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U.S. Department of Health and Human Services

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Enforcement Report for August 31, 2005

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.

August 31, 2005
05-35

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I

______________________________
PRODUCT
The product is a chocolate chip cookie packaged in clear cello bag and placed in cardboard box as a component of a kit. The kit is labeled in part: "CAMP SURVIVAL KIT***ELEGANT SWEETS, Net Wt 16 oz", Recall # F-598-5
CODE
No codes associated with the product
RECALLING FIRM/MANUFACTURER
Elegant Gourmet, Woodinville, WA, by telephone, letter and press release beginning on June 15, 2005. Firm initiated recall is ongoing.
REASON
The label of the "Camp Survival Kit" fails to bear an ingredient statement for the cookies, whereas ingredients of other components of the kit are listed. The cookies contains the allergenic ingredients derived from wheat, eggs, and milk.
VOLUME OF PRODUCT IN COMMERCE
1,431 kits
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) DOUBLE DEERS FORMULA brand EXPELLIN EXTRACT
(CONCENTRATED), DIETARY HERBAL SUPPLEMENT, CHUAN XIONG
CHA TIAO WAN --- CONTENTS 200 PILLS (160 mg each) ---
Net Wt. 1.13 OZ (32g), PRODUCT OF CHINA ---Supplement
Facts --- Serving size 8 pills (1280 mg) --- Servings
per container 25 --- Proprietary blend 1280 mg ---
Chinese mint (above ground parts) --- Fragrant angelica
(root) ---Notopterygium (root & rhizome) --- Ligusticum
wallichii (rhizome) --- Siler (root) --- The pills are
packed in amber plastic bottles with safety caps and
packaged into green cardboard boxes with black lettering
on the white panel & red line. Recall # F-599-5;
b) CARDIOFLEX (GUAN XIN SU HE WAN) DIETARY SUPPLEMENT ---
CONTENTS: 30 PILLS (500mg Each) NET WT. 0.53 OZ. (20g),
PRODUCT OF CHINA --- Supplement Facts --- Serving Size
1 PILL --- Servings per container 30 --- Proprietary
blend 500 mg+ --- Santalum wood (Santali lignum)(root)
--- Aristochia root (Radix aristolochiae )(root) ---
Myrrh resin (Myrrha) (root) --- Scarlet root (Salvia
militorrhiza)(root) --- Styrax resin (Styrax
obassia)(root) --- The pills are packed in white plastic
bottles with safety caps and packaged into white
cardboard boxes with black lettering and pink & blue
colored stripes. Recall # F-600-5
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kingsway Trading Inc., Brooklyn, NY, by Press Release on November 10, 2004, and letters dated November 16, 2004.
Manufacturer: Shanghai Chinese Herbal CO., LTD. Shanghai People's Republic of China. Firm initiated recall is complete.
REASON
FDA's analysis revealed that the products contain Aristolochic Acid, a potent carcinogen and nephrotoxin found in certain plants and botanicals.
VOLUME OF PRODUCT IN COMMERCE
a) 80 cartons x 120 bottles (9,600 bottles);
b) 4,562 bottles
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Nabisco Pure Milk Chocolate Covered Oreo Sandwich Cookies in 7.5 oz. boxes, packaged in 12 box cases for sale in WalMart, and in 26 box display cases, UPC 44000-01094, Recall # F-601-5
CODE
"Best When Used By" dates on or before 05 NOV 05
RECALLING FIRM/MANUFACTURER
Kraft Inc, Northfield, IL, by press release on July 15, 2005. Firm initiated recall is ongoing.
REASON
Some of the boxes Pure Milk Chocolate Covered Oreo Sandwich Cookies actually contain Pure Milk Chocolate Covered Nutter Butter Peanut Butter Sandwich Cookies.
VOLUME OF PRODUCT IN COMMERCE
780,770 boxes
DISTRIBUTION
Nationwide

