Enforcement Report

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.

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August 10, 2005
05-32

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

______________________________
PRODUCT
a) Cake Batter Ice Cream. Product is made in-house
at stores by combining ice cream with cake mix.
It is then used by stores as an ingredient in
ìcreationsî (individually made-to-order combinations
of ice cream and add-ins) and ice cream cakes.
Recall # F-580-5
b) Custom made in-store ice cream products (ìcreationsî
and cakes) containing Cake Batter Ice Cream as an
ingredient. Recall # F-581-5
CODE
N/A
RECALLING FIRM/MANUFACTURER
Cold Stone Creamery, Scottsdale, AZ, by email on July 1, 2005. Firm initiated recall is ongoing.
REASON
Products are associated with outbreak of Salmonella Typhimurium infections.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Small dried red berries marketed as King of Medlar/Fructus Lychii/Dried Chinese Berry. Chinese text identifies product as Wolfberry Fruit (Fructus lycii). Packaged in 6 ways: a) 12 oz. City Aroma brand King of the Medlar b) 30 lb bulk King of the Medlar, Tiandu brand c) 10 oz Roxy briand Dried Chinese Berry/Medlar/Fructus lycheii d) 8 oz. Asian Taste Brand Dried Chinese Berries e) 13 oz. Sinbo brand Dried Chinese Berries f) 7 oz Asian Taste brand Dried Chinese Berries g) 5 lb Tiandu brand Dried Medlar Large h) 20 lb bulk King of Medlar, Recall # F-582-5.
CODE
No codes are applied to products.
RECALLING FIRM/MANUFACTURER
Recalling Firm: West Honest International, City of Industry, CA, by press release on May 4, 2005 and May 20 and May 26, 2005, and by letters on June 7, 2005.
Manufacturer: Fujian Fuzhou Tian Shan Foods Co., LTD, Fujian, China. Firm initiated recall is ongoing.
REASON
Product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
1,961 cartons
DISTRIBUTION
CA, NY, and NJ

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
K Effervescent Tablets Potassium (978mg), Orange Flavored, Potassium Bicarbonate Effervescent Tablets for Oral Solution, Rx only, 30 Effervescent Tablets, NDC 0603-4170-16, Recall # D-443-5
CODE
KL40834-1, Exp. 8/07, and KL50126-1, Exp. 1/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bajamar Chemical Co, Inc., Olivette, MO, by telephone on July 22, 2005, and letter dated July 25, 2005.
Manufacturer: Project Inc., St. Louis, MO. Firm initiated recall is ongoing.
REASON
Mispacked; outer carton incorrectly labeled as K Effervescent Tablets actually contains correct labeled product Effervescent Potassium/Chloride Tablets Fruit Punch Flavor.
VOLUME OF PRODUCT IN COMMERCE
7,680/30-tablet boxes
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
a) Whole Blood, Recall # B-1138-5;
b) Red Blood Cells, Recall # B-1139-5;
c) Red Blood Cells, Irradiated, Recall # B-1140-5;
d) Platelets, Recall # B-1141-5;
e) Fresh Frozen Plasma, Recall # B-1142-5
CODE
a) Unit number: 19GV01596;
b) Unit numbers: 19LY20698, 19LY24139, 19GK25953,
19GK26233, 19GM08933, 19GN21032, 19GN26362,
19GH15546, 19GH16190, 19GH17038, 19GH17431,
19GF41007, 19GH19937, 19GH20319, 19GJ38623,
19GJ38625, 19GJ42370, 19GK21408, 19GK21530,
19GK21539, 19GK21569, 19GR16380, 19GS19024,
19GS19199, 19GS20568, 19GC06220, 19GE02027,
19GF35296, 19GF35308, 19GS22981, 19GS23504,
19GS24166, 19GT19576, 19GW17645, 19GW22825,
19GZ21571, 19GZ21786, 19GZ29090, 19GZ29969,
19LE07546, and 19GZ29533;
c) Unit number: 19GT19748;
d) Unit numbers: 19GK25953, 19GN21032, 19GH16190,
19GF41007, 19GH16743, 19GJ42370, 19GK21539,
19GK21569, 19GR16380, 19GS19024, 19GF35296,
19GS23504, 19GZ21786, 19GZ22931, 19GZ5699, and
19LE07546;
e) Unit numbers: 19LY20698, 19GM08933, 19GH16190,
19GF41007, 19GK21408, 19GK21539, 19GR15427,
19GR16380, 19GR17134, 19GS19024, 19GC06220,
19GF35296, 19GF35308, 19GF36588, 19GT17706, and
19LE07546
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tennessee Valley Region, Nashville, TN, by letter on May 10, 1999. Firm initiated recall is complete.
REASON
Blood products, manufactured from overweight units of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE
75 units
DISTRIBUTION
TN, OH, and KY

