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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.
July 27, 2005
05-30
______________________________
PRODUCT
Rice Krispy Treats, sold in a heat sealed cellophane plastic wrapper as a
single 3 oz unit. The labeling on the wrapper reads in part, "Rice Krispy
Treats The Coffee Bean & Tea Leaf Ext 1963". The labeling is tan and
black in color. The writing on the label is black in color. The rice krispy
treat is a square sized product and beige in color. Recall # F-535-5
CODE
All products.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coffee Bean Tea Leaves, Los Angeles, CA, by press release
on June 9, 2005.
Manufacturer: Debbie Boghosian dba Nana's Bakery, Los Angeles, CA. Firm initiated
recall is complete.
REASON
The product contains undeclared egg whites.
VOLUME OF PRODUCT IN COMMERCE
4,506 units
DISTRIBUTION
CA
_______________________________
PRODUCT
Red Pear Tomatoes in half pound clam shells w/o labels, case labeled, Red
Pear Tomato, 7 lbs net wt, Recall # F-536-5
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: California Specialty Produce, Vista, CA, by telephone on
May 24, 2005, press release on May 27, 2005, and by letters on May 29, 2005.
Manufacturer: Jose Garcia, Juan Rose Rios, B.C., Mexico. Firm initiated recall
is complete.
REASON
FDA's analysis found the product to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
254 cartons
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Product is Smoked Nova Salmon under two labels:
a) packaged in an 8 oz. vacuum-packed bag,
Product is labeled in part "SeaSpecialties MAMAS***
Naturally Smoked Sliced Nova Salmon, Net Wt. 8 oz.
(227 grams)Product of U.S.A.";
b) Product is King Salmon brand Smoked Nova Salmon,
Recall # F-537-5
CODE
a) Batch 32178
b) undetermined
RECALLING FIRM/MANUFACTURER
SeaSpecialties, Inc, Miami, FL, by fax on April 13, 2005, and press release
on April 15, 2005. Firm initiated recall is ongoing.
REASON
On March 31, 2005, Florida Department of Agriculture and Consumer Services
(FDACS) collected a sample of Mama's Smoked Nova Salmon and this product
tested positive for Listeria Monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
67 cases
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) Heaven Dragon Quality Food brand Chinese
Candy, Net. Wt. 12 oz./340g. Product of
China. The product is packaged in a
Sealed plastic bag, Barcode # 6 43719 12649 6,
Recall # F-538-5;
b) Zheng Feng Brand Cane & Arrown Root Stock,
Net Wt. 227g, Product of China. Barcode #
6 923692 930025, Recall # F-539-5
CODE
a) Barcode and no other coding;
b) Best Before 03072006
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Dragon Trading Corp, Brooklyn, NY, by press release
and letters on May 24, 2005.
Manufacturers: a) Jiangmen Great Harvest Import & Export Co., Ltd, Xinhui
Jiangmen Guangdong, China, and
b) Zhongshan Zhengfeng Dried Fruit Foodstuffs Import & Export Co., Ltd,
Guangdong, China. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites based on sampling & analysis
by the New York State Department of Agriculture and Markets.
VOLUME OF PRODUCT IN COMMERCE
a) 50 cartons (50 x 12 oz. packages per carton)
b) 50 cartons (50 x 8 oz. packages per carton)
DISTRIBUTION
NY
______________________________
PRODUCT
Seyfert's brand Kettle Cooked Potato Chips Original (original flavor) 10
oz. bag. Recall # F-540-5
CODE
12 0720B15
RECALLING FIRM/MANUFACTURER
Troyer Potato Products, Inc., Waterford, PA, by press release on May 20,
2005 and by letters on May 21, 2005. Firm initiated recall is ongoing.
REASON
Some bags labeled as potato chips consist of a mixture of potato chips and
cheese puffs. The cheese puffs contain milk-derived ingredients and food
color FDC yellow #5 that are not listed on the potato chip bag.
VOLUME OF PRODUCT IN COMMERCE
257 cases x 8 bags per case
DISTRIBUTION
IN and MI
______________________________
PRODUCT
a) Royal Spanish Rice Pilaf, 8 oz,
Recall # F-542-5;
b) Royal Chicken Pilaf, Recall # F-543-5
CODE
All codes
RECALLING FIRM/MANUFACTURER
Kusha Inc, Irvine, CA, by press release and letters on/about April 16, 2003.
Firm initiated recall is complete.
REASON
The product contains undeclared allergenic ingredients including soy and
milk found in the seasoning packet.
VOLUME OF PRODUCT IN COMMERCE
a) 1446.48 cases;
b) 2251.83 cases
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Diet Coke * Sweetened with Splenda, 12/12oz can PACK. Each can labeled Diet
Coke with Lemon 12 oz (355 ml), recall # F-541-5
CODE
NOV2105NWF 15:22-15:29(printed on bottom of each can)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coca Cola Enterprises, Atlanta, GA, by representative visit
on June 16, 2005 and by letter on/about June 29, 2005.
Manufacturer: Coca Cola USA, Harahan, LA. Firm initiated recall is complete.
REASON
Cans labeled as Diet Coke with Lemon actually contained Diet Coke with Splenda
(undeclared sucralose).
VOLUME OF PRODUCT IN COMMERCE
132 cases
DISTRIBUTION
LA
_______________________________
PRODUCT
Betac®, Ascorbic Acid Injection, USP, 500mg/mL, 50mL vial Rx Only, Sterile
injection solution, for prescription use, NDC 62086-139-50, Recall # D-380-5
CODE
040816, 040718, 040615, 040520, 040517, 040402, 040216, 040120, 031219, 031006,
030926, 030717
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bioniche Animal Health, Athens, GA, by press release on June
18, 2004.
Manufacturer: Bioniche Pharma, Casla, Ireland. Firm initiated recall is ongoing.
REASON
Particulate Matter (calcium oxalate)
VOLUME OF PRODUCT IN COMMERCE
118,370 units
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Nicotine Polacrilex Gum, USP, 2mg (nicotine), blister cards of 110 chewing
pieces (Starter Kits) and 220 chewing pieces (Refills), over the counter,
Rx Only. The product was sold under the following private labels labeled
in part: (1) CVS® Pharmacy NICOTINE POLACRILEX GUM, USP, 2 mg (nicotine),
ORIGINAL, STARTER KIT, NDC 59779-600-62;
(2) Nicotine Polacrilex Gum, USP, STOP SMOKING AID, 2mg(nicotine), STARTER
KIT, [Note: this was manufactured for Novartis which is not mentioned in
the product labeling] *** NDC 61955-600-62 --- (3) Rugby®, Nicotine Polacrilex
Gum USP, 2mg (nicotine), STOP SMOKING AID, STARTER KIT, NDC 0536-3106-23
--- (4) BERKLEY & JENSENô Nicotine Polacrilex Gum, USP, STOP SMOKING
AID, 2mg (nicotine), REFILL, NDC 71114-4210-3. Recall # D-350-5
CODE
Lot 2NB04043 (exp. Date February 2006),
Lot 2NB04048 (exp. Date February 2006)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watson Pharmaceuticals, Inc., Corona, CA, by letters, dated
June 20, 2005.
Manufacturer: Watson Laboratories, Inc., Copiague, NY. Firm initiated recall
is ongoing.
REASON
Degradation Failure.
VOLUME OF PRODUCT IN COMMERCE
26,160 cartons of 110 chewing pieces and 5,704 cartons of 220 chewing pieces
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Glucotrol XL (Glipizide) Extended Release Tablets, 10mg, 100 count bottles,
Rx only, NDC 0049-1560-66, Recall # D-377-5
CODE
4XP036A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer, Inc., Cruze Davila, NY, by letter on June 17, 2005.
Manufacturer: Pfizer Pharmaceuticals, LLC, Barceloneta, PR. Firm initiated
recall is ongoing.
REASON
Incorrect Tablet Imprint; tablet incorrectly imprinted as Glipizide XL (the
generic name) instead of Glucotrol XL (the brand name).
VOLUME OF PRODUCT IN COMMERCE
1,920 units
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Premarin 0.3 mg (Conjugated Estrogens Tablets, USP), 100 tablet bottles,
Rx only, NDC 0046-0868-81. Recall # D-378-5
CODE
Lot 07732 esp. 07/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rx PAK, Memphis, TN, by E-mail on April 6, 2005.
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY. Firm initiated recall
is complete.
REASON
Dissolution Failure (by manufacturer)
VOLUME OF PRODUCT IN COMMERCE
29,898 units
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Premarin 1.25 mg (Conjugated Estrogens Tablets, USP), 100 count bottles,
Rx only, NDC 0046-0866-81. Recall # D-379-5
CODE
Lot 08182 Exp 07/05, Lot 11048 Exp 07/05,
Lot 13724 Exp 07/05, Lot 14346 Exp 07/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rx PAK, Memphis, TN, by letter, dated June 29, 2005.
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY. Firm initiated recall
is complete.
