CATH1 281420LAB23100 541382CV3 205783BCL5 2035763100 843797TCL2 361980INNOVA2 214590PH3100 303629CL4 303629EP 3027443100 303788CL2 239939CLA 8184093100 919731WMINOV 305364P3100 281440CL3 208227CATH2 7028533100 865693CCL1 6619483100 219326IN31 7022333100 209334LINNOVA1 502587LAB1 219877IN31 9734293100 215335INNOVA1 239436CATH3 239513CRLAB1 812858GWLAB1 812858GWLAB2 8014793100 270688INN 65049331 8508573100 850469BCV1 207662CL4 207879CL131 541677MINNOVA1 5033703100 253968INNOVA 412437INNOVA 303425CL4 2595303 228818VASC 316651INNOVA31 316962WCVC1 316962WCVC2 325428CATH1 336832MCPV 360456XCL3 361857CATH1 405272SCL2 405604D3100 405840OIC3100 406447VAIN3 406543IN3 413582C3100 414447CL1 414647CL1 414649CL3 414649CL4 414805INNOVA1 415925INV1 423495MCL6 423844CCL1 478274CTH1 502852INNOVA 510797INV8 512901NI3100 516562INNOVA8 516562INNOVA9 530244XC106 561548CL4 570476INNOVA31 573458CL1 573632CRC2 6012883100CV2 603421PCL 610595CL1 610770INNOVA31 610983INNOVA1 616392INNOVA 617732IN9 618241GSI3100 631968INNOVA2 631968INNOVA3 671GMHAINVA 708WESTSUB3100 713359INC 713948INA 717782INNOVA31A 718245UNITY 718470INNOVA2 718780CATH2 732776CATH6 770991CL1 772LWCL1 775982CATH2 781340IN2 803255CL1 804285CATH1 814676C1 815344CARDIAC3 816478MC1 816861KCVAI1 816943STJIC1 816985NKCI 847362CONCATH4 856596IN3100 864255SFCL3 901516R3 903UT3100 904276CTH1 909464IN3 909825VAINNOVA 910343NHIN4 913345MI1 940626DCH3100 954987CCL9 956698INN31 970350CL1 970945CL1 973877LAB4 ECXV1406B FHORLCL7 480728LAB2 865481CCL2 8157413100 251633PROV 907562CATH1 201996LAB1 207351YCL1 281420LAB1 412623LAB2 480821IN2 508856IN2 541MWHINNOVA 573882UMC1 610447CL1 610891CL1 617789IN1 706774CCL4 706774CCL5 713776M3100 717782INNOVA31 803256PCL1 812450CATH1 815226INN2 918494IN31A 952993INNOVA5 BPINNOVA1 845365V19 918333JPIN1 909788INNOVA1 516663INNOVA2 312STMNAZ3100 518525LAB1 540953INNOVA 717217INN31 573815BCR1 313593IC2 561266IN31 812450EP1 808547QCV2A 765453INNOVA1 413447CATH 770991CL3 417269SCLD 619340VA8 928779INNOVA1 713794LAB9 313593IC1 713794LAB7 956389INN31 316268INNOVAA 732294INOV 318448INNOVA2 318449INNOVA2 602239LAB4 7028803100A 310423INNOVA1 602239LAB6 812482INNOVA 702616INNOVA 724773C1 502587LAB4 973971LAB3 4103323100 214324INNOVA2 619482INNOVA1 BPINNOVA2 602266LAB2 956994INN1 773792CL3100 314768SMCL3 812238LIB1 812283IN31 FHORLCL1 409899LAB3 936266CL1 8613100 563421CATHLAB8 309691P3100 956994INN2 817433HSW3100 803329CL31 413540IN1 601553CL3 608524NOVA 850678IN3100 714966INNOVA 7083333100 619541INNOVA31 904202CATH3 615769SKYCV2 201541LAB2 615338CV2 718283INNOVA3 773NORWG3100 5034353100 4103623100 8019643100 7278253100 505662NOVA 378INV31 AH4300XR03 910064009 910163012 910163013 910163015 910064007 910064008 910162006 910162008 910163006 910163007 910163009 BA4080VA01 140024RX09 2573329 BE5003VA02 82416040018 82416290001 82416140003 82416130018 82416080001 82416010006 82416020004 82416030006 82416040015 82416040019 82416100013 82416110003 82416120010 82416140002 82416150001 82416160008 82416160009 82416190004 82416190001 82416190002 82416190003 82416210006 82416210008 82416220008 82416270002 82416300001 82416310003 82416310006 82416170002 82416030003 82416100006 82416100010 82416120007 82416130015 82416160006 82416210003 82416210004 82416220009 82416130017 82416040016 82416070004 82416070003 82416040010 82416100008 82416120006 82416120005 82416050002 82416040017 2625365INNOVA 2645993INNOVA CS1006VA03 HC4348XR01 HC1536XR04 DK1066VA01 FPG86403 FPG93008 DPM32143 DPN88402 FI1064VA01 M2030709 M4163030 M4166988 M5480755 M6083613 M2848425 M2970614 M4016034 M40480151 A9190149 M40480167 GE1005VA01 GE1004VA01 H1420VAS04 24516572980IN HU1099VA04 IQ1083VA01 IR1747VA01 A5127281 A5112597 A5162256 A5333035 A5812244 B5274834 B5332001 B5810907 A5125119 A5108239 A5203215 JO1000VA01 YV0048 YV0033 YV0034 YV0035 YV0038 YV0039 YV0040 YV0042 YV0043 YV0044 YV0045 YV0046 YV0047 YV0023 YV0024 YV0025 YV0027 YV0028 YV0029 YV0030 YV0031 YV0032 YV0037 YV0036 YV0026 YV0022 850060719 850060724 850060726 850060727 850060728 LB1160XR07 LV4012VA01 52XVINN2565367 477XVIN2553211 834160003 NO1005VA05 920169007 2048000INNOVA PL1082VA01 PL1622VA01 600050VA02 PL1681VA01 PL1688VA01 600098VA01 RU1482VA02 RU1142VA01 RU2581VA01 RU2457VA01 RU1550VA01 RU1156VA01 RU1449VA01 RU1457VA01 RU3092VA01 RU1692VA01 RU2741VA01 RU1001VA02 600130VA01 SA1010VA02 TN1016VA01 01012VAS01 41018VAS01 58002VAS01 60001VAS01 06074VAS01 853060194 388567772VASMET 3882569347VAMET;
d) 3184734100 706774USP3 6309784100 6616324100 304256INNOVA 2035764100 352596SPEC 5135844100 719560INN41 303320OR41 303436ANGIO 3027444100 574294IN41 239939INNOVA 864255SF4100 3016094100 414649CL2 812858GWSP 212639ACT1 8014794100 4134474100 5033704100 509474SH41 201541SP1 281401T4100 918744JR4100 22925941V2 SHOWCASE4100 317887INNOVAPV 330489SPEC9 352333INVOR 386254HS1 386254HS2 386HPOS1 404GHSIR1 412647OR10 414649DVI 419696LAB1 505848V4100 508650IN41 509482HFI 512901NI4100 530888ANG206 541686SPR1 570321LAB2 610988INNOVA4 617636IN1 619229INNOVA1 623848SP 630275G41 630275G41B 650493ANGIOCT 662244GTSP 678EJCIR1 706291RINN2 706651SP1 706733SP1 708783SP4100 713375U4100 718630LIBERTY 727791INNOVA 770535N4100 803256SP 804594ANGIO 812238UN41 812825INNOVA1 813615CL10 817465AR4100 817922BA4100 843577CL2 845368RM10 850747IN4100 863687INV24 864573LAB2 865373SP 865481SUR 908522SP1 915577SP1 918682IN41 954MW4100 COR359867 DR4100 PEMBROKE4100 RADNETXV1 RHD4100 423495M4100E 423493I4100 8593134100 708WESTSUB4100 80140841 80180741 2194654100 4082594100 4105434100 4137484100 5094744100 5417684100 5703214100 5705224100 6082634100 7028804100 219326IN41 229228INNOV41C 22925941V 252816INNOVA 269226IN1 269226IN2 269983IN41 303839CL1 308534ANG 313876SP41 316651INNOVA41 317338PV3 360754INNOVA 401274IN41 412623LAB1 412623LAB3 414328INN4100 419251LAB1 508383IN4100 603650ANG1 608263ACT 608263XMR 617726RF2Y6 626359INNOVA 706291RINN 718206LIBERTY1 760633IR1 773878SWGANGIO1 801268INNOVA 804285CATH2 804764CATH3 810342A41 813558INTV 816943SP1 817433HSW4100 828298VASC 847842GS4100 856365ANGIO 903GS4100 904202SP1 904BSSP 952993INNOVA2 972335LIB 972566INNOVA3 985867INNOVA2 MIRAMAR41 WCATHLAB41 334286BSP 706278INNOVA1 561747IN4 252847PRS2 918744JC4100 850494WSP1 252816INNOVA 804594CATH 574535IN41 