Enforcement Report

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.

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January 21, 2009
09-03

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

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PRODUCT
Ying Feng Foodstuffs brand Pumpkin Seeds, Net Wt: 10 oz (283g) --- Product of P.R.C.; Nutrition Facts: Serving Size: 141 pcs (100 g); Servings Per Container: 3. The product is packed in a sealed, flexible plastic bag. UPC 6 911749 381852, Recall # F-068-9
CODE
EXP 03 25 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fine Land Corp., Brooklyn, NY, by press release on September 22, 2008.
Manufacturer: Ying Feng Foodstuffs Co., Ltd. Guangdong, China. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (4030 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
36 cases (50 X 10 oz. packages per case)
DISTRIBUTION
NY
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PRODUCT
Louisiana Fish Fry Products, Chicken and Fish Bake, Seasoned Coating Mix, net wt. 6 oz (170g). UPC 039156002828, Recall # F-069-9
CODE
Best by Jan. 1, 2008 thru Sept. 25, 2011
RECALLING FIRM/MANUFACTURER
Louisiana Fish Fry Products, Ltd., Baton Rouge, LA, by press release, e-mail, facsimile and letters on December 5, 2008. Firm initiated recall is ongoing.
REASON
Product contains undeclared buttermilk.
VOLUME OF PRODUCT IN COMMERCE
15,865 cases of 12 units
DISTRIBUTION
Nationwide and Canada
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PRODUCT
Kashi GoLean High Protein & High Fiber Shake Mix, Chocolate, in 14.8 oz. canisters packed 12 cans per case, UPC code 1862771000, Recall # F-070-9
CODE
Better if used by date on bottom of the canister and on the case: JAN 17 2009 LSA, JAN 18 2009 LSA, FEB 22 2009 LSA, FEB 25 2009 LSA, APR 04 2009 LSA, APR 05 2009 LSA, APR 08 2009 LSA, MAY 07 2009 LSA, MAY 20 2009 LSA, JUN 18 2009 LSA, JUN 19 2009 LSA, JUL 14 2009 LSA, JUL 15 2009 LSA, AUG 26 2009 LSA, AUG 27 2009 LSA, SEP 17 2009 LSA, SEP 18 2009 LSA, OCT 11 2009 LSA, OCT 12 2009 LSA, NOV 14 2009 LSA and NOV 15 2009 LSA
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kashi Co., LaJolla, CA, by telephone and letter on December 12, 2008 and by press release dated December 13, 2008.
Firm initiated recall is complete.
REASON
Product contained undeclared whey caseinate.
VOLUME OF PRODUCT IN COMMERCE
116,100 canisters
DISTRIBUTION
Nationwide
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PRODUCT
Bownberry brand Whole Grains Bread, 100 % Whole Wheat, 1 lb 8 oz (680g), UPC 73410 01745, Recall # F-071-9
CODE
Date “Oct 11”
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arnold Foods Co, Inc., Horsham, PA, by visit on October 7, 2008 and by press release on October 8, 2008.
Manufacturer: George Weston Bakeries, Inc., Oconomowoc, WI. Firm initiated recall is complete.
REASON
Product contained undeclared walnuts and hazelnuts.
VOLUME OF PRODUCT IN COMMERCE
10,584 units
DISTRIBUTION
IL, IN, IA, MN, WI
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PRODUCT
Flower brand Dried Sweet Potato, Net Wt: 12 oz (340g); UPC 6 938512 950084, Product of China. Serving Size 1 oz (42g). Servings per container 8; The product is packaged in a sealed, clear plastic bag, Recall # F-072-9
CODE
No code
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hop Lee Trading Co., Inc. Brooklyn, NY, by press release on August 12, 2008.
Manufacturer: BinJi Food Factory, Guandong, China. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (556 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
10 cases/50 x 12 oz. bags per case
DISTRIBUTION
NY
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PRODUCT
KFI K Fat Inc. Mut Gung Sweetened Ginger --- Net Wt. 150G; UPC 935001 200758, PRODUCT OF VIETNAM, Recall # F-073-9
CODE
No code
RECALLING FIRM/MANUFACTURER
Recalling Firm: K-Fat Inc. Brooklyn, NY, by press release and letters dated September 12, 2008.
Manufacturer: Hua Heong Industries Vietnam Co., Ltd., Ho Chi Minh City, Vietnam. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (944.5 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
45 cases/24 boxes x150 gram containers per case
DISTRIBUTION
NY, NJ, PA
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PRODUCT
Organic Pastures Grade A raw cream, keep refrigerated, Recall # F-075-9
CODE
Date Sept 12
RECALLING FIRM/MANUFACTURER
Organic Pastures Dairy, Fresno, CA, by press release on September 11, 2008. Firm initiated recall is ongoing.
REASON
This product is contaminated with Campylobacter based on the California Department of Food and Agriculture's analysis.
VOLUME OF PRODUCT IN COMMERCE
764 units
DISTRIBUTION
CA, NV

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

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PRODUCT
Kopper Kettle Gourmet Popcorn in 8 oz. plastic bag. Ingredients: Brown Sugar, Popcorn, Butter Corn Syrup, Solids, Lecithin, Salt, Vanilla, Soda. UPC 31338 00450, Recall # F-067-9
CODE
No codes
RECALLING FIRM/MANUFACTURER
Kopper Kettle Co., Springfield, OR, by visit, on October 15, 2008. Firm initiated recall is complete.
REASON
Product lists butter and lecithin as ingredients but fails to identify milk and soy as the ingredient sources.
VOLUME OF PRODUCT IN COMMERCE
80/8 oz bags
DISTRIBUTION
OR
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PRODUCT
Black licorice packaged as follows: a) Net wt. 6 oz. (170g) cello bags labeled Lucky Country Aussie Style, 98% Fat Free, Soft Fresh Licorice Candy, All Natural, b) 1.5 oz (680g) cello bags labeled Licorice Candy, All Natural, c) bulk 3 lb bags packed 3 bags per carton, total 15 lbs, labeled Lucky Country, All Nat. Black Bulk Licorice, Recall # F-074-9
CODE
All lots of Natural Black Licorice invoiced form 01/01/2008 to 08/29/2008, including Lots A2059, A2060, A2061, A2062 and A2123
RECALLING FIRM/MANUFACTURER
Lucky Country, Inc., Lincolnton, NC, by press release, letter and telephone on August 20, 2008 and August 29, 2008. Firm initiated recall is ongoing.,
REASON
Tests conducted by the California Department of Public Health (CDPH) and by FDA revealed that the product contained lead in excess of the 0.1 ppm maximum level recommended by FDA.
VOLUME OF PRODUCT IN COMMERCE
28,153 cases
DISTRIBUTION
CA, CO, CT, FL, GA, HI, IO, IL, ID, MA, MN, NH, PA, UT, VA, WA