REASON
Dissolution Failure (by manufacturer)
VOLUME OF PRODUCT IN COMMERCE
41,161 units
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Source Plasma, Recall # B-1394-5
CODE
Unit numbers: LQ29664, LQ29780
RECALLING FIRM/MANUFACTURER
Western Plasma Products, Inc, Logan, UT, by e-mail dated May 29, 2001. Firm
initiated recall is complete.
REASON
Source Plasma, testing repeatedly reactive for antibodies to the human immunodeficiency
virus (HIV-1/2, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
_______________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-1538-5
CODE
Unit number: 029GK54016
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letters
dated December 7, 2004 and January 10, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported living in an area considered
endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1542-5;
b) Fresh Frozen Plasma, Recall # B-1543-5
CODE
a) and b) Unit number: 22KE15021
RECALLING FIRM/MANUFACTURER
American Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on
December 21, 2004, and by letter, dated December 26, 2004. Firm initiated
recall is complete.
REASON
Blood products, corresponding to a unit of Platelets possibly contaminated
with E. coli, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA and NJ
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1558-5
CODE
Unit numbers: 6125358, 6125361
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by letter dated
October 4, 2004. Firm initiated recall is complete.
REASON
Blood products, which were irradiated, but were not labeled as such, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
_______________________________
PRODUCT
Source Plasma, Recall # B-1574-5
CODE
Unit numbers: 04LKYA4067, 04LKYA3503, and 04LKYA3214
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Louisville, KY, by facsimile on March 26, 2004.
Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected
from a donor that presented with unexplained needle marks, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC
_______________________________
PRODUCT
Source Plasma, Recall # B-1576-5
CODE
03LKYA2408, 03LKYA2551, 03LKYA3007, 03LKYA3105, 03LKYA5254, 03LKYA5399
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Louisville, KY, by fax on June 16, and July
8, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk
of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-1582-5
CODE
Unit number: R61861
RECALLING FIRM/MANUFACTURER
Costal Bend Blood Center, Corpus Christi, TX, by facsimile and by telephone
on December 3, 2004. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration time, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
_______________________________
PRODUCT
Platelets Pheresis, Leukoreduced, Recall # B-1583-5
CODE
Unit number: Y08643
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated November 1, 2004.
Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility
of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
_______________________________
PRODUCT
Source Plasma, Recall # B-1600-5
CODE
Unit numbers: 04LKYB2802, 04LKYB2987, 04LKYB3437, 04LKYB6491, 04LKYB6874,
04LKYB7076, 04LKYB7352, 03LKYC6244, 03LKYC5772, 03LKYC5470, 03LKYC4434, 03LKYC4090,
03LKYC2859, 03LKYC2446, 03LKYC2132, 03LKYC1586, 03LKYC0875, 03LKYC0607, 03LKYC0095,
03LKYB9838, 03LKYB9395, 03LKYB8734, 04LKYB2494, 04LKYB1992, 04LKYB1766, 04LKYB1438,
04LKYB0004, 04LKYA9804, 04LKYA9530, 04LKYA9316, 04LKYA8797, 04LKYA8574, 04LKYA8332,
04LKYA8055, 04LKYA7859, 04LKYA7555, 04LKYA7363, 04LKYA7079, 04LKYA6881, 04LKYA6560,
04LKYA6374, 04LKYA6099, 04LKYA5933, 04LKYA5596, 04LKYA5344, 04LKYA4966, 04LKYA4781,
04LKYA4283, 04LKYA4012, 04LKYA3316, 04LKYA2879, 04LKYA2557, 04LKYA2098, 04LKYA1760,
04LKYA1309, 04LKYA1041, 04LKYA0592, 04LKYA0338, 03LKYC9916, 03LKYC9291, 03LKYC9112,
03LKYC8633, 03LKYC8270, 03LKYC7954, 03LKYC7646, 03LKYC7334, 03LKYC6961, and
03LKYC6610
RECALLING FIRM/MANUFACTURER
Source Plasma Services L.P., Louisville, KY, by facsimile on September 10
and 15, 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
68 units
DISTRIBUTION
NC and CA
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1601-5;
b) Platelets, Recall # B-1602-5;
c) Fresh Frozen Plasma, Recall # B-1603-5
CODE
a), b), and c) Unit number: 6721481
RECALLING FIRM/MANUFACTURER
LifeShare, Inc., Elyria, OH, by letter on December 27, 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
OH
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1604-5;
b) Platelets, Recall # B-1605-5
CODE
a) and b) Unit number: 0116684
RECALLING FIRM/MANUFACTURER
LifeShare, Inc., Elyria, OH, by letter on September 16, 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
OH
_______________________________
PRODUCT
Platelets, Recall # B-1606-5
CODE
Unit number: 6007605
RECALLING FIRM/MANUFACTURER
LifeShare, Inc., Elyria, OH, by letter on December 28, 2004. Firm initiated
recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
_______________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced, Recall # B-1607-5
CODE
Unit number: 16LN47272
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Ohio Region, Columbus, OH, by telephone
on December 8, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to a blood product possibly contaminated with
coagulase negative Staphylococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
_______________________________
PRODUCT
c) Red Blood Cells, Leukocytes Reduced,
Recall # B-1608-5;
b) Recovered Plasma, Recall # B-1609-5
CODE
a) and b) Unit number: 016GX08968
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Ohio Region, Columbus, OH, by telephone
and electronic mail on December 18, 2004, and by letter on December 20, 2004.
Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected
from a donor that was subsequently determined to have multiply risk factors
for increased incidence of infection with human immunodeficiency virus (HIV),
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD and CA
_______________________________
PRODUCT
Source Plasma, Recall # B-1610-5
CODE
Unit numbers: 0450749440, 0450745680, and 0450745611
RECALLING FIRM/MANUFACTURER
Nabi Biopharmaceuticals, Youngstown, OH, by facsimile on April 8, 2004. Firm
initiated recall is complete.
REASON
Blood products, collected in a manner that may compromise the sterility of
the products, were distributed
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC and FL
_______________________________
PRODUCT
Platelets, Recall # B-1611-5
CODE
Unit number: 2113235
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc, Lexington, KY, by letter on September
1, 2004. Firm initiated recall is complete.
REASON
Blood product, manufactured with a centrifuge that had not been validated
for use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
_______________________________
PRODUCT
Plasma, Frozen, Recall # B-1614-5
CODE
Unit number: 22FC26060
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone
on March 12, 2005 and by letter dated March 16, 2005. Firm initiated recall
is complete.
REASON
Blood product, in which the corresponding Platelets were possibly contaminated
with Staphylococcus aureus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
______________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-1615-5
CODE
Units numbers: 4279143 and 4279154
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on
May 16, 2005. Firm initiated recall is complete.
REASON
Blood products, manufactured with a centrifuge that had not been validated
for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN
______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1618-5
CODE
Unit number: 4503606
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma
City, OK, by facsimile on October 16, 2002.
Manufacturer: Southwest Oklahoma Blood Institute, Lawton, 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).
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1619-5
b) Red Blood Cells, Leukocytes Reduced;
Recall # B-1620-5;
c) Platelets, Recall # B-1621-5;
d) Cryoprecipitated AHF, Recall # B-1622-5;
e) Fresh Frozen Plasma, Recall # B-1623-5;
f) Plasma, Cryoprecipitate Reduced,
Recall # B-1624-5;
g) Recovered Plasma, Recall # B-1625-5
CODE
a) Unit numbers: 5176789, 5162863, 5145948,
5141245,5120553, and 5113134;
b) Unit numbers 6117853, 6113442, 6109375,
6105200, 6101804, 5196683, 5192007, 5188805,
and 5184863;
c) Unit numbers 5145948, 5120553, and 5113134;
d) Unit numbers 5196683 and 5184863;
e) Unit numbers 6109375, 5192007, 5171570,
5141245, and 5113134;
f) Unit number 5184863;
g) Unit numbers 6117853, 6113442, 6105200,
6101804, 5196683, 5188805, 5176789, 5145948,
and 5120553
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by facsimile
on March 1, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from
an ineligible donor due to a history of jaundice from mononucleosis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
TX, NC, CA, Switzerland, and Austria
_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1626-5
CODE
Units numbers: 41LZ12919, 41LR85662, 41GM58017, 41GF76951, 41GE80113, 41FY37577,
41FY36077, 41FY36076, 41FV60365, 41FV60197, 41FV59371, 41FR54030
RECALLING FIRM/MANUFACTURER
American National Red Cross, Alabama Region, Birmingham, AL, by telephone
on October 20, 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
12 units
DISTRIBUTION
AL
_______________________________
PRODUCT
Platelets Pheresis, Leukoreduced, Recall # B-1627-5
CODE
Unit number: 53LP47802
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore,
MD, by letters dated November 17, 2004 and December 10, 2004. Firm initiated
recall is complete.