813745INTV 813972INTV 229228INNOV41V 508856OR41 717763INNOVA41 865541CCL5 SLIN4100 717763OR4100 239436CATH1 609652CATH3 80158241 216844INNOVA 77573841 727819SPSC ECXVINNOVARST3 404GHSIR2 989466INNOVA 404616INNOVA 352333VASC 812279INNOVA1 901726SP2 817255NH4100 828696IN41 304347INNOVA 918307SHIN4 724656ANG 757736INNOVA 315448RM4 941483INNOVA41 515263IL4100 4103374100 5138534100 8595724100 352401CATH 6029234100 5134754100 816276SP1 903CSM4100 319338VA4100 715369INN4100 407518SP3 956632INN4100 407518SP2 414961INN4100 904276SP 614293LIBERTY1 325670CATH 251435ICV5 315448RM5 573761SMA 3018774100 865693CCL3 614293LIBERTY2 229434INNOV 757398INNOVA 574647IN41 205759CL2 304255INNOVA 352401VASC 407SPECIALS 6012884100SP1 4438494100 740592INNOVA 804320CATH2B 478633INOV 8159374100 910063039 190020RX09 BG4037XR01 BE5005VA01 82406070010 82406310005 82416100016 82416130020 82416130021 82416130025 82416220006 82406120016 82416130010 82416130011 82416130013 82416160005 82406010011 82416130012 514842AINNOVA 613548INNOVA3 4163694100 250370INNOVA 306766INNOVA 416756INNOVA 519685INNOVA CS1054VA01 HC0220XR07 487692XR01 FI1015VA02 FI1015VA01 M1230007 00490VAS02 01278VAS01 10091VAS01 00137VAS01 00171VAS01 HU1039VA02 IE1100VA01 IL1043VA01 8.30062E+13 A5102671 A5163317 A5605732 C5603903 B5801711 XF0150 XF0151 XF0152 XF0153 XF0154 XF0155 XF0200 YV0007 XF0022 XF0149 YV0004 YV0003 YV0005 850060718 850060720 850060721 850060722 850060725 850060707 0850BOSNIA1 KW1001VA03 KW1018VA04 KW1013VA01 LB1037VA01 MA1020VA01 BRD0411 NO1015VA04 600042VA02 600050VA01 787620IN4100 787653INNOVA 600152VA01 RU1018VA03 RU1106VA02 SA1005VA06 SA1188VA03 06004VAS02 853060187;
e) 2000- ECXV1406C 812450CATH2 256880IN1 508856IN4 615316INOV2 610988INNOVA1 310540INNOVA 210297NECATH1 314966DCL2A 213977INNOVA1 650696INV1 865541CCL2 415206CATH 609653INNOVA 732776CATH5 985867INNOVA1 615327CV2 FHORLCL6 315448RM3 573472CATH 315448RM1 315448RM2 865541CCL1 318448INNOVA 636916SPCL1 410543CATH6 606439INNOVA 801373EP 423495CHIRM1 316268INNOVAEP 973971LAB1 440835INNOVA 801373CATH1 718780CATH1 801373CATH2 AL9INNOVAVAN 865481CCL1 518525LAB2 708425INNOVA1 408259INV 610270INNOVA 207795CL2 619260INNOVA 516663INNOVA1 860210CV 610954INNOVA2 717270INNOVA1 803329CL20 920288CATH2 865693CCL5 702731INNOVA2 601553CL2 831624INV1 936266CL2 775982CATH3 832355SMIN 713897CIN 636947JCL3 861EP2 717544CATH4 407518OPCL 330375LAB1 801429INNOVA 701234GE2 701234GE3 610988INNOVA3 918494IN2A 920015947 219947EP 336832MCCL1 DR2000 ECXV1401A 773878WCL 217258CATH MCTHSC2 717763INNOVA2 713776MINNOVA 508798INC2 626915INNOVA 920288CATH1 615222STCL3 540932INNOVA 541282CV1 361788NOVA 727825CATH 262243INNOVA1 352344CATH1 414291CL3 FHVIN2000 817255NH2000 410614CV7 719560HCL2 603668CLCB 352INVCATH 512341RI 219465CL1 612467INNOVA1 602239LAB1 918307SHIN1 619739INNOVA 918307SHIN2 805497INNOVA1 513559INNOVA 414219INNOVA 707546INNOVA 940384INNOVA2 573632CRC1 904202CATH1 206598INNOVA1 972540INN 972335INN 405272SCL4 615284CV2 312792RINOV2 480512IN1 423844CCL2 516562INNOVA5 309691HCL1 502587LAB3 229259INOV2 718226INNOVA1 904202CATH2 219465EP 619457INNOVA3 843692INNO 843674INNOVA 401274IN3 419227CL3 619691INNOVA 940764INOV1 940764INOV3 563421CATHLAB7 513861INNOVA 614293INNOVA3 561798CL1 208381INNOVA 212746J412 816932HRT2 803256PEP1 940764INOV2 623848LAB1 415750SCL2 WCATHLAB2000 KMCINNOVA 817922INNOVA 205783BCL4 330837INNOVA 570969CATH 615327CV1 727521CATH3 773STJINNOVA200 619340VA7 601268INNOVA1 512447SI2 256386IN1 407321INCL1 773878SWGCATH1 615222STCL5 503215INNOVA 281351TINNOVA 920926CATH1 903798WINN 209526ICATH1 805497INNOVA2 717270INNOVA2 717544CATH1 215728INNOVA 773878SWGCATH2 732776CATH1 573761SMC1 760633INNOVA 239436CATH2 973971EP2 412647LABA 859233INNOVA2 610988INNOVA2 412647LABB 812283IN20 908668INNOVA 724773C2 718918CATH1 443849INNOVA 610447CL2 708202VA2K 856342INNOVA 952993INNOVA4 952993INNOVA3 859233INNOVA1 814534C1 719776EP1 281893INNOVA 502587LAB5 317621EP2 478765CTH2 718963INNOVA1 718226INNOVA2 708597EP 478765CTH1 910162005 910163008 0910162004A 910163010 910163004 1157760 BE5006VA01 82416100005 82416120002 82416130009 82416220005 82416220004 82416220007 82406140020 82416210002 82416040008 82416030002 82416010004 82416160004 82416040013 82416210005 82416200006 82416040007 82416120003 82416120004 82416050001 82416310005 82416310004 613548INNOVA2 905895INNOVA1 514843AINNOVA 819563CINNOVA2 514376CARDIO 604682INNOVA 905895INNOVA2 905895INNOVA3 266150XR14 2575962INNOVA HC1536XR02 HC5533XR08 HC1627XR20 HC5546XR09 UC3287XR05 HC3285XR06 HC3121XR01 DZ1027VA01 EG1003VA01 EG1524VA01 ME256638 DE203229 FE421134 FEE08424 FEE12418 M2030707 E4167627 M4163751 M2147243 M2569312 M2002611 A9793302 X100378801 M2208714 S4160056 X76305701 B4498640 B4498642 M4046541 M4159626 M1327506 01224VAS02 00577VAS04 00159VAS03 00577VAS03 10238VAS01 00391VAS01 10044VAS01 00463VAS05 01245VAS01 10100VAS05 00162VAS03 10100VAS04 01224VAS03 00171VAS02 00285VAS03 00285VAS02 00490VAS01 00327VAS01 00506VAS01 10086VAS03 00424VAS01 00285VAS01 10501VAS01 00529VAS01 H2015VAS15 H2009VAS17 828060057 HU1044VA01 835160015 835160019 IE1018VA02 IE1029VA01 IE1031VA04 IE1006VA01 IL1098XR02 8.30168E+13 8.30162E+13 8.3016E+13 8.30162E+13 8.30168E+13 8.30161E+13 8.30168E+13 8.30162E+13 8.30168E+13 8.30166E+13 8.30162E+13 8.30168E+13 8.30166E+13 8.30168E+13 8.30166E+13 8.3016E+13 8.30168E+13 IR1632VA03 IR1667VA01 A5113511 A5189713 A5807006 A5203209 A5108714 A51152101 A5130609 A5108235 A5129951 A5129954 A5359404 A5129022 C5343110 A5129953 B5418905 A5730901 YX1487 YX1486 YX1492 YXZ471 YX1493 YX1494 YX1491 850060711 850060715 850060709 850060708 850060710 850060712 850060713 850060714 850060717 LB1050VA02 LWD0302 NO1064VA01 PK1251VA01 PL1101VA02 PL1008VA01 PL1529VA01 809840INNOVA 809852INNOVA RU1070VA01 600107VA01 RU1016VA01 RU1463VA01 RU1717VA01 RU2167VA01 SA1054VA01 SA2045VA01 SY1007VA01 SY2011VA01 856160001 856160003 856160004 856160005 TN1194VA01 TN1012VA01 TN1059VA01 07010VAS01 06070VAS01 16016VAS01 853060179 388558268VASAND 388256938VASMET 3882591464VAMET;
f) ECXV1402B 4146492121 COR373252 N4192939
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, by letter dated January 14, 2008.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
Risk of sudden table drop.