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

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PRODUCT
Hershey's Cookie 'n' Cream 1.55 ounces candy bars. The product is shipped in cases containing 432 bars, Recall # F-064-9
CODE
Codes on the Cases: 78NK3 best before Feb 2010; 78PK3 best before Feb 2010; 78RK1 best before Feb 2010; 78RK2 best before Feb 2010; 78SK2 best before Feb 2010; 78SK3 best before Feb 2010; 79CK3 best before Mar 2010; 79HK3 best before Mar 2010; and 79LK3 best before Mar 2010;
Codes on the Bars: 78N K best before Feb 2010; 78P K best before Feb 2010; 78R K best before Feb 2010; 78S K best before Feb 2010; 78S K best before Feb 2010; 79C K best before Mar 2010; 79H K best before Mar 2010; and 79L K best before Mar R 2010
RECALLING FIRM/MANUFACTURER
The Hershey Co, Hershey, PA, by telephone on November 25, 2008. Firm initiated recall is ongoing.
REASON
Candy bars may contain small metal fragments.
VOLUME OF PRODUCT IN COMMERCE
314 cases
DISTRIBUTION
AL, DE, FL, LA, NC, NY, NJ, PA, TN, and VA
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PRODUCT
Naturally Preferred Organic Tomato Ketchup Net. Wt. 24 oz. (1 lb 8oz); UPC 1111079372, Recall # F-065-9
CODE
Lot: Feb/12/09 A2
RECALLING FIRM/MANUFACTURER
Chelten House Products, Inc., Bridgeport, NJ, by telephone and e-mail on July 31, 2008. Firm initiated recall is complete.
REASON
Product is spoiled.
VOLUME OF PRODUCT IN COMMERCE
90 cases (12 x 24 oz. bottles)
DISTRIBUTION
AZ, OH
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PRODUCT
a) M&M's Milk Chocolate Candies "Tear & Share" 3.14 oz. and
b) M&M's Milk Chocolate Candies "Fund Raiser" 2.0 oz. packages, Recall # F-066-9
CODE
a) 842BSCLV01, 842BTCLV01, 842CRCLV01, 842GSCLV01, and 842GTCLV01;
b) 843ASCLV01 and 843ATCLV01
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mars Snackfood US LLC, Hackettstown, NJ, by telephone on December 16, 2008.
Manufacturer: MARS Snackfood US, LLC, Cleveland, TN. Firm initiated recall is ongoing.
REASON
Product may contain pieces of nylon bristles.
VOLUME OF PRODUCT IN COMMERCE
4,094 cases of 144 units
DISTRIBUTION
Nationwide, El Salvador and Panama

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
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PRODUCT
Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL). Rx only. The NDC number of the individual vial is 0703-8315-01 and the NDC number for packages containing 10 vials is 0703-8315-03. The product is shipped as 10 vials per pack and 10 packs per shipper, Recall # D-167-2009
CODE
Lot numbers: 31302508B exp 3/2009, 31302510B exp 3/2009, 31302957B exp 4/2009, and 31303195B exp 4/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter dated October 16, 2008.
Manufacturer: Teva Parenteral Medicines, Inc., Irvine, CA. Firm initiated recall is ongoing.
REASON
Exceeded Impurity Specifications
VOLUME OF PRODUCT IN COMMERCE
199,500 vials
DISTRIBUTION
Nationwide
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PRODUCT
Granisetron Hydrochloride Injection 1mg/mL For I.V. Use Only, Contains no Preservatives. Rx only, NDC number for individual vials is 0703-7871-01. NDC number for packages containing 10 vials is 0703-7871-03, Recall # D-168-2009
CODE
Lot number: 31300740B exp 2/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on October 24, 2008.
Manufacturer: Teva Parenteral Medicines, Inc., Irvine, CA. Firm initiated recall is ongoing.
REASON
Exceeds pH Specifications
VOLUME OF PRODUCT IN COMMERCE
8,430 vials
DISTRIBUTION
Nationwide
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PRODUCT
a) Soma Compound Tablets USP, Carisoprodol 200 mg and aspirin 325 mg, Rx only, 100 tablets; NDC 0037-2103-01, Recall # D-170-2009;