______________________________
PRODUCT
Misys Laboratory, Version 6.1, Recall # B-1566-5
CODE
Version 6.1
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by facsimile and e-mail dated May 20, 2005. Firm initiated recall is ongoing.
REASON
Defects in the design of software could result in loss of patient information.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Nationwide, UK and Denmark

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1688-5;
b) Recovered Plasma, Recall # B-1689-5
CODE
a) and b) Unit number: 4724902
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on January 21, 2004, January 22, 2004, and May 3, 2004.
Manufacturer: Oklahoma Blood Institute, Norman Center, Norman, OK. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose spouse had previously tested positive for the antibody to the hepatitis B core antigen (anti-HBc), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Ok and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1703-5;
b) Red Blood Cells, Leukocytes Reduced,
Irradiated, Recall # B-1704-5;
c) Platelets, Leukocytes Reduced, Recall # B-1705-5
CODE
a) Unit numbers: LG03318, LG16406, FK96643, FV10152,
LG16418, LG17504, FV10147;
b) Unit numbers: LE97510, FV08017, LH05261, FK93878;
c) Unit numbers: LE97510, FK96643, LH09800, LG15941,
FK93878, LG03318
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., Providence, Rhode Island, by telephone and letter dated February 25, 2005. Firm initiated recall is complete.
REASON
Blood products, possibly associated with a transfusion associated transmission of Babesiosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
MA and RI

_______________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1706-05
CODE
Unit number 100449173
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., dba United Blood Services, Scottsdale, AZ, by telephone on December 29, 2003, and by letter dated January 12, 2004. Firm initiated recall is complete.
REASON
Red Cells, lacking appropriate quality control, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ

_______________________________
PRODUCT
StemCXP Software, version 1.0 for Cytomics FC 500, Recall # B-1738-5
CODE
Version 1.0
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter dated February 24, 2005.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is complete.
REASON
StemCXP Software, which had a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL, IA, IL, MA, and Canada

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1743-5;
b) Platelets, Recall # B-1744-5;
c) Recovered Plasma, Recall # B-1745-5
CODE
a), b), and c) Unit number: 03KJ04207
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Hialeah, FL, by telephone or by letter dated November 28, 1997. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA and FL

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1749-5;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-1750-5;
c) Red Blood Cells, Leukocytes Reduced, Irradiated,
Recall # B-1751-5;
d) Cryoprecipitated AHF, Recall # B-1752-5;
e) Platelets, Recall # B-1753-5;
f) Platelets, Leukocytes Reduced, Recall # 1754-5;
g) Platelets, Irradiated, Recall # B-1755-5;
h) Fresh Frozen Plasma, Recall # B-1756-5;
i) Plasma, Recall # B-1757-5;
j) Plasma, Cryoprecipitate Reduced, Recall # B-1758-5
CODE
a) Unit numbers: 22FK99493, 22LW54350, 22KM73847,
22LJ50762;
b) Unit numbers: 22FJ87964, 22LY90788, 22KV43883,
22LC09066, 22GW74213, 22KL12925, 22KV43294,
22KM79317, 22KJ94734, 22FC03071, 22LJ59179,
22FJ88884, 22FK98166, 22KN49543, 22GL02425,
22LW63552, 22GZ98517, 22KY68485, 22KP65356,
22KV61348, 22GE51777;
c) Unit number: 22KX45483;
d) Unit numbers: 22FJ87964, 22GE51777, 22LC09066,
22LW54350, 22FK98166, 22KV43883, 22KM79317;
e) Unit numbers: 22KP65356, 22KV43883, 22KV43294,
22LW54350, 22GW74213, 22LJ50762;
f) Unit numbers: 22KL12925, 22KX45483, 22LW63552,
22GL02425, 22LJ59179, 22KJ94734, 22KY68485;
g) Unit number: 22LY90788;
h) Unit numbers: 22FJ88884, 22LJ50762, 22KL12925,
22KJ94734, 22KP65356, 22LW63552, 22GZ98517,
22KY68485, 22LY90788, 22GL02425, 22KV43294
i) Unit numbers: 22KN49543, 22KV61348;
j) Unit numbers: 22FJ87964, 22GE51777
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone or facsimile on November 3, 12, 30, 2004 or December 1, 2004 and by letters dated December 4, 7, December 8, 2004, January 4, 7, and 8, 2005. Firm initiated recall is complete.
REASON
Blood products, manufactured from overweight units of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE
60 units
DISTRIBUTION
CT, NJ, PA, and VA

