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U.S. Department of Health and Human Services

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Enforcement Report for September 28, 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.

September 28, 2005
05-39

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

______________________________
PRODUCT
a) The Boy's Farmer Market Smoked Nova Salmon, packed
in a one pound (1 lb) vacuum pack plastic bag,
Recall # F-644-5;
b) Marshall's Naturally Smoked Nova Salmon, packed
in a one pound (1 lb) vacuum pack plastic bag,
Recall # F-645-5;
c) SeaSpecialties Sliced Smoked Salmon,
Recall # F-646-5;
d) Naturally Smoked Homarus Norwegian Salmon packaged
in a 4 oz. vacuum packaged bag, Recall # F-647-5;
e) Marshall's Naturally Smoked Nova Salmon New York Style,
packaged in a 4 oz vacuum packaged plastic bag,
Recall # F-648-5;
f) Smoked Salmon Shreds packaged in 10 lb. plastic
buckets and 5 lb. plastic bags. Recall # F-649-5
CODE
a) Batch # 31997, sell by 4/25/05;
b) and c) Batch # 31997;
d) Batch # 31973;
e) Batch # 32123;
f) Batch # 31980
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida Smoked Fish Certified, Miami, FL, by letter on February 22, 2005.
Manufacturer: Sea Specialties, Miami, FL. Firm initiated recall is ongoing.
REASON
Smoked Salmon is contaminated with Listeria Monocytogenes based on the Florida Department of Agriculture and Consumer Services' analysis.
VOLUME OF PRODUCT IN COMMERCE
1,386 lbs.
DISTRIBUTION
FL

______________________________
PRODUCT
a) Home Special brand Dessert of Pear, Net Wt. 3.5 oz,
Packed in China. The product is a dry soup mix
packaged in a heat-sealed plastic bag,
UPC bar code # 6 64460 10464 9, Recall # F-650-5;
b) Home Special brand Soup Mix, net wt. 4.3 oz.
The product is a dry soup mix packaged in a
heat-sealed plastic bag, UPC bar code # 6 64460 10497 7,
Recall # F-651-5
CODE
All product on the market at the time recall was initiated
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ho's Trading, Inc., Brooklyn, NY, by press releases and letters on May 20, 2005.
Manufacturer: Sinojet Development Ltd, Hong Kong, China. Firm initiated recall is complete.
REASON
Products contain undeclared sulfites based on the New York State Department of Agriculture & Markets' analysis.
VOLUME OF PRODUCT IN COMMERCE
a) 22 cases (100 plastic bags per case);
b) 30 cases (100 plastic bags per case)
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Sun Dried Tomatoes, Casale brand, Net wt. 5 lbs., Crop 2003, Product of Turkey. Each case contains a vacuum packed 5-lb. plastic bag. Recall # F-652-5
CODE
All product that does not declare sulfites as an ingredient is affected.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Atlantic International Products, Utica, NY, by letters on August 15, 2005.
Manufacturer: Kareks Tarim Orm.vdTeks.Urun.Ins.Turz.San.Tic.Ltd.Sti, Izmir, Turkey. Firm initiated recall is ongoing.
REASON
The product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
1,350 cases (approximately)
DISTRIBUTION
CA, CT, FL, LA, MA, MD, NY, NJ and RI

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Furosemide, 40mg, 1000 count bottles (packaged in white HDPE bottles), Rx only, NDC #0591-3437-10, Recall # D-484-5
CODE
Lot # T053L04A, expiry 12/06
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC, Huntsville, AL, by letter on August 12, 2005. Firm initiated recall is ongoing.
REASON
Mold Growth was found on tablets.
VOLUME OF PRODUCT IN COMMERCE
2,574 bottles of 1000
DISTRIBUTION
CA

_______________________________
PRODUCT
a) Zonegran® (zonisamide) capsules, 25mg, 100 capsules,
Rx only, EGC White Op./White Op Size 4, Black
lettering "e" and "Zonegran 25", Recall # D-485-5;
b) Zonegran® (zonisamide) capsules, 50mg, 100 capsules,
Rx only, EGC White Op./Grey Op Size 3, Black
lettering "e" and "Zonegran 50", Recall # D-486-5
CODE
a) Lot number: 34940 & 34941;
b) Lot number: 34943 & 34944
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eisai Inc, Research Triangle Park, NC, by e-mail on September 7, 2005, and by letter on September 8, 2005.
Manufacturer: Elan Pharma Ltd., Westmeath, Ireland. Firm initiated recall is ongoing.
REASON
Adulteration: Presence of foreign capsules.
VOLUME OF PRODUCT IN COMMERCE
7,949 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Fluorouracil Injection, USP, 50 mg/mL in 10 mL single dose vials, 10 vials per shelf tray, 10 trays per case; Rx only, Sterile, For IV Use, product code 101710, NDC 63323-117-10, Recall # D-487-5
CODE
Initially lot 141481, exp. 06/06 was recalled on 9/8/05. The recall was expanded to include the following lots by letter dated 9/19/05: lot 140493, exp 11/05; lot 140683, exp 12/05; lot 140684, exp 12/05; lot 140943, exp 2/06; lot 140944, exp 2/06; lot 141057, exp 3/06; lot 141058, exp 3/06; lot 141192, exp 4/06; lot 141193, exp 4/06; lot 141328, exp 5/06; lot 141329, exp 5/06; lot 141438, exp 5/06; lot 141349, exp 5/06; lot 141452, exp 6/06; lot 141482, exp 6/06; lot 200117, exp 7/06; lot 200123, exp 7/06; lot 200124, exp 7/06; lot 200143, exp 8/06; lot 200144, exp 8/06; lot 200175, exp 8/06; lot 200176, exp 8/06; lot 200364, exp 9/06; lot 200383, exp 10/06; lot 200384, exp 10/06; lot 200463, exp 10/06; lot 200466, exp 10/06; lot 200467, exp 10/06; lot 200500, exp 11/06
RECALLING FIRM/MANUFACTURER
American Pharmaceutical Partners, Inc., Melrose Park, IL, by letters dated August 24, 2005, September 19, 2005 and September 20, 2005. Firm initiated recall is ongoing.
REASON
Presence of particulate matter: The product may contain glass particles.
VOLUME OF PRODUCT IN COMMERCE
1,454,080 vials
DISTRIBUTION
Nationwide including Puerto Rico

