October 1, 2003
03-40
_______________________________
PRODUCT
Schwartz Appetizing brand Schmaltz Herring, Net Wt. 7 oz. Product is packaged in plastic tub containers. Barcode # 7 87434 22222 1. Recall # F-464-3.
CODE
Date Code "08/06" (exp. date) found on stick-on label on bottom of container.
RECALLING FIRM/MANUFACTURER
Schwartz Appetizing, Brooklyn, NY, by press release, telephone and letter on July 29, 2003. FDA initiated recall is complete.
REASON
Product contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
Approx. 272-7oz containers.
DISTRIBUTION
NY.
_______________________________
PRODUCT
Primera Brand, Macapuno Strings, Net Wt. 340 g. Recall # F-465-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Mandalay Trading Corp., City of Industry, CA, by letters on August 8, 2003 and by press release on September 5, 2003. FDA initiated recall is ongoing.
REASON
Product contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
17 cases.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Morinaga Hi-Chew Strawberry brand candy; net. wt: 2.01 oz (57g). Product of Japan. UPC # 074410640071. Recall # F-522-3.
CODE
Item # 64007.
RECALLING FIRM/MANUFACTURER
Nishimoto Trading Co., Carlstadt, NJ, by press release on May 19, 2003, and by letters on May 23, 2003. FDA initiated recall is complete.
REASON
The Japanese yogurt candy contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
9,348 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Country Farm Raisin Bread. Recall # F-523-3;
b) Winn Dixie Raisin Bread. Recall # F-524-3;
c) Cobblestone Mill 16 oz. Cinnamon Raisin Bread.
Recall # F-525-3;
d) Cobblestone Mill Banana Bread. Recall # F-526-3;
e) Cobblestone Mill 16 oz. Jewish Rye Bread.
Recall # F-527-3;
f) Broad Street Bakery 16 oz. Jewish Rye Bread.
Recall # F-528-3;
g) Cobblestone Mill 16 oz. Pumpernickel Bread.
Recall # F-529-3;
h) Broad Street Bakery 16 oz. Pumpernickel Bread.
Recall # F-530-3;
i) Cobblestone Mill 16 oz. Sourdough Bread.
Recall # F-531-3;
j) Broad Street Bakery 16 oz. Sourdough Bread.
Recall # F-532-3;
k) Cobblestone Mill 24 oz. 9-Grain Bread. Recall # F-533-3;
l) Cobblestone Mill 24 oz. Wheatberry Bread.
Recall # F-534-3;
m) Flowers 32 oz Pumpernickel Bread. Recall # F-535-3;
n) Flowers 32 oz. Sourdough Bread. Recall # F-536-3;
o) Flowers 42 oz. Club White Bread. Recall # F-537-3;
p) Flowers 42 oz. Club White Bread. Recall # F-538-3;
q) Flowers Breadsticks. Recall # F-539-3;
r) Foodservice Breadsticks. Recall # F-540-3;
s) Cobblestone Mill Garlic Breadsticks. Recall # F-541-3;
t) Broad Street Bakery Garlic Breadsticks.
Recall # F-542-3;
u) Flowers 6" Hot Dog Buns. Recall # F-543-3.