VOLUME OF PRODUCT IN COMMERCE
1,684 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Bausch & Lomb Millennium Phacoemulsification Needles, Needle Tapered Hub 15
Degree, REF DP8115, 6 needles per pouch, nonsterile, Recall # Z-2044-2008;
b) Bausch & Lomb Millenium Phacoemulsification Needles, Needle Tapered Hub 30
Degree, REF DP8130, 6 needles per pouch, nonsterile, Recall # Z-2045-2008;
c) Bausch & Lomb Millenium Phacoemulsification Needles, Needle Tapered Hub 45
Degree, REF DP8145, 6 needles per pouch, nonsterile, Recall # Z-2046-2008;
d) Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip 15
Degree, REF DP8415, 6 needles per pouch, nonsterile, Recall # Z-2047-2008;
e) Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip 30
Degree, REF DP8430, 6 needles per pouch, nonsterile, Recall # Z-2048-2008;
f) Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip Angled
30 Degree, REF DP8430A, 6 needles per pouch, nonsterile, Recall # Z-2049-2008;
g) Bausch & Lomb Millenium Phacoemulsification Needles, Needle Microflow 2.2
30 Degree, REF DP8730, 6 needles per pouch, nonsterile, Recall # Z-2050-2008;
h) Bausch & Lomb Millenium Phacoemulsification Needles, Needle Frag 15 Degree,
REF MVS 1600A, 6 needles per pouch, nonsterile, Recall # Z-2051-2008;
i) Bausch & Lomb Millenium Phacoemulsification Needles, Needle Frag 60 Degree,
REF MVS1601A, 6 needles per pouch, nonsterile, Recall # Z-2052-2008;
CODE
a) Lot number 3168901;
b) Lot numbers 3168943, 3169532, 3169835, 3170331, 3170923, 3171342,
3171562, 3171566, 3172013, 3172110, 3172318, 3172319;
c) Lot numbers 3169597, 3170626, 3171091, 3171345, 3171567, 3171819,
3172014, 3172111, 3172320, 3172619;
d) Lot numbers 3168902, 3171340, 3172112, 3172321, 3172885;
e) Lot numbers 3169293, 3169294, 3170628, 3171200, 3171343, 3171344, 3171560,
3171561, 3171817, 3172015, 3172113, 3172114, 3172322, 3172527, 3172529;
f) Lot numbers 3169954, 3169955, 3169977, 3171339, 3171565, 3171820, 3172323,
3172525, 3172886;
g) Lot numbers 3167767, 3169291, 3170562, 3171088, 3171199, 3171346, 3171564;
h) Lot number 3171341;
i) Lot number 3168937
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb, Inc., Rochester, NY, by letters dated March 26, 2008.
Manufacturer: Accellent, Inc., Orchard Park, NY. Firm initiated recall is ongoing.
REASON
The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and non-reusable.
VOLUME OF PRODUCT IN COMMERCE
4,055/6-needle packages
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
EasyVision RAD - Radiological Image Processor, software versions: SW R4 2V2L2, SW R4 2V2L3, SW R4 2V2L4, SW R4 2V2L5, SW R4 2V2L6, and SW R4 2V2L7. The EasyVision RAD consists of a computer with digital interfaces, one or two (optional) monitors with keyboard and mouse, and software. The viewing, analysis, processing and printing functions are sent to the EasyVision by means of PMSNet (Philips Medical Systems communication protocol). The main image source for the PCR (Philips Computed Radiography) system is the CR-Reader. Remote database access and image transfer functions are implemented using the DICOM Query/Retrieve and Storage services. The EasyVision RAD provides the following features: receives images sent to it by remote applications (e.g. workstations or imaging modalities) and stores them in a local database; allows the operator to copy images from the local database to remote databases and vice versa; allows a remote system to query the EasyVision local database and to retrieve images from it; allows the operator to view, analyze, process and print the images stored in the local database. Operator may print images stored in the database on a DICOM printer, and is able to read and write DICOM CD-R disks. The device allows processing of and access to the stored raw data so that an image can be post-processed using different image processing algorithms. Part numbers and cooresponding software version in: 9896 050 03232 (SW R4 2V2L2), 9896 050 03233 (SW R4 2V2L3), 9896 050 03234 (SW R4 2V2L4), 9896 050 03235 (SW R4 2V2L5), 9896 050 03236 (SW R4 2V2L5, not delivered to the US), 9896 050 03237 (W R4 2V2L6), and 9896 050 03238 (W R4 2V2L7)., Recall # Z-2053-2008
CODE
Site ID: 540176, 540154, 534389, 534391, 521504, 521505, 521506, 521670, 521672, 521673, 521376, 534390, 521328, 521375, 521379, 104351, 104354, 104355, 104356, 104357, 521374, 521381, 534392, 534395, 104353, 534830, 534865, 535443, 535445, 535446, 546779, 540166, 521382, 540180, 540181, 540179, 504854, 102954, 102955, 102942, 105492, 505042, 505043, 534936, 86442, 520994, 520995, 521692, 521693, 521710, 521834, 522170, 104166, 519567, 533563, 102123, 532780, 103361, 531781, 533089, 533120, 533779, 533782, 533783, 533784, 533785, 533899, 534249, 506123, 506177, 506836, 506837, 505266, 541000, 541001, 105920, 105767, 505230, 104192, 104757, 104759, 104760, 104761, 104762, 105768, 505683, 531848, 531849, 531851, 531853, 537547, 102125, 102126, 102127, 506300, 506301, 506302, 506303, 506304, 531845, 531846, 536186, 102121, 105702, 533813, 105381, 105170, 105706, 105709, 506023, 506025, 506127, 519528, 104363, 105162, 105701, 250408, 519157, 520528, 520991, 520992, 530694, 105383, 105398, 105400, 105401, 105698, 505489, 519837, 87167, 105697, 105710, 105711, 105712, 105782, 105907, 505842, 505843, 505844, 534167, 536167, 539032, 105632, 521453, 535448, 521454, 521937, 521938, 105168, 105172, 536086, 536593, 536595, 102643, 105384, 104350, 105161, 105163, 105175, 250063, 250077, 250078, 519572, 520164, 520671, 522174, 522176, 534383, 542527, 506399, 506400, 506551, 506552, 519840, 522259, 105166, 522262, 105936, 535449, 103978, 103979, 104011, 105320, 520684, 521674, 532073, 532108, 532109, 534384, 104053, 104006, 504357, 103326, 103567, 104362, 505121, 505128, 505133, 506204, 519806, 519885, 520047, 521006, 522256, 531850, 83034, 83035, 83036, 86029, 86030, 86239, 86240, 87150, 87151, 87152, 87166, 100920, 100922, 100923, 100956, 101306, 101646, 101696, 101698, 101892, 102029, 102145, 102146, 102147, 102644, 102831, 102832, 102906, 103042, 103177, 103205, 103226, 103294, 103339, 103565, 103578, 103706, 103715, 103810, 103822, 103824, 103825, 103853, 103914, 103918, 103940, 103973, 103974, 104031, 104092, 104344, 104352, 104522, 104524, 104525, 104527, 104538, 104582, 104583, 104633, 104677, 104790, 104970, 105164, 105171, 105173, 105192, 105231, 105321, 105354, 105669, 105704, 105893, 105962, 504740, 504880, 504881, 505004, 505051, 505092, 505122, 505123, 505124, 505126, 505127, 505129, 505130, 505131, 505132, 505667, 505889, 506154, 506294, 506351, 506352, 506395, 506444, 506472, 506780, 506847, 506849, 519108, 519109, 519110, 519111, 519112, 519123, 519647, 519876, 519877, 519878, 519882, 519884, 520243, 520407, 520408, 520672, 520673, 520683, 520685, 520686, 520704, 520757, 520763, 520767, 520771, 520782, 520786, 520788, 520789, 520790, 520796, 520797, 520931, 520962, 520963, 520970, 520972, 521052, 521112, 521230, 521447, 521517, 521519, 521746, 521827, 521865, 521891, 521963, 522175, 522196, 522217, 522246, 522252, 522371, 522460, 522474, 530402, 530414, 530561, 530563, 530606, 530627, 530674, 530758, 531831, 532071, 532270, 532276, 532277, 532475, 532476, 532784, 533241, 533247, 533321, 533529, 533561, 534379, 534381, 534407, 534430, 534601, 534626, 535410, 535442, 535679, 536615, 537529, 539244, 539371, 539937, 541901, 542525, 543598, X1776