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Genteal Gel Severe Lubricant Eye Gel. Hypromellose, 0.3%, lubricant. Relieves dryness of the eye. Preservative Free in the Eye, Made in Puerto Rico. NDC 58768-790-36, Recall # D-483-5
CODE
Lot Z13322 Exp 8/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Pharmaceuticals Corp, East Hanover, NJ, by fax and letter on June 24, 2005.
Manufacturer: Cardinal Health Manufacturing Services B.V., Humacao, PR. Firm initiated recall is ongoing.
REASON
Defective container: Possibility of tubes leaking.
VOLUME OF PRODUCT IN COMMERCE
13,056 tubes
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Premarin (conjugated estrogens) tablets, USP, 0.9 mg, 100 tablet bottles, Rx, NDC 0046-0864-81, Recall # D-488-5
CODE
Lot A67610, Exp. 07/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Richmond Division of Wyeth, Richmond, VA, by letters dated September 8, 2005.
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY. Firm initiated recall is ongoing.
REASON
Dissolution Failure: Fails to conform to USP dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE
98,260 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1509-5
CODE
Unit numbers: 0759500, 075200
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 22, 2004. 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
2 units
DISTRIBUTION
CO

_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced, Recall # B-1996-5;
b) Frozen Plasma, Recall # B-1997-5
CODE
a) Unit numbers: 004FJ63475, 004FJ67669;
b) Unit number: 004FJ84238
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone, fax and letter on March 1, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MA and VT

_______________________________
PRODUCT
Source Plasma, Recall # B-2111-5
CODE
Unit number: 04TTXC5260
RECALLING FIRM/MANUFACTURER
Plasma Center -- Tyler, Inc., Tyler, TX, by facsimile on May 28, 2004. Firm initiated recall is complete.
REASON
Source Plasma, which tested positive for hepatitis B surface antigen (HbsAg), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

_______________________________
PRODUCT
Source Plasma, Recall # B-2170-5
CODE
Unit numbers: AY0492741, AY0493023, AY0493506, AY0493750
RECALLING FIRM/MANUFACTURER
Yale Blood Plasma, LLC, Albuquerque, NM, by e-mail 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, but subsequently tested positive for hepatitis C virus (HCV) by NAT, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
England

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2171-5
CODE
Unit number: 6577256
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on July 31, 2003. Firm initiated recall is complete.
REASON
Blood product, which was leukoreduced twice, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2175-5;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-2176-5
CODE
a) Unit number: 6580297;
b) Unit number: 6583543
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on April 22, 2004. 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
2 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2177-5
CODE
Unit numbers: 6951227, 7043123
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on April 19, 2004. 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
2 units
DISTRIBUTION
CO and IL

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2178-5;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-2179-5
CODE
a) Unit number: 6867816;
b) Unit numbers: 6873283, 6864770, 6861183
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 4, 2004. 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
4 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-2202-5
CODE
Unit number: 55FH62443
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock, AR, by telephone and letter on July 10, 2003. Firm initiated recall is complete.
REASON
Blood product, which initially tested positive for West Nile Virus (WNV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AK

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2206-5
CODE
Unit numbers: 19GS18400, 19GM08233
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by telephone on June 4, 1997. Firm initiated recall is complete.
REASON
Red Cells, collected from donors with a history of a positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2207-5
CODE
Unit number: 4762386
RECALLING FIRM/MANUFACTURER
Department of the Army, Brooke Army Medical Center, Fort Sam Houston, TX, by fax on March 11, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2213-5
CODE
Unit numbers: 20039-2515, 20726-3809
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on August 30, 2004.
Manufacturer: Blood Systems, Inc., Lafayette, LA. Firm initiated recall is complete.
REASON
Red Blood Cells, collected from ineligible donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA

_______________________________
PRODUCT
Human Corneas for Transplantation, Recall # B-2214-5
CODE
Tissues 05341OD and 05341OS
RECALLING FIRM/MANUFACTURER
Upstate NY Transplant Svc, Inc, Buffalo, NY, by letters dated June 27, 2005. Firm initiated recall is complete.
REASON
Human Corneas, procured from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
NY and PA

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-2215-5;
b) Platelets, Recall # B-2216-5;
c) Recovered Plasma, Recall # B-2217-5
CODE
a), b), and c) Unit number: 4738645
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on July 12, 13, and 15, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and NY

_______________________________
PRODUCT
Human Corneas for Transplant, Recall # B-2220-5
CODE
Tissue 05-0992-200
RECALLING FIRM/MANUFACTURER
Rocky Mountain Lions Eye Bank, Aurora, CO, by telephone on July 21, 2005, and by facsimile dated July 21, 2005. Firm initiated recall is complete.
REASON
Corneal tissue was distributed before eligibility screening was complete.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
HI

_______________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-2228-5
CODE
Unit numbers: W16-36079A, W16-36079B
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Inc., Trenton, NJ, by fax on December 21, 2003l. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2232-5;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-2233-5
CODE
a) Unit number: 6640999;
b) Unit number: 6651361
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on June 28, 2004. 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
2 units
DISTRIBUTION
NC and PA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2234-5
CODE
Unit numbers: 6656388, 3912090, 6632022
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on August 2, 2004. 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
CO, IL, and KS

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2235-5
CODE
Unit number: 6628444
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on June 18, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2238-5;
b) Red Blood Cells Leukoreduced, Recall # B-2239-5;
c) Platelets Pheresis Leukocytes Reduced, Recall # B-2240-5
CODE
a) Unit numbers: K13692, K13702, K22932, K32087,
K32088, K32089;
b) Unit numbers: K13700, K13696;
c) Unit numbers: K13709-P1, K13709-P2
RECALLING FIRM/MANUFACTURER
Regional Health Resource Center, Urbana, IL, by telephone on May 5, 2005 and by letter on June 15, 2005. Firm initiated recall is complete.
REASON
Blood products, tested for anti-HBc using an expired reagent, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
IL

