November 19, 2003
03-47
_______________________________
PRODUCT
OPRA BREAM, a.k.a. "Leshch", is packaged in heat-sealed plastic bags of various weights of about half a pound. The product is a whole dried fish, approximately 12-13 inches long. Recall # F-024-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Baltic Star Food Production, Inc., Richmond Hill, NY, by press release on April 11, 2003. New York State initiated recall is complete.
REASON
The product was an uneviscerated processed fish based on NYSDAM sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
25 packages.
DISTRIBUTION
NY.
_______________________________
PRODUCT
MR. NUMBER ONE brand BAMBOO SHOOT SLICED (Pai Tong), net wt. 24 oz. (680 g.) Product of Thailand. Product is packaged in glass jars. Barcode #8 850643 013439. Recall # F-025-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Gusto Food, Inc., Maspeth, NY, by press release and letters, dated July 18, 2003. New York State initiated recall is complete.
REASON
The product contained undeclared sulfites (186 ppm) based on NYSDAM's sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
3 cases (12 jars per case).
DISTRIBUTION
NY.
_______________________________
PRODUCT
NICER SUCCADE brand Dried Potatoes, Net Wt. 5.5 oz. Product of China. Product is packed in a sealed foil bag, &labeled in English and Chinese. Serving size: 100g. UPC #: 6921585 433493. Recall # F-026-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Mon Chong Loong Trading Corp., Maspeth, NY, by press release on March 25, 2003. New York State initiated recall is complete.
REASON
The product contained undeclared sulfites based on NYSDAM's sampling & analysis.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
SABRA Salads brand White Fish Salad, Net Wt. 7 oz. (Less than 1/10 of 1% Sodium
Benzoate & Potassium Sorbate to Preserve Freshness). Product is packed in a
plastic tub with plastic lid. Barcode # 0 40822 13125 4. Recall # F-027-4.
CODE
Code 071803.
RECALLING FIRM/MANUFACTURER
Blue and White Food Products Corp., Astoria, NY, by a press release and letters
dated June 26, 2003. New York State initiated recall is complete.
REASON
The product was contaminated with Listeria monocytogenes based on NYSDAM's sampling
& analysis.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
Nationwide and Canada.
_______________________________
PRODUCT
The Nut Boy brand Banana Nut Mix, 8oz. & 16 oz. bags. Label appears as a rectangular label with a yellow border. Label reads in part, ***THE NUT BOY***BANANA NUT MIX NO CHOLESTEROL ***3212***Nutrition Facts***ONE POUND NET WT. 16OZ (453g)***"or"***ONE HALF POUND NET WT. 8OZ (227g)*** Note: Label included is for the one pound bag. The one half pound bag was not available. Recall # F-028-4.
CODE
No manufacturing code applied. Distributed between 5/1-8/1/03.
RECALLING FIRM/MANUFACTURER
Superior Nut Company, Inc., Los Angeles, CA, by telephone and letter on August 20, 2003. FDA initiated recall is complete.
REASON
The product contained undeclared sulfites based on FDA's analysis.
VOLUME OF PRODUCT IN COMMERCE
60 cases/24/8 oz bags.
DISTRIBUTION
CA.
_______________________________
PRODUCT
PET brand Butter Pecan Ice Cream, Half Gallon (1.89 Liters). Product is packed in rectangular paper cartons. Recall # F-030-4.
CODE
B FEB 15 04 45051 1836 through 1849.
RECALLING FIRM/MANUFACTURER
Pet Dairy Div Land-o-Sun Spartanburg, SC, by press release, telephone and fax on June 11, 2003. Firm initiated recalls is complete.
REASON
Cartons labeled as Butter Pecan Ice Cream actually contained Nutty Buddy Chocolate Nut Sundae Cone Ice Cream with peanuts and wheat flour as ingredients.
VOLUME OF PRODUCT IN COMMERCE
250 half gallon containers.
DISTRIBUTION
AL, GA, NC, SC, TN and VA.
***CORRECTION***
On the October 8, 2003 Enforcement Report 03-41, Recall # F-566/582-3 Distribution was reported as Nationwide. The area of distribution is Washington and Oregon.