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America, Co. Phillips, Bothell, WA, by letters on March 14, 2008.
Manufacturer: Philips Medical Systems Gmbh, DMC, Hamburg, Germany. Firm initiated recall is ongoing.
REASON
Inaccurate measurements when exporting radiography images to Picture Archiving and Communications System (PACS).
VOLUME OF PRODUCT IN COMMERCE
401 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) OmniFit HFx X-ray Templates, Literature No.: LTEM80 1-7; The device consists of a
pattern or guide intended for medical purposes, such as selecting or positioning
orthopedic implants or guiding the marking of tissue before cutting,
Recall # Z-2054-2008;
b) OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1. The device consists
of a pattern or guide intended for medical purposes, such as selecting or positioning
orthopedic implants or guiding the marking of tissue before cutting, Recall #
Z-2055-2008
CODE
a) Literature Number: LTEM80 1-7;
b) LHFX-SS rev 1; Literature Number: LCEA-B
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on March 9, 2005. Firm initiated recall is complete.
REASON
The OmniFit HFx Templates were produced without a warning statement indicating a potential function of fit issue when using -3mm and -5mm heads or sleeves on certain stems.
VOLUME OF PRODUCT IN COMMERCE
Templates - 865 units; Sell Sheets - 1,919; Cutting Edge - 810
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantization of phenytoin in human serum or plasma, Recall # Z-2059-2008
CODE
Lot Numbers: 42036HW00, 44084HW00, 45051HW00, 47055HW00, 50039HW00, 52013HW00, 55015HW00, 59088HW00
RECALLING FIRM/MANUFACTURER
Abbott Laboratories Inc., South Pasadena, CA, by letter on February 15, 2008. Firm initiated recall is ongoing.
REASON
An Abbott investigation has determined that the phenytoin reagent does not maintain an onboard stability of 28 days as stated in the phenytoin package insert. In addition, the 14 day calibration interval is also not being met. Further investigation is required to determine the root cause of this issue. Until the cause has been determined and a corrective action defined, specific instructions are provided.
VOLUME OF PRODUCT IN COMMERCE
3266 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile. The
device is intended to be used in conjunction with a Radio Therapeutics Corporation
radiofrequency (RF) generator for thermal coagulation necrosis of soft tissue,
including partial or complete ablation of nonresectable liver lesions, Recall #
Z-2091-2008;
b) Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile. The
device is intended to be used in conjunction with a Radio Therapeutics Corporation
radiofrequency (RF) generator for thermal coagulation necrosis of soft tissue,
including partial or complete ablation of nonresectable liver lesions, Recall # Z-2092-
2008;
c) Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/15 cm, sterile. The
device is intended to be used in conjunction with a Radio Therapeutics Corporation
radiofrequency (RF) generator for thermal coagulation necrosis of soft tissue,
including partial or complete ablation of nonresectable liver lesions, Recall # Z-2093-
2008;
d) Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile. The
device is intended to be used in conjunction with a Radio Therapeutics Corporation
radiofrequency (RF) generator for thermal coagulation necrosis of soft tissue,
including partial or complete ablation of nonresectable liver lesions, Recall # Z-2094-
2008;
CODE
All lots
RECALLING FIRM/MANUFACTURER
Boston Scientific, Corp., Spencer, IN, by letters on October 1, 2007. Firm initiated recall is complete.
REASON
The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
VOLUME OF PRODUCT IN COMMERCE
15,604 devices
DISTRIBUTION
Japan
___________________________________
PRODUCT
Artisan Control Catheter, model number 04454. Steerable guide catheter for human use intended to facilitate manipulation, positioning and control for collecting electrophysiological data within the heart atria, Recall # Z-2106-2008
CODE
Lot numbers: 2182, 2185, 2186, 2199, 2200-2203, 2205, 2206, 2008, 2213-2218, 2220, 2223-2231, 2233, 2234, 2236-2245, 2247, 2249, 2251, 2261-2263, 2265, 2267-2271, 2273, 2274, 2276-2279, 2284, 2288-2297, 2301-2303, 2305, 2309, 2315, 2318, 2320-2322, 2324, 2327, 2328, 2330, 2332, 2334, 2342, 2344-2349, 2351, 2353, 2355-2357, 2359-2363, 2366-2367, 2370, 2370, 2374-2375, 2377-2378, 2381-2382, 2384, 2387-2389, 2391, 2392, 2394,2395, 2397, 2399, 2400, 2404, 2405, 2412, 2417, 2420, 2421, 2423-2426, 2429, 2430, 2432-2434, 2436, 2442, 2444, 2446-2448, 2450, 2453, 2457-2461, 2463-2467, 2469-2472, 2475-2483, 2485-2490, 2494, 2497, 2500, 2502-2504, 2508, 2510, 2512-2518, 2522, 2526, 2529, 2531-2532, 2534, 2536, 2538, 2539, 2547, 2549, 2551, 2553, 2556, 2558-2560, 2562-2565, 2568, 2569, 2571, 2574-2577, 2579, 2581-2582, 2586, 2588-2589, 2591-2596, 2601, 2604, 2609, 2610, 2612, 2617, 2619, 2626, 2627, 2636, 2637, 2639-2642, 2644, 2675, 2682, 2684, 2685, 2688, 2689, 2698-2699, 2701-2707, 2709, 2716, 2720, 2722-2723, 2726-2727, 2729, 2732-2735, 2738, 2741, 2743, 2745, 2746, 2752, 2754-2757, 2761, 2767, 2773-2774, 2776, 2779, 2782, 2783, 2785-2789, 2791, 2797-2798, 2801, 2803-2804, 2806, 2809, 2812, 2814-2815, 2817-2818, 2821, 2822, 2824, 2827, 2829-2831, 2833-2837, 2839, 2843, 2848, 2850, 2854, 2857, 2862, 2865, 2872, 2879, 2882, 2886, 2888, 2889, 2894, 2896, 2898, 2904, 2908-2909, 2913, 2915, 2920, 2922, 2924, 2925, 2930, 2932, and 2940
RECALLING FIRM/MANUFACTURER
Hansen Medical, Inc., Mountain View, CA, by letter and verbally on May 21, 2008. Firm initiated recall is ongoing.