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2241-5
CODE
Unit number: 6891510
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on August 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, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2242-5
CODE
Unit number: 6646981
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on August 11, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2243-5;
b) Platelet Pheresis, Leukocytes Reduced,
Recall # B-2244-5
CODE
a) Unit numbers: 0750307, 0758893, and 0761465;
b) Unit numbers: 0755255 and 0753664
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on August 2, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CO, NB, NC, and FL

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2246-5
CODE
Unit numbers: 6950016, 6952526
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 21, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL and MA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2247-5
CODE
Unit numbers: 6910443, 6419944
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 21, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO and IL

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2248-5;
b) Red Blood Cells, Leukocytes Reduced, Irradiated,
Recall # B-2249-5
CODE
a) Unit number: 6952525;
b) Unit number: 6950014
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 21, 2004. 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
2 units
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2251-5
CODE
Unit number: 4954252
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by fax on April 4, 2005. Firm initiated recall is complete.
REASON
Blood product, which failed Red Blood Cell QC testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2252-5
CODE
Unit number: 5560077
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by fax on April 11, 2005. Firm initiated recall is complete.
REASON
Blood product, which failed Red Blood Cell QC testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2253-5;
b) Recovered Plasma, Recall # B-2254-5
CODE
a) and b) Unit number: 01FC35421
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, West Henrietta, NY, by electronic mail on September 10, 2004, and by letter dated August 11, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had medical history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY and CA

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2255-5
CODE
Unit numbers: 3938002, 3938016, and 3938017
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., New Brunswick, NJ, by telephone and facsimile on February 12, and 23, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NY

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2258-5;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-2259-5
CODE
a) Unit number: 6416207;
b) Unit number: 6418103
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 9, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL and CO

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2260-5;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-2261-5
CODE
a) Unit number: 6589572;
b) Unit number: 6583197
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on July 21, 2004. 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
2 units
DISTRIBUTION
NY and CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2262-5
CODE
Unit number: 6871943
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on July 12, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2263-5
CODE
Unit numbers: 6891542, 6637553
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on July 21, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2264-5
CODE
Unit numbers: 6578044, 6572683
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on January 30, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2265-5
CODE
Unit number: 6571556
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on February 13, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2266-5
CODE
Unit number: 6612228
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on January 21, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes, Reduced,
Recall # B-2267-5;
b) Cryoprecipitated AHF, Pooled, Recall # B-2268-5;
c) Recovered Plasma, Recall # B-2269-5
CODE
a) and c) Unit numbers: 3165611 and 3148673;
b) Unit number: 3165611
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone and by letter on October 7, 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 reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes, Reduced,
Recall # B-2275-5;
b) Platelet, Recall # B-2276-5;
c) Recovered Plasma, Recall # B-2277-5
CODE
a), b), and c) Unit number: 20032-3450
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated October 27, 2004.
Manufacturer: Blood Systems, Inc., Lafayette, LA. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had a non-confidential health history screening, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
LA and Switzerland

_______________________________
PRODUCT
Platelets Pheresis, Recall # B-2285-5
CODE
Unit number: N23627
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw, MI, by facsimile on June 24, 2005. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications for release, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2286-5;
b) Red Blood Cells Leukocytes Reduced, Recall # B-2287-5;
c) Red Blood Cells Leukocytes Reduced
Irradiated, Recall # B-2288-5;
d) Red Blood Cells (Apheresis) Leukocytes Reduced,
Recall # B-2289-5;
e) Platelets, Recall # B-2290-5;
f) Fresh Frozen Plasma, Recall # B-2291-5
CODE
a) Unit numbers: 38FS14735, 38FS14736, 38J52385,
38J52386, 38J52387 and 38LV00284;
b) Unit numbers: 38FM89525, 38FM89526, 38FM89531,
38FM89532, 38FM89538, 38FM89539, 38FM89541, 38FM89545,
38FV35418, 38FV35420, 38FV35421, 38FV35422, 38FV35424,
38FV35425, 38FV35426, 38FV35427, 38FV35428, 38FV35429,
38FV35431, 38FV35432, 38FV35433, 38FV35434, 38FV35437,
38FV35441, 38FV35442, 38FV35443, 38FV35444, 38FV35445,
38FV35446, 38FV35449, 38FV35450, 38FV35451, 38FV35452,
38FV35453, 38FV35455, 38FV35456, 38FV35457, 38FV35458,
38FV35459, 38FV35460, 38FV35461, 38FV35463, 38FV35464,
38FV35465, 38FV35466, 38FV35467, 38FV35468, 38FV35469,
38KT28641, 38KT28647, 38KT28648, 38KT28649, 38KT28650,
38KT28656, 38KT28659, 38KT28660, 38KT28665, 38KT28666,
38KT28669, 38KT28675, 38KT28679, 38L92590, 38L92593,
38L92594, 38L92595, 38L92597, 38L92599, 38L92601,
38L92605, 38L92608, 38L92611 (2 units), 38L92612,
38L92613, 38L92614, 38L92616 (2 units), 38L92617,
38L92618, 38L92619, 38LC94178, 38LC94181, 38LC94182,
38LC94183, 38LC94184, 38LC94185, 38LC94186, 38LC94187,
38LC94188, 38LC94189, 338LC94197, 38LC94199, 38LC94200,
38LC94204, 38LC94205, 38LC94206, 38LC94207, 38LC94209,
38LC94212, 38LC94213, 38LC94214, 38LC94217, 38LC94218,
38LC94220, 38W39131, 38W39135, 38W39139, 38W39144, and
38W39145;
c) Unit number: 38LV00283;
d) Unit numbers: 38FV35448 (2 units), 38FV35454 (2 units)
and 38FV35462 (2 units);
e) Unit numbers: 38FS14735, 38FS14736, 38J52385, 38J52386,
38J52387, and 38LV00284;
f) Unit numbers: 38FV35428
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Fort Wayne, IN, by telephone starting April 28, 2005. Firm initiated recall is complete.
REASON
Blood products, which were untested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
129 units
DISTRIBUTION
IN, KY, and MI