b) Soma Compound with Codeine Tablets, USP, CIII, Carisoprodol 200 mg, aspirin 325 mg, and codeine, phosphate 16 mg, 100 tablets, Rx only, NDC 0037-2403-01, Recall # D-171-2009
CODE
a) Lot #: 61060A1, Exp Nov 08;
b) Lot #: 5513A1, Exp July 08; 60484A1, Exp May 08; 70257A1, Exp. March 09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Meda Pharmaceuticals Inc., Somerset, NJ, by letters on May 29, 2008 and June 2, 2008.
Manufacturer: Actavis Totowa LLC, Totowa, NJ. Firm initiated recall is ongoing.
REASON
Superpotent: 12 month stability (by mfr Actavis, Totowa, NJ)
VOLUME OF PRODUCT IN COMMERCE
a) 849 bottles; b) 2716 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
Ultram ER (tramadol HCL) Extended-Release Tablets, 100 mg, 30 tablets, HPDE bottle, Rx only, NDC 0062-0653-30, Recall # D-169-2009
CODE
Lot/Expiration: P07L026, Exp. 9/2009; P07L027, Exp. 9/2009; P08A039, Exp 9/2009; P08B043, Exp. 9/2009; P08A040, Exp. 10/2009; P08A041, Exp. 10/2009; P08A042, Exp. 10/2009; P08C040, Exp. 11/2009; P08E024, Exp. 11/2009; P08E025, Exp. 11/2009; P08E026, Exp. 11/2009; 08D010P, Exp. 1/2010; 08D012P, Exp. 1/2010; P08E055, Exp. 1/2010; P08E056, Exp. 1/2010; P08F025, Exp. 1/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-McNeil Pharmaceutical, Inc. Raritan, NJ, by letters on December 30, 2008 and January 5, 2009.
Manufacturer: Biovail Corp., Manitoba, Canada. Firm initiated recall is ongoing.
REASON
Specific lot numbers may release the active ingredient at a slightly faster rate than required by the products release rate specification at the 8-hour time point
VOLUME OF PRODUCT IN COMMERCE
271,920 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
a) Recovered Plasma, Recall # B-0365-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0366-09
CODE
a) and b) Recall #: 9621705
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Baton Rouge, LA, by telephone on November 8, 2007, or by electronic notification on December 17, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had sexual contact with a person who was born in an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AR, Switzerland
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PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0381-09
CODE
Unit: FQ87827
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on December 30, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0382-09
CODE
Units: GN23880, GN24950
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on December 19, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
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PRODUCT
Recovered Plasma, Recall # B-0385-09
CODE
Unit: LE79752
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by electronic mail on October 11, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0386-09
CODE
Unit: 026FW11484
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone or electronic notification on August 7, 2007 and by letter dated August 13, 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
FL
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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0389-09
CODE
Unit: 026GG14372
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone or electronic notification on September 17, 2007 and by letter dated September 18, 2007.
Manufacturer: The American National Red Cross, Mobile, AL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0393-09
CODE
Unit: 4036137
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on April 15, 2008 and by letter on April 21, 2008. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0380-09
CODE
Unit: 9457027
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Inc., Jackson, TN, by verbal notification on August 15, 2008. Firm initiated recall is complete.
REASON
Blood product, which tested positive for red cell antibodies, but was labeled as negative for red cell antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
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PRODUCT
Recovered Plasma, Recall # B-0387-09
CODE
Unit: 026FW11484
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone or electronic notification on August 7, 2007 and by letter dated August 13, 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
Israel
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PRODUCT
Recovered Plasma, Recall # B-0388-09
CODE
Unit: 026GG14372
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone or electronic notification on September 17, 2007 and by letter dated September 18, 2007.
Manufacturer: The American National Red Cross, Mobile, AL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
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PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Irradiated, Recall # B-0390-09;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-0391-09
CODE
a) Units: 026KP28295 Part 1, 026KP28295 Part 2, 026KP28289;
b) Unit: 026KP28304
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone and letter on October 16, 2007.
Manufacturer: American Red Cross Blood Services, Montgomery, AL. Firm initiated recall is complete.
REASON
Blood products, collected using an expired blood collection set, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AL

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. This product is used for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file, Recall # Z-0129-2009
CODE
Software version 2.2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter dated October 17, 2007.
Manufacturer: Beckman Coulter, Inc., Fullerton, CA. Firm initiated recall is complete.
REASON
Software error: The CXP software does not refresh the dataset automatically under certain circumstances. The User documentation does not clearly state that the user should refresh the dataset after changes is made.
VOLUME OF PRODUCT IN COMMERCE
594 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) Mainline Confirms Strep A, 1) Catalog # 3030-20 and 2) Catalog # 3030-40, Recall # Z-0525-2009;

b) Mainline Confirms Strep A DOTS, Catalog # 4040, Recall # Z-0526-2009;

c) Mainline Confirms III Serum/Urine control set, Catalog # 3029-CTR, Recall # Z-0527-2009;

d) Mainline hCG Accuracy Check, Catalog # 3c1001, Recall # Z-0528-2009;

e) Mainline Confirms hCG Serum/Urine III, Catalog # 3029-25, Recall # Z-0529-2009;

f) f.y.i. hCG Urine one-step pregnancy test, Catalog # 43065, Recall # Z-0530-2009

g) Mainline Confirms hCG urine pregnancy test, Catalog # 6008C, Recall # Z-0531-2009
CODE
a) 1) Lots: 94355, 94385, 94395, 94415, 94445, 94455, 94485, 94505, 94545, 94585, and 94595; 2) Lots 94350, 94370, 94380, 94410, 94420, 94440, 94450, 94480, 94500, 94510, 94540, 94580, 94590, 94610, 94620, 94630, and 94880;

b) Lots: 92465, 92480, 92525, 92540, 92580, 92600, 92640, 92650, 92680, 92700, 92705, 92720, and 92721;

c) Lot: 06054;

d) Lots: 50074 and 50075;

e) Lots: 96101- 96206, 96218, 96235, 96260, 96295, 96300, 96320, 96360, 96380, and 96381;

f) Lot: 20087;

g) Lots: 19540, 19590, 19914, 20110, 20343, 20537, 20717, 20906, 21060, 21089, 21495, 21733, 21762, 22407, 22408, 22926, 23217, 23525, 23694, 23703, 23994, 24483, and 25080
RECALLING FIRM/MANUFACTURER
Mainline Technology, Inc., Ann Arbor, MI, by letter dated August 18, 2008. Firm initiated recall is ongoing.
REASON
Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates.
VOLUME OF PRODUCT IN COMMERCE
45,330 kits
DISTRIBUTION
Nationwide, Belgium and Switzerland
___________________________________
PRODUCT
a) Depuy DELTA Xtend, Standard humeral PE Cup Dia 38/+3 STD, sterile, Depuy France; REF 130738203. The device is used as a shoulder implant. Recall # Z-0532-2009;

b) Depuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 130738206. The device is used as a shoulder implant, Recall # Z-0533-2009;

c) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+9 STD, sterile, Depuy France; REF 130738209. The device is used as a shoulder implant, Recall # Z-0534-2009;

d) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+6R RET, sterile, Depuy France; REF 130738106. The device is used as a shoulder implant, Recall # Z-0535-2009;

e) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+3 STD, sterile, Depuy France; REF 130742203. The device is used as a shoulder implant, Recall # Z-0536-2009;

f) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+6 STD, sterile, Depuy France; REF 130742206. The device is used as a shoulder implant, Recall # Z-0537-2009;

g) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+9 STD, sterile, Depuy France; REF 130742209. The device is used as a shoulder implant, Recall # Z-0538-2009;

h) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42+6R RET, sterile, Depuy France; REF 130742106. The device is used as a shoulder implant, Recall # Z-0539-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
Depuy Orthopaedics, Inc., Warsaw, IN, by letter dated July 8, 2008 and July 15, 2008. Firm initiated recall is complete.
REASON
Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
VOLUME OF PRODUCT IN COMMERCE
1,521 devices
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Balloon Inflation Device Model #'s: MED15-105 MED15-106 and SCI04527-01. The reprocessed Balloon inflation device is intended for use with balloon dilatation catheters to create and monitor pressure in the balloon and to deflate the balloon. Recall # Z-0546-2009;