_______________________________
PRODUCT
The Nut Boy brand Tropics Mix Yogurt Mix, 8oz. bag. Label appears as a rectangular label with a green border. Label reads in part, ***THE NUT BOY***TROPICS MIX YOGURT MIX NO CHOLESTEROL NO SALT***3178***Nutrition Facts***ONE HALF POUND NET WT. 8OZ(227g)***. Note: Label included is for the one pound bag and differs from the one half pound bag label. Instead of "***WITH YOGURT***" as shown in the included label, the actual label reads, "***YOGURT MIX***". Recall # F-029-4.
CODE
All products that were distributed between 6/24 and 8/1/03.
RECALLING FIRM/MANUFACTURER
Superior Nut Company, Inc., Los Angeles, CA, by telephone and letter on August 20, 2003. FDA initiated recall is complete.
REASON
The product contained undeclared sulfites based on FDA's analysis.
VOLUME OF PRODUCT IN COMMERCE
60 cases/24/8 oz bags.
DISTRIBUTION
CA.
______________________________
PRODUCT
Gooey Butter Bars, a cake type dessert, frozen, approximately 4 lbs, 5 bars to the case, product packaged in a wax covered cardboard tray and shrink wrapped. Recall # F-031-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Colt, Inc., Nashville, TN, by letter and email beginning October 15, 2003. FDA initiated recall is complete.
REASON
The firm's Gooey Butter Bars contained undeclared color, FD&C Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
378/5 bar cases.
DISTRIBUTION
TN and AL.
***CORRECTIONS***
On the November 12, 2003 Enforcement Report 03-46, Recall # D-032-4, Lipitor Tablets, the Reason was reported incorrectly, it should be: REASON Counterfeit product.
On the October 29, 2003 Enforcement Report 03-44, Recall # D-003-4, a) Zyprexa Tablets (Olanzapine), 5 mg, 60 tablet bottles, RX only.; and Recall # D-006-4, d) Zyprexa Tablets (Olanzapine), 20 mg, 60 tablet bottles, RX only, was submitted in error - and should be deleted.
Recall # D-004-4 and Recall # D-005-4 are correct.
____________________________
PRODUCT
Terramycin (oxytetracycline), 50 mg/mL, Intramuscular Solution, (contains 2% lidocaine) 10 mL vials, FOR INTRAMUSCULAR USE ONLY, Rx only. Recall # D-003-4.
CODE
Lot 0141K01A, Exp. Date 10/1/05.
RECALLING FIRM/MANUFACTURER
Pfizer Inc., New York, NY, by letter on October 29, 2003. Firm initiated recall is ongoing.
REASON
Presence of Precipitate/cloudy appearance.
VOLUME OF PRODUCT IN COMMERCE
44,820 Vials.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Zyprexa Tablets (Olanzapine), 10 mg, 60 tablet bottles,
Rx only. Recall # D-046-4;
b) Zyprexa Tablets (Olanzapine), 15 mg, 60 tablet bottles,
Rx only. Recall # D-047-4.
CODE
a) Lot No./Exp Date: 6AH19A (01/05), 7AA39A (03/05), and
7EA97A (04/05).
b) Lot No./Exp. Date: 6AH35A (01/05) and 6AG70A (11/04).
RECALLING FIRM/MANUFACTURER
Walsh Southwest, LLC, San Antonio, TX, by letter dated August 15, 2003. Firm initiated recall is ongoing.
REASON
Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE
547.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Mexiletine Hydrochloride Capsules, USP, 150 mg, 100 capsule bottles, Rx only. Recall # D-051-4.
CODE
Lot 49101M02 (Sept 2004).
RECALLING FIRM/MANUFACTURER
Watson Diagnostic, Inc, Corona, CA, by letter on October 8, 2003. Firm initiated recall is ongoing.
REASON
Capsule Defects: Split or broken capsules.
VOLUME OF PRODUCT IN COMMERCE
3352.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Sterile Diluent for Humulin L, Humulin U and Lente Iletin, Lilly, 10 ml. vial. Warning: Use ONLY with insulins listed on side panel. PROFESSIONAL PACKAGE NOT TO BE SOLD. Recall # D-053-4.