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PRODUCT
a) Veggie Golden Roast -- YTS brand; Net wt. 1 lb.,
ready to eat appetizers, Recall # F-604-5;
b) Veggie Smoked Duck -- KIMBO brand; Net wt. 1 lb.,
ready to eat appetizers, Recall # F-605-5;
c) Vegetarian Steamboat Flavoring -- YTS and KIMBO
brands; Net Wt 10 oz. (283g), Recall # F-606-5;
d) Vegetarian Smoked Drum Stick -- YTS and KIMB
brands; Net wt. 10 oz. (283 g), Recall # F-607-5;
e) Vegetarian Lamb -- YTS and KIMB brands; Net wt.
10 oz. (283 g), Recall # F-608-5;
f) YTS brand Liang Zen Golden Ham; Net wt. 2.2 lb
(35.3 oz), Recall # F-609-5;
g) KIMBO brand Veggie Golden Ham; Net wt. 2.2 lb
(35.3 oz), Recall # F-610-5;
h) Mushroom Cake -- YTS and KIMBO brands, Net wt.
12 oz. (340 g), Recall # F-611-5;
i) YTS brand New Century Veggie; Net wt. 12 oz.,
Recall # F-612-5;
j) YTS brand Curry Veggie Ham, Net wt. 2.2 lb.
(35.3 oz.), Recall # F-613-5
CODE
Exp Dated 4/27/04 thru 4/27/06
RECALLING FIRM/MANUFACTURER
YTS Group Inc., El Monte, CA, by letter and press release on May 2, 2005. Firm initiated recall is complete.
REASON
Products contain undeclared egg.
VOLUME OF PRODUCT IN COMMERCE
a) 352 cases, 24 pieces per case;
b) 360 cases, 24 pieces per case;
c) YTS brand -- 41 cases; KIMBO brand -- 10 cases,
24 pieces per case;
d) YTS brand -- 66 cases; KIMBO brand -- undetermined;
e) YTS brand -- 216 cases; KIMBO brand -- 200 cases;
f) 972 cases, 10 pieces per case;
g) 563 cases;
h) YTS brand -- 79 cases; KIMBO brand -- 95 cases,
24 pieces per case;
i) 37 cases, 24 pieces per case;
j) 75 cases; 10 pieces per case
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II

______________________________
PRODUCT
Publix brand Drinking Water in 1 gallon, UPC code 41415-22463 and 2.5 gallon, UPC code 41415-22563, HDPE containers with tamper evident caps, Recall # F-603-5
CODE
Recalled product bore plant code 12595 and the following manufacturing codes:
1 gallon -- PDR May 02, 2005 and PDR MAY 04 2005;
2.5 gallon -- PDR Apr 27, 2005 and PDR MAY 03 205
RECALLING FIRM/MANUFACTURER
Publix Supermarkets, Inc., Deerfield Beach, FL, by letter on June 2, 2005. Firm initiated recall is complete.
REASON
Bottled water has off-odor and off-taste
VOLUME OF PRODUCT IN COMMERCE
48,764 -- 1 gallon containers; 16,064 -- 2.5 gallon containers
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS III

______________________________
PRODUCT
Glitterati Miniature Hard Candies Fruit & Berry Medley 16 lb (4 x 4 lb) Master Carton. Product of Italy, Product Number: 5070, Recall # F-594-5
CODE
Lot code: 4280
RECALLING FIRM/MANUFACTURER
Recalling Firm: Chipurnoi, Inc., Sharon, CT, by letter dated June 23, 2005.
Manufacturer: Theobroma, Villa Guardia, Italy. Firm initiated recall is ongoing.
REASON
Mislabeled: Pear Flavor Candy may contain Eucalyptus menthol candy.
VOLUME OF PRODUCT IN COMMERCE
1,061 cases
DISTRIBUTION
CA, IL, IN, NY, NC, NV, OR, and TX

______________________________
PRODUCT
Coca Cola Classic, 12 Fl. oz (355 mL, Recall # F-602-5
CODE
WATER TEST (printed on bottom of the can)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coca Cola Enterprises, Atlanta, GA, by representative visit and letter on July 29, 2005.
Manufacturer: Coca Cola Beverages, Hartford, CT. Firm initiated recall is complete.
REASON
Product contains treated water, not Coca Cola Classic.
VOLUME OF PRODUCT IN COMMERCE
148 cases
DISTRIBUTION
CT

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Albuterol Sulfate Inhalation Solution, 0.083% (2.5mg/3mL), 60 x 3 mL Sterile Unit Dose Vials, Rx Only, For Oral Inhalation Use Only. Recall # D-467-5
CODE
Lot # W12241 and W12242
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami, FL, by letter issued on July 19, 2005.
Manufacturer: IVAX Pharmaceuticals U.K. Ltd, Preston Brook, Runcorn Cheshire WA7 3FA, UK. Firm initiated recall is ongoing.
REASON
Discoloration
VOLUME OF PRODUCT IN COMMERCE
3,540 cartons (60 x 3mL Unit Dose Vials per carton)
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Anagrelide Hydrochloride Capsules, 0.5 mg (base), 100 tablet bottles, Platelet-Reducing Agent, Rx only. Recall # D-468-5
CODE
Lot 358001V, expiration date Jun 06
RECALLING FIRM/MANUFACTURER
Boehringer Ingelheim Roxane, Inc, Columbus, OH, by letter dated July 26, 2005. Firm initiated recall is ongoing.
REASON
Dissolution Failure
VOLUME OF PRODUCT IN COMMERCE
6,180/100 tablet bottles
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
MINOXIDIL Tablets, USP, 2.5 mg, 100-tablet bottles, Rx only, NDC # 0591-5642-01, Recall # D-470-5
CODE
Lot L5A0061, Expiration date 01/31/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watson Pharmaceuticals, Inc., Corona, CA, by letters dated July 22, 2005.
Manufacturer: Watson Laboratories, Inc., Carmel, NY. Firm initiated recall is ongoing.
REASON
Oversized tablets
VOLUME OF PRODUCT IN COMMERCE
7,685 bottles x 100 bottles
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Adenoscan Adenosine Injection, 3 mg/mL in a 30 mL single dose vial, 10 vials per shelf tray, 10 trays per case; an Rx injectable drug for intravenous infusion only, product code 87130, NDC # 0469-0871-30, Recall # D-472-5
CODE
Lot 20-251-DK, Expiration date 8/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Astellas Pharma US Inc., Deerfield, IL, by letters dated August 12, 2005.
Manufacturer: Hospira Inc., Rocky Mount, NC. Firm initiated recall is ongoing.
REASON
There has been an increase in adverse events reported for this lot of Adenoscan.
VOLUME OF PRODUCT IN COMMERCE
137,340 vials
DISTRIBUTION
Nationwide, PR, Guam, and Canada