2) Bed Check Model #'s: BED65815-021 BED65815-025 BED65815-025IT BED65815-030 BED65815-031 BED73000 BED73010 BED74000 BED74010 NURBPP-30A NURBPP-30WC POS8283 RFT1000-1210 RFT1000-1250 RFT1000-1810 and RFT1000-1820. A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed. Recall # Z-0547-2009;

3) Drill Bits Model #'s: DEP14043 MIC8053-019 RIC21-0438 RIC21-0439 RIC21-0441 RIC21-0442 RIC71173504 RIC71173505 RIC71631117 SMI21-0445 STR5800-4-125 STR60-13570 SYN03.010.060 SYN03.010.061 SYN03.010.101 SYN310.19 SYN310.24 SYN310.25 SYN310.288 SYN310.31 SYN310.35 SYN310.431 SYN310.44 SYN310.63 SYN310.65 SYN310.66 SYN310.67 SYN315.28 SYN315.40 SYN315.92 SYN317.861 SYN317.871 SYN356.982 SYN357.407 ZIM00-2318-020-00 and ZIM5056-146. An orthopedic manual surgical instrument is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench. Recall # Z-0548-2009;

4) Biopsy Forceps, Hot Model #'s: BAL60110 BAR000852 BAR000854 and MIC1550. Laparoscopic electric instruments are designed for use in minimally invasive procedures and open surgical procedures to facilitate coagulation, transection, resection, mobilization, and dissection of tissue. Recall # Z-0549-2009;

5) Burrs Model #'s: ANSL-3SB ANSL-5D ANSQD11-4OVDC HAL5056-118 HAL5056-166 HAL5091-106 HAL5091-112 HAL5091-122 HAL5091-125 HAL5091-136 HAL5091-144 HAL5091-164 HAL5092-120 HAL5092-168 HAL5092-170 KOM04-D0139 LIN5091-101 LIN5091-102 LIN5091-142 LIN5092-132 LIN5092-160 MED874-447 MICZB-228 MICZB-232 MID14CY50 MID14MH30D MIDG6-450 MIDG8-130 MIDMC254 STR1607-2-35 STR1608-6-137 STR1608-6-141 STR1608-6-149 STR277-10-62 STR5120-10-40 STR5120-10-50 STR5120-71-48 STR5300-10-511 STR5300-10-513 STR5300-10-903 STR5300-20-513 STR5300-30-903 XOM31-55641 ZIM5056-116 ZIM5056-117 ZIM5056-118 ZIM5056-125 ZIM5056-140 ZIM5056-150 ZIM5056-159 ZIM5056-161 ZIM5056-162 ZIM5056-164 and ZIM5056-167. Surgical instruments motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Recall # Z-0550-2009;

6) Cardiac Imaging Catheter Model #'s: ACU08267996 and ACU55790. Intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart. Recall # Z-0551-2009;

7) Colorado Electrodes Model #'s: COLN104A COLN112A and STRN103A. Intended for precision cutting or dissecting and cauterizing soft tissue. Recall # Z-0552-2009;

8) Compression Sleeves Model #'s: HUNDVT10-1 and KEN5329. The SterilMed Intermittent Compression Sleeve, 400 series used in conjunction with the Talley DVT-275 pump is indicated for any person that is at risk for deep vein thrombosis or could otherwise benefit from enhanced blood flow and circulation and/or a reduction in post operative pain and swelling. Recall # Z-0553-2009;

9) EP Cables Model #'s: BAR560004P BIOC10MR10MSTKS BIOC5-MH/NAVMH-S CORC6-MR10/EPTR-S DAI401972 DAI401976 DAI401977 DAI401981 DAI401983 EPT5454S EPT613 and EPT651. An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine. Recall # Z-0554-2009;

10) EP Catheter Model #'s: BIOD6-DR-005-RT BIOD6-DR-010-RT DAI401381 DAI401449 DAI401904 DAI401915 and EPT7003D. Intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and stimulation. Recall # Z-0555-2009;

11) External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84 SYN394.85 and SYN394.86. Intended for use in the construction of an external fixation frame for treatment of a various fracture types that require external fixation. Recall # Z-0556-2009;

12) Femoral Compression Device Model #'s: RAD11163 Intended for use in the compression of the femoral artery or vein after cauterization. Recall # Z-0557-2009;

13) Guidewires - Endoscopic (Jag Wires) Model #'s: MIC5658 and MIC630-100. Intended to be used for selective cannulization of the billary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic billary procedures for catheter introduction and exchanges. Recall # Z-0558-2009;

14) Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05 ETHLCS-C5 and ETHLCSC5HA. Intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired. Recall # Z-0559-2009;

15) Lap Instruments/Graspers/Forceps - HOT Model #'s: AUT173016 AUT174301 AUT176643 ETH5DCD ETH5DCS ETHEBF01 ETHPOUCH GYR3000PK GYR3005PK GYR3640 and GYR920005PK. Laparoscopic electric instruments are designed for use in minimally invasive procedures and/or open surgical procedures to facilitate coagulation, transaction, resection, mobilization and dissection of tissue. Recall # Z-0560-2009;

16) Lap Instruments/Graspers/Forceps - COLD Model #'s: AUT173030 AUT174233 AUT174317 AUT176613 AUT176647 AUTECATCH10G and ETH5DSG. A manual surgical instrument for general use is a non-powered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. Recall # Z-0561-2009;

17) Laser Probe Model #': SYN55.26.25. Reprocessed laser probes are part of a laser delivery system and are used in ophthalmic procedures where laser energy is the mode of treatment. Recall # Z-0562-2009;

18) Masks - Laryngeal Model #'s: AMB321-300-000 AMB321-400-000 AMB321-500-000 LMA12015 LMA12020 LMA12030 LMA12040 LMA12050 LMA12120 LMA12125 LMA12130 LMA12140 and LMA21140. An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway. Recall # Z-0563-2009;

19) Multi-Clip Applier Model #'s: APPCA080 AUT134031 AUT134046 AUT134051 AUT134053 AUT176625 AUT176657 AUTPTACK30 ETHEL5ML ETHER320 ETHMCL20 ETHMCM20 ETHMCM30 ETHMCS20 ETHMSM20 and WEC543965. A manual surgical instrument for general use is a non-powered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. Recall # Z-0564-2009;