CODE
a) Item # 4004215 Best By Date Codes: Aug 2nd 155 0227;
Aug 3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267; and
Aug 8th 155 0267 (raisin and banana bread only);
b) Item # 4004219 Best By Date Codes: Aug 2nd 155 0227;
Aug 3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267; and
Aug 8th 155 0267 (raisin and banana bread only);
c) Item # 4004296 Best By Date Codes: Aug 2nd 155 0227;
Aug 3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267; and
Aug 8th 155 0267 (raisin and banana bread only);
d) Item # 4004299 Best By Date Codes: Aug 2nd 155 0227; Aug
3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267; and
Aug 8th 155 0267 (raisin and banana bread only);
e) Item # 4004226 Best By Date Codes: Aug 2nd 155 0227; Aug
3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267; and
Aug 8th 155 0267 (raisin and banana bread only);
f) Item # 4004229 Best By Date Codes: Aug 2nd 155 0227; Aug
3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267; and
Aug 8th 155 0267 (raisin and banana bread only);
g) Item # 4004240. Best By Date Codes: Aug 2nd 155 0227;
Aug 3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267;
and Aug 8th 155 0267 (raisin and banana bread only);
h) Item # 4004242. Best By Date Codes: Aug 2nd 155 0227;
Aug 3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267;
and Aug 8th 155 0267 (raisin and banana bread only);
i) Item # 4004251. Best By Date Codes: Aug 2nd 155 0227;
Aug 3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267;
and Aug 8th 155 0267 (raisin and banana bread only);
j) Item #4004253 Best By Date Codes: Aug 2nd 155 0227; Aug
3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267; and
Aug 8th 155 0267 (raisin and banana bread only);
k) Item # 4009442 Best By Date Codes: Aug 2nd 155 0227; Aug
3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267; and
Aug 8th 155 0267 (raisin and banana bread only);
l) Item # 4009444 Best By Date Codes: Aug 2nd 155 0227; Aug
3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267; and
Aug 8th 155 0267 (raisin and banana bread only);
m) Item # 4009490. Best By Date Codes: Aug 2nd 155 0227;
Aug 3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267;
and Aug 8th 155 0267 (raisin and banana bread only);
n) Item # 4009491;Best By Date Codes: Aug 2nd 155 0227;
Aug 3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267;
and Aug 8th 155 0267 (raisin and banana bread only);
o) Item # 4004277 Best By Date Codes: Aug 2nd 155 0227;
Aug 3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267;
and Aug 8th 155 0267 (raisin and banana bread only);
p) Item #4004280 Best By Date Codes: Aug 2nd 155 0227;
Aug 3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267;
and Aug 8th 155 0267 (raisin and banana bread only);
q) Item # 4004340 Best By Date Codes: Aug 2nd 155 0227;
Aug 3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267;
and Aug 8th 155 0267 (raisin and banana bread only);
r) Item #4004341 Best By Date Codes: Aug 2nd 155 0227;
Aug 3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267;
and Aug 8th 155 0267 (raisin and banana bread only).
s) Item #4004342 Best By Date Codes: Aug 2nd 155 0227;
Aug 3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267;
and Aug 8th 155 0267 (raisin and banana bread only);
t) Item # 4004345 Best By Date Codes: Aug 2nd 155 0227;
Aug 3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267;
and Aug 8th 155 0267 (raisin and banana bread only);
u) Item # 4109619 Best By Date Codes: Aug 2nd 155 0227;
Aug 3rd 155 0237; Aug 5th 155 0257; Aug 6th 155 0267;
and Aug 8th 155 0267 (raisin and banana bread only).
RECALLING FIRM/MANUFACTURER
Flowers Foods, Inc., Thomasville, GA, by press release and trade notice issued on July 30, 2003. Firm initiated recall is complete.
REASON
The products may have been contaminated with mesh from a metal screen.
VOLUME OF PRODUCT IN COMMERCE
24,745 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Chicken-Free Nuggets, Net Wt. 12 OZ. (340g). Recall # F-521-3.
CODE
Date code 3077. The product's date is embossed on the side panel of the retail package, and the first five numbers are 23077. A manufacturer's date of 30772 appears on the outside case.
RECALLING FIRM/MANUFACTURER
Health Is Wealth Products, Inc., Williamstown, NJ, by telephone and fax on August 1, 2003. Firm initiated recall is complete.
REASON
Chicken-Free Nuggets are mislabeled because the product inside the package is made of chicken.
VOLUME OF PRODUCT IN COMMERCE
1,442 cases/12 boxes per case.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Albuterol Sulfate 0.083%, unit-dose vial containing
Albuterol Sulfate Inhalation Solution, Rx ONLY, Pre-mix
solution for inhalation only, Distributed and
manufactured by Farmacia (Pharmacy) La Monserrate, Calle
Munoz Rivera, Esq. Monserrate, Aguas Buenas, PR. The
units are packaged in white cardboard boxes containing
the vials needed by the patient for the month. The box
has a custom made, typewritten pharmacy label. At the
other side of the box, there is another label with the
lot # and expiration date. Recall # D-335-3;
b) Ipratropium Bromide 0.02%, unit-dose vial, pre-mixed
solution for inhalation only, Rx Only. The units are
packaged in white cardboard boxes containing the vials
needed by the patient for the month. The box has a
custom made, typewritten pharmacy label in one side. At
the other side of the box, there is another label with
the lot# and expiration date. Recall # D-336-3
CODE
a) All codes manufactured and distributed between June and
July 2003.
b) All codes manufactured and distributed between April and
July 2003.