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
Recall # B-2292-5;
b) Fresh Frozen Plasma, Recall # B-2293-5
CODE
a) and b) Unit number: 13FR67969
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit, MI, by telephone and by letter dated on March 1, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had taken the medication Avodart, were collected.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
Recall # B-2294-5;
b) Platelets, Recall # B-2295-5;
c) Recovered Plasma, Recall # B-2296-5
CODE
a) and c) Unit numbers: 18FK60222 and 18FX24650;
b) Unit number: 18FX24650
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Lansing, MI, by facsimile and by letter dated September 14, 2004, or by electronic mail on January 12, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had engaged in multiple high behavior activities, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA, MA, and MI

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2297-5
CODE
Unit number: 6910559
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 21, 2004. Firm initiated recall is complete.
REASON
Blood product, which was 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
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2298-5
CODE
Unit number: 6837455
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 17, 2004. Firm initiated recall is complete.
REASON
Blood product, which was 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
NC

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2299-5
CODE
Unit number: 6842323
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 13, 2004. Firm initiated recall is complete.
REASON
Blood product, which was 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
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2300-5
CODE
Unit number: 7018627
RECALLING FIRM/MANUFACTURER
HemaCare Corporation, Sherman Oaks, CA, by letter on October 8, 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
CA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2301-5
CODE
Unit number: 2125000
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc, Lexington, KY, by letter on May 4, 2005. 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
KY

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2302-5
CODE
Unit number: 2128372
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc, Lexington, KY, by letter on February 22, 2005. 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
KY

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2303-5;
b) Platelets, Recall # B-2304-5
CODE
a) and b) Unit number: 2140358
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc, Lexington, KY, by letter on March 23, 2005. 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
2 units
DISTRIBUTION
KY and NY

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-2305-5
CODE
Unit number: 4817563
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone on September 5, 2004. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1unit
DISTRIBUTION
TX

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2306-5;
b) Recovered Plasma, Recall # B-2307-5
CODE
a) and b) Unit numbers: 3138491, 3117542, 1212487
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by facsimile on July 15, 2003, and by letter dated July 29, 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 and Switzerland

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2316-5
CODE
Unit number: 6833936
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on September 3, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm scrub may have been incorrectly performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-2319-5
CODE
Unit numbers: 6947151, 6945920, and 6942247
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 10, 2004. 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
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2329-5
CODE
Unit number: 6611946
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 13, 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
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2330-5
CODE
Unit number: 6531221
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 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
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2331-5
CODE
Unit number: 6863871
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 10, 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
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2332-5
CODE
Unit number: 6625804
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 10, 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
CO

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-2333-5
CODE
Unit number: 6834619
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 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
CO

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
Recall # B-2335-5;
b) Platelets Pheresis, Leukocytes Reduced
Irradiated, Recall # B-2336-5
CODE
a) and b) Unit number: 04GH13188
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on June 4, 2005, and by letter on June 6, 2005. Firm initiated recall is complete.
REASON
Blood products, that tested positive for microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MA

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-2337-5
CODE
Unit numbers: 04GH13152P1 and 04GH13152P2
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone and letter on May 27, 2005. Firm initiated recall is complete.
REASON
Blood products, that tested positive for microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2339-5
CODE
Unit number: 7018470
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 10, 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
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2340-5
CODE
Unit number: 6415050
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 3, 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
CO

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2341-5;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-2342-5
CODE
a) Unit number: 6603207;
b) Unit number: 7031297
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 10, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2366-5
CODE
Unit number: 6871175
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 2, 2004. 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
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2369-5
CODE
Unit number: 6869677
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 24, 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
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2370-5
CODE
Unit number: 6868779
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 11, 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
IL

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2371-5
CODE
Unit number: 6888296
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 5, 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
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2372-5
CODE
Unit number: 6617893
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 30, 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
CO

_______________________________
PRODUCT
Platelet Pheresis Leukoreduced, Recall # B-2374-5
CODE
Unit number: 6833578
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on August 26, 2003. Firm initiated recall is complete.
REASON
Blood product, with incomplete irradiation documentation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2380-5
CODE
Unit number: 12LV27754
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on April 10, 2004 and by letter on April 14, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who lived in an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2382-5
CODE
Unit number: 12GM96685
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on April 9, 2004 and by letter on April 17, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2384-5
CODE
Unit number: 12FZ31792
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone and letter on September 22, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2391-5
CODE
Unit number: 0752551
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 29, 2004. Firm initiated recall is complete.
REASON
Blood product, which was 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
CO

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
Recall # B-2392-5;
b) Recovered Plasma, Recall # B-2393-5
CODE
a) and b) Unit number: 7037679
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on November 30, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received acupuncture therapy and had come into contact with someone else's blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL and Switzerland

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2394-5
CODE
Unit number: 6943114
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on November 10, 2003. Firm initiated recall is complete.
REASON
Blood product, which was 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
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2395-5
CODE
Unit number: 7025863
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on December 22, 2003. Firm initiated recall is complete.
REASON
Blood product, which was 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
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2396-5
CODE
Unit number: 6417490
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on November 12, 2003. Firm initiated recall is complete.
REASON
Blood product, which was 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
AL

_______________________________
PRODUCT
Source Plasma, Recall # B-2437-5
CODE
Unit numbers: SP-152026, SP-151399, SP-151455, SP-151565, SP-151637, SP-151764, SP-151297, SP-151944, SP-153215, SP-152140, SP-152790, SP-152867, SP-152982, SP-153043, SP-153137, and SP-151839
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, San Diego, CA, by facsimile on October 3, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on an unexplained weight loss, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
Australia