20) Phaco Tips Model #'s: ALC30RTS ALC8065740806 ALC8065740809 ALC8065740837 ALC8065740839 ALC8065750852 ALC8065790020 ALC8065790022 and ALLOPOR3020L. Intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens. Recall # Z-0565-2009;

21) Rasps Model #'s: KOMKM5100-37-113 KOMKM-82 STR1675-115 STR5100-37-113 and STR5100-37-115. A manual surgical instrument for general use is a non-powered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. Recall # Z-0566-2009;

22) Retractors Model #'s: ADE3204 BOS820-175 LON3304 and LON3334-4G. A manual surgical instrument for general use is a non-powered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. Recall # Z-0567-2009;

23) RF Arthroscopy Probe Model #'s: ARTA1325-01 ARTA1335-01 ARTA1345-01 ARTA1730-01 ARTA2630-01 ARTA3625-01 ARTA4330-01 ARTAS1335-01 ARTAS4630-01 ARTASC1335-01 ARTASC2530-01 ARTASC4250-01 ARTASC4830-01 ARTASC5000-01 ARTASC5500-01 ARTEIC4845-01 MIT225203 MIT225301 MIT225302 MIT225305 MIT225350 MIT225360 SMI7209681 SMI7209682 SMI7209683 and STR278-510-500. These devices are designed for general surgical use, including orthopedic and arthroscopic applications or resection, ablation, excision of soft tissue, hemostatis of blood vessels, and coagulation of soft tissue. Recall # Z-0568-2009;

24) Saw Blade Model #'s: BIO506112 BIO506113 DEP2555-91-000 DEP5627-11-500 HAL5023-118 HAL5059-32 HAL5071-133 HAL5071-145 HAL5071-163 HAL5071-181 HAL5071-572 HOWHB-NST-6828-7-791 HOWHB-NST-6828-7-792 KOMK-2000-65 KOMKM-004 KOMKM-005 KOMKM-101 KOMKM-101C KOMKM-102 KOMKM-234 KOMKM-275R KOMKM-3101 KOMKM-3107 KOMKM3-225 KOMKM-325R KOMKM-619 KOMKM-660 KOMKM-693 LIN5023-170 MICSO-601 MICSO-610 MICSP-414A MICZO-062 MICZO-7052 MMM5756 STR2108-100 STR2108-102 STR2108-105 STR2108-107-4 STR2108-109 STR2108-110 STR2108-113 STR2108-115 STR2108-118 STR2108-120 STR2108-125 STR2108-140 STR2108-140-6 STR2108-148 STR2108-150 STR2108-150S2 STR2108-151 STR2108-152 STR2108-152-6 STR2108-158 STR2108-160 STR2108-161-2 STR2108-183 STR2108-185 STR2108-189 STR2108-192 STR2108-218 STR2108-302 STR2108-309 STR2108-351 STR2108-356 STR2296-3-103 STR2296-3-105 STR2296-3-111 STR2296-3-115 STR2296-3-125 STR2296-3-212 STR2296-3-225 STR2296-33-105 STR2296-33-111 STR2296-33-125 STR2296-3-412 STR2296-3-414 STR2296-3-511 STR277-88-100 STR277-88-125 STR277-96-250 STR277-96-275 STR277-96-277 STR277-96-325 STR277-96-326 STR298-97-100 STR4111-107-090 STR4125-089-075 STR4125-097-090 STR5100-137-233 STR5301-30-172 STR5301-40-33 STR6113-127-90 STR6125-89-75 SYN11-2217 SYN11-3500 SYN11-3534 TER98-0702-1234-9 ZIM5979-95-35 and ZIM5979-95-41 Surgical instruments motors and accessories are AC-powered, battery-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Recall # Z-0569-2009

25) Scissor Tips Model #'s: AESPO888 AESPO889 ENCES0102 MIC3112 MIC3122 MIC3142 MIC3152 SNO89-5100 and SNO89-5300. Intended to be used with a reusable hand piece and are designed to use in minimally invasive and open surgical procedures to facilitate coagulation, preparation, mobilization, and cutting tissue. Recall # Z-0570-2009;

26) Stone Retrieval Basket Model #': BOS390-10. Used to entrap and remove renal stones and calculi via a rig id or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures. Recall # Z-0571-2009;

27) Tourniquet Cuffs Model #'s: INSDT-7024-02 INSDT-7218-01 SMI553322 SMI7010-7002 SMI7010-7006 SMI7010-7007 SMI7010-7008 SMI7010-7010 SMI7010-7011 SMI7010-7012 SMI7010-7015 STR5921-018-136 STR5921-018-235 STR5921-024-135 STR5921-024-136 STR5921-024-146 STR5921-024-235 STR5921-030-135 STR5921-030-235 STR5921-034-135 STR5921-034-136 STR5921-034-235 STR5921-044-135 STR5921-044-136 STR5921-044-235 STR5921-212-135 ZIM60-7070-02 ZIM60-7070-03 ZIM60-7070-04 ZIM60-7070-05 ZIM60-7070-06 ZIM60-7070-07 ZIM60-7070-101 ZIM60-7070-102 ZIM60-7070-103 ZIM60-7070-104 ZIM60-7070-105 ZIM60-7070-106 ZIM60-7070-107 ZIM60-7075-006 ZIM60-7075-03 ZIM60-7075-04 ZIM60-7075-05 ZIM60-7075-06 ZIM60-7075-07 ZIM60-7075-101 ZIM60-7075-102 ZIM60-7075-103 ZIM60-7075-104 ZIM60-7075-106 ZIM60-7075-107 ZIM60-7080-102 and ZIM60-7080-103. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff, Recall Z-0572-2009;

28) TURP Electrodes Model #'s: CIRMLE-24-012 CIRMLE-24-015 OLYA22205C STO27050F STO27050G and STO27050NK. Reprocessed endoscopic electrodes are intended to be used for vaporization, ablation, coagulation and/or resection for soft tissue in the prostate and bladder as well as when ablation and coagulation are required in gynecological and urological surgical procedures. Recall # Z-0573-2009;