RECALLING FIRM/MANUFACTURER
Monserrat Pharmaceuticals, Inc., Aguas Buenas, PR, by visit starting on July 20, 2003. Firm initiated recall is ongoing.
REASON
Good Manufacturing Practice deviations; including, but not limited to, lack of testing for approval or release, stability data, and validation for cleaning/manufacturing operations.
VOLUME OF PRODUCT IN COMMERCE
44,000.
DISTRIBUTION
Puerto Rico.
_______________________________
PRODUCT
a) Zyprexa Tablets (Olanzapine), 5 mg., 60-tablet bottles,
Rx only, Eli Lilly and Company, Indianapolis, IN.
Recall # D-338-3;
b) Zyprexa Tablets (Olanzapine), 10 mg., 60-tablet bottles,
Rx only, NDC 0002-4117-60, Eli Lilly and Company,
Indianapolis, IN. Recall # D-339-3;
c) Zyprexa Tablets (Olanzapine), 15 mg., 60-tablet bottles,
Rx only, NDC-0002-4115-60, Eli Lilly and Company,
Indianapolis, IN. Recall # D-340-3;
d) Zyprexa Tablets (Olanzapine) 20 mg., 60-tablet bottles,
Rx only, Eli Lilly and Company, Indianapolis, IN.
Recall # D-341-3.
CODE
a) Lot Number 6AA66A;
b) Lot numbers 6AH19A, 7AA39A,and 7EA97A;
c) Lot Numbers 6AH35A, 6AG70A, 7AA77A, 7ED06A, 7ED00A, and
7EA53A;
d) Lot Numbers 7AA79A, 7EC85A, 7EA19A, and 7EA22A.
RECALLING FIRM
D & K Healthcare Resources, Inc., Saint Louis, MO, by e-mail on August 25, 2003.
MANUFACTURER-UNKNOWN. 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
31,553/60-tablet bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Oxygen, USP, compressed, steel and aluminum cylinderss C, D, E, K, Dey, Filled by Southern Welding Supply, Inc., Savannah, GA. Recall # D-313-3.
CODE
Lot Numbers 031081/4, 031082/5, 031901/4, 031901/5, 031901/3, 031911/4, 031911/5, 031921/3, 031921/4, 031921/5, 031951/4, 031951/5, 031952/4, 031952/5, 031961/4, 031961/5, 031971/3, 031971/4, 031981/3, 031981/4, 031981/5.
RECALLING FIRM/MANUFACTURER
Southern Welding Supply, Inc., Savannah, GA, by telephone on July 23, 2003. Firm initiated recall is ongoing.
REASON
Good Manufacturing Practice (GMP's) deviations, including but not limited to, failure to document testing of product purity in batch records.
VOLUME OF PRODUCT IN COMMERCE
573 cylinders.
DISTRIBUTION
GA and SC.
_______________________________
PRODUCT
M.T.E. - 6 Concentrated, Mixture of Six Trace Elements Additive (Each mL providing: Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, Chromium 10 mcg, Selenium 60 mcg, Iodide 75 mcg), 10 mL Multiple Dose Vial, Must Be Diluted Before IV Use, Rx only, American Pharmaceutical Partners, Inc., Schaumburg, IL, NDC 63323-036-10. Recall # D-317-3.
CODE
Lot numbers 100669 Expiration Date 8-30-03, 110316 Expiration Date 3-30-04 and 111223 Expiration Date 12-30-04.
RECALLING FIRM/MANUFACTURER
American Pharmaceutical Partners, Inc., Melrose Park, IL, by letters dated July 29, 2003 and August 5, 2003. Firm initiated recall is ongoing.
REASON
Subpotent (Iodide).
VOLUME OF PRODUCT IN COMMERCE
68,650 vials.
DISTRIBUTION
Nationwide, Puerto Rico, and Canada.