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

*****CORRECTION*****

The July 27, 2005 Enforcement Report 05-30, Recall # D-378-5, Premarin 0.3 mg, the Lot number is 07632 NOT 07732.

_______________________________
PRODUCT
Hemocyte Tablets (Ferrous Fumarate 324 mg) Folic Acid 1 mg US Pharmaceutical Corporation-Decatur, GA 300235 USA * Distributors. Container/closure system is film and foil blister package. Blisters are inserted into 0.16 sold bleach sulfate cardboard cartons. Product is packed: 100's: 10 blister cards x 10 tablets; 30's: 3 blister cards x 10 tablets, UPC Codes: 100's: 52747307701101, 30's: 52747307301101 Recall # D-463-5
CODE
Lot number: 050520-01, Expiration date: 05/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: U S Pharmaceutical Corporation, Decatur, GA, by fax and Company website on August 2, 2005.
Manufacturer: Opti-med Controlled Release Labs, Seymour, IN. Firm initiated recall is ongoing.
REASON
Mislabeling: The blister cards are printed with "Folic Acid 1 mg" as an ingredient, which in not in the Hemocyte Tablets.
VOLUME OF PRODUCT IN COMMERCE
7,391 cartons
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Fougera Nystatin and Triamcinolone Acetonide Cream USP, Each gram contains 100,000 USP Nystain Units and l mg triamcinolone acetonide, Net Wt. 30 grams, Rx only, NDC # 0168-0081-30, Recall # D-469-5
CODE
Lot M303, Expiration date 8/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Altana Inc., Melville, NY, by letters dated July 25, 2005.
Manufacturer: Altana Inc., Hicksville, NY. Firm initiated recall is ongoing.
REASON
Subpotent: Triamcinolone Acetonide (21 month stability).
VOLUME OF PRODUCT IN COMMERCE
64,662 tubes
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Zovia 1/35E-28 Tablets USP (Ethynodiol Diacetate and Ethinyl Estradiol), cartons of 6 tablet dispensers, 28 tablets each, Rx only, Recall # D-471-5
CODE
Lot #38303H04
RECALLING FIRM/MANUFACTURER
Watson Laboratories, Corona, CA, by letter on August 9, 2005. Firm initiated recall is ongoing.
REASON
There was an out-of-specification result for total impurities at the 12-month stability test point.
VOLUME OF PRODUCT IN COMMERCE
14,880 cartons
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Rite Aid brand Acid Reducer Tablets (Ranitidine USP), 75 mg, 75 tablets, 75 Doses, Made in India, Recall # D-478-5
CODE
Lot # 4MB0447
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leiner Health Products Llc, Carson, CA, by letter on August 8, 2005.
Manufacturer: Dr. Reddy's Laboratories, Hyderabad, India. Firm initiated recall is ongoing.
REASON
Mispacked; Lot was packaged without a desiccant.
VOLUME OF PRODUCT IN COMMERCE
22,188 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1944-5
CODE
Unit number: 027LW47648
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by telephone on April 1, 2005, and by letter dated April 4, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-1952-5
CODE
Unit number: FV10195
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on April 29, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a whole blood unit in which the associated Red Blood Cells and component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
Human Cornea For Transplant Tissue, Recall # B-1954-5
CODE
Tissue 05-0940-100
RECALLING FIRM/MANUFACTURER
Rocky Mountain Lions Eye Bank, Aurora, CO, by telephone on July 12, 2005, and by letter dated July 12, 2005. Firm initiated recall is complete.
REASON
Human Tissue, procured from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
CO

_______________________________
PRODUCT
Source Plasma, Recall # B-1974-5
CODE
Unit numbers: 370044259, 370035534, 370031700, 370031219, 370030380
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Toledo, OH, by facsimile dated August 18, 2004. Firm initiated recall is complete.
REASON
Source Plasma, collected from a previously deferred donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Spain