29) Open & Unused Items - This refers to a sterilization service provided by SterilMed, Inc. (devices were not reprocessed) for Class 1 and Class 2 devices that were opened, most likely in O. R. suites, in which for whatever reason the physician elected to select a different type of device, different size of device, or maybe elected to not use the device at all in a procedure. This is not a process regulated by FDA, but is included in the recall process as product would still be considered misbranded and or represent a potential risk to patients. Model #'s: ABB6543-01 ABB6544-01 ACM23116 ACR800-499 ACU014719 ALL2N2704X ALLASC1201 ALLF-5501 ALLSU130-404E ARTAR-6530 ARTAR-6540 ARTAR-6560 ARTAR-6562 ARTAR-6564 ARTAR-6570 AUT054887 AUT059035 AUT059037 AUT174001 AUT8886803712 AUTGIA6025S BAL60417 BAR0043620 BAR0070740 BAR0601110 BAR072231 BARBRD100R BAX2C4005 BER610 BIO418200 BIO631031 BOUTC001NSKA CARASU1510 COD26-1221 CON130309 CON130321 CON134006 CON1412 CON29410 CON29415H CON29496 CON60-6085-100 CON8535 CON9413 CON9448 COO081012 COO081014 COOCTI-512N COOTD-1 COOZSI1151 DAV0035280 DAV0043650 DEN50-7000 DEN50-7500 DER28-0211 DLP10012 EDWDSAFE61 EDWFEMII016A ETH10BB ETH2189 ETH2211 ETH5BB ETH6TB45 ETHBTD05 ETHPMW35 ETHPRW35 ETHPXW35 ETHUV120 FUT4549 GUIOM-9000S GUIXP-4000 GYR240060 GYR240072 GYR70138000 GYR7013-8100 GYR70140257 JOH2214 KEN31140240 KEN31140562 KEN8884720221 KEN8888505172 KIM111 KIM228 kim279 KIM311 KIM330 KIM345 KIM70321 KIM79043 KIM79870 KIM79878 KIM888 KIM89601 KIM95111 KIM95521 KIR10-4000 KIR10-4001 KIR14-3000 KRO6003 LIN9718 LINESA-5333 LINESA-5339 MECEPT03 MED05897/JP2311 MED10001S/JP10001 MED11348/DYNJP2500 MED14184/JP2414 MED14184A/JP2414A MED21394P/JP2302P MED2457S/JP8303 MED2505/JP2510 MED3110A/JP3003A MED3110S/JP3003 MED3130S/JP3008 MED3140S/JP3005 MED3820A/JP3102A MED3820S/JP3102 MED4202S/JP4003 MED6052-53 MED8610S/JP8005 MED91263 MED96570-021 MEDDYNJ01201H MEDDYNJ05933 MEDDYNJO5933 MEDDYNJP8201 MEDSPT-2314/JP2314HD MEG0012 MEG0020 MEG0035H MEG0039H MIC390-310 MIC6131 MIC6237 MIC670-308 MIC710-111 MIC81010 MPS5001689 OLS20-1410KI ORSORS-300 Q2M20-1370 RMITF-3646-0 SMI4116 SMI4615 SMI4616 SMI71111579 SMI7204727 SMI72200195 SPIXDWIK28 STR1608-2-59 STR1608-2-63 STR206-16 STR206-546 STR250-070-530 STR250-070-540 STR275-802-000 STR306-553 STR350-202-000 STR3910-075-500 STR3910-075-501 STR3910-075-650 STR3910-075-651 STR3910-075-800 STR400-800 STR501-140-50 STR5120-103-15 STR606-563 STR620-030-301 STR620-030-407 STR620-30-301 SYN55.36E SYNSDLB TELDP-40K TELMDP-40K TER5842 TERL7328 TEX311033-000 USE00712031 VALE1450-6 VALE1510 VALE2350H VALE2450H VALE2505-10FR VALE2515H VALE2516H WAL909009 WEC528235 WEL24-6001 XOM1014242 XOM10-46001 XOM1850200 XOM31-55631 XOM31-55632 XOM31-55636 XOM31-55637 XOM31-55638 and XOM8225825, Recall # Z-0574-2009;

30) Biopsy Forceps, Cold Model #'s: BAR000386 BAR000388 MIC1012 MIC1331 MIC1333 MIC1337 MIC1536 MIC1589 MIC1597 MIC1598 and MIC1599. The Reprocessed Cold Biopsy Forceps are intended to be used during endoscopic procedures of the gastrointestinal tract to collect tissue samples for histologic examination. Recall # Z-0575-2009;

31) Taps Model #'s: SYN311.15 SYN311.190 SYN311.39 and SYN311.32. An orthopedic manual surgical instrument is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. Recall # Z-0576-2009;