_______________________________
PRODUCT
Non-Aspirin Sinus Gelcaps, (Acetaminophen, 500mg and Pseudoehedrine HCl, 30mg), 24 Gelcaps blister packed cartons, Extra Strength, Pain Reliever/Nasal Decongestant, Pharmacist Formula is Marketed by: Leiner Health Products Carson, CA -----Also sold under other brand names as ----Pain Relief Sinus, Day Non-Drowsy, Extra Strength, Pain Reliever, Nasal Decongestant, 24 Gelcaps blister packed cartons, Longs brand, Distributed by Longs Drugs, Walnut Creek, CA----Non-Aspirin Sinus, Non-Drowsy, Extra Strength, 24 Gelatin Caplets blister packed cartons, American Fare brand, Made for Kmart Corporation, Troy, Michigan----Non-Drowsy Sinus, Non-Aspirin, Maximum Strength, Multi-Symptom Relief, Pain Reliever, Nasal Decongestant, 24 Gelatin Caplets blister packed cartons, Eckerd brand, Distributed by Eckerd Drug Company Clearwater, FL----Pain Reliever Sinus, Pain Reliever, Nasal Decongestant, Maximum Strength, 24 Gelatin Tablets blister packed cartons, ElectHealth brand, Distributed by: Shopko Stores, Inc. Green Bay, WI. Recall # D-327-3.
CODE
Lot Numbers 3EB1154 (Eckerd), 3EB1156 (American Fare), 3EB0999 (Longs), 3EB1155 (Longs), 3EB1157 (Pharmacist Formula) & 3EB1000 (ElectHealth).
RECALLING FIRM/MANUFACTURER
Leiner Health Products, Carlson, CA, by letters on August 5, 2003. Firm initiated recall is ongoing.
REASON
Mislabeling; Extended expiration date-product incorrectly bears expiry as 11/2005 rather than correct date of 12/2004.
VOLUME OF PRODUCT IN COMMERCE
864,000 pills.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Duradryl Jr. Capsules, Each T.D. Capsule contains: (Phenylephrine HCl 10mg, Chlorpheniramine Maleate 4.0mg, Methscopolamine Nitrate 1.25mg), 100 Capsule bottles, Rx Only, Dist. by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. NDC 51991-700-01 Recall # D-329-3.
CODE
Lot No. 046G3002.
RECALLING FIRM/MANUFACTURER
Nutramed, Inc., Rahway, NJ, by letter on July 24, 2003. Firm initiated recall is ongoing.
REASON
Dissolution failure; Phenylephrine HCI and Methscopolamine Nitrate.
VOLUME OF PRODUCT IN COMMERCE
4,992 bottles.
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Oxygen, USP, compressed, cylinders (125 and 281-cubic ft), RX only. Recall # D-334-3.
CODE
Lot number 184SPO3018B-Exp date 07/03/08.
RECALLING FIRM/MANUFACTURER
Air Liquide America LP, Houston, TX, by letter dated July 17, 2003. Firm initiated recall is complete.
REASON
Good Manufacturing Practices deviation; failure to maintain cylinder fill and testing records.
VOLUME OF PRODUCT IN COMMERCE
36 cylinders.
DISTRIBUTION
WA.
_______________________________
PRODUCT
Glucophage XR tablets (metformin HCl extended release), 500 mg, 100 count bottles, Rx only, Distributed by: Bristol-Myers Squibb Company, Princeton, NJ, NDC 0087-6063-13. Recall # D-337-3.
CODE
Lot No. Exp. date 304622 Jan 2005 304623 Mar 2005 304624 Mar 2005 305518 Mar 2005 305519 Mar 2005 305520 Mar 2005 305521 Mar 2005 305522 Mar 2005 305523 Mar 2005 305524 Mar 2005 305525 Mar 2005 305526 Mar 2005 305527 Mar 2005 305528 Mar 2005 305529 Mar 2005 305530 Mar 2005 305531 Mar 2005 305532 Mar 2005 305535 Mar 2005.
RECALLING FIRM/MANUFACTURER
Bristol-Myers Squibb Company, New Brunswick, NJ, by letter on August 13, 2003. Firm initiated recall is ongoing.
REASON
Subpotency; some tablets may contain less than the minimum specification for potency (blend validation).
VOLUME OF PRODUCT IN COMMERCE
205,655 units.
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) Platelet, Pheresis. Recall # B-1491-3;
b) Platelets. Recall # B-1492-3.
CODE
a) Unit 7045890, 7047566, 7055336, 7055748, 7055933,
7056472 and 7057040;
b) Unit 1753940.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on September 25, 2002 or October 14, 2002. Firm initiated recall is ongoing.
REASON
Blood products, collected from a donor taking the drug Lodine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 14 units (split units);
b) 1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Plasma. Recall # B-1727-3.