REASON
The catheter's flexible bellows portion may develop a leak. This has the potential to cause loss of homeostasis, flush fluid leakage, and/or introduction of air into the catheter with a risk of subsequent embolism.
VOLUME OF PRODUCT IN COMMERCE
369 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Fountain Infusion System, 4F, REF IS4-90-50, Sterile. Continuous flush catheter intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient, Recall # Z-2107-2008
CODE
Lot numbers: F496042, and F587928
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by letter on May 14, 2008. Firm initiated recall is ongoing.
REASON
Catheters were packaged with occluding wires that were too long for the catheter. Potential for wire to not occlude the catheter appropriately, allowing the wire to exit the tip of the catheter further than intended, posing a potential risk of physical damage to the patient.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites, Recall # Z-2133-2008
CODE
Lot Numbers: 792457 and 7A2667
RECALLING FIRM/MANUFACTURER
I-Flow Corporation, Lake Forest, CA, by letters on February 14, 2008. Firm initiated recall is ongoing.
REASON
Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label.
VOLUME OF PRODUCT IN COMMERCE
220 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Vacuette, Plastic Cannula HOLDEX®, Ref 450216, Single packed, sterile, single use disposable tube holder with off center plastic cannula at the top and a stainless steel needle on the underside of the holder. It is intended for use in routine specimen withdrawal from collection bags or bottles through needless cannula ports, Recall # Z-2134-2008
CODE
Lot #A10074, A100745, A100746, A100747, A110749, and A110750
RECALLING FIRM/MANUFACTURER
Recalling Firm: Greiner Bio-One North America, Inc., Monroe, NC, by letter on/about May 16, 2008.
Manufacturer: Greiner Bio-One Gmbh, Kremsmunster, Austria. Firm initiated recall is ongoing.
REASON
At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out.
VOLUME OF PRODUCT IN COMMERCE
1,606,005 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic Part Number: 9043K2101. (9043K2111 is the OUS version) The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Correct Overflow lid: Medela CH-6341 Baar Switzerland Art. No. 077.0440, Small lid with conical patient connection 6-10mm and overflow protection device.(Incorrect overflow lid is Medela P/N: 077.0450), Recall # Z-2168-2008
CODE
Serial #: 1163101 - 1163120
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letter April 2008.
Manufacturer: Medela AG Medical Technology, Baai. Firm initiated recall is ongoing.
REASON
Some Medela Vario 18 Vacuum Pumps were provided with an incorrect suction Jar Lid that did not have the correct conical connection for the Vacuum Tube.
VOLUME OF PRODUCT IN COMMERCE
1,500 units (20 affected)
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. This product is used for the intracytoplasmic single sperm injection of oocytes, Recall # Z-2178-2008
CODE
Lot #: 72169
RECALLING FIRM/MANUFACTURER
Cook Vascular, Inc., Vandergrift, PA, by email on December 14, 2007 and letters on December 18, 2007. Firm initiated recall is complete.
REASON
Mislabeled – 300 micron flexipets were labeled as 80 microns.
VOLUME OF PRODUCT IN COMMERCE
80 vials
DISTRIBUTION
TN, NJ, MD, Indonesia, Australia, and Ireland
___________________________________
PRODUCT
Zimmer 4.5 Compression plate-broad, 10 hole, 167 MM length, stainless steel, non sterile, Manufactured at Zimmer; REF 4945-10-01. The product is used for stabilization of fractures during the normal healing process, Recall # Z-2179-2008
CODE
Lot: 60985554
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated June 9, 2008.
Manufacturer: Zimmer Manufacturing B.V. Mercedita, PR. Firm initiated recall is ongoing.
REASON
An impurity in the metal may affect the strength of the plate or biocompatibility of the material with the body.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Internationally
___________________________________
PRODUCT
Varian Medical Systems FastPlan, versions 5.5 and 5.5.1, model number HZ3. The product is a radiation treatment planning system, Recall # Z-2195-2008
CODE
Serial numbers HZ30495 HZ30077 HZ39010 HZ30021 HZ30398 HZ30540 HZ30698 HZ32020 HZ32054 HZ38006 HZ30258 HZ30110 HZ39011 HZ30033 HZ30403 HZ30556 HZ30703 HZ32021 HZ32056 HZ38062 HZ30737 HZ30111 HZ39012 HZ30054 HZ30404 HZ30557 HZ30727 HZ32024 HZ32058 HZ39018 HZ30273 HZ30112 HZ39013 HZ30061 HZ30407 HZ30571 HZ30731 HZ32026 HZ32059 HZ39066 HZ32023 HZ30154 HZ39014 HZ30131 HZ30422 HZ30572 HZ30740 HZ32028 HZ32060 HZ39071 HZ39019 HZ30181 HZ39015 HZ30144 HZ30426 HZ30574 HZ30762 HZ32029 HZ32062 HZ39165 HZ30630 HZ30182 HZ39016 HZ30171 HZ30460 HZ30588 HZ32001 HZ32032 HZ32063 HZ39997 HZ32045 HZ30190 HZ30178 HZ30207 HZ30461 HZ30612 HZ32002 HZ32033 HZ32064 HZ39998 HZ32046 HZ30368 HZ30283 HZ30208 HZ30462 HZ30617 HZ32004 HZ32034 HZ32065 HZ30743 HZ30108 HZ30500 HZ30167 HZ30224 HZ30485 HZ30620 HZ32005 HZ32035 HZ32069 HZ32025 HZ30139 HZ30712 HZ32019 HZ30230 HZ30507 HZ30640 HZ32006 HZ32036 HZ32071 HZ32027 HZ30594 HZ32013 HZ30280 HZ30251 HZ30508 HZ30646 HZ32007 HZ32037 HZ32072 HZ30624 HZ32052 HZ30573 HZ30265 HZ30509 HZ30649 HZ32008 HZ32044 HZ32073 HZ30604 HZ39001 HZ32040 HZ30293 HZ30510 HZ30656 HZ32010 HZ32047 HZ32074 HZ32003 HZ39002 HZ32061 HZ30294 HZ30511 HZ30670 HZ32012 HZ32048 HZ32077 HZ30219 HZ39004 HZ30032 HZ30312 HZ30513 HZ30674 HZ32014 HZ32049 HZ35070 HZ30019 HZ39005 HZ30730 HZ30330 HZ30520 HZ30675 HZ32016 HZ32050 HZ36101 HZ30044 HZ39006 HZ32009 HZ30342 HZ30531 HZ30681 HZ32017 HZ32051 HZ36102 HZ30058 HZ39007 HZ30001 HZ30349 HZ30537 HZ30684 HZ32018 HZ32053 and HZ37015
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on May 29, 2008. Firm initiated recall is ongoing.
REASON
Due to issues with image orientation verification, a patient may receive all or some of prescribed high dose to healthy tissue instead of intended area.
VOLUME OF PRODUCT IN COMMERCE
182 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
CABG PACK, Surgical Convenience Kit, Sterile, Reorder #: K12T-02449B. A combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the products’ intended uses, Recall # Z-2197-2008
CODE
Lot Number: V583783
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merit Medical Systems, Inc., South Jordan, UT, by letter on March 13-14, 2008.