REASON
Blood product, corresponding to platelets that were implicated in a transfusion
reaction and found to be contaminated with Staphlococcus, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced;
Recall # B-1628-5;
b) Recovered Plasma, Recall # B-1629-5
CODE
a) and b) Unit number: 7172572
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by telephone on October 15, 2003,
or by letter dated October 16, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability
was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Switzerland
_______________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1632-5
CODE
Unit numbers: 18235-1405 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on August
3, 2004.
Manufacturing Firm: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall
is complete.
REASON
Blood products, collected from a donor whose medical history was incomplete,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and WY
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1635-5
CODE
Unit number 0770955
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letter
on October 23, 2001. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1639-5
CODE
Unit number 4775875
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma
City, OK, by facsimile on February 27, 2004.
Manufacturer: Oklahoma Blood Institute, Ardmore, OK. Recalling 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
OK
_______________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced,
Recall # B-1643-5;
b) Red Blood Cells, Leukocytes Removed,
Irradiated, Recall # B-1644-5;
c) Plasma, Cryoprecipitate Reduced,
Recall # B-1645-5;
d) Cryoprecipitated AHF, Recall # B-1646-5
CODE
a), c), and d) Unit number 4694584
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma
City, OK, by facsimile on October 27-28, 2003, February 4, 2004 and May 3,
2004.
Manufacturer: Southwest Oklahoma Blood Institute, Lawton, OK. Recalling Firm
initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to the use of the
medication, Macrodantin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OK
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1647-5
CODE
Unit numbers: 0664762 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone
on July 31, 2001.
Manufacturing Firm: Blood Centers of the Pacific, Peninsula So. Bay Center,
Burlingame, CA. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that possibly compromised the sterility
of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
_______________________________
PRODUCT
Platelets, Recall # B-1650-5
CODE
Unit 6706275
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL, by telephone on March 30, 2005.
Manufacturing Firm: LifeSource, Mundelein, IL. Recall Firm initiated
recall is complete.
REASON
Platelets, corresponding to red cells that were contaminated with Staphylococcus
and implicated in an adverse transfusion reaction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1652-5;
b) Recovered Plasma, Recall # B-1653-5
CODE
a) and b) Unit number: 49KQ04379
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southwest Region, Tulsa, OK, by letter dated
July 31, 2003 and by facsimile on July 31, 2003. Firm initiated recall is
complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication
Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and Switzerland
_______________________________
PRODUCT
Human Tissue for Transplantation, Corneas, Recall # B-1654-5
CODE
Numbers: 012-04-171 and 012-04-172
RECALLING FIRM/MANUFACTURER
East Tennessee Lions Eye Bank, Knoxville, TN, by telephone on February 21,
2005, and by letter on February 22, 2005. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior
to distribution, but was subsequently found to test repeatedly reactive for
antibodies to hepatitis B core antigen (anti-HBc) by a different facility,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
TN and NC
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1659-5;
b) Recovered Plasma, Recall # B-1660-5
CODE
a) and b) Unit number 4011763
RECALLING FIRM/MANUFACTURER
Ogden Medical Center, Inc., Columbia Ogden Medical Center, Ogden, UT, by
telephone on July 19, 2000, and by letter on August 15, 2000. Firm initiated
recall is complete.
REASON
Blood products, that tested elevated for alanine aminotransferase (ALT),
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UT
_______________________________
PRODUCT
Recovered Plasma, Recall # B-1661-5
CODE
Unit number 8608400
RECALLING FIRM/MANUFACTURER
Poudre Valley Health Care, Inc., Fort Collins, CO, by letter on March 8,
2001. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected
from an ineligible donor due to behavior known to increase risk of infection
with human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1662-5;
b) Fresh Frozen Plasma, Recall # B-1663-5;
c) Platelets, Leukocytes Reduced,
Recall # B-1664-5
CODE
a) Unit 22GE72135;
b) Units 22GE72135, 22LJ62198;
c) Unit 22LJ62198
RECALLING FIRM
American National Red Cross, Penn-Jersey Region,
Philadelphia, PA, by letter dated January 28, 2005. Firm initiated recall
is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus
(anti-HCV), but were collected from an ineligible donor based on previous
positive testing for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NJ and PA
_______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-1666-5;
CODE
Units 1136736 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, Cincinnati, OH, by letter dated February 23, 2005.
Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received a piercing within
12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1674-5
CODE
Unit number: 1117839
RECALLING FIRM
Hoxworth Blood Center, Cincinnati, OH, by letter dated February 10, 2005.
Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an
area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1675-5
CODE
Unit number 2626969
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on March 28, 2005. Firm initiated
recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1676-5
CODE
Unit numbers: 7784298, 3607132, and 2821335
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on April 5, 2005. Firm initiated recall
is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL
_______________________________
PRODUCT
Red Blood Cells, Recall # B-1677-5
CODE
Unit number: 5561026
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL, by telephone on March 28, 2005.
Manufacturer: LifeSource Oak Lawn, Oak Lawn, IL. 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, Recall # B-1678-5
CODE
Unit number FG01861
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aurora Area Blood Bank, Heartland Blood Centers, Aurora,
IL, by telephone on April 11, 2005, and by letter dated April 19, 2005.
Manufacturer: Heartland Blood Centers, Elgin Donor Center, Elgin, IL. 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
FL
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1679-5
CODE
Unit numbers: 40FK48736, 40FK48744, and 40FK48752
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of America Region, Peoria, IL, by
telephone on April 15 and 18, 2005, and by letter on April 25, 2005. Firm
initiated recall is complete.
REASON
Blood products, collected from ineligible donors due to decreased hematocrit
values, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL and MI
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1680-5
CODE
Unit number 49LH66165
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Southwest Region, Tulsa,
OK, by telephone on October 28, 2003.
Manufacturer: American Red Cross Blood Services, Waco, TX. Firm initiated
recall is complete.
REASON
Blood product, collected from an ineligible donor due to decreased hematocrit
values, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1681-5;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-1682-5;
c) Recovered Plasma, Recall # B-1683-5
CODE
a) Unit numbers 49GQ01425 and 49GQ08544;
b) Unit number 49KQ01085;
c) Unit numbers 49GQ01425, 49GQ08544,
49GQ32111, and 49KQ01085
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by facsimile
on February 13, 2004. 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
7 units
DISTRIBUTION
TX, MA, and Switzerland
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1684-5
CODE
Unit number: 042FH33543
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH, by
telephone on November 1, 2004. Firm initiated recall is complete.
REASON
Red Cells, in which the corresponding platelets were implicated in a transfusion
reaction and possibly contaminated with Staphylococcus aureus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1686-5;
b) Fresh Frozen Plasma, Recall # B-1687-5
CODE
a) and b) Unit 49GW14243
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southwest Region, Tulsa, OK, by telephone on
February 23, 2004. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of Platelets that was possibly contaminated
with gram-positive cocci, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1695-5
CODE
Unit number: 2650952
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Ventura, CA, by letter on February 20, 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
CA
_______________________________
PRODUCT
Platelets, Leukocytes Reduced, Recall # B-1697-5
CODE
Unit number: 49GW23906
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by telephone
on February 8, 2005, and by facsimile on February 10, 2005. Firm initiated
recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1698-5
CODE
Unit number: 49GP21374
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by letter on
December 10, 2004. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may compromise the sterility of
the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1699-5
CODE
Unit number: 49GG14243
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Southwest Region, Tulsa,
OK, by telephone on September 8, 2003.
Manufacturer: American Red Cross Blood Services, College Station, TX. Firm
initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to an unacceptable
hemoglobin value, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
Recall # B-1700-5;
b) Platelets Pheresis, Leukocytes Reduced
Irradiated, Recall # B-1701-5
CODE
a) and b) Unit number 49GP22095
RECALLING FIRM
The American National Red Cross, Southwest Region, Tulsa, OK, by letter on
January 28, 2005. Firm initiated recall is complete.
REASON
Blood products, collected in an apheresis collection kit that had exceeded
the acceptable time period for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1702-5
CODE
Unit number: 5934225
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on April 24, 2005. Firm initiated
recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that tested positive
for coagulase negative Staphylococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1724-5;
b) Cryoprecipitated AHF, Recall # B-1725-5
CODE
a) and b) Unit number 49LH46297
RECALLING FIRM
Recalling Firm: The American National Red Cross, Southwest Region, Tulsa,
OK, by letter on May 12, 2004.