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-2443-5
CODE
Unit number: 71X089578 (Part 2)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Gainesville, FL, by facsimile on December 7, 2004. Firm initiated recall is complete.
REASON
Platelets Pheresis, with an unacceptably low volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

_______________________________
PRODUCT
Red Blood Cells Leukoreduced, Recall # B-2444-5
CODE
Unit number: 10041-8973
RECALLING FIRM/MANUFACTURER
Blood Systems Inc, Scottsdale, AZ, by telephone on November 17, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-1879-5
CODE
Unit number: 10042-9924
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Scottsdale, AZ, by telephone on November 13, 2003. Firm initiated recall is complete.
REASON
Blood product, not prepared in accordance with specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-1998-5
CODE
Unit number: 027GV85498
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on May 9, 2005 and letter dated May 17, 2005. Firm initiated recall is complete.
REASON
Blood product, which tested positive for the S-antigen but was labeled as S-antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WV

_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced,
Recall # B-2168-5;
b) Recovered Plasma, Recall # B-2169-5
CODE
a) and b) Unit numbers: 4684850, 4685490, 4800231, 4800825, 4570579, 4684028
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on June 17, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the antibiotic ampicillin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
OK, VA and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced,
Recall # B-2173-5;
b) Recovered Plasma, Recall # B-2174-5
CODE
a) and b) Unit number: 4836994
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on November 22, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the drug Aygestin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2199-5;
b) Recovered Plasma, Recall # B-2200-5
CODE
a) and b) Unit number: 1645152
RECALLING FIRM/MANUFACTURER
Carter Blood Care, Bedford, TX, by telephone, letter and electronic on June 14, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced,
Recall # B-2203-5;
b) Fresh Frozen Plasma, Recall # B-2204-5;
c) Recovered Plasma, Recall # B-2205-5
CODE
a) Unit numbers: 1098552, 1069139, 1078831;
b) Unit number: 1078831;
c) Unit number: 1069139
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated January 14, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Embrel, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
OH and Switzerland

_______________________________
PRODUCT
Platelets, Recall # B-2218-5
CODE
Unit number: 4865390
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated November 12, 2004. Firm initiated recall is complete.
REASON
Platelets, manufactured from whole blood units that were collected while the mobile site temperature was out of range, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Platelets, Recall # B-2224-5
CODE
Unit number: 4841779
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated November 17, 2004. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that had an incorrectly documented collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Platelets, Recall # B-2225-5
CODE
Unit number: 4865255
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on October 21, 2004. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that had an incorrectly documented collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Red Blood Cells, Leukocytes, Reduced, Recall # B-2229-5
CODE
Unit number: 200381688
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on March 1, 2004.
Manufacturer: Blood Systems, Inc., Lafayette, LA. Firm initiated recall is complete.
REASON
Blood product, collected on a trip scale that was incorrectly calibrated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # 2231-5
CODE
Unit numbers: 38FV35807 (2 units), 38FV35834 (2 units), 38LLC94134 (2 units), and 37LC94139 (2 units)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Fort Wayne, IN, by telephone on May 23, 2005. Firm initiated recall is complete.
REASON
Blood products, which were not tested for white blood cell counts, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
IN

_______________________________
PRODUCT
Platelets, Recall # B-2237-5
CODE
Unit number: 4840802
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated January 7, 2005. Firm initiated recall is complete.
REASON
Blood product, lacking documented collection times, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-2245-5
CODE
Unit number: 6876703
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on June 6, 2004. Firm initiated recall is complete.
REASON
Blood product, which was out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Granulocytes Pheresis, Recall # B-2250-5
CODE
Unit number: 49GP20305
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by telephone and letter on September 11, 2004. Firm initiated recall is complete.
REASON
Blood product, collected in an expired collection bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2256-5;
b) Platelets, Recall # B-2257-5
CODE
a) and b) Unit number: 1681754
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and by letter dated June 10, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor stability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2230-5
CODE
Unit number: 20726-8578
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on October 12, 2004.
Manufacturer: Blood Systems, Inc., Lafayette, LA. Firm initiated recall is complete.
REASON
Blood product, which was untested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

_______________________________
PRODUCT
Source Plasma, Recall # B-2270-5
CODE
Unit number: VA-113100
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by facsimile on October 31, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not acceptable, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

_______________________________
PRODUCT
Source Plasma, Recall # B-2271-5
CODE
Unit number: VA-182763
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by facsimile on December 29, 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
Austria

_______________________________
PRODUCT
Source Plasma, Recall # B-2272-5
CODE
Unit number: SP-21257
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, San Diego, CA, by facsimile on December 9, 2002. 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
Austria

_______________________________
PRODUCT
Source Plasma, Recall # B-2273-5
CODE
Unit number: YA-134557
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, San Diego, CA, by facsimile on August 30, 2002. 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
Austria

_______________________________
PRODUCT
Source Plasma, Recall # B-2274-5
CODE
Unit number: CH-100149
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Colton, CA, by facsimile on December 22, 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
Source Plasma, Recall # B-2322-5
CODE
Unit number: VP-180016
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by facsimile on January 7, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

_______________________________
PRODUCT
Source Plasma, Recall # B-2323-5
CODE
Unit number: VP-191194
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by facsimile on July 7, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

_______________________________
PRODUCT
Source Plasma, Recall # B-2324-5
CODE
Unit number: VA-126685
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by facsimile on August 8, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

_______________________________
PRODUCT
Source Plasma, Recall # B-2325-5
CODE
Unit number: VA-125877
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by facsimile on July 31, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whom there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

_______________________________
PRODUCT
Source Plasma, Recall # B-2326-5
CODE
Unit number: VP-186141
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by facsimile on April 16, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whom there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

_______________________________
PRODUCT
Source Plasma, Recall # B-2327-5
CODE
Unit number: F-00895-046
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by facsimile on October 21, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whom there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-2334-5
CODE
Unit number: 0754572 (distributed as two split products)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on October 8, 2003. Firm initiated recall is complete.
REASON
Blood products, collected in an expired collection bag, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-2367-5
CODE
Unit number: 6835267
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on October 10, 2003. Firm initiated recall is complete.
REASON
Blood product, that was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-2368-5
CODE
Unit number: 6579639 (distributed as two split units)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on August 25, 2003. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but was 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
CO