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced Irradiated,
Recall # B-1763-5;
b) Fresh Frozen Plasma (Apheresis), Recall # B-1764-5
CODE
a) and b) Unit number: 07FP21397
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Arizona Region, Tucson, AZ, by letter on November 1, 2004.
Manufacturer: The American National Red Cross, Tucson, AZ. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that was not asked all the medical history questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1765-5
CODE
Unit number: 0312997
RECALLING FIRM/MANUFACTURER
Floridaís Blood Centers, Inc., Orlando, FL, by facsimile on March 29, 2001. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that was possibly contaminated with Corynebacterium sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1766-5;
b) Fresh Frozen Plasma, Recall # B-1767-5
CODE
a) Unit numbers: 03F07445, 03KH11236, 03KM10630,
03KN09467, 03C08276, 03KN09460, 03KN09472,
and 03KH11230;
b) Unit numbers 03KN09460, 03KN09472, 03KH11236,
03KM10630, 03KH11230, 03F07445, 03C08276, and
03V09150
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern Region -- South Florida Division, Miami, FL, by telephone on August 19, 1998. Firm initiated recall is complete.
REASON
Blood products, corresponding to units of Platelets that were pooled and possibly contaminated with coagulase negative Staphylococcus sp. bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
FL

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
Recall # B-1768-5;
b) Platelets Pheresis, Irradiated, Recall # B-1769-5
CODE
a) Unit numbers: 06KF17341, 06KF17343, 06KF17284,
06KF17288, and 06KF17342 (distributed as two
split units);
b) Unit number 06KF17343
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern California Region, Pomona, CA, by letter on March 9, 2004. Firm initiated recall is complete.
REASON
Blood products, collected during a period when quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced, Recall # B-1770-5
CODE
Unit numbers 10190-0353, 10190-3841, and 10189-9985
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on January 24, 2005. Firm initiated recall is complete.
REASON
Blood products, that were not properly evaluated for possible hemolysis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AZ

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
Recall # B-1771-5;
b) Platelets Pheresis, Recall # B-1772-5
CODE
a) and b) Unit number 4920807
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on August 6, 2004. Firm initiated recall is complete.
REASON
Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1774-5
CODE
Unit number: 4737552
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, 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
OK

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1775-5
CODE
Unit number: 4867777
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on June 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
NJ

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1776-5
CODE
Unit number: 4879420
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on September 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
OK

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated, Recall # B-1777-5
CODE
Unit number: 4840727 (distributed as two split units)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on June 1, 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
2 units
DISTRIBUTION
OK

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1778-5;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-1779-5;
c) Red Blood Cells, Leukocytes Reduced Irradiated,
Recall # B-1780-5;
d) Platelets, Recall # B-1781-5
CODE
a) Unit number: 4707162;
b) Unit numbers: 4762724, 4577855, and 4108355;
c) Unit number: 4789389;
d) Unit numbers: 4707162, 4789389, and 4108355
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on July 23, 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
8 units
DISTRIBUTION
OK, TX, NY, and NJ

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1782-5;
b) Platelets, Recall # B-1783-5
CODE
a) Unit numbers: 4882517, 4882049, and 4800502;
b) Unit number: 4800502
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on August 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
4 units
DISTRIBUTION
OK and NY