Manufacturer: American Red Cross Blood Services, Waco, TX. Firm initiated
recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected
from a donor that was subsequently determined to have multiple risk factors
for increased incidence of infection with human immunodeficiency virus (HIV),
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1726-5
CODE
Unit number 49KN06861
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by letter on
September 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
TX
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced
Recall # B1727-5;
b) Red Blood Cells, Leukocytes Reduced
Irradiated, Recall # B1728-5;
c) Red Blood Cells, (Apheresis),Leukocytes
Reduced, Recall # B1729-5;
d) Red Blood Cells, (Apheresis),Leukocytes
Reduced Irradiated, Recall # B1730-5;
e) Cryoprecipitated AHF, Recall # B-1731-5;
f) Plasma, Cryoprecipitated Reduced,
Recall # B-1732-5;
g) Plasma, Recall # B-1733-5;
h) Platelets Pheresis, Leukocytes Reduced
Irradiated, Recall # B-1734-5;
i) Platelets Pheresis, Leukocytes Reduced,
Recall # B-1735-5
CODE
a) Unit numbers 10184-4201, 10184-4205, 10184-4218, 10184-4231, 10184-4244,
10184-4252, 10184-4258, 10184-4261, 10184-4273, 10184-4280, 10184-4285, 10184-4290,
10184-4334, 10184-4369, 10184-4377, 10184-4412, 10184-4451, 10184-4468, 10184-4477,
10184-4500, 10184-4518, 10184-4564, 10184-4569, 10184-4573, 10184-4579, 10184-8808,
10184-8811, 10184-8817, 10184-8828, 10184-8833, 10184-8841, 10184-8853, 10184-8881,
10184-8897, 10184-8907, 10184-8919, 10184-8927, 10184-8931, 10184-8937, 10184-8947,
10184-8967, 10184-8973, 10184-9000, 10184-9024, 10184-9088, 10184-9090, 10184-9095,
10184-9115, 10184-9128, 10184-9129, 10184-9132, 10184-9138, 10184-9140, 10184-9143,
10184-9149, 10184-9152, 10184-9153, 10184-9168, 10184-9173, 10184-9189, 10185-4031,
10185-4036, 10185-4041, 10185-4064, 10185-4069, 10185-4073, 10185-4159, 10185-4173,
10185-4205, 10185-4215, 10185-4217, 10185-4234, 10185-4237, 10185-4250, 10185-4277,
10185-4294, 10185-4297, 10185-4300, 10185-4302, 10185-4346, 10185-4354, 10185-4359,
10185-4363, 10185-4364, 10185-9709, 10185-9726, 10185-9736, 10185-9739, 10185-9749,
10185-9752, 10185-9757, 10185-9778, 10185-9795, 10185-9799, 10185-9806, 10185-9807,
10185-9817, 10185-9819, 10185-9905, 10185-9914, 10185-9924, 10185-9928, 10185-9929,
10185-9937, 10185-9946, 10185-9947, 10185-9949, 10185-9958, 10185-9963, 10185-9966,
10185-9979, 10185-9981, 10185-9983, 10185-9985, 10185-9987, 10185-9989, 10186-4005,
10186-4019, 10186-4022, 10186-4025, 10186-4029, 10186-4033, 10186-4036, 10186-4048,
10186-4053, 10186-4065, 10186-4072, 10186-4076, 10186-4080, 10186-4081, 10186-4084,
10186-4090, 10186-4101, 10186-4116, 10186-4152, 10186-4160, 10186-4166, 10186-4174,
10186-4177, 10186-4199, 10186-4202, 10186-4206, 10186-4214, 10186-4216, 10186-4220,
10186-4229, 10186-4246, 10186-4255, 10186-4261, 10186-4268, 10186-4359, 10186-7210,
10186-7232, 10186-7251, 10186-7276, 10186-7280, 10186-7286, 10186-7291, 10186-7294,
10186-7300, 10186-7306, 10186-7309, 10186-7310, 10186-7326, 10186-7336, 10186-7371,
10186-7384, 10186-7387, 10186-7389, 10186-7531, 10186-7543, 10186-7927, 10293-6367,
10293-6372, 10293-6377, 10293-6385, 10295-7902, 10295-7941, 10295-7949, 10295-7962,
10295-7966, 10295-7971, 10295-7992, 10296-1870, 10296-1903, 10296-1946, 10296-1969,
10296-1986, 10296-1994, 10296-2012, 10296-2038, 10296-2044, 10296-2047, 10296-2051,
10296-2055, 10296-2059, 10296-2073, 10296-2092, 10296-2101, 10296-2104, 10296-2109,
10296-2112, 10296-2116, 10296-2122, 10296-6647, 10296-6666, 10296-6785, 10298-1402,
10298-1452, 10298-1517, 10298-1537, 10298-1555, 10298-1570, 10298-1577, 10298-1588,
10298-1717, 10298-1736, 10298-1743, 10298-1798, 10298-5400, 10298-5403, 10298-5409,
10298-5415, 10298-5422, 10298-5426, 10298-5429, 10298-5443, 10298-5446, 10298-5491,
10298-5500, 10298-5518, 10298-5521, 10298-5776, 10298-5782, 10298-5793, 10298-9800,
10298-9861, 10298-9867, 10298-9871, 10298-9894, 10298-9919, 10298-9935, 10298-9940,
10299-0055, 10299-0063, 10299-0080, 10299-0089, 10299-0095, 10299-0101, 10299-0124,
10299-0126, 10299-0136, 10299-0140, 10299-0147, 10299-0159, 10299-0169, 10299-0176,
10299-0189, 10299-0194, 10184-9111, 10185-4256, 10185-4260, 10185-9763, 10186-4381,
10296-1935, 10296-2027, 10298-9883, 10299-0144, 10299-0152, and 10296-2050;
b) Unit numbers 10185-4183, 10185-4188, 10185-4331, 10185-9917, 10186-7362, 10293-6394, 10295-7957, and 10299-0077;
c) unit numbers:
First Bag: 10184-4213, 10184-4216, 10184-4234, 10184-4277, 10184-4305, 10184-4308,
10184-4347, 10184-4361, 10184-4515, 10184-4578, 10184-8838, 10184-8882,
10184-8935, 10184-8994, 10184-8996, 10184-9157, 10184-9159, 10184-9170,
10184-9193, 10185-4048, 10185-4142, 10185-4145, 10185-4200, 10185-4244,
10185-4274, 10185-4347, 10185-9910, 10185-9913, 10185-9957, 10185-9960,
10185-9969, 10186-4002, 10186-4051, 10186-4058, 10186-4078, 10186-4096,
10186-4098, 10186-4190, 10186-4194, 10186-4195, 10186-4225, 10186-4263,
10186-4363, 10186-7221, 10186-7236, 10186-7243, 10295-7886, 10295-7893,
10295-7910, 10295-7913, 10295-7934, 10295-7986, 10295-7998, 10296-1800,
10296-1890, 10296-1911, 10296-1940, 10296-1956, 10296-1971, 10296-1980,
10296-2000, 10296-2001, 10296-2006, 10296-2041, 10296-2080, 10296-2082,
10296-2089, 10298-1434, 10298-1495, 10298-1545, 10298-1567, 10298-1582,
10298-5496, 10298-5504, 10298-5796, 10298-9917, 10298-9950, 10298-9954,
10298-9965, 10299-0065, 10299-0083, and 10299-0154;
Second Bag: 10184-4213, 10184-4216, 10184-4234, 10184-4277, 10184-4305, 10184-4308,
10184-4347, 10184-4361, 10184-4515, 10184-4578, 10184-8838, 10184-8882, 10184-8935,
10184-8996, 10184-9157, 10184-9159, 10184-9170, 10184-9193, 10185-4048, 10185-4142,
10185-4145, 10185-4200, 10185-4244, 10185-4274, 10185-4347, 10185-9910, 10185-9913,
10185-9957, 10185-9969, 10186-4002, 10186-4051, 10186-4058, 10186-4078, 10186-4096,
10186-4190, 10186-4194, 10186-4195, 10186-4225, 10186-4263, 10186-4363, 10186-7221,
10186-7243, 10295-7886, 10295-7893, 10295-7910, 10295-7913, 10295-7934, 10295-7986,
10295-7998, 10296-1800, 10296-1890, 10296-1911, 10296-1940, 10296-1956, 10296-1971,
10296-1980, 10296-2000, 10296-2001, 10296-2006, 10296-2041, 10296-2080, 10296-2082,
10296-2089, 10298-1434, 10298-1495, 10298-1545, 10298-1567, 10298-1582, 10298-5496,
10298-5504, 10298-5796, 10298-9917, 10298-9950, 10298-9954, 10298-9965, 10299-0065,
10299-0083, and 10299-0154;
d) Unit number 10185-9785;
e) Unit numbers 10184-4231, 10293-6377, 10295-7941, 10296-2092, 10298-1452, 10298-1717, 10298-5415, 10298-5422, 10298-5491, and 10298-5776;
f) Unit numbers 10184-4265, 10184-8947, 10296-1870, 10296-6647, 10298-5415, 10298-5422, 10298-5491, and 10298-9861;
g) Unit numbers 10184-4201, 10184-4252, 10184-4381, 10184-4451, 10184-4468, 10184-8811, 10184-8833, 10184-8853, 10184-9024, 10184-9115, 10184-9168, 10185-4064, 10185-9938, 10295-7902, 10295-7949, 10295-7971, 10296-1969, 10296-1994, 10296-2012, 10296-2038, 10296-2047, 10296-2050, 10296-2116, 10298-1402, 10298-1517, 10298-1577, 10298-1736, 10298-1743, 10298-5403, 10298-5446, 10298-5500, 10298-5521, 10298-5793, 10298-9800, 10298-9894, 10298-9919, 10298-9935, 10299-0077, 10299-0089, 10299-0095, 10299-0124, 10299-0126, 10299-0136, 10299-0140, and 10299-0159;
h) Unit number 10186-4231 (distributed as two split units);
i) Unit numbers 10186-4258, 10184-4415, and 10184-8982; and the following
three units were distributed as two split products, unit numbers 10184-4456,
10184-8921, and 10185-9921
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by Facsimile on December 3, 2004. Firm
initiated recall is complete.