Manufacturer: Linvatec Corp., Largo, FL. Firm initiated recall is complete.
REASON
Component of convenience kit may not be sterile.
VOLUME OF PRODUCT IN COMMERCE
36 kits
DISTRIBUTION
PA
___________________________________
PRODUCT
Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery, Recall # Z-2199-2008
CODE
Lots# 790554, 790555, 807340, 799305, 807340, 790082, and 808640
RECALLING FIRM/MANUFACTURER
Biomet 3i, Inc., Palm Beach Gardens, FL, by telephone and letter on May 9, 2008. Firm initiated recall is ongoing.
REASON
The drill malfunctions while in use. The drill has been observed to become lodged in the handle.
VOLUME OF PRODUCT IN COMMERCE
182 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400, IUP-400S, IUP-450, IUP-450S, IUP-500, IUP-550, IUP-600, IUP-600S, IUP-650, IUP-650S, IUP-700, IUP-750, Sterile, Single Use, Recall # Z-2200-2008
CODE
Lot numbers less than 1072755. Also 1080086, 1080087, 1080088, 1080089, 1080091, 1080093, 1080095, 1080245, 1080246, 1080247, 1080248, 1080249, 1080250, 1080266, 1080296, 1080297, 1080298, 1080299, 1080301, 1080302, 1080393, 1080394, 1080395, 1080432, 1080610, 1080669, and 1080721
RECALLING FIRM/MANUFACTURER
Utah Medical Products, Inc., Midvale, UT, by letters beginning on June 16, 2008. Firm initiated recall is ongoing.
REASON
Possibility of compromised package sterility prior to the expiration date.
VOLUME OF PRODUCT IN COMMERCE
300,000 units
DISTRIBUTION
CA, KS, MO, NC, NV, TX, VA, WA and Japan
___________________________________
PRODUCT
740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN. Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals, Recall # Z-2203-2008
CODE
Serial Numbers: 0809834-0823035
RECALLING FIRM/MANUFACTURER
CAS Medical Systems, Inc., Branford, CT, by letter on June 24, 2008, Firm initiated recall is ongoing.
REASON
Software: Audible alarm may be silenced if changed from the factory setting.
VOLUME OF PRODUCT IN COMMERCE
820 units
DISTRIBUTION
Nationwide, Canada, Jordan, UK, France and Taipei
___________________________________
PRODUCT
da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System, Recall # Z-2204-2008
CODE
Serial numbers SG099, SG145, SG162, SG205, SG294, SG295, SG298, SG299, SG300, SG301, SG302, SG303, SG304, SG305, SG306, SG307, SG308, SG309, SG310, SG311, SG312, SG313, SG314, SG315, SG316, SG317, SG318, SG319, SG320, SG321, SG322, SG323, SG324, SG325, SG326, SG327, SG328, SG329, SG330, SG331, SG332, SG333, SG334, SG35, SG336, SG337, SG39, SG340, SG341, SG342, SG323, SG344, SG345, SG346, SG347, SG348, SG349, SG350, SG351, SG352, SG353, SG355, SG356, SG357, SG358, SG359, SG360, SG361, SG362, SG363, SG364, SG365, SG367, SG368, SG369, SG370, SG371, SG373, SG374, SG375, SG376, SG379, SG380, SG381, SG382, SG383, SG384, SG385, SG386, SG387, SG388, SG390, SG393, SG394, SG395, SG396, SG397, SG399, SG400, SG401, SG402, SG403, SG404, SG405, SG406, SG407, SG408, SG409, SG410, SG411, SG412, and SG413
RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc., Sunnyvale, CA, by letters, telephone and service visits beginning June 1, 2008. Firm initiated recall is ongoing.
REASON
Defective software chip may cause the system to fail and lock up.
VOLUME OF PRODUCT IN COMMERCE
112 systems
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Hospira Intralock Lipid Compatible 3-Way Stopcock, Item Number 423830401
Indicated for fluid flow directional control and for providing access port(s) for
administration of solutions, Recall # Z-2205-2008;
b) Hospira Monitoring Kit (PA Line) with 03ml Flush Device. Item Number: 460760451
Indicated for fluid flow directional control and for providing access port(s) for
administration of solutions, Recall # Z-2206-2008;
c) Hospira Left Heart Kit, Item Number: 46084053 Indicated for fluid flow directional
control and for providing access port(s) for administration of solutions, Recall # Z-
2207-2008;
d) ICU Medical, Inc. Cath Lab Kit W/3Port "ON" Manifold, Waste Bag, Syringe & TP4;
Item Number: AG7843 Indicated for fluid flow directional control and for providing
access port(s) for administration of solutions, Recall # Z-2208-2008
CODE
a) Lot Numbers: 49-208-YJ, 49-209-YJ, 49-210-YJ, 49-211-YJ, 49-212-YJ, 50-052-SN,
51-451-K4, 53-306-YJ, 54-499-K4, 54-569-SN, 55-915-K4, 56-752-LA, 56-912-YJ,
58-191-LA, 58-331-LA, 60-465-2A, 61-821-LA, 61-855-LA, 62-717-R5, 63-222-SN;
b) Lot Number: 41-501-LA;
c) Lot Numbers: 48-807-K4 and 61-844-K4;
d) Lot Numbers: 44-504-R5, 558884, 570634, and 603566
RECALLING FIRM/MANUFACTURER
Recalling Firm: ICU Medical, Inc., San Clemente, CA, by letter on June 11, 2008.
Manufacturer: ICU Medical de Mexico, S.A., Baja California, Mexico. Firm initiated recall is ongoing.
REASON
Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility.
VOLUME OF PRODUCT IN COMMERCE
490,998 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608 (single unit) This product has multiple uses, including ureteral dilation, anesthetic injection, stone displacement, contrast injection, and safety wire / guidewire placement. The "ACMI" Dual Lumen Catheter is a radiopaque ureteral catheter. Recall # Z-2226-2008
CODE
Lot Numbers: 7124026, 7131020, 7138014, 7152018, 7158015, 7169005, 7201018, 721 1016, 72I404l, 7227021, 7232046, 7253048, 7256034, 7263052, 7269089, 7276035, 7277024, 7284042, 7291034, 7296052, 7303068, 7306089, 7312076, 7324062, 7337052, 7 344047, 7347078, 7354102, 7361043, 8010043, 8017047, 8025006, 8031030, 8036057, 8045050, 8052064, 8059055, 8066067, and 8073030
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gyrus ACMI Corp., Southborough, MA, by letter dated June 25, 2008 and July 9, 2008.
Manufacturer: Primrose Medical, Inc., Walpole, MA. Firm initiated recall is ongoing.
REASON
Particulate matter in the catheter.