_______________________________
PRODUCT
Red Blood Cells Leukoreduced Irradiated, Recall # B-2373-5
CODE
Unit numbers: 6886219, 6946572, 6946610, 6613476, 6866337, 6833642, 6417254, 6631268, 0754967, 6417284, 6417643, 6579952, 6620964, 6620039
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on September 24, 2003. Firm initiated recall is complete.
REASON
Blood products, labeled with extended expiration dates, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
CO and WY

_______________________________
PRODUCT
a) Platelet Pheresis Leukocytes Reduced,
Recall # B-2378-5;
b) Platelets Pheresis Leukocyte Reduced Irradiated,
Recall # B-2379-5
CODE
Unit number: 6402624
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone and letter on July 19, 2005. Firm initiated recall is complete.
REASON
Blood products, labeled as "Leukocyte Reduced" but which failed to meet the criteria for leukoreduced units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN

_______________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-2383-5
CODE
Unit number: 6579278
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on August 15, 2003. Firm initiated recall is complete.
REASON
Blood product, labeled as leukoreduced but which was not tested for White Blood Cell count as required, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Recovered Plasma, Recall # B-2445-5
CODE
Unit number: 10041-8973
RECALLING FIRM/MANUFACTURER
Blood Systems Inc, Scottsdale, AZ, by fax on November 19, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

______________________________
PRODUCT
a) Baxter Colleague Single Channel Volumetric Infusion
Pumps; Made in Singapore; product codes 2M8151,
2M8151R, 2M8161, 2M8161R, Recall # Z-1543-05;
b) Baxter Colleague Triple Channel Volumetric Infusion
Pumps; Made in Singapore; product codes 2M8153,
2M8153R, 2M8163, 2M8163R, Recall # Z-1544-05
CODE
a) All serial numbers below 13120001CS,
All serial numbers below 13110181CC;
b) All serial numbers below 13120001CT,
All serial numbers below 13110338TC
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corporation, Round Lake, IL, by letters dated February 25, 2005. Firm initiated recall is ongoing.
REASON
Swelling of the sealed lead-acid batteries in the infusion pump can cause internal pump damage, and excessive battery discharge can damage the batteries if the pump is left on battery power for an extended period of time after the Battery Depleted alarm occurs.
VOLUME OF PRODUCT IN COMMERCE
253,185 pumps
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

*****CORRECTION*****

In the August 17, 2005, 05-33 Enforcement Report, Recall # Z-1062-05 B. Braun Tearaway Sheath should not include the following: Catalog number 612122, Lot number 0060752209, and Catalog number 612124 lot numbers 0060755565 and 0060759158.

______________________________
PRODUCT
a) Product is an Orthopedic device contained in a
Peel Foil Pouch. Product is labeled in part:
"REF C6121 QTY 1 3.5mm Bio-Anchor with Disposable
Driver, STERILE", Recall # Z-1547-05;
b) Product is an Orthopedic device contained in a Peel
Foil Pouch. Product is labeled in part: "REF C6121H
QTY 1 3.5 x 10.5 mm Bio-Anchor with Disposable Driver,
Preloaded with One #2 Herculine Suture, STERILE",
Recall # Z-1548-05;
c) Product is an Orthopedic device contained in a Peel
Foil Pouch. Product is labeled in part: REF C6120A
QTY 1 BIO-ANCHOR, PRE-LOADED 3.5mm x 10.5 mm,
Sterile, Recall # Z-1549-05;
d) Product is an Orthopedic device contained in a Peel
Foil Pouch. Product is labeled in part: REF, QTY 1,
Hornet Disposable Inserter, BioStinger Implant,
STERILE, Recall # Z-1550-05;
e) Product is an Orthopedic device contained in a Peel
Foil Pouch. Product is labeled in part: REF, QTY 1
BioScrew XtraLok, STERILE, Recall # Z-1551-05
CODE
a) Lot number's: BBB34096, BBB35001, BBB38590,
BBB47862, BBB56209, BBB59492, BBB61957, BBB63207,
BBB66991, BBB69760, BBB70775;
b) Lot number's: BBB65719, BBB67474, BBB68490;
c) Lot number's: BBB31322, BBB33118, BBB35867,
BBB36669, BBB37705, BBB39726, BBB40462, BBB45116,
BBB46067, BBB46733, BBB52902, BBB55911, BBB57543,
BBB59489, BBB61937, BBB63968, BBB66392, BBB67468;
d) Lot number's: BBB32927, BBB33173, BBB34093,
BBB40588, BBB41400, BBB43500, BBB44122, BBB47021,
BBB51947, BBB54961, BBB61003, BBB63978, BBB67469,
BBB71590, BBB32928, BBB33170, BBB33172, BBB34090,
BBB35000, BBB37713, BBB40589, BBB41401, BBB42354,
BBB43059, BBB45125, BBB47861, BBB48837, BBB49882,
BBB50769, BBB57155, BBB57550, BBB61002, BBB62845,
BBB66407, BBB68489, BBB33174, BBB36672, BBB50768,
BBB62844, BBB69766;
e) Lot number's: BBB32078, BBB34094, BBB34999,
BBB35880, BBB38626, BBB48838, BBB49880, BBB59210, BBB53860, BBB55923, BBB59491, BBB65474, BBB66408, BBB68488, BBB31428, BBB34095, BBB35002, BBB36673, BBB48839, BBB51999, BBB55022, BBB59493, BBB66410, BBB35055, BBB50780, BBB61023, BBB34089, BBB35879, BBB37714, BBB48840, BBB52911, BBB55921, BBB65475, BBB30602, BBB31323, BBB49881, BBB52912, BBB67472, BBB52000
RECALLING FIRM/MANUFACTURER
Linvatec Corp, Largo, FL, by letter on February 23, 2005. Firm initiated recall is ongoing.
REASON
There is a possibility that the pouch Tyvek header to foil longitudinal seal was not properly sealed, prior to sterilization. Therefore there is a potential for compromised sterility of the devices.
VOLUME OF PRODUCT IN COMMERCE
9,967 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Baxter Flo-Gard 6201 Volumetric Infusion Pump,
catalog #2M8063, 2M8063R (refurbished), 2M8063G
(global), 2M8063U, 2M8063F, 2M8063A, 2M8063D & 2M8063B,
Recall # Z-1552-05;
b) Baxter Flo-Gard 6301 Dual Channel Volumetric
Infusion Pump, catalog #2M8064, 2M8064R (refurbished),
2M8064G, 2M8064U, 2M8064F, 2M8064A, 2M8064D &
2M8064B, Recall # Z-1553-05
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling firm: Baxter Healthcare Corporation, Round Lake, IL, by letters dated May 3, 2005.
Manufacturer: Baxter Healthcare Corporation, Singapore, Singapore. Firm initiated recall is ongoing.
REASON
The mounting screws of the pole clamp may come loose, allowing the pole clamp assembly to detach from the rear pump housing, if they are not maintained on at least an annual basis.
VOLUME OF PRODUCT IN COMMERCE
188,000 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
The TRIO Spondylolisthesis Reduction Instrument is a Manual Surgical Instrument unique to the implantation of Stryker Spine TRIO PS this instrument is intended for use in the reduction of degenerative Spondylolisthesis. Catalog No: 48905110, Recall # Z-1554-05
CODE
Lot Code: 039524; 039981; 045152; 045153; 045154; 045155; 045156; 045157; 045158; 045159; 048721; 048722
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp, Mahwah, NJ, by letters on May 16, 2005.
Manufacturer: Stryker Spine, Cestas, France. Firm initiated recall is ongoing.
REASON
The threaded part of the instrument may break when connected to the screw and potentially result in an adverse health consequence.
VOLUME OF PRODUCT IN COMMERCE
107 Instruments
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Clinitron At Home Air Fluidized Therapy Bed, Recall # Z-1555-05
CODE
Serial numbers: CS102304, CS103257, CS103901, CS103902, CS103903, CS103904, CS103909, CS103911, CS103914, CS103915, CS103916, CS103917, CS103919, CS103921, CS103923, CS103924, CS103925, CS103928, CS103932, CS103933
RECALLING FIRM/MANUFACTURER
Hill-Rom Manufacturing, Inc, Charleston, SC, by letter on May 20, 2005. Firm initiated recall is complete.
REASON
Sudden unexpected lowering of the head of the bed may occur due to failure of the head of the bed actuator.
VOLUME OF PRODUCT IN COMMERCE
21 beds
DISTRIBUTION
AL, FL, KY, LA, MA, NC, NY, TN, TX, and VA