REASON
Blood products, collected from donors whose health history screenings were
inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
513 units
DISTRIBUTION
AZ, FL, NV, ND, SD, TN, and TX
_______________________________
PRODUCT
Red Blood Cells, Leukoreduced, Irradiated, Recall # B-1540-5
CODE
Unit number: 29KE47024
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by telephone
on December 8, 2004, and letter dated December 10, 2004 and January 10, 2005.
Firm initiated recall is complete.
REASON
Blood product, which was not prepared in accordance with specifications,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
_______________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced, Recall # B-1541-5
CODE
Unit numbers: 22GH06261 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
American Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on
December 14, 2004, and by letter, dated December 17, 2004. Firm initiated
recall is complete.
REASON
Blood products, manufactured in a manner that may have compromised their
sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1561-5;
b) Platelets, Leukocytes Removed, Recall # B-1562-5
CODE
a) and b) Unit number: 33GF70663
RECALLING FIRM/MANUFACTURER
American Red Cross, Connecticut Region, Farmington, CT, by telephone and
letter, dated April 6, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CT
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1573-5
CODE
Unit numbers: 4655455, 4700141, 4695039, 4695030, 4695031, 4695032, 4695033,
4695034, 4695035, 4695037, 4695038, 4695029, 4695028, 4695027, 4655469, 4655452,
4655454, 4655451, and 4655449
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by
facsimile on November 3, 4, and 6, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors during a period when quality control
testing was not performed for equipment used to determine donor suitability,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
OK and NJ
_______________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced, Recall # B-1578-5
CODE
Unit number: 101853539
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Scottsdale, AZ, by facsimile on April 14, 2005. Firm
initiated recall is complete.
REASON
Blood product, incorrectly tested for the presence of red cell antigens,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
_______________________________
PRODUCT
Red Blood Cells, Recall # B-1585-5
CODE
Unit number: GE16067
RECALLING FIRM/MANUFACTURER
Southern California Permanente Medical Group, Blood Donor Center, Downey,
CA, by telephone on April 22, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature exceeded the
acceptable range, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
Source Plasma, Recall # B-1613-5
CODE
Unit numbers: 00GNDA6470, 00GNDA6902, 00GNDA7372, 00GNDA8129, 00GNDA8405,
00GNDB0163, 00GNDB0735, 00GNDB6293, 00GNDB6621, 00GNDB7219, 00GNDB7543, 00GNDB8039,
00GNDB8551, 00GNDB9477, 00GNDC0741, 00GNDC1017, 00GNDC1969, 00GNDC2276, 00GNDC3412,
00GNDC3909, 00GNDC4360, 00GNDC4819
RECALLING FIRM/MANUFACTURER
BioLife Plasma Service, L.P., Grand Forks, ND, by letter dated September
15, 2000. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency
virus (anti-HIV-1/2), but were collected from a donor who was subsequently
determined to have previously tested positive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
Austria
_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1616-5
CODE
Unit number: L87820
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI, by facsimile on April
18, 2005. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that had an extended
collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
_______________________________
PRODUCT
Source Plasma, Recall # B-1617-5
CODE
Unit number: 77899064
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Birmingham, AL, by facsimile on January 7,
2004. Firm initiated recall is complete.
REASON
Blood product, that tested negative for the antibody to hepatitis C virus
(anti-HCV), but was not properly quarantined after the receipt of subsequent
repeatedly reactive anti-HCV results for the donor of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
Platelets, For Further Manufacture into Non-injectables, Recall # B-1630-5
CODE
Unit number: 7172572
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by letter dated October 16, 2003.
Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability
was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
_______________________________
PRODUCT
Recovered Plasma, Recall # B-1631-5
CODE
Unit number: 5555429
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by facsimile on March 19, 2004.
Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated, Recall # B-1633-5
CODE
Unit number: R61065
RECALLING FIRM
Coastal Bend Blood Center, Corpus Christi, TX, by facsimile on October 21
and 27, 2004, and by telephone on February 9, 2005. Firm initiated recall
is complete.
REASON
Blood product, subjected to an irradiation dose higher than allowed, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1638-5
CODE
Unit number: 12470-9608
RECALLING FIRM
Recalling Firm: Blood Systems, Inc, Scottsdale, AZ, by telephone on November
6, 2001, and by letter, dated November 26, 2001.
Manufacturer: Blood Systems, Inc, Albuquerque, NM, Firm initiated recall
is complete.
REASON
Blood product, collected on equipment that had not been validated for use,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NM
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1640-5
CODE
Unit number: 368507376 (distributed as two split units)
RECALLING FIRM
Blood Systems, Inc., Ventura, CA, by telephone on March 25, 2005. Firm initiated
recall is complete.
REASON
Blood products, that were labeled leukoreduced but possibly had an elevated
white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1641-5;
b) Platelets Pheresis, Leukocytes Reduced,
Recall # B-1642-5
CODE
a) Unit numbers S39041, S39040, KC79717,
KC79464, and S39038;
b) Unit numbers KC79458 and S38876; and the
following two units were distributed as
two split products: unit numbers S38875
and KC79465
RECALLING FIRM
HCSC Blood Center, Bethlehem, PA, by telephone on March 3, 2005, and by letter
on March 11, 2005. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for human immunodeficiency virus (HIV)
and hepatitis C virus (HCV) by the nucleic acid testing (NAT) method, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
PA and MD
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1648-5;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-1649-5
CODE
a) Unit number: 0419899;
b) Unit number: 0419856
RECALLING FIRM
Community Blood Bank of Erie County, Erie, PA, by telephone on April 26,
2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose body temperature was not properly
recorded, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1651-5
CODE
Unit number: 4201376
RECALLING FIRM
Ogden Medical Center, Inc., Ogden, UT, by letter dated July 16, 2001. Firm
initiated recall is complete.
REASON
Blood product, which 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
UT
_______________________________
PRODUCT
Source Plasma, Recall # B-1655-5
CODE
Unit number: 7050095902
RECALLING FIRM
ZLB Bioplasma, Inc., Ft. Collins, CO, by facsimile on My 10, 2000. Firm initiated
recall is complete.
REASON
Blood product, collected from a donor that did not answer the medical history
questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
United Kingdom
_______________________________
PRODUCT
Source Plasma, Recall # B-1656-5
CODE
Unit numbers: OU145003, OU046717, OU046383, OU045881, and OU045670
RECALLING FIRM
BioLife Plasma Services, L.P., Ogden, UT, by facsimile on September 24, 2001.
Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer the medical history
questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA and NC
_______________________________
PRODUCT
Source Plasma, Recall # B-1657-5
CODE
Unit numbers: OU045662, OU045441
RECALLING FIRM
BioLife Plasma Services, L.P., Ogden, UT, by facsimile on September 24, 2001.
Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer the medical history
questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
_______________________________
PRODUCT
Source Plasma, Recall # B-1658-5
CODE
Unit numbers: OU066479, OU066689
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Ogden, UT, by facsimile on October 31, 2002.
Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer the medical history
questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-1665-5
CODE
Unit number: 4711064
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL, by telephone on March 4, 2005.
Manufacturer: LifeSource, Glen Ellyn, Il. Firm initiated recall is complete.
REASON
Blood product, which was labaeled 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
IL
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1667-5
CODE
Unit number: 49FH08762
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southwest Region, Tulsa, OK, by letter dated
December 7, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for Leishmaniasis,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Irradiated, Recall # B-1668-5;
b) Platelets, Leukocytes Reduced,
Recall # B-1669-5;
c) Fresh Frozen Plasma, Recall # B-1670-5
CODE
a), b), and c) Unit number: 1037631
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, Cincinnati, OH, by letter dated March 16, 2004. Firm
initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for Leishmaniasis,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OH
_______________________________
PRODUCT
Red Blood Cells, Recall # B-1671-5
CODE
Unit number: 1183314
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, Irwin Center, San Francisco,
CA, by letter dated September 28, 2001.
Manufacturer: Blood Centers of the Pacific, San Rafael, CA. Firm initiated
recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
Source Plasma, Recall # B-1690-5
CODE
Unit number: YP-175343
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, San Diego, CA, by facsimile on February 19,
2004. 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-1691-5
CODE
Unit number: YP-176253
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, San Diego, CA, by facsimile on March 2, 2004.