VOLUME OF PRODUCT IN COMMERCE
6,820 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Panda® iRes and Giraffe® Infant Warmers, labeled in part: Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology, Recall # Z-2227-2008
CODE
HDJL50229 HDJL50230 HDJL50231 HDJL50232 HDJM50087 HDJM50085 HDJL50290 HDJL50291 HDJL50292 HDJL50293 HDJL50512 HDJL50513 HDJL50514 HDJL50515 HDJL50516 HDJM50199 HDJM50200 HDJM50201 HDJL50279 HDJL50285 HDJL50496 HDJL50497 HDJL50498 HDJL50499 HDJL50500 HDJL50501 HDJL50502 HDJL50503 HDJL50504 HDJM50203 HDJL50256 HDJL50257 HDJL50327 HDJL50543 HDJL50539 HDJM50066 HDJM50067 HDJM50068 HDJM50008 HDJM50009 HDJM50010 HDJM50011 HDJL50489 HDJL50490 HDJL50492 HDJL50518 HDJL50519 HDJL50520 HDJM50088 HDJM50089 HDJM50090 HDJM50091 HDJL50233 HDJL50234 HDJL50235 HDJL50236 HDJL50190 HDJL50191 HDJL50192 HDJL50193 HDJL50194 HDJL50384 HDJL50385 HDJL50386 HDJL50387 HDJL50388 HDJL50389 HDJL50390 HDJL50391 HDJL50397 HDJL50398 HDJL50399 HDJL50400 HDJL50488 HDJL50491 HDJL50493 HDJL50494 HDJL50517 HDJL50521 HDJL50522 HDJL50523 HDJL50289 HDJM50069 HDJM50070 HDJL50457 HDJL50538 HDJL50472 HDJL50428 HDJL50429 HDJL50430 HDJL50432 HDJL50433 HDJL50434 HDJL50435 HDJL50364 HDJL50485 HDJL50318 HDJL50319 HDJL50320 HDJL50321 HDJL50322 HDJL50323 HDJL50324 HDJL50401 HDJL50402 HDJM50012 HDJL50311 HDJL50312 HDJL50313 HDJL50314 HDJL50478 HDJL50462 HDJL50463 HDJL50464 HDJL50380 HDJL50381 HDJL50524 HDJL50525 HDJL50526 HDJL50527 HDJL50270 HDJL50271 HDJM50016 HDJM50017 HDJM50018 HDJM50071 HDJL50540 HDJL50541 HDJM50053 HDJM50054 HDJM50098 HDJM50099 HDJM50101 HDJM50103 HDJM50105 HDJM50124 HDJL50166 HDJL50167 HDJL50168 HDJL50169 HDJL50170 HDJL50171 HDJL50172 HDJL50173 HDJL50174 HDJL50175 HDJL50176 HDJL50177 HDJL50303 HDJL50304 HDJL50305 HDJL50306 HDJL50307 HDJL50308 HDJL50309 HDJL50310 HDJL50466 HDJL50467 HDJL50470 HDJL50471 HDJL50365 HDJL50366 HDJL50367 HDJL50368 HDJL50369 HDJL50370 HDJL50371 HDJL50372 HDJL50373 HDJL50374 HDJL50379 HDJM50030 HDJM50031 HDJM50032 HDJM50033 HDJM50034 HDJM50035 HDJM50036 HDJM50037 HDJM50038 HDJM50039 HDJM50040 HDJM50041 HDJM50042 HDJM50106 HDJM50107 HDJM50126 HDJM50127 HDJM50128 HDJM50129 HDJM50130 HDJM50131 HDJM50132 HDJM50133 HDJM50134 HDJM50135 HDJM50136 HDJM50137 HDJL50254 HDJL50255 HDJM50073 HDJM50074 HDJM50075 HDJM50076 HDJM50077 HDJM50078 HDJM50079 HDJM50080 HDJM50081 HDJM50082 HDJL50461 HDJL50479 HDJL50246 HDJL50247 HDJL50248 HDJL50249 HDJL50250 HDJL50251 HDJL50252 HDJL50253 HDJL50315 HDJL50316 HDJL50300 HDJL50299 HDJL50301 HDJL50195 HDJL50196 HDJL50197 HDJL50198 HDJL50199 HDJL50200 HDJL50201 HDJL50202 HDJL50203 HDJL50204 HDJL50205 HDJL50206 HDJL50207 HDJL50208 HDJL50209 HDJL50210 HDJL50211 HDJL50212 HDJL50213 HDJL50287 HDJL50288 HDJL50473 HDJL50474 HDJL50475 HDJL50476 HDJL50477 HDJL50468 HDJL50469 HDJL50508 HDJL50509 HDJL50510 HDJL50511 HDJM50005 HDJM50006 HDJM50007 HDJL50448 HDJL50456 HDJL50458 HDJL50268 HDJL50269 HDJL50046 HDJL50047 HDJL50048 HDJL50049 HDJL50050 HDJL50051 HDJL50052 HDJL50053 HDJL50054 HDJL50055 HDJL50056 HDJL50057 HDJL50058 HDJL50059 HDJL50060 HDJL50067 HDJL50068 HDJL50069 HDJL50070 HDJL50071 HDJL50072 HDJL50073 HDJL50074 HDJL50075 HDJL50076 HDJL50077 HDJL50078 HDJL50079 HDJL50080 HDJL50081 HDJL50082 HDJL50083 HDJL50084 HDJL50085 HDJL50086 HDJL50087 HDJL50088 HDJL50089 HDJL50090 HDJL50091 HDJL50092 HDJL50093 HDJL50094 HDJL50095 HDJL50096 HDJL50097 HDJL50098 HDJL50099 HDJL50100 HDJL50101 HDJL50102 HDJL50103 HDJL50104 HDJL50105 HDJL50106 HDJL50107 HDJL50108 HDJL50109 HDJL50110 HDJL50111 HDJL50112 HDJL50113 HDJL50114 HDJL50115 HDJL50116 HDJL50117 HDJL50118 HDJL50119 HDJL50120 HDJL50121 HDJL50122 HDJL50123 HDJL50124 HDJL50125 HDJL50126 HDJL50127 HDJL50128 HDJL50129 HDJL50130 HDJL50131 HDJL50132 HDJL50133 HDJL50134 HDJL50135 HDJL50136 HDJL50137 HDJL50138 HDJL50139 HDJL50140 HDJL50141 HDJL50142 HDJL50143 HDJL50144 HDJL50145 HDJL50146 HDJL50147 HDJL50148 HDJL50149 HDJL50150 HDJL50151 HDJL50152 HDJL50153 HDJL50155 HDJL50156 HDJL50161 HDJL50162 HDJL50163 HDJL50164 HDJL50165 HDJL50237 HDJL50238 HDJL50239 HDJL50241 HDJL50242 HDJL50240 HDJL50243 HDJL50244 HDJL50245 HDJL50403 HDJL50404 HDJL50405 HDJL50406 HDJL50407 HDJL50408 HDJL50409 HDJL50410 HDJL50411 HDJL50412 HDJL50413 HDJL50414 HDJL50415 HDJL50416 HDJL50417 HDJL50418 HDJL50419 HDJL50420 HDJL50421 HDJL50294 HDJL50505 HDJM50083 HDJM50084 HDJL50273 HDJL50274 HDJL50506 HDJL50507 HDJL50295 HDJL50375 HDJL50376 HDJL50377 HDJL50378 HDJL50357 HDJL50358 HDJL50359 HDJL50360 HDJL50362 HDJL50383 HDJM50072 HDJL50317 HDJL50356 HDJL50459 HDJL50460 HDJL50422 HDJL50423 HDJL50226 HDJL50227 HDJL50228 HDJL50443 HDJL50444 HDJL50445 HDJL50446 HDJL50447 HDJM50202 HDJM50204 HDJL50481 HDJL50482 HDJL50483 HDJL50484 HDJM50019 HDJM50020 HDJM50021 HDJM50022 HDJM50023 HDJM50024 HDJM50025 HDJM50026 HDJM50027 HDJM50028 HDJL50363 HDJL50542 HDJL50465 HDJM50003 HDJM50004 HDJM50198 HDJM50092 HDJL50328 HDJL50452 HDJL50453 HDJL50454 HDJL50455 HDJM50206 HDJM50207 HDJL50280 HDJL50281 HDJL50449 HDJL50450 HDJL50451 HDJM50086 HDJL50261 HDJL50262 HDJL50263 HDJL50264 HDJL50265 HDJL50266 HDJL50267 HDJL50278 HDJL50528 HDJL50529 HDJL50530 HDJL50531 HDJL50532 HDJL50533 HDJL50534 HDJL50535 HDJL50536 HDJL50537 HDJL50275 HDJL50276 HDJL50277 HDJL50480 HDJL50258 HDJL50259 HDJL50260 HDJM50095 HDJM50064 HDJM50065 HDJL50214 HDJL50215 HDJL50216 HDJL50217 HDJL50218 HDJL50219 HDJL50220 HDJL50221 HDJL50222 HDJL50223 HDJL50224 HDJL50225 HDJL50296 HDJL50297 HDJL50298 HDJL50272 HDJL50392 HDJL50393 HDJL50394 HDJL50436 HDJL50437 HDJL50438 HDJL50439 HDJL50440 HDJM50013 HDJM50014 HDJM50000 HDJM50001 HDJM50002 HDJM50044 HDJM50043 HDJL50442 HDJL50441 HDJL50286 HDJL50287 HDJL50325 HDJL50326 HDJL50329 HDJL50330 HDJL50424 HDJM50148 HDJM50149 HDJM50150 HDJM50151 HDJM50152 HDJM50153 HDJM50154 HDJM50155 HDJM50156 HDJM50157 HDJM50158 HDJM50159 HDJM50160 HDJM50161 HDJM50162 HDJM50163 HDJM50164 HDJM50165 HDJM50166 HDJM50167 HDJM50168 HDJM50169 HDJM50170 HDJM50171 HDJM50172 HDJM50173 HDJM50174 HDJM50175 HDJM50176 HDJM50177 HDJL50487 HDJM50015 HDJL50018 HDJL50019 HDJL50020 HDJL50021 HDJL50022 HDJL50023 HDJL50024 HDJL50025 HDJL50026 HDJL50027 HDJL50028 HDJL50029 HDJL50030 HDJL50031 HDJL50032 HDJL50033 HDJL50034 HDJL50037 HDJL50038 HDJL50040 HDJL50043 HDJL50044 HDJL50045 HDJL50154 HDJL50178 HDJL50179 HDJL50180 HDJL50181 HDJL50182 HDJL50183 HDJL50184 HDJL50185 HDJL50186 HDJL50187 HDJL50188 HDJL50189 HDJL50431 HDJM50029 HDJM50045 HDJM50046 HDJM50047 HDJM50048 HDJM50049 HDJM50050 HDJM50051 HDJM50052 HDJM50055 HDJM50056 HDJM50057 HDJM50058 HDJM50059 HDJM50060 HDJM50061 HDJM50062 HDJM50093 HDJM50094 HDJM50096 HDJM50097 HDJM50100 HDJM50102 HDJM50104 HDJM50143 HDJM50178 HDJM50179 HDJM50180 HDJL50036 and HDJL50061
RECALLING FIRM/MANUFACTURER
Datex, Ohmeda, Inc. dba GE Healthcare, Laurel, MD, by certified letter on May 20, 2008. Firm initiated recall is ongoing.