_______________________________
PRODUCT
Source Plasma, Recall # B-1980-5
CODE
Unit numbers: 370044674, 370043691, 370043326, 370042636, 370042310, 370041074, 370039859, 370039531, 370038574, 370038255, 370036110, 370034856, 370034313, 370033823, 370033399, 370007539, 370007130, 370006195, 370005829, 370005335, 370004818
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Toledo, OH, by facsimile dated September 10, 2004. Firm initiated recall is complete.
REASON
Source Plasma, collected from a previously deferred donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
Spain

_______________________________
PRODUCT
Recovered Plasma, Recall # B-1981-5
CODE
Unit number: A139963
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by fax on June 16, 2003. 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
Austria

_______________________________
PRODUCT
Source Plasma, Recall # B-1982-5
CODE
Unit numbers: N71143020, N71184020, G95802020, G09926020, G10374020, G10732020, G11273020, G14795020, G15112020, G17165020, G17662020, G18066020, G18428020, G18783020, F00313020, F00665020, F01120020, F01703020, and F07705020
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, McAllen, TX, by facsimile on March 28, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who provided post donation information regarding to having engaged in multiple high risk behavior activities, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
NC, CA, and Switzerland

_______________________________
PRODUCT
Red Blood Cells Leukoreduced, Recall # B-1993-5
CODE
Unit number: G142574
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letter dated March 7, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to an area endemic for malarial, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1994-5;
b) Platelets, Recall # B-1995-5
CODE
a) and b) Unit number: R164706
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letter dated June 9, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to an area endemic for malarial, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2005-5
CODE
Unit number: 04KM58966
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letter on May 31, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VT

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-2006-5
CODE
Unit numbers: P10-20475A and P10-20475B
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Inc., Trenton, NJ, by facsimile on January 22, 2004. Firm initiated recall is complete.
REASON
Platelets Pheresis with elevated platelet counts were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated,
Recall # B-2007-5;
b) Platelets, Recall # B-2008-5;
c) Fresh Frozen Plasma, Recall # B-2009-5
CODE
a), b) and c) Unit number: 4689834
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on June 23, 2004. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and OK

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated,
Recall # B-2010-5;
b) Buffy Coat, Recall # B-2011-5;
c) Recovered Plasma, Recall # B-2012-5
CODE
a), b) and c) Unit number: 4539511
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on April 14, 2004. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL, OK, and NB

_______________________________
PRODUCT
Source Plasma, Recall # B-2013-5
CODE
Unit numbers: 370024563, 370024248, 370017309, 370017101, 370016582, 370016231
RECALLING FIRM/MANUFACTURER
Biomat USA Inc., Toledo, OH, by fax on September 3, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously permanently deferred, were distributed
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Spain

_______________________________
PRODUCT
Red Blood Cells Leukocyte Reduced, Recall # B-2016-5
CODE
Unit number: R12-00521
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Trenton, NJ, by fax on April 23, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had previously been implicated in a case of post-transfusion hepatitis transmission, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

_______________________________
PRODUCT
a) Red Blood Cells Leukoreduced, Recall # B-2018-5;
b) Recovered Plasma, Recall # B-2019-5
CODE
a) and b) Unit numbers: 55Z44548, 55Z45007, 55Z45537
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by telephone and letter on November 26, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Multiple Sclerosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
AR, AL, CA, and D.C.

_______________________________
PRODUCT
a) Red Blood Cells Leukoreduced, Recall # B-2020-5;
b) Fresh Frozen Plasma, Recall # B-2021-5
CODE
a) and b) Unit numbers: 55FK38567
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by telephone and letter on May 12, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AR

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2022-5;
b) Platelets, Recall # B-2023-5;
c) Fresh Frozen Plasma, Recall # B-2024-5;
d) Recovered Plasma, Recall # B-2025-5
CODE
a) Unit numbers: 4855895, and 4801967;
b) and c) Unit numbers: 4855895;
d) Unit number: 4801967
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on October 28, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
OK, MI, VA, and Switzerland

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2026-5
CODE
Unit number: 12FZ40918
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Charlotte, NC, by facsimile and letter dated February 25, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2027-5;
b) Recovered Plasma, Recall # B-2028-5
CODE
a) and b) Unit numbers: 4624350, and 4707130
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on March 2, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OK, and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2029-5;
b) Recovered Plasma, Recall # B-2030-5
CODE
a) and b) Unit numbers: 4758589
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on September 3, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK, and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-2031-5;
CODE
Unit number: 4800698
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on June 24, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced
Irradiated, Recall # B-2032-5;
b) Recovered Plasma, Recall # B-2033-5
CODE
a) and b) Unit numbers: 4859848
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on July 6, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK, and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced
Recall # B-2034-5;
b) Recovered Plasma, Recall # B-2035-5
CODE
a) and b) Unit numbers: 4776367
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile and letters dated May 13, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC, and Switzerland

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2036-5
CODE
Unit number: 3154136
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letter dated September 29, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Source Plasma, Recall # B-2037-5
CODE
Unit number: AY0486356
RECALLING FIRM/MANUFACTURER
Yale Blood Plasma, LLC, Albuquerque, NM, by telephone on June 8, 2004. Firm initiated recall is complete.
REASON
Blood product, which was untested for human immunodeficiency virus (HIV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
England