CODE
7RE39M and 7RT38M.
RECALLING FIRM/MANUFACTURER
Lilly, Eli & Co., Indianapolis, IN, by letter on October 3, 2003. Firm initiated recall is ongoing.
REASON
Particulates: vials exhibit white particles/white precipitate on vial wall which does not resuspend.
VOLUME OF PRODUCT IN COMMERCE
6,814 vials.
DISTRIBUTION
Nationwide, Canada and Japan.
_______________________________
PRODUCT
a) Entrobar Barium Sulfate Suspension, Rx Only, (50% w/v
barium sulfate USP suspension), Net Contents: 500 ml,
Recall # D-054-4;
b) Entrocel, Methylcellulose solution, (1.8% w/v
hydroxpropyl methylcellulose solution...), For
Professional Use Only, Net Contents: 500 ml.
Recall # D-055-4;
c) Entrokit Enteroclysis Kit,(This kit contains both
Entrobar and Entrocel product). Recall # D-056-4;
d) Entrokit Enteroclysis Kit with Catheter.
Recall # D-057-4.
CODE
a) Lot 21265, exp 12/31/2005;
b) Lot 21009, Exp 10/31/2005; Lot 21112, Exp 11/30/2005;
Lot 21140, Exp11/30/2005.
c) Lot 30179, exp 12/31/2003; Lot 30442, exp 03/31/2004;
d) Lot 30179, exp 12/31/2003; Lot 30422, exp 03/31/2004;
Lot 30494, exp 03/31/2004.
RECALLING FIRM/MANUFACTURER
Mallinckrodt Inc, Hazelwood, MO, by letter on October 2, 2003. Firm initiated recall is ongoing.
REASON
Mislabeling: Entrobar labeled bottles may contain Entrocel (clear liquid) or Entrocel labeled bottles may contain Entrobar (milky-white liquid).
VOLUME OF PRODUCT IN COMMERCE
906 cases (12 units/case).
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Kaletra capsules (Lopinavir/Ritonavir), Each soft gelatin capsule contains: Lopinavir 133.3mg, Ritonavir 33.3mg, 180 capsule bottles, Rx only. Recall # D-061-4.
CODE
Lot # 852072E25, EXP Date 06/04 Lot #852002E21, EXP Date 12/03 or 2/04.
RECALLING FIRM/MANUFACTURER
Dialysist West, Inc., Tempe, AZ, by letter on August 15, 2003. FDA initiated recall is complete.
REASON
Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE
143 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) SYNTEST H.S. (Half-Strength Tablets), EACH TABLET
CONTAINS: Esterified Estrogens .625mg/Methyltestosterone
1.25mg, 100 Tablet bottles, Syntho, Rx only.
Recall # D-063-4;
b) SYNTEST D.S. (Double-Strength Tablets), EACH TABLET
CONTAINS: Esterified Estrogens 1.25 g/Methyltestosterone
2.5 mg, 100 Tablet bottles. Recall # D-064-4.
CODE
a) Lot Nos: S02D02 (exp. date 03/04),
S02D03 (exp. date 03/04), S02K02 (exp. date 09/04),
S02K03 (exp. date 09/04), S02K10 (exp. date 09/04);
b) Lot No. S02D01 (exp. date 03/04).
RECALLING FIRM/MANUFACTURER
Syntho Pharmaceuticals, Inc., Farmingdale, NY, by letter dated October 13, 2003. FDA initiated recall is ongoing.
REASON
Subpotency: finished product and/or content uniformity testing.
VOLUME OF PRODUCT IN COMMERCE
59,693 bottles of 100 tablets in total.
DISTRIBUTION
Nationwide.
***CORRECTION***
On the November 5, 2003 Enforcement Report 03-45, Recall # D-031-4, Morphine-Sulfate Extended-Release Tablets. The manufacturer is listed as Bristol-Myers Squibb in Princeton, NJ but this product/lot was actually made by Bristol-Myers Squibb in Garden City, NY.
___________________________________
PRODUCT
Tarka Tablets (trandolapril/verapamil HCI ER), 4mg/240mg, 100 count bottles, Rx only. Recall # D-006-4.