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1790-5
CODE
Unit number: 01W12020
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, West Henrietta, NY, by letter dated March 18, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated platelet component was contaminated with Staphlyococcus aureus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1791-5;
b) Red Blood Cells (Apheresis), Leukocytes Reduced,
Recall # B-1792-5
CODE
a) Unit number: 4823778;
b) Unit numbers: 4889286, 4888110, and 4824365
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on December 1, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OK

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1796-5;
b) Platelets, Recall # B-1797-5
CODE
a) and b) Unit number: 4924375
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on September 3, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and TX

_______________________________
PRODUCT
Red Blood Cells Apheresis Leukocytes Reduced, Recall # B-1798-5
CODE
Unit number: 4813169 (split unit)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on July 7, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected in a manner that may have compromised sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1799-5
CODE
Unit 4993709 (split units)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on December 21, 2004. Firm initiated recall is complete.
REASON
Blood products, which did not meet product release specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AK

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1800-5
CODE
Unit number: 107246789
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by letter dated May 21, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

_______________________________
PRODUCT
Platelets, Recall # B-1801-5
CODE
Unit number: 6007954
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Inc, Elyria, OH, by letter dated March 27, 2005. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated Red Blood Cells were found to contain clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1803-5
CODE
Unit numbers: 0002008 and 0002136
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Inc, Elyria, OH, by letter dated March 16, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1804-5
CODE
Unit number: 0707861
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Inc, Elyria, OH, by letter dated April 11, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1807-5
CODE
Unit number: 1233252
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by telephone on August 17, 2004. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

_______________________________
PRODUCT
Source Plasma, Recall # B-1808-5
CODE
Unit number: 04FOHC5076
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Findlay, OH, by facsimile on March 28, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had been incarcerated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1810-5
CODE
Unit numbers: 4835855, and 4835870
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone on January 5, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors with unacceptable hematocrit determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI and OK

_______________________________
PRODUCT
Source Plasma, Recall # B-1812-5
CODE
Unit number: 01BNDE4214
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Bismarck, ND, by facsimile on March 20, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who received the MMR vaccination within two weeks of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1813-5
CODE
Unit number: 0675304
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by letter dated October 8, 2001. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1815-5
CODE
Unit number: 038GP22834
RECALLING FIRM/MANUFACTURER
American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by letter dated April 7, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1816-5
CODE
Unit number: 4831603
RECALLING FIRM
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile transmission dated May 5, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose eligibility to donate was not adequately verified, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced,
Irradiated, Recall # B-1818-5;
b) Fresh Frozen Plasma (Apheresis), Recall # B-1819-5
CODE
a) and b) Unit number: 4962251
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile transmission dated February 22, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of melanoma, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK, and CA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1826-5
CODE
Unit number: KC40599
RECALLING FIRM/MANUFACTURER
Tri-Counties Blood Bank, Santa Barbara, CA, by telephone on November 20, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1827-5;
b) Recovered Plasma, Recall # B-1828-5
CODE
a) and b) Unit number: 107338599
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Scottsdale, AZ, by letter dated November 22, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1829-5;
b) Fresh Frozen Plasma, Recall # B-1830-5
CODE
a) and b) Unit number: 1073141656
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Scottsdale, AZ, by telephone on October 4, 2002 or by letter dated October 30, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor whose arm inspection was unsatisfactory, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ

_______________________________
PRODUCT
Source Plasma, Recall # B-1832-5
CODE
Unit numbers: CCSXQN, CCSYBD, CCSYYQ
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc, (formerly known as Aventis Bio-Services, Inc., Kansas City, MO, by letter dated September 19, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1833-5;
b) Fresh Frozen Plasma, Recall # B-1834-5
CODE
a) and b) Unit number: 5085121
RECALLING FIRM/MANUFACTURER
HemaCare Corporation, Sherman Oaks, CA, by letter dated November 14, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Platelets, Recall # B-1836-5
CODE
Unit number: 4802737
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 14, 2004. Firm initiated recall is complete.
REASON
Blood product, with an elevated ALT, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1837-5
CODE
Unit number: 4904606
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on June 11, 2004. Firm initiated recall is complete.
REASON
Blood product, with an elevated ALT, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-1558-5
CODE
Unit numbers: 100402285, 107599484
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on October 2, 2003 and by letter dated October 15, 2003. Firm initiated recall is complete.
REASON
Blood products, which were out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1747-5
CODE
Unit number: 4935915 (Part 1)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on October 20, 2004. Firm initiated recall is complete.
REASON
Blood product, which was labeled leukoreduced, but had an unacceptable white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1748-5
CODE
Unit numbers: 10758-7231 (split unit), 10759-0493 (split unit), 10758-7145, 10759-0739
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on August 28, 2003 and September 23, 2003. Firm initiated recall is complete.
REASON
Blood products, possibly out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
AZ