CODE
Unit number 53G55737.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter on March 12, 2002. Firm initiated recall is complete.
REASON
Blood product 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
1 unit.
DISTRIBUTION
MD.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1732-3;
b) Recovered Plasma. Recall # B-1733-3.
CODE
a) and b) FT06292.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Annandale, VA, by letter and facsimile on February 25, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA, and NJ.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1734-3.
CODE
Unit number FE81351.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Annandale, VA, by letter on April 1, 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
VA.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1735-3.
CODE
Unit number KS12681.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Annandale, VA, by letter on March 17, 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
VA.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1736-3.
CODE
Unit number L23345.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on March 26, 2003. Firm initiated recall is complete.
REASON
Blood products, 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
VA.
_______________________________
PRODUCT
Source Plasma. Recall # B-1737-3.
CODE
Unit numbers FFJGDY, FFJFYP, FFJFRJ, FFJFMW, FFJDWX, FFHWBP, FFHVWT, FFHVCW, FFHTXB, FFHTMY, and FFHTJV.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Lynchburg, VA, by letter on March 14, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Source Plasma. Recall # B-1738-3.
CODE
Unit numbers 77130808, 77088451, 76397448, 76049620, 75748418, 75741860, 75657369, 75651725, 75938826, 75932572, 75379803, 75371869, 74854943, 74850983, 74626410, 74623082, 74526710, 74524020, 73154136, 63190199, and 63187458.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Richmond, VA, by facsimile on June 12, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis B surface antigen (HBsAg), but were collected from an ineligible due to previous reactive testing for HBsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1740-3.
CODE
Unit numbers 1277729A, 1277932A, 1278076B, 1278266, 1277729B, 1277932B, 1278088A, 1278298, 1277736, 1277940, 1278088B, 1278306A, 1277746A, 1277950, 1278097, 1278306B, 1277746B, 1277963A, 1278100A, 1278313A, 1277767, 1277963B, 1278100B, 1278313B, 1277771, 1277978A, 1278135, 1278315, 1277778, 1277978B, 1278155, 1278322, 1277792, 1278024, 1278165, 1278346A, 1277798, 1278030, 1278177, 1278346B, 1277813, 1278035A, 1278193, 1278349A, 1277835, 1278035B, 1278220, 1278349B, 1277916, 1278050, 1278227, 1277921A, 1278062, 1278246, 1277921B, 1278076A, and 1278238.
RECALLING FIRM/MANUFACTURER
Houchin Blood Services,Bakersfield, CA, by letter on July 2, 2002. Frm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but were collected during of period of increased leukoreduction failures due to elevated white blood cell counts, were distributed.
VOLUME OF PRODUCT IN COMMERCE
57 units.
DISTRIBUTION
Ca.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1741-3;
b) Platelets. Recall # B-1742-3.
CODE
a) and b) Unit 1944553.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by facsimile transmission dated June 27, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KY.
_______________________________
PRODUCT
Platelets. Recall # B-1743-3.
CODE
Units Y31870, Y31871, Y31872, Y31873, and Y31874.
RECALLING FIRM/MANUFACTURER
Central Pennsylvania Blood Bank, Hummelstown, PA, by telephone on April 17, 2003, and by letter dated April 21, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from ineligible donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
PA.
_______________________________
PRODUCT
Corneas. Recall # B-1744-3.
CODE
Tissue numbers 2003-04-3003, 2003-04-3004.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartland Lions Eye Banks, Columbia, MO, by letter dated July 7, 2003.
Manufacturer: Heartland Lions Eye Bank, St. Louis, MO. Firm initiated recall is complete.
REASON
Human corneas, collected from a donor with bacterial endocarditis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
NY and CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-1747-3.
CODE
Units 44800635, 47188716.
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by facsimile dated January 16, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that had a piercing within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-1748-3.
CODE
Units 92523838, 92521926, 90169977, 90167959, 90165689, 90162190.
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by facsimile dated January 16, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-1749-3.
CODE
41664209, 41663332, 41661680, 41660829, 42168980, 42167938, 42166153, 42165057, 42163343, 42162674, 42161004, 40659848, 40658070, 40657073, 40654362, 40651927, 40651101, 30619784.
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., East Jackson, TN, by facsimile dated August 28, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus types 1 and 2 (anti-HIV-1/2), but were collected from a donor that was subsequently determined to have a previous react test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1750-3;
b) Recovered Plasma. Recall # B-1751-3.