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-1692-5
CODE
Unit number: YP-171654
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, San Diego, CA, by facsimile on November 20,
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
a) Red Blood Cells, Recall # B-1693-5;
b) Fresh Frozen Plasma, Recall # B-1694-5
CODE
a) and b) Unit number: 1183294
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone
on September 26, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with an elevated body temperature,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-1696-5
CODE
Unit number 042FS89595
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by
telephone on October 21, 2004. Firm initiated recall is complete.
REASON
Blood product that was out of controlled storage for more than 30 minutes
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1707-5
CODE
Unit numbers: 07FY06129, 07FY06125, 07FY06126, 07FY06143, 07FY06119, 07FY06113
RECALLING FIRM/MANUFACTURER
American National Red Cross, Arizona Region, Tucson, AZ, by telephone on
December 11, 2002. Firm initiated recall is complete.
REASON
Blood products, labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
AZ
_______________________________
PRODUCT
Recovered Plasma, Recall # B-1736-5
CODE
Unit numbers 10184-4205, 10184-4224, 10184-4500, 10184-8907, 10184-8919,
10184-8927, 10184-8973, 10184-9111, 10184-9140, 10185-4069, 10185-4073, 10185-4188,
10185-4256, 10185-4277, 10185-4294, 10185-4297, 10185-4331, 10185-4346, 10185-4359,
10185-4363, 10185-4364, 10185-9736, 10185-9749, 10185-9757, 10185-9763, 10185-9817,
10185-9914, 10185-9946, 10185-9949, 10185-9958, 10185-9963, 10185-9966, 10186-4005,
10186-4033, 10186-4036, 10186-4048, 10186-4090, 10186-4160, 10186-4166, 10186-4174,
10186-4177, 10186-4206, 10186-4229, 10293-6394, 10295-7855, 10295-7957, 10295-7962,
10295-7966, 10296-1903, 10296-1935, 10296-2027, 10296-2051, 10296-2055, 10296-2059,
10296-2109, 10296-6666, 10298-1570, 10298-1588, 10298-1798, 10298-5400, 10298-5443,
10298-9883, 10298-9940, 10299-0080, 10299-0144, 10299-0147, 10299-0152, 10299-0189,
10184-4231, 10184-4258, 10184-4261, 10184-4273, 10184-4280, 10184-4285, 10184-4412,
10184-4477, 10184-4569, 10184-4573, 10184-8828, 10184-8841, 10184-8881, 10184-8931,
10184-8937, 10184-9088, 10184-9095, 10184-9128, 10184-9129, 10184-9132, 10184-9138,
10184-9143, 10184-9149, 10184-9152, 10184-9153, 10184-9189, 10185-4036, 10185-4237,
10185-9806, 10186-4081, 10186-4084, 10293-6367, 10293-6377, 10295-7992, 10296-1946,
10296-1986, 10296-2044, 10296-2073, 10296-2092, 10296-2101, 10296-2104, 10296-2112,
10296-2122, 10296-6650, 10296-6785, 10298-1452, 10298-1717, 10298-5409, 10298-5426,
10298-5429, 10298-5518, 10298-5776, 10298-9867, 10298-9871, 10299-0063, 10299-0169,
and 10299-0176
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by Facsimile on December 3, 2004. Firm
initiated recall is complete.
REASON
Blood products, collected from donors whose health history screenings were
inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
126 units
DISTRIBUTION
NY and Switzerland
_______________________________
PRODUCT
a) Baxter Colleague Single Channel Volumetric
Infusion Pumps, product codes: 2M8151,
2M8151R, 2M8161, 2M8161R, Recall # Z-1022-05;
b) Baxter Colleague triple Channel Volumetric
Infusion Pumps, product codes: 2M8153,
2M8153R, 2M8163, 2M8163R, Recall # Z-1023-05
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Deerfield, IL, by letter on
March 15, 2005.
Manufacturer: Baxter Healthcare Corporation, Singapore, Singapore. Firm initiated
recall is ongoing.
REASON
The pumps may experience inadvertent power off, external communications port
failures and electronic pump failure codes 402, 403, 533, 535, 599, 810:04
and 810:11.
VOLUME OF PRODUCT IN COMMERCE
253,185 pumps
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
a) Right Heart Catheter Product Line:
Catalog Number 601129-----5011094
0106 x 1007BBMWS, Recall # Z-0995-05;
b) Right Heart Catheter Product Line:
Catalog Number 601258-----WP604P Wedge
Press Catheter, Recall # Z-0996-05;
c) Right Heart Catheter Product Line:
Catalog Number 601261-----WP605P Wedge
Press Catheter, Recall # Z-0997-05;
d) Right Heart Catheter Product Line:
Catalog Number 601272-----WP1106 Wedge
Press Catheter, Recall # Z-0998-05;
e) Right Heart Catheter Product Line:
Catalog Number 601276-----WP1107 Wedge
Press Catheter, Recall # Z-0999-05;
f) Right Heart Catheter Product Line:
Catalog Number 601285-----WP11055 Wedge
Press Catheter, Recall # Z-1000-05;
g) Right Heart Catheter Product Line:
Catalog Number 601293-----WP1107S Monitory
Wedge Press, Recall # Z-1001-05;
h) Right Heart Catheter Product Line:
Catalog Number 604000-----417D10061
Recall # Z-1002-05;
i) Right Heart Catheter Product Line:
Catalog Number 604025-----T046-02
0426D10091 RMM, Recall # Z-1003-05;
j) Right Heart Catheter Product Line:
Catalog Number 604028-----T047(90)
427D10221, Recall # Z-1004-05;
k) Right Heart Catheter Product Line:
Catalog Number 604037-----T047-02
0427D10061, Recall # Z-1005-05;
l) Right Heart Catheter Product Line:
Catalog Number 604057----T147
A427D1014KANI, Recall # Z-1006-05;
m) Right Heart Catheter Product Line:
Catalog Number 604100----T147-03
A427D1014KANI 25PP, Recall # Z-1007-05;
n) Right Heart Catheter Product Line:
Catalog Number 604103-----T047(97) 427D4036I,
Recall # Z-1008-05;
o) Right Heart Catheter Product Line:
Catalog Number 604165-----T047-04 0427D1022I,
Recall # Z-1009-05;
p) Right Heart Catheter Product Line:
Catalog Number 604239-----426D1009I,
Recall # Z-1010-05;
q) Right Heart Catheter Product Line:
Catalog Number 604264-----427D1006I
Round Molded Manifold, Recall # Z-1011-05;
r) Right Heart Catheter Product Line:
Catalog Number 604315-----406-1H-018
426D1009I18PP, Recall # Z-1012-05;
s) Right Heart Catheter Product Line:
Catalog Number 608054-----827D1006I 4P
BBM RMM Catheter, Recall # Z-1013-05;
t) Right Heart Catheter Product Line:
Catalog Number 608055-----827D1006I 4P
BBM RMM Catheter, Recall # Z-1014-05
CODE
a) Lot Number, exp.date: 0060436563, 3/31/05;
0060449283, 4/30/05; 0060460576, 6/30/05;
0060478672, 7/31/05; 0060479191, 6/30/05;
0060485755, 7/31/05; 0060488734, 8/31/05;
0060496446, 9/30/05; 0060514308, 10/31/05;
0060520693, 11/30/05; 0060541501, 1/31/06;
0060551085, 2/28/06; 0060558243, 3/31/06;
0060572138, 4/30/06; 0060572440, 4/30/06;
0060577179, 5/31/06; 0060577413, 4/30/06;
0060706970, 6/30/06; 0060710249, 8/31/06;
0060721648, 9/30/06; 0060724465, 10/31/06;
0060732313, 10/31/06; 0060738463, 12/31/06;
0060746723, 1/31/06.
b) Lot Number, Exp Date: 0060554715, 2/28/06;
0060558246, 2/28/06; 0060568209, 4/30/06;
0060721656, 8/31/06.
c) Lot Number, Exp Date: 0060461139, 5/31/05;
0060468252, 6/30/05; 0060484327, 7/31/05;
0060490856, 8/31/05; 0060534557, 12/31/05;
0060541502, 1/31/06; 0060558248, 2/28/06;
0060561935, 3/31/06; 0060565937, 4/30/06;
0060572444, 4/30/06; 0060577415, 5/31/06;
0060708815, 6/30/06; 0060710255, 7/31/06;
0060733103, 12/31/06; 0060743198, 1/31/06.
d) Lot Number, Exp. Date: 0060460588, 6/30/05;
0060478671, 6/30/05; 0060499553, 9/30/05;
0060514303, 10/31/05; 0060541506, 12/31/05;
0060558250, 3/31/06; 0060707682, 7/31/06;
0060715898, 8/31/06; 0060721686, 9/30/06;
0060724934, 9/30/06; 0060741461, 12/31/06;
0060746728, 1/31/06.