32) Reamers Model #'s: HAL5091-144 and ZIMS5979-95-41. An orthopedic manual surgical instrument is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery, devices individually packaged and sealed within a pouch. Recall # Z-0577-2009
CODE
n/a
RECALLING FIRM/MANUFACTURER
Sterilmed, Inc., Osseo, MN, by visit on August 8, 2008, by fax or email, on site visits on August 11, 2008 and by letter on August 14, 2008. Firm initiated recall is complete.
REASON
The possibility exists that some of the pouches were not properly sealed on one end.
VOLUME OF PRODUCT IN COMMERCE
7,044 devices
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04. The device is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. The product is used to calibrate assays used to determine bilirubin concentrations in neonate and adult patient samples, Recall # Z-0580-2009
CODE
Lot Number: 61388M100, 57919M100, 54754M100, and 52632M100
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., South Pasadena, CA, by letter on September 12, 2008. Firm initiated recall is ongoing.
REASON
The matrix of the secondary standard used in the value assignment of the calibrator is sensitive to the Diazo method. The matrix of this secondary standard caused a positive bias.
VOLUME OF PRODUCT IN COMMERCE
7,101 units
DISTRIBUTION
Nationwide, Mexico, Columbia, Uruguay, Puerto Rico, Canada, Hong Kong, New Zealand, Bahamas, Guatemala, Argentina, Germany, Thailand, Trinidad/Tobago, Venezuela, Chile, Brazil, El Salvador, Singapore, Australia, Curacao and Cayman Island
___________________________________
PRODUCT
Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3. The system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use. Recall # Z-0581-2009
CODE
Software versions 8.5.1 and 8.5.1SP3
RECALLING FIRM/MANUFACTURER
Dade Behring, Inc., Newark, DE, by telephone and follow-up letter dated September 8, 2008. Firm Initiated recall is ongoing.
REASON
Error messages, "Wash Aspirator Failure" and "Wash station unable to recover" are not generated when one or both HM wash probes are totally occluded.
VOLUME OF PRODUCT IN COMMERCE
57 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Quantum Pulse machine. The device is used to create light wave frequencies to effect cellular activity. Recall # Z-0582-2009
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
VIBE Technologies, Greeley, CO, by letter on September 16, 2008. Firm initiated recall is ongoing.
REASON
Medical Device marketed without marketing approval for claims that include strengthening, recharging and removing toxins from cells.
VOLUME OF PRODUCT IN COMMERCE
58 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Foot switch, Part Numbers: 1009.81, 1009.81A0, 1009.81A1, 1009.81A2, 1009.81A3, 1009.81B0, 1009.81B1, 1009.81B2, 1009.81C0, 1009.81C1, 1009.81D0, 1009.81D1, 1009.81D2, 1009.81D3, 1009.81D4, 1009.81E0, 1009.81E1, 1009.81E2, 1009.81E3, 1009.81F0, 1009.81F1, 1009.81F2, 1009.81F3, 1009.81G0, 1009.81G1 and 1009.81G2. The foot switches in the 1009.81 series are accessory components which can be connected to certain MAQUET operating tables. Several of the table top adjustment motions (depending on the table and foot switch versions in use) can then be executed by the foot. The foot switch is equipped with rocker switches. The switching elements are used to initiate the table top functions. Recall # Z-0620-2009
CODE
Product manufactured between 8/2004 and 9/2008 may be affected.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet, Inc., Bridgewater, NJ, by letter on December 8, 2008.
Manufacturer: Maquet Aktiengesellschaft, Rastatt, Germany. Firm initiated recall is ongoing.
REASON
A bearing point of the pedal of the foot switch may come loose. With continued use of the foot switch, one or both springs beneath the pedal can fall out of their mounting, and it is possible the pedal comes to rest on the switch causing an unintended motion of the operating table during patient use.
VOLUME OF PRODUCT IN COMMERCE
581 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48. Indicated for planning proton treatment of neoplasms of the eye.
CODE
Serial numbers H480016, H480051, H480052, H480053, H480054, H480055, H480107, H480133, H480293, H480346, H480347, H480472, H480652, H480920, H481467, H481510, H481639, H481724, H481807, H481815, H481816, H481912, H481913, H481914, H481915, H482194, H482195, H482289, H482793, H482807, H483204, H483407, H484367, H484635, H484636, H484637, H484638, H484781, H484864, H485100, H485125, H485244, H485346, H485466, H485729, H486858, H486859, H486860, H486861, H486946, H486947, H486948, H487190, H487212, H487414, H487580, H487581, H487623, H487640, H487641, H487642, H487700, and H487757
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter October 2, 2008. Firm initiated recall is ongoing.
REASON
When using the multiple static segment option, the device may alter dose delivery.
VOLUME OF PRODUCT IN COMMERCE
64 units
DISTRIBUTION
Nationwide, Switzerland and the Netherlands
___________________________________
PRODUCT
RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery System. Model number 025007. The CyberKnife 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. The RoboCouch Patient Support System is intended for use in the support and positioning of a patient during Radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required. Recall # Z-0856-2009
CODE
System numbers: C0158, C0078, C0141, C0160, C0128, C0178, C0179, C0152, C0110, C0113, C0130, C0060, and C0125
RECALLING FIRM/MANUFACTURER
Accuray, Inc., Sunnyvale, CA, by letter dated October 30, 2008. Firm initiated recall is ongoing.
REASON
Product may not be tensioned properly, potentially causing unexpected rotation or descent.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
Nationwide, France and Turkey
___________________________________
PRODUCT
Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Version 4.1 build 67 and automatic Motion of Flat Panel, part number 8139789. Intended use is to deliver x-ray radiation for therapeutic treatment of cancer. Recall # Z-0857-2009
CODE
Version 4.1 build 67
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions,
REASON
Under certain conditions, the flat panel may move unexpectedly and collide with the patient.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
Nationwide, Netherlands, Germany, Poland, Norway, Australia, Belgium, France, New Zealand, Malaysia, Spain and Canada
___________________________________
PRODUCT
RF Ablation System Foot Switch. (Can be used with Boston Scientific Maestro 3000 and EPT-1000XP Cardiac Ablation Cardiac Ablation Systems). Catalog numbers/UPN numbers 21840/M004 218400. Indicated for use in cardiac ablation procedures. Recall # Z-0858-2009
CODE
Serial numbers starting in 0430200, 0530100, 0606100, 0610000, 0620200, 0623700, 0626500, 0629900, 0634800, and ending in 001-405
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific, Corp., San Jose, CA, by letters dated November 26, 2008.
Manufacturer: Altech, Corp., Flemington, NJ. Firm initiated recall is ongoing.
REASON
Product malfunction may result in delivery of energy without depressing the foot switch that controls delivery.
VOLUME OF PRODUCT IN COMMERCE
322 units
DISTRIBUTION
Nationwide, France, Great Britain, Saudi Arabia, Spain, Canada, Portugal, Germany, Italy, Australia, Russia, Netherlands, Ireland, Libya
___________________________________
PRODUCT
Triathlon PKR Insert X3 #1 LM/RL - 8mm, Catalog number: 5630-G-108; Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122. Intended Use: - Moderately disabling joint disease of the knee resulting from painful osteo or post traumatic arthritis - Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis - As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, where bone stock is of poor quality or inadequate for other reconstructive techniques as indicted by deficiencies of the femoral condyle/tibia plateau. These components are intended for implantation with bone cement. Recall # Z-0869-2009
CODE
Lot code NXDMEE; Lot code M8JMEE
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on November 25, 2008. Firm initiated recall is ongoing.
REASON
Label mix-up: lot mix up between Triathlon PKR Insert X3 #1 LM/RL 8mm, 5630-G-108 lot code NXDMEE and Triathlon PKR Insert X3 #1 RM/LL- 12 mm 5630-G-122 lot code M8JMEE.
VOLUME OF PRODUCT IN COMMERCE
1 unit of 8 mm size; 8 units of 12 mm size
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Centricity Enterprise Web 3.0 software; the software allows physicians convenient, quick access to medical images and related data they need via a web browser, password and a standard PC. Recall # Recall # Z-0870-2009
CODE
Software versions 3.0, 3.0.1, 3.0.1.1, 3.0.2, 3.0.3, and 3.0.4
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated December 12, 2008. Firm initiated recall is ongoing.
REASON
Software error: There are two potential safety situations with Centricity Enterprise Web software - a forced log off may occur while using the Centricity Enterprise Web during an open session and Centricity Enterprise Web does not utilize calibration performed on image measurements in Centricity RA1000 Workstation.
VOLUME OF PRODUCT IN COMMERCE
742 units
DISTRIBUTION
Nationwide, Australia, Austria, Bahrain, Belgium, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Malaysia, Malta, Martinique, Netherlands, New Zealand, Nigeria, Norway, Portugal, Reunion, Russia, Saudi Arabia, Slovenia, Singapore, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom and Venezuela
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PRODUCT
a) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 55 mm; REF 32-485150. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0873-2009;

b) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 57.5 mm; REF 32-485151. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0874-2009;

c) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 60 mm; REF 32-485152. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0875-2009;

d) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 62.5 mm; REF 32-485153. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0876-2009;

e) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 65 mm; REF 32-485154. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0877-2009;

f) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 67.5 mm; REF 32-485155. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0878-2009;

g) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 70 mm; REF 32-485156. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0879-2009;

h) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 75 mm; REF 32-485157. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0880-2009;

i) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 80 mm; REF 32-485158. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0881-2009;

j) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 72.5 mm; REF 32-485159. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0882-2009
CODE
a) Lots 083700 and 132202;
b) Lots 083730 and 132302;
c) Lots: 083760 and 132402;
d) Lots: 083830, 132502 and 132503;
e) Lots 083940 and 132602;
f) Lots: 084280 and 132702;
g) Lots: 084400 and 132802;
h) Lots: 084520 and 132902;
i) Lots: 084710 and 133002;
j) Lot: 184801
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomet, Inc., Warsaw, IN, by letter dated December 18, 2008.
Manufacturer: Symmetry Medical USA, Inc., Warsaw, IN. Firm initiated recall is ongoing.
REASON
Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
VOLUME OF PRODUCT IN COMMERCE
444 units
DISTRIBUTION
Nationwide, Australia, Canada, Japan and UK

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

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PRODUCT
a) Boston Scientific Easy Core Biopsy Device, 18 ga. x 21 cm, sterile, latex free; UPN 500-104, REF M0065001040 and M0065001041. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0487-2009;

b) Boston Scientific Easy Core Biopsy Device, 18 ga. x 15 cm, sterile, latex free; UPN 500-105, REF M0065001050 and M0065001051. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0488-2009;

c) Boston Scientific Easy Core Biopsy Device, 15 ga. x 15 cm, sterile, latex free; UPN 500-106, REF M0065001060 and M0065001061. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0489-2009;

d) Boston Scientific Easy Core Biopsy Device, 18 ga. x 25 cm, sterile, latex free; UPN 500-107, REF M0065001070 and M0065001071. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0490-2009;

e) Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free; UPN 500-108, REF M0065001080 and M0065001081. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0491-2009;

f) Boston Scientific TruPath Biopsy Device, 18 ga. x 15 cm, sterile, latex free; UPN 500-114, REF M0065001140 and M0065001141. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0492-2009;

g) Boston Scientific TruPath Biopsy Device, 18 ga. x 21 cm, sterile, latex free; UPN 500-115, REF M0065001150 and M0065001151. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0493-2009;

h) Boston Scientific Easy Core Biopsy System, 15 ga. x 15 cm, sterile, latex free; UPN 1213, REF M00512130 and M00512131. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0494-2009;

i) Boston Scientific Easy Core Biopsy System, 18 ga. x 15 cm, sterile, latex free; UPN 1215, REF M00512150 and M00512151. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0495-2009
CODE
a) Lots: 0011520534, 0011539483 and 0011543121;

b) Lots: 0011528037, 0011558750, 0011598779, 0011634769 and 0011712309;

c) Lot 0011524376;

d) Lots 0011523878 and 0011629943;

e) Lot: 0011520533 and 0011575888;

f) Lots 0011520768, 0011539485, 0011579957, 0011583953, 0011628247, 0011633061 and 0011657171;

g) Lots: 0011523876, 0011523877, 0011527254, 0011527255, 0011528021, 0011532165, 0011532166, 0011539493, 0011541089, 0011543122, 0011546133, 0011547761, 0011550536, 0011550537, 0011551878, 0011554904, 0011565663, 0011628245, 0011628246, 0011631838, 0011631839, 0011663060, 0011634768, 0011635389, 0011635870, 0011639103, 0011639104, 0011640138, 0011642791, 0011644188, 0011646497, 0011665362, 0011668986 and 0011671278;

h) Lots 001153216 and 0011537469;

i) Lot 0011537463
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Spencer, IN, by letter dated October 17, 2008. Firm initiated recall is ongoing.
REASON
The devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
VOLUME OF PRODUCT IN COMMERCE
14,249 units
DISTRIBUTION
Nationwide, Algeria, Austria, Australia, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Japan and United Arab Emirates
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PRODUCT
Custom Waste Management Kit, K10-01756/B, Sterile EO, Recall # Z-0578-2009
CODE
Lot: F622787
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by telephone, fax or visit between September 15, 2008 and October 9, 2008. Firm initiated recall is complete.
REASON
Leak, disposal bag: A Merit Disposal Depot (MDD) bag contained in certain custom waste management kits may leak.
VOLUME OF PRODUCT IN COMMERCE
399 kits
DISTRIBUTION
Nationwide
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PRODUCT
BDD l ml Integra TB Syringe with Retracting Precision Glide Needle: 1 ml 27 g ½ (0.4 mm x 13 mm); Sterile; REF # 305298. Made in USA. Syringes for use in aspiration and injection of medications. Recall # Z-0619-2009
CODE
Lot: 8078251
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, by letters on November 24, 2008.
Manufacturer: BD Medical, Diabetes Care, Holdrege, NB. Firm initiated recall is ongoing.
REASON
Expiry date on the shelf carton is incorrect. It reads 2013-13; it should read 2013-03.
VOLUME OF PRODUCT IN COMMERCE
334,400 units
DISTRIBUTION
GA, KS, OH, MO, FL, PA, KY and NY

END OF ENFORCEMENT REPORT FOR JANUARY 21, 2009

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