______________________________
PRODUCT
Product is a Powerflex P3 Dilation Catheter, Recall # Z-1556-05
CODE
Lot numbers R0305581, R0305159, R0305284, R0305286, R0305155 and R0305104.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cordis Corporation, Miami Lakes, FL, by letter on May 11, 2005.
Manufacturer: Cordis Europa N.V., Roden, Netherlands. Firm initiated recall is ongoing.
REASON
During competitive product testing, wire movement difficulties were observed in Powerflex P3 units. Due to the possibility of user inconvenience, Cordis is recalling the six affected lots of Powerflex P3. There is no patient impact.
VOLUME OF PRODUCT IN COMMERCE
100 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) BD DTX Plus, 60" complete single-line pressure
monitoring kit, Part Number 682000, Recall # Z-1557-05;
b) BD DTX Plus, 60" complete dual-line pressure
monitoring kit, Part Number 682007, Recall # Z-1558-05;
c) BD DTX Plus, 72" complete single-line pressure
monitoring kit, Part number 682014, Recall # Z-1559-05;
d) BD DTX Plus, Stand-alone pressure transducer
with 3cc/hr flush device, Part number 682018,
Recall # Z-1560-05;
e) BD DTX Plus, 12" single-line neonatal pressure
monitoring kit. Part number 682040, Recall # Z-1561-05;
f) BD DTX Plus, Custom single-line neonatal pressure
monitoring kit, Part number 687104, Recall # Z-1562-05;
g) BD DTX Plus, Custom single-line pressure monitoting kit.
Part number 687196, Recall 3 Z-1563-05;
h) BD DTX Plus, Custom triple-line pressure monitoring kit.
Part number 687206, Recall # Z-1564-05;
i) BD DTX Plus, Custom dual-line pressure monitoring kit.
Part number 687341, Recall # Z-1565-05
CODE
a) Lot Numbers: 407104, 407387;
b) Lot Number 407467;
c) Lot number 407026;
d) Lot number 407109;
e) Lot numbers 407033, 408053;
f) Lot Number 408038;
g) Lot number 410174;
h) Lot numbers: 411062, 411539, 501148;
i) Lot Numbers: 410177, 411063, 411540
RECALLING FIRM/MANUFACTURER
Recalling Firm: BD Medical Systems, Sandy, UT, by telephone and fax on July 1, 2005.
Manufacturer: BD Critical Care Systems, Singapore, Singapore. Firm initiated recall is ongoing.
REASON
Actuating tab may detach from the stopcock body, allowing fluid leak.
VOLUME OF PRODUCT IN COMMERCE
7,839 units
DISTRIBUTION
Nationwide, Guam and Japan

_______________________________
PRODUCT
Encore Reverse Shoulder Prosthesis (RSP), Recall # Z-1566-05
CODE
Catalog number: 506-00-006, lot numbers: 260212, 260222, and 244642; Catalog number: 506-00-007, lot number: 250272; Catalog number: 506-00-008, lot numbers: 260242, 254342, 260252, 244662, and 244312; Catalog number: 507-06-175, lot numbers: 261832, 244732, 967721, and 006192; Catalog number: 507-08-175, lot numbers: 261842, 241392, 872681, and 872671
RECALLING FIRM/MANUFACTURER
Encore Medical Lp, Austin, TX, by letter on July 28, 205. Firm initiated recall is ongoing.
REASON
Incorrect alignment markings or no markings at all on a reverse shoulder prosthesis unit.
VOLUME OF PRODUCT IN COMMERCE
93 primary stems; 56 revision stems
DISTRIBUTION
MA, MD, OK, TX, FL, SC, CA, MT, CO, SD, and NM