CODE
Lot 02TK441016, Exp Date 12/2004.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter dated October 23, 2003. FDA initiated recall is ongoing.
REASON
Mislabeling: Extended expiration date-product incorrectly declares expiration date as 12/2004 rather than the correct date of 7/2004.
VOLUME OF PRODUCT IN COMMERCE
7,453 bottles.
DISTRIBUTION
Nationwide and Puerto Rico.
___________________________________
PRODUCT
Vicodin HP Tablets (hydromorphone bitartrate and acetaminophen tablets, USP), 10mg/660mg, 500 count bottles, Rx only. Recall # D-048-4.
CODE
Lot 03VICH5004, Exp. Date June 2006.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter dated October 21, 2003. FDA initiated recall is ongoing.
REASON
Mislabeling: Extended expiration date-product incorrectly declares expiration date as 6/2006 rather than the correct date of 6/2005.
VOLUME OF PRODUCT IN COMMERCE
108 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Actifed Cold & Allergy tablets (60 mg Pseudoephedrine HCl, 2.5 mg Triprolidine
HCl), 12 count blister/carton. Recall # D-062-4.
CODE
Lot No. Exp. Date 24112V 10/2005 15952V 6/2005.
RECALLING FIRM/MANUFACTURER
Pfizer Inc., Morris Plains, NJ, by letter on October 1, 2003. Firm initiated
recall is ongoing.
REASON
Misbranding; some of the dosing information and/or ingredient listing information
may be missing from the carton.
VOLUME OF PRODUCT IN COMMERCE
666,678.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0136-4;
b) Platelets. Recall # B-304-4.
CODE
a) and b) Unit 6707979.
RECALLING FIRM/MANUFACTURER
Lifeshare, Inc., Elyria, OH, by letter dated July 31, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0275-4.
CODE
Unit number 53LL59082.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter on March 14, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to the application of a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0276-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0277-4;
c) Platelets. Recall # B-0278-4;
d) Fresh Frozen Plasma. Recall # B-0279-4;
e) Recovered Plasma. Recall # B-0280-4.
CODE
a), c), and d) Unit number KT08214;
b), and e) Unit number KT04390.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Annandale, VA, by letter and facsimile on February 27, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
VA, and NJ.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0281-4.
CODE
Unit number T99694.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on June 5, 2003. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0282-4.
CODE
Unit number 0891022.
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Jackson, TN, by letter on June 18, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
_______________________________
PRODUCT
Source Plasma. Recall # B-0283-4.
CODE
Unit number VL116243.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Shreveport, LA, by facsimile on November 6, 2002. Firm initiated recall is complete.
REASON
Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0284-4.
CODE
Unit numbers VL127096, VL126189, VL125789, VL125544, VL125204, VL124967, VL124518, VL124274, VL123804, VL123522, VL123149, VL122844, VL122215, VL121898, VL121453, VL121098, VL120771, VL120363, VL120240, VL119718, and VL119622.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Shreveport, LA, by facsimile on August 13, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for syphilis, but were collected from an ineligible donor based on previous reactive testing for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
a) Red Blood Cells Leukoreduced. Recall B-0290-4;
b) Recovered Plasma. Recall # B-0291-4.
CODE
a) Units: 3048919, 3048973, 3049029, 4061527;
b) Units: 3048919, 3048973, 3049029.
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by letter dated June 14, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from donors who had body piercing within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
MA, MI, WI, and FL.
_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0292-4.
CODE
Unit 21KP38884.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Pacific Northwest Region, Portland, OR, by letter dated December 10, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OR.
_______________________________
PRODUCT
Source Plasma. Recall # B-0293-4.
CODE
Unit 39865687, 39852366, 39845009, 39840738, 39820006, 39788030, 39779601, 39775535, 39767318, 39763594.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Medford, OR, by facsimile on March 27, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on a previous deferral for IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0294-4.
CODE
Unit 13898465, 13502010, 21653582, 21656033, 21658778, 23683488, 18973310, 18872286, 18878486, 25841893, 25844313, 25848465, 25849394, 25241518, 25247732, 25233889.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc, Gresham, OR, by facsimile on April 9, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on a previous deferral for IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0295-4.