e) Lot Number, Exp. Date: 0060447424, 4/30/05;
0060449287, 4/30/05; 0060460591, 5/31/05;
0060461660, 6/30/05; 0060479198, 7/31/05;
0060485764, 8/31/05; 0060499554, 9/30/05;
0060503596, 10/31/05; 0060510910, 10/31/05;
0060534551, 12/31/05; 0060542987, 1/31/06;
0060551093, 2/28/06; 0060558251, 2/28/06;
0060563877, 3/31/06; 0060568298, 4/30/06;
0060577421, 4/30/06; 0060704964, 6/30/06;
0060707117, 8/31/06; 0060709910, 7/31/06;
0060720394, 9/30/06; 0060724488, 9/30/06;
0060724492, 10/31/06; 0060730638, 11/30/06;
0060733105, 11/30/06; 0060735054, 11/30/06;
0060741469, 12/31/06; 0060743202, 1/31/06.
f) Lot Number, Exp.Date: 0060449299, 5/31/05;
0060451743, 4/30/05; 0060460616, 8/31/05;
0060465318, 8/31/05; 0060488695, 9/30/05;
0060507456, 9/30/05; 0060515836, 10/31/05;
0060538329, 2/28/06; 0060541514, 12/31/05;
0060749802, 1/31/06.
g) Lot Number, Exp. Date: 0060443014, 4/30/05;
0060496739, 9/30/05; 0060534548, 12/31/05;
0060541540, 1/31/06; 0060707630, 6/30/06;
0060721175, 9/30/06; 0060724938, 9/30/06;
0060741497, 12/31/06.
h) Lot Number, Exp. Date: 0060444167, 3/31/05;
0060449163, 4/30/05; 0060451494, 4/30/05;
0060451497, 4/30/05; 0060460629, 6/30/05;
0060471018, 6/30/05; 0060480355, 7/31/05;
0060488611, 10/31/05; 0060537207, 1/31/06;
0060551137, 2/28/06; 0060554768, 2/28/06;
0060564022, 3/31/06; 0060575807, 4/30/06;
0060709793, 10/31/06; 0060721740, 9/30/06;
0060725206, 11/30/06; 0060725207, 11/30/06;
0060735650, 1/31/06; 0060743268, 1/31/06.
i) Lot Number, Exp. Date: 0060575999, 4/30/06;
0060581062, 5/31/06; 0060717194, 8/31/06;
0060725153, 9/30/06; 0060730984, 10/31/06;
0060733271, 11/30/06.
j) Lot Number, Exp.Date: 0060714530, 8/31/06;
0060714554, 10/31/06; 0060715260, 9/30/06;
0060716585, 8/31/06; 0060721764, 10/31/06;
0060730636, 11/30/06; 0060737274, 12/31/06;
0060738518, 11/30/06.
k) Lot Number, Exp. Date: 0060460638, 5/31/05;
0060471048, 6/30/05; 0060486204, 7/37/05;
0060490913, 8/31/05; 0060510913, 11/30/05;
0060514285, 10/31/05; 0060527620, 11/30/05;
0060537029, 12/31/05; 0060541565, 1/31/06;
0060551161, 2/28/06; 0060558495, 2/28/06;
0060568861, 3/31/06; 0060579881, 5/31/06;
0060714560, 9/30/06; 0060716589, 8/31/06;
0060726783, 10/31/06; 0060733295, 10/31/06;
0060738519,11/30/06; 0060741037, 12/31/06;
0060745654, 12/31/06; 0060746780, 1/31/06.
l) Lot Number, Exp. Date: 0060709903, 7/31/06.
m) Lot Number, Exp.Date: 0060708624, 7/31/06;
0060720757, 8/31/06.
n) Lot Number, exp.Date: 0060454893, 4/30/05;
0060467329, 6/30/05'' 0060486208, 7/31/05;
0060486209, 7/31/05; 0060491077, 9/30/05;
0060510922, 11/30/05; 0060514276, 10/31/05;
0060537036, 12/31/05; 0060541575, 2/28/06;
0060551166, 2/28/05; 0060568862, 5/31/06;
0060570914, 5/31/06; 0060579875, 5/31/06;
0060710236, 8/31/06; 0060716577, 8/31/06;
0060721776, 9/30/06; 0060721777, 8/31/06;
0060721778, 10/31/06; 0060726790, 11/30/06.
o) Lot Number, Exp. Date: 0060709920, 08/31/06;
0060725197, 8/31/06; 0060732988, 10/31/06;
0060741502, 11/30/06.
p) Lot Number, exp. Date: 0060460643, 4/30/05;
0060461604, 5/31/05; 0060471050, 6/30/05;
0060476785, 7/31/05; 0060486210, 8/31/05;
0060488589, 9/30/05; 0060507464, 10/31/05;
0060537807, 2/28/06; 0060541581, 1/31/06;
0060545788, 1/31/06; 0060550249, 2/28/06;
0060551170, 2/28/06; 0060710289, 8/31/06;
0060733310, 10/31/06.
q) Lot Number, Exp. Date: 0060443003, 3/31/05;
0060460648, 5/31/05; 0060471074, 6/30/05;
0060479256, 6/30/05; 0060486212, 7/31/05;
0060491081, 8/31/05; 0060514268, 10/31/05;
0060552185, 2/28/06; 0060577425, 5/31/06;
0060714385, 10/31/06; 0060720571, 8/31/06;
0060721744, 10/31/06; 0060733328, 11/30/06;
0060741506, 11/30/06; 0060741512, 12/31/06.
r) Lot Number, exp date: 0060514256, 01/31/06;
0060721684, 8/31/06.
s) Lot Number, exp date: 0060429437, 3/31/05;
0060448163, 4/30/05; 0060451580, 5/31/05;
0060464460, 6/30/05; 0060478913, 7/31/05;
0060487419, 8/31/05; 0060507290, 9/30/05;
0060535169, 12/31/05; 0060541493, 1/31/06;
0060549785, 2/28/06; 0060552125, 2/28/06;
0060558241, 3/31/06; 0060714523, 8/31/06;
0060735748, 11/30/06; 0060738710, 12/31/06;
0060746883, 1/31/06.
t) Lot Number, exp date: 0060420041, 3/31/05;
0060448164, 4/30/05; 0060451583, 4/30/05;
0060464461, 6/30/05; 0060470936, 7/31/05;
0060485412, 8/31/05; 0060499041, 8/31/05;
0060516425, 10/31/05; 0060535170, 13/31/05;
0060549811, 2/28/06; 0060558242, 4/30/06;
0060714514, 8/31/06; 0060714518, 10/31/06;
0060726942, 10/31/06; 0060738704, 11/30/06;
0060746884, 1/31/06.
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letters on May
27, 2005.
Manufacturer: B. Braun Medical, Inc., Cherry Hill, NJ. Firm initiated recall
is ongoing.
REASON
Reports in a small percentage of Right Heart Catheter Products Line related
to cracked catheter tips, leaking at the manifold and cracked hubs.
VOLUME OF PRODUCT IN COMMERCE
6,867 units
DISTRIBUTION
Nationwide, Germany and Japan
_______________________________
PRODUCT
Immulite/Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1, Recall # Z-1015-05
CODE
Lots 302 and 303
RECALLING FIRM
Recalling Firm: Diagnostic Products Corp, Los Angeles, CA, by telephone and
letter on May 26, 2005.
Manufacturer: EURO/DPC Limited. Firm initiated recall is ongoing.
REASON
Adverse trend in stability, controls biased or out of range.
VOLUME OF PRODUCT IN COMMERCE
269 units
DISTRIBUTION
Nationwide, Syria, United Kingdom, Puerto Rico, Aruba, Kuwait
_______________________________
PRODUCT
Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box.
For in vitro diagnostic use. Recall # Z-1016-05
CODE
Generations 18, 19, 20, 21, and 23
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letters dated May 26, 32005.
Firm initiated recall is ongoing.
REASON
Falsely elevated Carbamazepine results.
VOLUME OF PRODUCT IN COMMERCE
5,846 boxes
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
Implantable Cardioverter Defibrillators Epic DR/HF (V-233/V-337/V-338), Epic
Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-196T/V-350) Atlas DR (V242),and
Atlas Plus DR/VR/HF (V-243/V-193C/V-340/V-341/V-343), Recall # Z-1017-05
CODE
No serial numbers were given. All mentioned models are recalled.
RECALLING FIRM
St Jude Medical, Sylmar, CA, by letter on June 17, 2005. Firm initiated recall
is ongoing.
REASON
Two corrections to firmware due to Skipped-Charge Shock and Sensor Noise
Anomaly are being made with one noninvasive upgrade.
VOLUME OF PRODUCT IN COMMERCE
30,000 domestically, 11,684 internationally
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
a) HomeChoice Automated Peritoneal Dialysis
Systems; Made in U.S.A.; catalog numbers 5C4471,
5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R,
Recall # Z-1018-05;
b) HomeChoice PRO Automated Peritoneal Dialysis
Systems; Made in U.S.A.; catalog numbers
5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300,
T5C8300R, Recall # Z-1019-05
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Division, McGaw Park, IL, by letters
on June 21, 2005 and June 22, 2005.
Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall
is ongoing.
REASON
The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice
device are not reliably grounded to the device's ground system, posing an
electric shock hazard.
VOLUME OF PRODUCT IN COMMERCE
72,752 units
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
Adapter for ACMI Hysteroscope, Catalog Number: 55035, Recall # Z-1020-05
CODE
Lot Number: 20410191
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Marlborough, Marlborough, MA, by letter
dated June 28, 2005.
Manufacturer: Nexcore Technology, Inc., Hackensack, NJ. Firm initiated recall
is ongoing.
REASON
The Hysteroscope Adapter used with the HTA System may disassemble and result
in a fluid leak.
VOLUME OF PRODUCT IN COMMERCE
73 units
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) Depuy brand LCS Complete metal backed
patella, porocoat, STD; REF 1294-09-640.
Recall # Z-1024-05;
b) Depuy brand LCS Complete metal backed
patella, porocoat, STD+; REF 1294-09-650;
Recall # Z-1025-05;
c) Depuy brand LCS Complete metal backed
patella, porocoat, LRG; REF 1294-09-660.
Recall # Z-1026-05;
d) Depuy brand LCS Complete metal backed
patella, porocoat, LRG+; REF 1294-09-670,
Recall # Z-1027-05;
e) Depuy brand LCS Complete metal backed
patella, cemented, STD; REF 1294-09-740.
Recall # Z-1028-05;
f) Depuy brand LCS Complete metal backed
patella, cemented, STD+; REF 1294-09-750,
Recall # Z-1029-05;
g) Depuy brand LCS Complete metal backed
patella, cemented, LRG; REF 1294-09-760,
Recall # Z-1030-05;
h) Depuy brand LCS Complete metal backed
patella, cemented, LRG+; REF 1294-09-770,
Recall # Z-1031-05
CODE
a) Lots 1831720, 1831721, 1837366, 1837367,
1840603, 1845651 and 1855830;
b) Lots 1829091, 1831724, 1834697, 1834698,
1837368, 1840605, 1840609, 1851643,
1859876, 1859879 and 1862192;
c) Lots 1829092, 1831726, 1837370, 1845654,
1848385 and 1855839;
d) Lot 1851632;
e) Lots 1831957, 1831958, 1843280, 1850752,
1850753, 1855845, 1858741and 1858742;
f) Lots 1837372, 1840611, 1848388, 1855864,
1855865 and 1859890;
g) Lots 1850754 and 1855867;
h) Lots 1834705, 1837376 and 1851641
RECALLING FIRM/MANUFACTURER
Recalling Firm: Depuy Orthopedics, Inc, Warsaw, IN, by letter dated June
10, 2005.
Manufacturer: Depuy Ireland, Ltd., Cork, Ireland. Firm initiated recall is
ongoing.
REASON
There may be dissociation of the polyethylene from the baseplate because
the inside diameter of the polyethylene articular bearing was manufactured
to an oversized condition.
VOLUME OF PRODUCT IN COMMERCE
846
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number
B4233-10E, Recall # Z-1040-05
CODE
Lot number P152010 exp 4/30/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dade Behring, Inc., Newark, DE, by letter dated June 17,
2005.
Manufacturer: Dade Behring Gmbh, Marburg, Germany. Firm initiated
recall is ongoing.
REASON
Positive control shows weak agglutination reaction.
VOLUME OF PRODUCT IN COMMERCE
364 kits
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
Beckman Coulter 1500 Series Hematology Automation System; Part Number: 988609
(LH Basic Unit) 988610 (LH Connection Unit), Recall # Z-1041-05
CODE
N/A
RECALLING FIRM
Beckman Coulter Inc, Brea, CA, by letters on or about June 20, 2005. Firm
initiated recall is ongoing.
REASON
Risk of injury to workers due to mechanical or electrical hazards. Corrective
action will include shields, covers, software interlocks, a spill tray, and
edge smoothing.
VOLUME OF PRODUCT IN COMMERCE
34
DISTRIBUTION
Nationwide and Canada
_______________________________
PRODUCT
Healing Labsô Rite Choice Pregnancy Test Kit, packed in a cellophane display
box, containing one test strip and materials for one test, Made in China,
UPC 087399430205. Packed 48 boxes/case. Recall # Z-1042-05
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Core Brands, Baltimore, MD, by telephone on June 17, 2005,
and by letters on June 21, 2005.
Manufacturer: Ningbo Powerwell Fine Chemical Industrial Co., Ltd., Ningbo,
China. Firm initiated recall is ongoing.
REASON
Home pregnancy test kit lacks 510k approval and cannot be assured as safe
and effective.
VOLUME OF PRODUCT IN COMMERCE
2,710 cases
DISTRIBUTION
MI, NY, MD, MA, PA, NJ and RI
_______________________________
PRODUCT
ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double
pouch, 10 pouches per chipboard box, Catalog number 22-1006, Recall # Z-1043-05
CODE
Lot number 1905, Class I exempt device, Listing B091417
RECALLING FIRM
Recalling Firm: Arthocare Corp, Sunnyvale, CA, by letters on July 12, 2005.
Manufacturer: Clearform Plastics Ltd., North Shields Tyne& Wear NE298SE,
United Kingdom. Firm initiated recall is ongoing.
REASON
Potential loss of product sterility due to breach of outer and inner seal
packages, which may result in infection.
VOLUME OF PRODUCT IN COMMERCE
500 units
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro
Diagnostic Use, Recall # Z-0994-05
CODE
All analyzers; all serial numbers
RECALLING FIRM/MANUFACTURER
DPC Cirrus, Flanders, NJ, by letter on April 22, 2005. Firm initiated recall
is ongoing.
REASON
In the Tube Transport Chain Sensor, used to move a Reaction Tube within the
Immulite 2000, a false trigger can occur due to particulate contamination
or dust. Although extremely remote, this behavior can cause the instrument
to process a test using an incorrect bead. The failure occurs when debris
in the sensor triggers the signal, indicating the flag was detected before
the chain reaches position. In this case, the Processor Shuttle pushes a
blank space, and the instrument generates an error "473 - Reaction Cup
is not in the pipetting position." The reaction cup containing the bead
remains on the chain and moves to the pipette position for the launch of
the next test. Meanwhile, the reaction cup intended for the current test
remains in the indexer, where a second bead is dispensed. This generates
an error "408 - Two beads detected rerunning test". The test is
question is launched between the two errors. After these two cycles the instrument
returns to normal operation.
VOLUME OF PRODUCT IN COMMERCE
941 units nationwide; 3014 units Internationally
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
EMCEE Obturator (7F) for use with 8F Sheath, REF #92580008, packaged in individual
labeled pouches, 10 units per box, 40 boxes per case. Recall # Z-1021-05
CODE
884421 Exp 05/2006; 885027 Exp 05/2006;
937757 Exp 01/2007
RECALLING FIRM
Boston Scientific Corporation, Glens Falls, NY, by telephone on June 24,
and June 30, 2004, and by letter on October 18, 2004. Firm initiated recall
is complete.
REASON
Product labeled to contain Emcee Obturators contained Emcee Dilators.
VOLUME OF PRODUCT IN COMMERCE
90 units (pouches)
DISTRIBUTION
NJ, IN, and Belgium
_______________________________
PRODUCT
Kent Flav-R-Ized 20% Pig Nuggets M50 Medicated, containing 0.0055% (50 gm/ton)
carbadox, packaged in 50-lb. bags. Recall # V-093-5
CODE
Lot # W-040A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kent Feeds, Inc., Muscatine, IA, by telephone on May 5, 2005.
Manufacturer: Kent Feeds, Inc., Waterloo, IA. Firm initiated recall is complete.
REASON
Superpotent for carbadox
VOLUME OF PRODUCT IN COMMERCE
220/50 lb. bags
DISTRIBUTION
MN and IA
_______________________________
PRODUCT
a) Dermaxx™ (deracoxib) 25 mg tablets,
A coxib-class NSAID *For Use in Dogs Only*.
The product is packed in plastic screw top
bottles containing 30 and 90 tablets each.
Recall # V-091-5;
b) Deramaxx (deracoxib) 100 mg tablets,
A coxib-class NSAID *For Use in Dogs Only*.
The product is packed in plastic screw top
bottles containing 90 tablets. Recall # V-092-5
CODE
a) Lot numbers SPT3C001, SPT3C208, SPN3C213 and
SPT3C029;
b) Lot number SPN3C166
RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Animal Health US, Inc, Greensboro, NC, by telephone
and fax on June 15, 2005, and follow up letter on June 28, 2005.
Manufacturer: Pfizer Pharmaceuticals Llc formally Gd Searle Llc, Caguas,
PR. Firm initiated recall is ongoing.
REASON
Product does not meet the finished product assay specifications.
VOLUME OF PRODUCT IN COMMERCE
a) Unknown;
b) 4530 bottles
DISTRIBUTION
CA. GA, and HI
END OF ENFORCEMENT REPORT FOR July 27, 2005
###