_______________________________
PRODUCT
Source Plasma, Recall # B-2041-5
CODE
Unit numbers: AY0482676, AY0485027
RECALLING FIRM/MANUFACTURER
Yale Blood Plasma, LLC, Albuquerque, NM, by e-mail on June 8, 2004. Firm initiated recall is complete.
REASON
Blood product, which was untested for human immunodeficiency virus (HIV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
England

_______________________________
PRODUCT
Source Plasma, Recall # B-2042-5
CODE
Unit numbers: AY0481990, AY0482200, AY0482802, AY0483144, AY0483443, AY0483914, AY0484118, AY0484559, AY0485078, AY0485320
RECALLING FIRM/MANUFACTURER
Yale Blood Plasma, LLC, Albuquerque, NM, by e-mail on June 8, 2004. Firm initiated recall is complete.
REASON
Blood product, which was untested for human immunodeficiency virus (HIV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
England

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2044-5
CODE
Unit number: 55H54673
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock, AR, by telephone on May 7, 2004, and by letter dated May 13, 2004. Firm initiated recall is complete.
REASON
Blood product, which tested negative for antibody to hepatitis B core antigen (anti-HBc), but was collected from a donor who tested repeat reactive for anti-HBc on two previous occasions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AR

_______________________________
PRODUCT
Platelets, Recall # B-2046-5
CODE
Unit number: FC20-11062
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Inc., Trenton, NJ, by telephone on December 10, 2004, and by facsimile on January 5, 2005. Firm initiated recall is complete.
REASON
Blood product, which was untested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2057-5;
b) Platelets, Recall # B-2058-5;
c) Platelets Pheresis, Leukocytes Reduced,
Recall # B-2059-5;
d) Fresh Frozen Plasma, Recall # B-2060-5;
e) Fresh Frozen Plasma [Apheresis],
Recall # B-2061-5;
f) Recovered Plasma, Recall # B-2062-5
CODE
a) and b) Unit numbers: 4651063, 4649807, 4746914, and
4803426;
c) Unit numbers: 4583634 (2 split products), 4757152
(2 split products), 4620181 (3 split units);
d) Unit number: 4803426;
e) Unit number: 4619525
f) Unit numbers: 4651063, 4649807, and 4746914
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 27, 2004.
Manufacturer: Oklahoma Blood Institute, Midwest City Donor Center, Midwest City, OK. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD) were distributed.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
OK, TX, MI, AR, and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2066-5;
b) Platelets, Recall # B-2067-5
CODE
a) Unit numbers: 7872863 and 9206095;
b) Unit number: 7872863
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on June 14 and 15, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from unsuitable donors based on travel to areas considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2068-5;
b) Platelets, Recall # B-2069-5
CODE
a) Unit numbers: 6375547 and 6387786;
b) Unit number: 6387786
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL, by telephone on January 28, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2070-5
CODE
Unit number: 16-41235
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Inc., Trenton, NJ, by facsimile on December 6, 2004. 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
NJ

_______________________________
PRODUCT
a) Platelets, Recall # B-2071-5;
b) Fresh Frozen Plasma, Recall # B-2072-5
CODE
a) and b) Unit number: 71N950416
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Suwanne Valley Region, Lake City, FL, by facsimile on March 3, 2005. Firm initiated recall is complete.
REASON
Blood products, associated with a unit of Red Blood Cells, that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-2073-5
CODE
Unit numbers: 55C75463, 55C75526, 55C75615, 55C75687, 55C75963, 55C76073, 55E45023, 55E46468, 55E46514, 55FK31220, 55FS14315, 55FS14328, 55FS14337, 55FS14340, 55W43364, 55W43413, and 55C82553
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Ozarks -- Arkansas Region, Little Rock, AR, by telephone and letter on October 21, 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
17 units
DISTRIBUTION
TN, MO, and AR

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2074-5;
b) Recovered Plasma, Recall # B-2075-5
CODE
a) and b) Unit number: 4917920
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on September 22, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Phenobarbital, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2076-5;
b) Recovered Plasma, Recall # B-2077-5
CODE
a) and b) Unit number: 4624925
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on July 29, 2004 and August 2, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Phenobarbital, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY and Switzerland