CODE
Unit numbers 0181085324, 0181084930, 0181084672, 0181084230, 0181084010, 0181083622, 0181083319, 0181083134, 0181082650, 0181082422, 0181082019, 0181081786, 0181081324, 0181081203, 0181088815, 0181080269, 0181080039, 0181079623, 0181079413, 0181076976, 0181077460, 0181078195, 0181078421, 0181078789, and 0181079008.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc, Columbus, OH, by facsimile on April 16, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0296-4.
CODE
Unit numbers 0181084171, 0181082913, 0181082849, 0181081884, 0181081620, 0181081269, 0181081050, 0181080350, 0181080111, 0181079658, 0181079434, 0181079025, 0181077174, 0181076421, 0181075845, 0181075755, 0181075235, 0181074914, 0181074566, 0181073793, 0181073655, and 0181072934.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc, Columbus, OH, by facsimile on April 29, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0297-4.
CODE
Unit numbers N-65845-139, N-65860-139, G-09540-139,
G-09755-139, G-13082-139, G-13594-139, G-13745-139,
G-14110-139, G-14446-139, G-15176-139, G-16381-139,
G-16887-139, G-17767-139, G-17893-139, G-18561-139,
G-18883-139, G-19150-139, G-19531-139, G-20001-139,
G-20298-139, G-20697-139, G-21284-139, G-21586-139,
G-21822-139, G-22784-139, G-23016-139, G-23452-139,
G-25987-139, G-26046-139, G-27536-139, G-27617-139,
G-28014-139, G-28375-139, G-28629-139, G-29023-139,
G-29380-139, G-29777-139, G-30038-139, G-30337-139,
G-30754-139, G-30923-139, G-31296-139, G-31515-139,
G-32318-139, G-35520-139, G-35868-139, G-37675-139,
G-37976-139, G-38203-139, G-38898-139, G-39158-139,
G-40544-139, G-40611-139, G-41198-139, G-41408-139,
G-42356-139, G-42656-139, G-42900-139, G-43364-139,
G-49327-139, G-43505-139, G-43944-139, G-44537-139,
G-44930-139, G-45218-139, G-45652-139, G-45884-139,
G-46280-139, G-46518-139, G-47268-139, G-47604-139,
G-47956-139, G-48519-139, and G-49889-139.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Mobile, AL, by facsimile on October 28, 2002. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jacob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
74 units.
DISTRIBUTION
CA, and Spain.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0298-4.
CODE
Unit number 8088090.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on August 7, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Source Plasma. Recall # B-0299-4.
CODE
Unit numbers 0181029519, 0181029288, 0181021630, and 0181018865.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc, Columbus, OH, by facsimile on April 15, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0300-4.
CODE
Unit numbers 40GY00220 (distributed as two split units) and 40GY00219.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of American Region, Peoria, IL, by telephone on August 11, 2003, and by letter on September 3, 2003. Firm initiated recall is complete.
REASON
Blood products were collected in a manner that may compromise the sterility of the products.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
VistA Blood Bank Software. Recall # B-0301-4.
CODE
Version number 5.2, software patch LR*5.2*301.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Veterans Health Administration Office of Information, Hines, IL, by letter on October 2, 2003.
Manufacturer: Dallas Office of Information Field Office, Grand Prairie, TX. Firm initiated recall is complete.
REASON
Blood establishment computer software that could allow the release of unsuitable blood products was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 version.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Source Plasma. Recall # B-0303-4.
CODE
Units 54166084, 51456535, 51450793, 51409531, 51401870, 51379155, 51368005, 51364540, 51356071, 51350505.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc, Medford, OR, by facsimile on March 22, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Removed. Recall # B-0309-4.
CODE
Unit 6066738.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone and facsimile on August 6, 2003. Firm initiated recall is complete.
REASON
Blood product, that was labeled as leukoreduced but had an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0302-4.