_______________________________
PRODUCT
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor. Part Number 0040-00-0366-20, Recall # Z-1567-05
CODE
Version 8.02
RECALLING FIRM/MANUFACTURER
Datascope Corp, Mahwah, NJ, by letter on August 19, 2005. Firm initiated recall is ongoing.
REASON
The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse.
VOLUME OF PRODUCT IN COMMERCE
115 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Ultrasound probe cover, sterile. Catalog No. 910811, Recall # Z-1571-05
CODE
Lot number: 0520, expiration date: 1-10
RECALLING FIRM/MANUFACTURER
North Coast Medi-Tek Inc., Mentor, OH, by telephone on June 7, 2005. Firm initiated recall is ongoing.
REASON
Unsealed packages.
VOLUME OF PRODUCT IN COMMERCE
300 units
DISTRIBUTION
OH

_______________________________
PRODUCT
Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. The Enpath Deflectable Catheter is a flexible tipped percutaneous catheter designed for gaining access to the peripheral and coronary systems. The device features adjustable tip geometry through use of a sliding mechanism with locking feature to deflect the catheter. There are two versions of the tool: one with a luer fitting for Tuohy-Borst valve connection, the other with a hemostasis valve and a sideport infusion line. The kit includes a flexible catheter dilator to facilitate deflectable catheter passage. Recall # Z-1573-05
CODE
W34968 and W35440
RECALLING FIRM/MANUFACTURER
Enpath Medical, Inc., Plymouth, MN, by letter dated September 2, 2005. Firm initiated recall is ongoing.
REASON
Enpath has become aware that some of the Enpath Medical 8 Fr Steerable sheath devices may have non-conforming hemostasis valves in that the valve can leak or the valve was observed to have a small hole.
VOLUME OF PRODUCT IN COMMERCE
140 units
DISTRIBUTION
MA

_______________________________
PRODUCT
Medtronic Midas Rex Classic, GS and Legend dissecting tools, Rx only, Single Use Only, Recall # Z-1574-05
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Power Surgical Solutions, Fort Worth, TX, by letter on September 1, 2005. Firm initiated recall is ongoing.
REASON
Potential compromise of sterile packaging for disposable dissecting tools.
VOLUME OF PRODUCT IN COMMERCE
3,522,710 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2 3/4. All contents considered sterile unless package is opened or damaged.RX Only. Part number 10162-01. (The Vidaurri LASIK Flap Irrigators are included in the firm's Alcon Custom Pak Part Number 10162-01 under the description of dual tip irrigator, 8 ports, 16G.), Recall # Z-1575-05
CODE
Lot numbers: 520522H, 511655H, and 489635H
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alcon Research, Ltd, Fort Worth, TX, by letter on September 2, 2005. Manufacturer: Alcon Laboratories, Inc., Houston, TX. Firm initiated recall is ongoing.
REASON
Unknown residue noted on surface of flap irrigators incorporated into custom paks.
VOLUME OF PRODUCT IN COMMERCE
75 units
DISTRIBUTION
LA

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

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PRODUCT
Bard Davol Reliavac® 400 Closed Wound Suction Kit, Sterile/EO * Single use * Medium-Large 3/16" (15 Fr., 4.7mm) O.D. PVC Drain * 12.5" (31.7cm) Hole Pattern, X-ray Opaque Stripe Attached Trocar * 400cc Evacuator ** Y-Connecting Tube. The product contains a 400cc Evacuator, Y-connector with drainage tube and a 3/116 PVC drain with trocar. These components are provided together in a kit but not pre-assembled. Catalog Number: 0034630, Recall # Z-1568-05
CODE
Lot Number: NGPE0150
RECALLING FIRM/MANUFACTURER
Recalling Firm: C.R. Bard Inc., Urological Division, Covington, GA, by letter on/about August 17, 2005.
Manufacturer: Bard Sdn Bhd, Nogales Sonora, Mexico. Firm initiated recall is ongoing.
REASON
An incorrect Y-connector was placed in the kit.
VOLUME OF PRODUCT IN COMMERCE
360 units
DISTRIBUTION
AL, CA, FL, GA, IL, IN, NJ, TN, TX, Belgium and Japan

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PRODUCT
SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case. Recall # Z-1572-05
CODE
Lot number 0503, expiration date 11-07.
RECALLING FIRM/MANUFACTURER
North Coast Medi-Tek, Inc., Mentor, OH, by telephone on January 18, 2005. Firm initiated recall is ongoing.
REASON
Outside box labeling, containing 10 trays, incorrectly identified the product as ultrasound trays. Product is Breast Biopsy trays, Cat. 255826R2. Individual tray package labeling correctly identifies the product as Breast Biopsy tray.
VOLUME OF PRODUCT IN COMMERCE
50 kits, packaged as 10 kits per each of 5 boxes
DISTRIBUTION
OH

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

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PRODUCT
Hydrolyzed Feather Meal, 50 lb. bags, Recall # V-109-5
CODE
Lot number: 11579
RECALLING FIRM/MANUFACTURER
Recalling Firm: Griffin Industries, Inc., Cold Springs, KY, by telephone on September 2, 2005.
Manufacturer: Griffin Industries, Inc., Henderson, KY. Firm initiated recall is ongoing.
REASON
Product may contain prohibited material and is not identified with the cautionary statement: "Do not feed to cattle or other ruminants".
VOLUME OF PRODUCT IN COMMERCE
863/50 lb. bags
DISTRIBUTION
IN

END OF ENFORCEMENT REPORT FOR SEPTEMBER 28, 2005

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