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2078-5;
CODE
Unit number: W16-37925
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Inc., Trenton, NJ, by facsimile on February 16, 2004. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to a recent tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2083-5;
b) Platelets, Recall # B-2084-5;
c) Recovered Plasma, Recall # B-2085-5
CODE
a) Unit numbers: 4857801, 4712387, 4673791,
4636376, 4566323, and 4446787;
b) Unit numbers: 4673791 and 4636376;
c) Unit numbers: 4857801, 4712387, 4673791,
4636376, and 4446787
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on September 20, 2004 and by letters on March 10, 2005 and April 29, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
OK, TX, MS, NJ, NY and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2086-5;
b) Platelets, Recall # B-2087-5;
c) Recovered Plasma, Recall # B-2088-5
CODE
a) and c) Unit numbers: 4642576, 4729391,
4807247;
b) Unit number: 4642576;
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on April 11, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
OK, TX, and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2091-5;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-2092-5;
c) Platelets, Recall # B-2093-5;
d) Fresh Frozen Plasma, Recall # B-2094-5;
e) Recovered Plasma, Recall # B-2095-5
CODE
a) Unit numbers: C00-99918, C00-98970,
and V15-04860;
b) Unit numbers: FC20-02625 and FC20-04002;
c) Unit numbers: FC20-02625, C00-99918,
and V15-04860;
d) Unit numbers: FC20-02625, C00-99918,
C00-98970, and V15-04860;
e) Unit number: FC20-04002
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Inc, Trenton, NJ, by facsimile on October 27 and 28,2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
PA and NJ

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2096-5
CODE
Unit number: 9904017
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on November 17, 2003. Firm initiated recall is complete.
REASON
Blood product, that was not properly quarantined after the donor of the product reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1864-5;
b) Plasma Cryoprecipitate Reduced, Recall # B-1865-5
CODE
a) and b) Unit number: 8163182
RECALLING FIRM/MANUFACTURER
Florida Blood Centers, Inc., Lake Park, FL, by letter on November 22, 2000. Firm initiated recall is complete.
REASON
Blood Products, collected from a door whose health history screening was not adequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL and SC

_______________________________
PRODUCT
Six-Part Barcode Labels for Use with COBAS AmpliScreen System Roche M/N 03261549001; Computype M/N 1004639, Recall # B-1929-5
CODE
Batch Numbers 028868 and 029213
Barcode Human Readable D26DT through D5KLG (inclusive)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Molecular Systems, Inc., Somerville, NJ, by telephone on May 12, 2005, and by letter dated May 17, 2005.
Manufacturer: Computype, Saint Paul, MN. Firm initiated recall is complete.
REASON
Barcode labels, containing duplicate numbers that could lead to mismatched test results and sample ID numbers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
100 rolls
DISTRIBUTION
CA, FL, IA,MN,MO, NJ, WA, Canada, Spain, and Sweden

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1945-5
CODE
Unit numbers: 6945030 and 6945038
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shewsbury, NJ, by telephone on January 5, 2004. Firm initiated recall is complete.
REASON
Blood products, which failed acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ

_______________________________
PRODUCT
Fresh Frozen Plasma Apheresis, Recall # B-1946-5
CODE
Unit numbers: 6931901, 6931939, 6931903, 6943667, 6932274, 6932273, 6943827, 6931222, and 6931910
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shewsbury, NJ, by letter dated August 20, 2003. Firm initiated recall is complete.
REASON
Blood products, which were not frozen within six hours of collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
NJ

_______________________________
PRODUCT
Platelets, Recall # B-1947-5
CODE
Unit number: 4815205
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on April 28, 2004. Firm initiated recall is complete.
REASON
Blood product, which did not have a documented time of collection for the associated whole blood unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1948-5
CODE
Unit number: 6936177
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shewsbury, NJ, by telephone on January 5, 2004. Firm initiated recall is complete.
REASON
Blood product, which failed acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

_______________________________
PRODUCT
Platelets, Recall # B-1970-5
CODE
Unit number: 4815206
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on April 28, 2004. Firm initiated recall is complete.
REASON
Blood product, which did not have a documented time of collection for the associated whole blood unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Platelets, Recall # B-1971-5
CODE
Unit number: 5256401
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on February 8, 2005. Firm initiated recall is complete.
REASON
Blood product, which did not have a documented time of collection for the associated whole blood unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1983-5
CODE
Unit number: 6970592
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by facsimile on September 10, 2003. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving information regarding post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

_______________________________
PRODUCT
Platelets, Recall # B-1984-5
CODE
Unit number: 4837007
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 14, 2004. Firm initiated recall is complete.
REASON
Blood product, prepared from a unit of Whole Blood with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Platelets, Recall # B-1985-5
CODE
Unit number: 4821327
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 14, 2004. Firm initiated recall is complete.
REASON
Blood product, prepared from a unit of Whole Blood with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Platelets, Recall # B-1986-5
CODE
Unit number: 4809330
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 14, 2004. Firm initiated recall is complete.
REASON
Blood product, prepared from a unit of Whole Blood with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Platelets, Recall # B-1987-5
CODE
Unit number: 4845888
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 14, 2004. Firm initiated recall is complete.
REASON
Blood product, prepared from a unit of Whole Blood with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Platelets, Recall # B-1988-5
CODE
Unit number: 4844784
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on April 28, 2004. Firm initiated recall is complete.
REASON
Blood product, prepared from a unit of Whole Blood lacking phlebotomy documentation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Platelets, Recall # B-1989-5
CODE
Unit number: 4844810, 4844935
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 14, 2004. Firm initiated recall is complete.
REASON
Blood product, prepared from a units of Whole Blood with a discrepant collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI and TX