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1761-5;
b) Fresh Frozen Plasma, Recall # B-1762-5
CODE
a) Unit numbers: 007GK12877, 007GK12433, 007GQ04598,
007GE10212, and 007GQ04757;
b) Unit number 007GK12433
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Arizona Region, Tucson, AZ, by telephone on January 6 and 10, 2003, by facsimile on January 10, 16, 29, and 31, 2003, and by letter on January 29 and 31, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose health history screenings were inadequately documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
AZ and TX

_______________________________
PRODUCT
Platelets Pheresis, Leukocyters Reduced, Recall # B-1773-5
CODE
Unit number: 4884238 (distributed as two split units)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 27, 2004. Firm initiated recall is complete.
REASON
Blood products, that were not properly quarantined after the donor of the products reported a post donation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1788-5
CODE
Unit number: 49GP17990
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tulsa, OK, by telephone on May 1, 2004 and by letter dated May 3, 2004. Firm initiated recall is complete.
REASON
Blood product, which was contaminated with gram positive rods, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1795-5
CODE
Unit numbers: 4651771 and 4653514
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on June 10, 2005. Firm initiated recall is complete.
REASON
Blood products, which were stored at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1802-5
CODE
Unit number: 24KR28233
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Louisville, KY, by electronic mail on November 18, 2004 and by letter dated November 19, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had reported to feeling ill on the day of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY

_______________________________
PRODUCT
a) Platelets Leukocytes Reduced, Recall # B-1805-5;
b) Fresh Frozen Plasma, Recall # B-1806-5
CODE
a) and b) Unit number: 42FY61645
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by letter dated April 7, 2005. 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
OH

_______________________________
PRODUCT
Source Plasma, Recall # B-1809-5
CODE
Unit number: 04LKYA2185
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Louisville, KY, by facsimile on June 4, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1811-5
CODE
Unit numbers: FM85898, FM85904, FM85907, and FM85916
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Fort Wayne, IN, by electronic mail or letter dated April 7, 2005. 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
4 units
DISTRIBUTION
AL and IN

_______________________________
PRODUCT
Recovered Plasma, Recall # B-1817-5
CODE
Unit number: 4831603
RECALLING FIRM
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile transmission dated May 5, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose eligibility to donate was not adequately verified, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI and Switzerland

_______________________________
PRODUCT
Source Plasma, Recall # B-1820-5
CODE
Unit numbers: 02LWID3457, 02LWID4323, 02LWID6273
RECALLING FIRM
BioLife Plasma Services, L.P., Onalaska, WI, by facsimile on September 18, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MI and Austria

_______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced. Recall # B-1835-5
CODE
Unit number: 100438725 (part 2)
RECALLING FIRM
Blood Systems, Inc., Scottsdale, AZ, by telephone on January 5, 2004. Firm initiated recall is complete.
REASON
Blood product, which was labeled leukoreduced, but had an unacceptable white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS I

_______________________________
PRODUCT
Purina Antlermax Deer 20, for All Life Stages of Deer and Elk, Formula Number: 59SB, Item Number: 0049801, Recall # V-090-5
CODE
Lot Number 5FEB15LUBI
RECALLING FIRM/MANUFACTURER
Recalling Firm: Land Oí Lakes Purina Feed LLC, St. Louis, MO, by letter on March 31, 2005 and press release on April 15, 2005.
Manufacturer: Land Oí Lakes Purina Feed LLC, Lubbock, TX. Firm initiated recall is complete.
REASON
Deer feed contains Monensin.
VOLUME OF PRODUCT IN COMMERCE
1,000 x 50 lb. bags
DISTRIBUTION
TX and NM

END OF ENFORCEMENT REPORT FOR AUGUST 10, 2005

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