CODE
a) and b) Unit 0367709.
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Erie County, Erie, PA, by telephone on December 5, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from donor who took the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1752-3;
b) Platelets. Recall # B-1753-3.
CODE
a) and b) Unit 0376423.
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Erie County, Erie, PA, by telephone on April 30, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested repeatedly reactive for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.
_______________________________
PRODUCT
Corneas. Recall # B-1756-3.
CODE
Tissue numbers 02-1189 OD and 02-1189 OS.
RECALLING FIRM/MANUFACTURER
Northwest Lions Eye Bank, Seattle, WA, by telephone on July 29, 2003 and letter dated August 1, 2003. Firm initiated recall is complete.
REASON
Human corneas, collected from a donor who had been incarcerated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
WA.
_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1757-3.
CODE
Unit number 12796-1393.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 27, 2003.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is complete.
REASON
Blood product 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
1 unit.
DISTRIBUTION
NM.
_______________________________
PRODUCT
Source Plasma. Recall # B-1767-3.
CODE
Unit numbers 75487553, 75486297, 75484101, 75482954, 75027100, KP77777, 75023676, 75022075, 74430000, 74428557, KP77572, KP77516, 74424214, 74422654, 73350040, 73348511, KP77362, 73345367, 73343035, 73341727, 75299330, 75297848, 75295226, KP77108, 75292041, 75290696, KP76921, 72449875, 72447758, 72443118, 72444511, 72419182, KP76630, 72378038, 72375020, KP76537, KP76424, 62088770, 62086103, 62084253, 62019293, 62016094, 62014274, KP76156, KP76091, 61337756, 61335769, 61239418, KP75839, 61232778, 60089663, KP75663, 60085528, KP75539, 60081032, KP75516, KP75372, 59270317, 59267942, 59266143, 58938638, 58935149, 58930724, KP74604, 58147597, KP74511, 58141090, 56586619, 56584417, 56580976, KP74348, KP74232, 58165829, 56569193, 56566550, 56563757, 56561487, 56657852, 56656404, 56655223, and 56653892.
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile beginning on May 24, 2002. Firm initiated recall is complet.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to previous reactive testing for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
81 units.
DISTRIBUTION
CA, IL, and NC.
_______________________________
PRODUCT
a) Platelets. Recall # B-1768-3;
b) Cryoprecipitated AHF. Recall # B-1769-3;
c) Fresh Frozen Plasma. Recall # B-1770-3;
d) Plasma, Cryoprecipitate Reduced. Recall # B-1771-3.
CODE
a) Unit numbers 30GH23642, 30GH23543, 30GE08443, 30GE08464,
30GG45405, 30GF11426, 30GG46538, 30GS10116, 30GH28043,
30GH29216, 30GF13696, 30GX22862, 30GG64049, 30LL00024,
30GJ32756, 30GX35075, 30GN18736, 30GN18855, 30GX35847,
30GX38081, 30GM03163, and 30GH26881;
b) Unit numbers 30GJ57644, 30GR09661, 30GJ57484, 30GJ55326,
30GL32563, 30GY24484, 30GW59408, 30GG68978, 30GH23543,
30GH23987, 30GE08443, 30GN09747, 30GG45405, 30GF11426,
30GG46538, 30GX17042, 30GX17041, 30GX17030, 30GX17029,
30GX17027, 30GG47683, 30GF13696, 30GX22862, 30GG62254,
30GX23443, 30GG64049, 30LL00024, 30GH47764, 30GN15945,
30GX32107, 30GT05698, 30GH51794, 30GH51789, 30GY19694,
30GX39184, 30GN69089, 30GG67313, and 30GH26881;
c) Unit numbers 30GW62728, 30GV00658, 30GF39454, 30GY23861,
30GH23642, 30GH23567, 30GS10116, 30GH28043, 30GH29216,
30GH35283, 30GX25795, 30GJ32756, 30GM00240, 30GJ34481,
30GX35075, 30GN18742, 30GN18736, 30GY20942, 30GN18855,
30GX35847, 30GX38081, 30GM03163, 30GL36491, 30GN64627;
d) Unit numbers 30GJ57644, 30GR09661, 30GJ57484, 30GW59408,
30GG68978, 30GH23987, 30GX32107, and 30GN69089.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on April 3, 2003, and by letters on April 9 and 10, 2003. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 22 units;
b) 38 units;
c) 24 units;
d) 8 units.