CODE
Unit numbers: 13FV15457, 13FV15978, 13FP05903, 13FJ97099, 13GL13000, 13FY79490, 13GF00873, 13GW20027, 13GE06108, 13GE06107, 13GE06106, 13GF00912, 13GQ57560, 13GV33324, 13GV33323, 13FE22632, 13GV33322, 13GV33319, 13FE22631, 13GV33321, 13FY84034, 13GQ60446, 13GQ60476, 13GL12733, 13GL12732, 13GE06606, 13FM83902, 13FR50650, 13GM75083, 13FK10012, 13FK10011, 13GR37809, 13GQ58756, 13FQ14971, 13FH99483, 13FK09266, 13GX57002, 13FQ14721, 13FV13701, 13FK09682, 13FP04328, 13FQ15330, 13GQ57561, 13FE22633, 13FH98331, 13FE23543, 13FP04550, 13FP04540, 13FV15228, 13FN85642.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letter dated February 20, 2003, and April 3, 2003. Firm initiated recall is complete.
REASON
Red Blood Cells, prepared more than eight hours and thirty minutes from time of collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
50 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Sedecal SP-HF 4.0 Portable X-Ray System. Recall # Z-0001-04.
CODE
Serial # PK10058.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sedecal USA, Inc., Arlington Heights, IL, by an Important Safety Notice dated October 27, 2003.
Manufacturer: SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, Algete (Madrid) Spain. FDA initiated recall is ongoing.
REASON
A minimum source-skin-distance of less than 30 cm and not identifying the tube manufacturer on the tube housing label resulted in the SP-HF-4.0 Portable Systems not complying with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VT.
_______________________________
PRODUCT
Propper brand cal-mark(, Micro-Hematocrit Calibrated Capillary Tubes, Calibrated-Heparinized, reorder no. 043021, 6 Vials, 100 Tubes per Vial, Length 75 mm., 0.55 mm. I.D., 1040-1.75mm. O.D. Calibrated 60mm from end for use in direct reading centrifuges. Recall # Z-0051-04.
CODE
Lot # C0402.
RECALLING FIRM/MANUFACTURER
Propper Manufacturing Co., Inc., Long Island City, NY, by fax on August 9, 2002 and November 27, 2002. Firm initiated recall is complete.
REASON
Deviation in capillary tubes could cause a 10% increase in read out values which could make a slight anemic patient appear to have a normal reading.
VOLUME OF PRODUCT IN COMMERCE
178 boxes.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Clinitron At Home( Air Fluidized Therapy Unit. Model 206 (CS). Recall # Z-0057-04.
CODE
Serial numbers 101671 and 103443 510K K942184.
RECALLING FIRM/MANUFACTURER
Hill-Rom Manufacturing, Inc, Charleston, SC, by letter on January 14, 2002. Firm initiated recall is complete.
REASON
Power cord overheating.
VOLUME OF PRODUCT IN COMMERCE
1,703 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
AEROSET System Software, Catalog 2-95068-01 version 1.02ER000 and Catalog 2-95175-01 AEROSET System Software, version 1.02ER000 Upgrade Kit. Recall # Z-0091-04.
CODE
Version 1.02ER000 and Version 1.02ER000 Upgrade Kit.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on September 30, 2003. Firm initiated the recall is ongoing.
REASON
Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples.
VOLUME OF PRODUCT IN COMMERCE
133.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Solar 8000M Patient Monitor. Recall # Z-0092-04.
CODE
All devices with Solar 8000M software versions 3A, 3B or 3C.
RECALLING FIRM/MANUFACTURER
General Electric Medical Systems Information Technology, Milwaukee, WI, by letter dated June 4, 2002. Firm initiated recall is ongoing.
REASON
Various user settings may change without an audible warning or visual indication. Examples of settings that may change are pacemaker detection which may turn from on to off, selected ECG leads for display, and selected gain settings for a selected waveform.
VOLUME OF PRODUCT IN COMMERCE
2,809 monitors and 238 software update kits.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14. Product is packed in plastic Tyvek packaging and is labeled as sterile. Recall # Z-0105-04.
CODE
Lot 432978 Serial Numbers 0460912 to 0460954;
Lot 433954 Serial Numbers 0471589 to 0482514;
Lot 434846 Serial Numbers 0482490 to 0482514.
RECALLING FIRM/MANUFACTURER
Exactech, Inc., Gainesville, FL, by letter on June 17, 2003. Firm initiated recall is complete.