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1990-5
CODE
Unit number: 6956071
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by letter dated February 5, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose temperature was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

_______________________________
PRODUCT
Source Plasma, Recall # B-2038-5
CODE
Unit numbers: AY0483857, AY0483900, AY0483993, AY0486531, AY0486532, AY0486533, AY0486534, AY0486535, AY0486536, AY0486537, AY0486539, AY0486540, AY0486541, AY0486542, AY0486543, AY0486544, AY0486545, AY0486546, AY0486547, AY0486548, AY0486549
RECALLING FIRM/MANUFACTURER
Yale Blood Plasma, LLC, Albuquerque, NM, by telephone on June 8, 2004. Firm initiated recall is complete.
REASON
Blood products, which were untested for human immunodeficiency virus (HIV) by the nucleic acid test (NAT) method, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
England

_______________________________
PRODUCT
Source Plasma, Recall # B-2039-5
CODE
Unit numbers: AY0489088, AY0492764, AY0492785, AY0492804, AY0493751
RECALLING FIRM/MANUFACTURER
Yale Blood Plasma, LLC, Albuquerque, NM, by telephone on August 9, 2004. Firm initiated recall is complete.
REASON
Blood products, which were untested for human immunodeficiency virus (HIV) by the nucleic acid test (NAT) method, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
England

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2040-5
CODE
Unit numbers: 03KH16750 and 03KH16752
RECALLING FIRM/MANUFACTURER
The American National Red Cross, American Red Cross Blood Services, Daytona Beach, FL, by facsimile on October 4, 2000. Firm initiated recall is complete.
REASON
Blood products, that were collected in a manner that may compromise the sterility of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2043-5
CODE
Unit numbers: 9977479, 9977480, 9977481, 9977482, 9977485
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on September 28, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose body temperature determinations may have been inaccurate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
LA, MI, and OH

_______________________________
PRODUCT
Platelets, Recall # B-2045-5
CODE
Unit number: 16-38411
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Inc., Trenton, NJ, by telephone on April 6, 2004 and by facsimile on April 9, 2004. Firm initiated recall is complete.
REASON
Blood product, which was untested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

_______________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced Irradiated, Recall # B-2063-5
CODE
Unit number: 9454315
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on February 18, 2004. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-2064-5
CODE
Unit number: FG55250
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by telephone on May 31, 2005. Firm initiated recall is complete.
REASON
Blood product, collected in an expired collection bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2065-5
CODE
Unit number: 40GN09195
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Hearth of America Region, Peoria, IL, by telephone on May 10, 2005, and by letter on May 24, 2005. Firm initiated recall is complete.
REASON
Blood product, that did not have the complete amount of additive solution included, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2089-5
b) Red Blood Cells, Leukocytes Reduced
Irradiated, Recall # B-2090-5
CODE
a) Unit numbers: 03KC15795, 03KC15796,
03KC15798, and 03KC15799;
b) Unit number: 03KC15797
RECALLING FIRM/MANUFACTURER
The American National Red Cross, American Red Cross Blood Services, Daytona Beach, FL, by telephone on September 29, 2000, and by facsimile on October 5, 2000. Firm initiated recall is complete.
REASON
Blood products, that were collected in a manner that may compromise the sterility of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
GA

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Optetrak Finned Tibial Tray A/P 53 mm ML 83mm***4F/5T Ti Alloy Fits only SZ. 4 Femoral Cemented, Sterile, Single Use Only. For Cemented Use Only, Recall # Z-1379-05
CODE
Serial number range 0696020 -- 0696061.
RECALLING FIRM/MANUFACTURER
Exactech, Inc, Gainesville, FL, by letter on June 2, 2005. Firm initiated recall is complete.
REASON
Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information.
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international), a hemofiltration system, Recall # Z-1380-05
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div, Mc Gaw Park, IL, by letters dated July 13, 2005.
Manufacturer: Mesys Gmbh, Hannover, Germany. Firm initiated recall is ongoing.
REASON
In the event therapy is terminated, as part of routine instrument programming or therapy maintenance, the Accura instrument may experience difficulty in performing a successful self-test (failure) upon an immediate attempt to restart therapy.
VOLUME OF PRODUCT IN COMMERCE
264 units
DISTRIBUTION
Nationwide, China and Belgium