DISTRIBUTION
PA, CT, GA, MA, MD, MI, and NY.,
_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-1772-3;
b) Platelets. Recall # B-1773-3;
c) Fresh Frozen Plasma. Recall # B-1774-3.
CODE
a), b), and c) Unit 2385543.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on January 14, 2003 and February 25, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who resided in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Platelets. Recall # B-1775-3.
CODE
Unit M77187.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone on December 27, 2001. Firm initiated recall is complete.
REASON
Platelets, collected from a donor who had taken aspirin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1776-3;
b) Cryoprecipitated AHF. Recall # B-1777-3.
CODE
a) and b) Unit 980396.
RECALLING FIRM/MANUFACTURER
W.E. & Lela I. Stewart Blood Center, Tyler, TX, by letter dated October 3, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who tested reactive for Hepatitis B core antibody (HbcAb) on two occasions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Source Plasma. Recall # B-1778-3.
CODE
Unit QYP498.
RECALLING FIRM/MANUFACTURER
Alabama Plasma, Inc, Birmingham, AL, by facsimile on March 12, 2001. Firm initiated recall is complete.
REASON
Blood product, which was not tested for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1779-3;
b) Platelets. Recall # B-1780-3;
c) Cryoprecipitated AHF. Recall # B-1781-3;
d) Fresh Frozen Plasma. Recall # B-1782-3;
e) Plasma for Further Manufacture. Recall # B-1783-3;
f) Recovered Plasma. Recall # B-1784-3.
CODE
a) Unit numbers H536675, H528433, H515111, 427749, 422334,
405019, 399726, and 395468;
b) Unit numbers H536675, 427749, 422334, 405019, 399726, and
395468;
c) Unit number H528433;
d) Unit numbers 399726 and 395468;
e) Unit number H515111;
f) Unit numbers H536675, H528433, H515111, 427749, 422334,
and 405019.
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Bank, Springfield, IL, by facsimile on June 2, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 8 units;
b) 6 units;
c) 1 unit;
d) 2 units;
e) 1 unit;
f) 6 units.
DISTRIBUTION
IL, MO, and CA.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1788-3.
CODE
Unit number 2007835.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by telephone on May 19, 2003. Firm initiated recall is complete.
REASON
Blood product was not irradiated but was distributed with labeling that indicated that the unit had been irradiated.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1789-3.
CODE
Unit number 8469898.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Lake Charles, LA, by letter on April 30, 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
MI.
_______________________________
PRODUCT
Source Plasma. Recall # B-1790-3.
CODE
Unit numbers CYGFHT, CYDYYC, CYGFLQ, CYGFPD, CYGFJM, CYGFGF, CYGDZK, CYGDWW, CYHDVX, CYHDLK, CYHDHG, CYHDDB, CYHDBK, CYHCVY, and CYGFMD.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services, Inc, Knoxville, TN, by facsimile on March 6, 2003, and May 2, 2003.
Manufacturer: Aventis Bio-Services, Inc., Hamilton, OH. Firm initiated recall is complete.
REASON
Blood products, collected from donors 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
15 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Source Plasma. Recall # B-1791-3.
CODE
Unit 01GJBMHH .
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Cleveland, OH, by facsimile on March 28, 2003. Firm initiated recall is complete.
REASON
Blood product, which was not tested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1793-3.
CODE
Units 50LH38060 and 50LH38061.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by telephone on May 9, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH, and IL.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1795-3.
CODE
Unit number 1665795 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, Inc., East Orange, NJ, by telephone on April 8, 2002, and by letter on April 10, 2002. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but were not tested to determine the white blood cell count as required in the firm's standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Source Plasma. Recall # B-1799-3.
CODE
Unit numbers 7030204812, 7030204400, 7030203305, 7030200404, 7030200283, 7030199291, 7030199080, 7030198122, 7030197956, 7030196950, 7030196823, 7030196021, 7030195468, 7030194225, 7030193895, 7030193268, 7030192879, 7030191359, and 7030190591.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc.San Antonio, TX , by facsimile on February 21, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to previous incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units.
DISTRIBUTION
United Kingdom.
_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1800-3.
CODE
Unit 17KC39481.