REASON
Instrument is excessively flexible making it unusable by the surgeon.
VOLUME OF PRODUCT IN COMMERCE
21.
DISTRIBUTION
LA, ME, NV, and GA.
_______________________________
PRODUCT
Siemens Biograph, biograph LSO and CTI Models: Reveal RT. Recall # Z-0106-04.
CODE
All CPS manufactured PET/CT systems distributed between October 31, 2000 and June 24, 2003.
RECALLING FIRM/MANUFACTURER
Cti Pet Systems Inc., Knoxville, TN, by letter beginning October 2, 2003. Firm initiated recall is ongoing.
REASON
CPS has found that in some instances, when the CTE-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion.
VOLUME OF PRODUCT IN COMMERCE
73.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Mdline Blue O.R. Towel, Sterile; Reorder # MDT2168204, 4 towels per pack, 20 packs per case. Recall # Z-0114-04.
CODE
Lot 03IA0532.
RECALLING FIRM/MANUFACTURER
Medline Industries, Inc., Mundelein, IL, by telephone on October 7, 2003. Firm initiated recall is complete.
REASON
The product labeled as sterile, had not gone through the sterilization process at the time of shipment.
VOLUME OF PRODUCT IN COMMERCE
44 cases.
DISTRIBUTION
OH, IA, IL, WI, and IN.
_______________________________
PRODUCT
ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts .035" Wire Guide, Introduction system: 7 FR., Minimum Scope Channel: 2.8 MM., Disposable-Single Use Only, Rx Only, Catalog numbers: ZILBS-10-4, ZILBS-6-4, ZILBS-8-4, ZILBS-10-6, ZILBS-6-6, ZILBS-8-6, ZILBS-10-8, ZILBS-6-8, ZILBS-8-8. Recall # Z-0089-04.
CODE
Lot numbers: 1616783, 1616787, 1622794, 1622798, 1622802, 166958, 1622966, 162970, 162993, 1623007, 1623016,
1626424, 1631805, 1616784, 1616788, 1622795, 1622799, 1622803, 1622959, 1622803, 1622959, 1622963, 1622967, 1622982, 1622994, 1623008, 1623017, 1631388, 1633707, 1616785, 1616789, 1622796, 1622800, 1622804, 1622960, 1622964, 1622968, 1622985, 1623001, 1623009, 1623018, 1631803, 1634239, 1616786, 1616790, 1622797, 1622801, 1622956, 1622961, 1622965, 1622969, 1622986, 1623002, 1623015, 1626423, 1631804, 1635626.
RECALLING FIRM/MANUFACTURER
Wilson-Cook Medical Inc, Winston Salem, NC, by email on April 21, 2002. Firm initiated recall is complete.
REASON
Complaints were reported of difficulty in stent deployment.
VOLUME OF PRODUCT IN COMMERCE
155 units.
DISTRIBUTION
Nationwide, Ireland and Jordan.
_______________________________
PRODUCT
FastPack Total Testosterone Immunoassay. Device to determine quantitative total testosterone in human serum. Catalog #: 25000009. Recall # Z-0090-04.
CODE
Lots: 0307042, 0308019, and 0308020.
RECALLING FIRM/MANUFACTURER
Qualigen, Inc., Carlsbad, CA, by letter starting September 24, 2003 and certified or Airborne letter sent on September 29, 2003. Firm initiated recall is ongoing.
REASON
Kits may produce results that are falsely elevated.
VOLUME OF PRODUCT IN COMMERCE
81.
DISTRIBUTION
Nationwide and Switzerland.
_______________________________
PRODUCT
ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system. Product Model ZAN S61C01E. Recall # Z-0104-04.
CODE
Lot Number Z0306005.
RECALLING FIRM/MANUFACTURER
Sandhill Scientific, Inc., Highlands Ranch, CO, by telephone and letter on September 24, 2003. Firm initiated recall is ongoing.
REASON
Pouch containing pediatric probes was labeled as containing adult probes.
VOLUME OF PRODUCT IN COMMERCE
17 probes.
DISTRIBUTION
CO, MT, and TX.
END OF ENFORCEMENT REPORT FOR NOVEMBER 19, 2003
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