_______________________________
PRODUCT
a) Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL
Syringe. Sterile, Rx, For intraocular use.
P/N490-001, Recall # Z-1383-05;
b) ShellGell Sodium Hyaluronate 0.8mL Syringe,
12 mg/mL, Sterile, Rx. For intraocular use.
Product Number: 1000, Recall # Z-1383-05;
c) Amvisc® Sodium Hyaluronate 0.5 mL, Product Number:
59051, Recall # Z-1384-05;
d) Amvisc® Sodium Hyaluronate 0.8 mL, Product Number:
59081, Recall # Z-1385-05;
e) Amvisc® Plus Sodium Hyaluronate 0.5 mL, Product
Number: 60051, Recall # Z-1386-05;
f) Amvisc® Plus Sodium Hyaluronate 0.8 mL, Product
Number: 60081, Recall # Z-1387-05
CODE
a) Lot Numbers: B041118C, B050510A;
b) Lot Numbers: B041118E, B041118F, B050510C;
c) Lot Numbers: C050510A, C050510;
d) Lot Numbers: B050510B; B050120B, B040616R;
e) Lot Numbers: C050405, C050405A;
f) Lot Numbers: B050405A, B050428, B040930R
RECALLING FIRM/MANUFACTURER
Anika Therapeutics, Inc., Woburn, MA, by telephone and letters on July 14, 2005. Firm initiated recall is ongoing.
REASON
Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
VOLUME OF PRODUCT IN COMMERCE
Over 30,000 units
DISTRIBUTION
CA and NC

_______________________________
PRODUCT
Access Immunoassay Systems Assay Protocol: Dil-AFP, Recall # Z-1388-05
CODE
All Lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letters on July 18, 2005.
Manufacturer: Beckman Coulter, Inc, Chaska, MN. Firm initiated recall is ongoing.
REASON
Pipetting for dil-Alpha-fetoprotein when performed on the Access, Access 2 and Synchron LX I 725 has a potential to create splashing which may cause erroneous results.
VOLUME OF PRODUCT IN COMMERCE
311 USA; 16 Canada
DISTRIBUTION
Nationwide and Canada

_______________________________
PRODUCT
a) Stryker brand Consolidated Operating Room
Equipment (CORE) System Powered Instrument
Driver, REF 5400-50; Model 5400-050-000,
Recall # Z-1389-05;
b) Stryker brand Consolidated Operating Room
Equipment (CORE) System Powered Instrument
Driver, REF 5400-50; Model 5400-050-000A,
Recall # Z-1390-05
CODE
a) All units manufactured July 22, 2005
through July 25, 2005;
b) All units manufactured June 23, 2005
through July 22, 2005
RECALLING FIRM/MANUFACTURER
Stryker Instruments, Div. Of Stryker Corporation, Kalamazoo, MI, by letter dated August 5, 2005. Firm initiated recall is ongoing.
REASON
Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.
VOLUME OF PRODUCT IN COMMERCE
a) 25 units;
b) 27 units
DISTRIBUTION
VA, Australia, Canada, England, France, Germany, Japan, Netherlands, Sweden, and Switzerland

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil pouches. 45 foil pouches per shelf carton box, Recall # Z-1381-05
CODE
Catalog No. JACT-LR Lot No's: M4JLR164, Exp. 3/2006; M4JLR165, Exp. 3/2006; A5JLR001, Exp. 4/2006; A5JLR002, Exp. 4/2006; A5JLR003, Exp. 4/2006; C5JLR032, Exp. 6/2006.
RECALLING FIRM/MANUFACTURER
International Technidyne Corp, Edison, NJ, by letter on April 27, 2005. Firm initiated recall is ongoing.
REASON
Validation had been initiated for a molded component of the finished device but not completed. Also, the device did not meet mean clotting time using Normal Donor Blood as media.
VOLUME OF PRODUCT IN COMMERCE
924 boxes x 45 cuvettes per box
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal) coated; Recall # Z-1392-05
CODE
List number 7B34-16, lot numbers 16006M200 and 19199M300
RECALLING FIRM
Abbott Laboratories MPG, Abbott Park, IL, by e-mail on March 16, 2005. Firm initiated recall is ongoing.
REASON
False Positive results may be obtained with the identified lots of list 7B34-16 when using a negative patient sample or a negative control.
VOLUME OF PRODUCT IN COMMERCE
7,607 kits
DISTRIBUTION
Canada, Germany, Hong Kong and Australia

_______________________________
PRODUCT
NAMIC Custom Angiographic Kit: (1) Pouch Catalog # 60131481; (2) Pouch Catalog #60131603; (3) Pouch Catalog #60101041; (4) Pouch Catalog #61020031 (5) Kit #65185472 ****** Each kit is customized to the needs of the particular hospital identified on the product labeling, Recall # Z-1393-05
CODE
1) Lot 942414
2) Lot 939982, 943645;
3) Lot 940424;
4) Lot 940054;
5) Lot 945456; 943043
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Glens Falls, NY, by letters dated May 4, 2004. Firm initiated recall is complete.
REASON
Molded handles used in Angiographic Manifolds may be occluded.
VOLUME OF PRODUCT IN COMMERCE
1,115 kits
DISTRIBUTION
IL, KY, MI, SC, and TX

END OF ENFORCEMENT REPORT FOR AUGUST 31, 2005

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