RECALLING FIRM/MANUFACTURER
The American Red Cross, North Central Region, St. Paul, MN, by letter dated June 7, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from A donor whose health history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MN.
_______________________________
PRODUCT
Source Plasma. Recall # B-1802-3.
CODE
Unit 02EWIC3295.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Deerfield, IL, by facsimile dated August 16, 2002. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have affected the sensitivity of viral marker test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.
_______________________________
PRODUCT
Source Plasma. Recall # B-1805-3.
CODE
Unit 31 8GX6740.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services, Inc, Knoxville, TN, by e-mail dated May 18, 2001.
Manufacturer: Aventis Bio-Services, Inc., Minneapolis, MN. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to behavior associated with an increased risk of infection with the human immunodeficiency virus (HIV) or the hepatitis B virus (HBV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
_______________________________
PRODUCT
a) Platelets. Recall # B-1807-3;
b) Recovered Plasma. Recall # B-1808-3.
CODE
a) and b) Unit number 4966151.
RECALLING FIRM/MANUFACTURER
Our Lady of the Lake Hospital, Inc., Baton Rouge, LA, by facsimile on September 17, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to previous incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA and FL.
_______________________________
PRODUCT
Source Plasma. Recall # B-1809-3.
CODE
Unit numbers 0200284877, 0200284420, 0200284163, 0200283714, 0200283272, 0200283015, 0200282643, 0200282321, 0200281833, 0200281651, 0200281132, 0200280897, 0200280588, 0200280431, 0200277313, 0200276899, 0200276142, 0200275658, 0200275076, 0200274868, 0200274610, 0200274449, 0200274110, 0200273426, and 0200272650.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc.Norman, OK, by facsimile on May 21, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units.
DISTRIBUTION
United Kingdom.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-1816-3.
CODE
Unit 22KT46430.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Penn Jersey Region, Philadelphia, PA, by facsimile on June 5 and July 7, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor with a history of hepatitis A, was distributed.lk
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1818-3;
b) Fresh Frozen Plasma. Recall # B-1819-3.
CODE
a) and b) Unit number T45002.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on March 10, 2003. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of Platelets that failed quality control testing for pH, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.
_______________________________
PRODUCT
Source Plasma. Recall # B-1552-3.
CODE
Unit numbers BFFQMS and BFFQSL.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Fort Worth, TX, by letter dated November 29, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-1801-3.
CODE
Unit 17KC39481.
RECALLING FIRM/MANUFACTURER
The American Red Cross, North Central Region, St. Paul, MN, by letter dated June 7, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from A donor whose health history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MN.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1806-3.
CODE
Units 24216-1014, 24216-1007..
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on September 19, 2002. Firm initiated recall is complete.
REASON
Blood products, that may have been shipped at an unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AZ.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1810-3.
CODE
Unit numbers C40051, C40055, C40107, C40108, C40113, C40117, C40118, C40120, C40122, C40123, and C40127.
RECALLING FIRM/MANUFACTURER
Heritage Valley Health System, Valley Medical Facilities, Inc., Beaver, PA, by letter on December 11, 2002. Firm initiated recall is complete.
REASON
Blood products, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units.
DISTRIBUTION
PA.
_______________________________
PRODUCT
Source Plasma. Recall # B-1811-3.
CODE
Unit number 53-DDNCKF-B.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Melrose Park, IL, by facsimile on April 22, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Source Plasma. Recall # B-1812-3.
CODE
Unit number 53-DDPHWH-O.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Melrose Park, IL, by facsimile on April 22, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Source Plasma. Recall # B-1813-3.
CODE
Unit number 80-FRDXVV-O.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Rockford, IL, by facsimile on June 9, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1814-3.
CODE
Unit 6961232.
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on January 19, 2003. Firm initiated recall is complete.
REASON
Blood product, which was prepared from a Whole Blood unit with an extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-1815-3.
CODE
Unit 6852524.
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on January 2, 2003. Firm initiated recall is complete.
REASON
Blood product, which the corresponding red blood cells were found, during filtering, to have clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Source Plasma. Recall # B-1817-3.
CODE
Unit 00EWIC0791.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P. (Formerly Community Bio-Services), Eau Claire, WI, by fax dated September 15, 2000. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received MMR vaccine 24 days prior to donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.
END OF ENFORCEMENT REPORT FOR OCTOBER 1, 2003
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Hypertext created by clb 2003-OCT-01.