REASON
Medical device software may be subject to signal interference of the Hands Free Alarm Silence feature that could impact patient safety.
VOLUME OF PRODUCT IN COMMERCE
639 devices
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Hill-Rom Procedural Stretcher with auto-contour option; Model P8000F. Wheeled hospital stretcher consisting of a platform mounted on a wheeled frame, designed to transport patients and to allow for patient care before, during and after transport, Recall # Z-1655-2008
CODE
All units with serial numbers H352AN3566 through I222AN9588 and shipped prior to 8/13/07
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by visit and letter dated April 3, 2008. Firm initiated recall is ongoing.
REASON
The auto contour function on/off handle may be inadvertently activated while the head of the stretcher is raised, increasing the possibility of the head section to become jammed and preventing it from lowering. This may result in a delay to the procedure.
VOLUME OF PRODUCT IN COMMERCE
564 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Straumann Handpiece Driver for RN Solid Abutment 6° L 26.0mm,Stainless Steel -- Reference Number: 80426. Product is intended as radiographic guides and surgical templates for the initial placement of the 2.2 mm pilot drill used in the site preparation for the placement of Straumann dental implants, Recall # Z-1876-2008
CODE
Lot Number: C4724
RECALLING FIRM/MANUFACTURER
Recalling Firm: Straumann Manufacturing Inc., Andover, MS, by letter on May 28, 2008.
Manufacturer: Instituit Strauman, Basel, Switzerland. Firm initiated recall is ongoing.
REASON
Handpiece driver is out of specification and will not function with the dental solid abutment. Possible risks involved include: inconvenience to patient and the need to reschedule surgery or proceed without the device.
VOLUME OF PRODUCT IN COMMERCE
129 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Essenta DR - digital multifunctional x-ray system (application SW release 1.0.2 and lower). The device is intended for routine exams, including specialist areas like trauma or pediatric work, excluding mammography. Equip No: 553491, 554498, 554944, 554358, 553270, 557203, 556089, 556080, 555457 and 556275, Recall # Z-1895-2008
CODE
Serial Number: 368645, 372631, 375371/SN0800002, 375730/SN07000032, 375372/SN07000028, 383083/SN07000023, 378493/SN07000025, 379442/SN0800001, 379183/SN07000030 and 379050/SN0800005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, North America Co. Philips, Bothell, WA, by letter on April 8, 2008.
Manufacturer: Philips Medical Systems Gmbh, DMC, Hamburg, Germany. Firm initiated recall is ongoing.
REASON
Bright artifacts may appear on a patient image from a previous exposure, which might lead to a misdiagnosis.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Cook Hilal Embolization Microcoil, 3 mm, sterile. The device is an intravascular
implant intended to permanently occlude blood flow to cerebral aneurysms and
cerebral arteriovenous malformations, Recall # Z-2057-2008;
b) Cook Hilal Embolization Microcoil, 6 mm, sterile. The device is an intravascular
implant intended to permanently occlude blood flow to cerebral aneurysms and
cerebral arteriovenous malformations, Recall # Z-2058-2008
CODE
a) Lots 1897765, 1902927, 1908780, 1910237, 1918237, 1921667, 1929329,
1934204, 1971324, 1971325, 1987735, 1991576, 1994124, 2000417, 2007745,
2012753x, 2012753, 2021721, 2026715, 2031205, 2034254, 2039748, 2051785,
2063422, 2066776, 2072751 and 2080653;
b) Lots F2100451, F2102327, F2102038, F2102833, F2109137, F2112851,
F21114679, F2122527, F2125284, F2126416, F2136920, F2141567, F2142403,
F2142578, F2143038, F2146823, F2146882, F2147969, F2150692, F2159335,
F2159263, F2161387, F2172446, F2188499, F2189353, F2203609, F2204861,
F2207480, F2213136, F2213468 and F2215748
RECALLING FIRM/MANUFACTURER
Cook, Inc., Bloomington, IN, by letter dated May 9, 2008. Firm initiated recall is complete.
REASON
The product length is declared incorrectly in mm when the unit of measurement should be cm.
VOLUME OF PRODUCT IN COMMERCE
1,338 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) EndoVive Safety PEG Kits 24 Fr Universal Product Number (UPN): MOO56648 1.
The product provides nutrition directly into the stomach of adult and pediatric
patients who are unable to consume by conventional methods, Recall # Z-2236-2008;
b) EndoVive Safety PEG Kits 20 Fr Universal Product Number (UPN): MOO566460.
The product provides nutrition directly into the stomach of adult and pediatric
patients who are unable to consume by conventional methods, Recall # Z-2237-2008
CODE
a) and b) Lot Number: 11712923
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Natick, MA, by letter on June 17, 2008. Firm initiated recall is complete.
REASON
Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG
VOLUME OF PRODUCT IN COMMERCE
16 kits
DISTRIBUTION
NJ, SC, TN, VA, WI
___________________________________
PRODUCT
Zimmer Metasul Head 32/-4”S”, taper 12/14, hip implant component; REF 19.32.05, Recall # Z-2299-2008
CODE
Lot: 2299218
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN, by letter dated June 20, 2008.
Manufacturer: Zimmer Gmbh, Winterthur, Switzerland. Firm initiated recall is ongoing.
REASON
The wrong part may be in the package. Package may contain a 28 mm head.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
FL, PA, TX, VA
___________________________________
PRODUCT
Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used during surgery for the cutting guide. This screw is not permanently implanted, Recall # Z-2300-2008
CODE
Lot: 60954069
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by letter dated June 30, 2008. Firm initiated recall is ongoing.
REASON
An impurity in the metal may affect the strength of the screw, resulting in breakage and/or surgical delays.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
FL, China, India
END OF ENFORCEMENT REPORT FOR SEPTEMBER 24, 2008
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