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U.S. Department of Health and Human Services

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Enforcement Report for May 24, 2006

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.

May 24, 2006
06-21

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

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PRODUCT
a) Schnucks 2% Reduced Fat Milk, Grade A, packaged in 1/2-gal and Glenview Farms
2% Reduced Fat Milk, Grade A, packaged in 1-gal plastic containers,
Recall # F-169-6;
b) Schnucks Vitamin D Milk, Grade A, packaged in 1/2-gal plastic containers,
Recall # F-170-6;
c) Sealtest Fat Free Milk, packaged in 1/2-pt. paper cartons, Recall # F-171-6
CODE
a) Schnucks label - Sell by March 23; Glenview Farms label - Sell by March 27;
b) Sell by March 23;
c) Sell by March 24
RECALLING FIRM/MANUFACTURER
Recalling Firm: Schnuck Markets, Inc, St. Louis, MO, by press release, e-mail and telephone on March 15, 2006.
Manufacturer: Schnucks/Mid-States Dairy, Hazelwood, MO, firm initiated recall is complete.
REASON
Milk was contaminated with an acid sanitizer.
VOLUME OF PRODUCT IN COMMERCE
2,779 1/2-gal. Vitamin D; 7,275 1/2-gal. and 96 gal. 2%; and 432 1/2 pts fat free
DISTRIBUTION
MO, IL, TN, IA, IN, MS, WI, and KY
 

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

______________________________
PRODUCT
Our Family Shredded & Sweetened Coconut (UPC70253-29364) and Our Family Sweetened Fancy Flakes Coconut (UPC 70253-29368) in 12 oz packages. Ingredients: Coconut, sugar, water, propylene Glycol and sodium propionate (a preservative), Recall # F-172-6
CODE
Flake coconut: all codes prior to and including 07april08. Shredded Coconut all codes prior to and including 22dec07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gurley's Foods Company, Inc, Wilmar, MN, by visit on May 19, 2006.
Manufacturer: International Coconut Corp., Elizabeth, NJ, firm initiated recall is ongoing.
REASON
Coconut contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
400 cases of 12-12 oz packages per case
DISTRIBUTION
IA, MN, ND, NE, SD, WI

______________________________
PRODUCT
LA SQUISITA --- SINCE 1918 --- FIRST COLD PRESS --- EXTRA VIRGIN OILVE OIL --- Product of Italy --- 34 fl oz (1 qt 2 oz) 1 liter --- Ingredients: Extra Virgin Olive Oil ---UPC # 0 9938130021 2, Recall # F-173-6
CODE
L.22105SELS207 (found on bottle cap)
RECALLING FIRM/MANUFACTURER
Recalling Firm: La Squisita Food Corp. Mount Vernon, NY, by letters beginning on January 31, 2006.
Manufacturer: Olea Srl, Partanna, Italy, firm initiated recall is complete.
REASON
FDA's analysis revealed that the extra virgin olive oil consists mostly of soybean oil with some olive oil.
VOLUME OF PRODUCT IN COMMERCE
660 cases (12 – 1 liter bottles per case)
DISTRIBUTION
NY, CT, and PA

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
Theophylline Extended-Release Tablets, 450 mg, Rx only, 100 tablets per bottle, Recall # D-249-6
CODE
Lot 5185001SB, Exp. 2/2008
RECALLING FIRM/MANUFACTURER
Pliva, Inc, East Hanover, NJ, by letters on April 7, 2006, firm initiated recall is ongoing.
REASON
Subpotent: OOS result obtained for the 6 month stability station during the L3 drug release analysis at the 12th hour time point.
VOLUME OF PRODUCT IN COMMERCE
3,114 bottles
DISTRIBUTION
Nationwide

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PRODUCT
Trimethoprim Tablets, USP, 100 mg, 100 count bottles, Recall # D-250-6
CODE
Lot # 139935A, Exp. 11/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals, USA, Sellersville, PA, by letters on April 12, 2006.
Manufacturer: Novapharm Limited, Toronto, Canada, firm initiated recall is ongoing.
REASON
Oversized Tablets; may contain a superpotent dose.
VOLUME OF PRODUCT IN COMMERCE
13,596 bottles
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
Sodium Sulfate Decahydrate USP, BP, PhEur, in 500 gram plastic bottles and 12 kg poly pail, Use in manufacturing, processing, and repacking, Recall # D-251-6
CODE
Lot TA793642, (A), (B), (D)
RECALLING FIRM/MANUFACTURER
Recalling Firm: EMD Chemicals, Inc, Gibbstown, NJ, by telephone on March 1, 2006 and letter on March 7, 2006.
Manufacturer: Merck KgaA, Darmstadt, Germany, firm initiated recall is ongoing.
REASON
Failed USP Loss on Drying Test.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
MA, KY, and Canada
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-766-6
CODE
Units: 12Y63789, 12Y63796, 12Y63797, 12Y63802
RECALLING FIRM/MANUFACTURER
National Red Cross, Carolinas Region, Charlotte, NC, by phone on June 21, 2005 and by letter on June 23, 2005, firm initiated recall is complete.
REASON
Blood products, processed from overweight units of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC and GA

______________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0922-6;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-0923-6;
c) Red Blood Cells, Recall # B-0924-6
CODE
a) Units: B212072 (split product), B21179
b) Unit: B21179
c) Unit: Z110691
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letter dated September 5, 2003, firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
WA

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0950-6
CODE
Unit 40P08591
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Peoria, IL, by telephone on January 16, 2006, 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
IL

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall B-0955-6
CODE
Units: 12LT52139 (split product), 12LT52141, 12LT52142 (split product), 12LT52143, 12LT52144 (split product), 12LT52147, 12LT52155, 12LT52158, 12LT52159, 12LT52160 (split product), 12LT52161, 12LT52162, 12LT52163, 12LT52165, 12LT52166, 12LT52167 (split product), 12LT52170 (split product), 12LT52171 (split product), 12LT52172 (split product), 12LT52173 (split product), 12LT52174, 12LT52175, 12LT52177, 12LT52178 (split product), 12LT52179, 12LT52181, 12LT52182 (split product), 12LT52183 (split product), 12LT52184, 12LT52186 (split product), 12LT52187 (split product), 12LT52191, 12LT52192, 12LT52193 (split product), 12LT52194 (split product), 12LT52195 (split product), 12LT52197 (split product)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on February 27, 2004 and by letter on March 11, 2004, firm initiated recall is complete.
REASON
Blood products, which did not have a pH performed as part of monthly QC, were distributed.
VOLUME OF PRODUCT IN COMMERCE
55 units
DISTRIBUTION
NC

______________________________
PRODUCT
Source Plasma, Recall # B-0956-6
CODE
Units: 08729194, 08727947, 08724434, 08723659, 08721259, 08559869, 08558640, 92654181, 92651319, 92129856, 92121478, 90640230, 90634918, 91020239, 91018588, 91016690, 91015051, 91013118, 91011428, 91366023, 91363725, 91362339, 90220012, 90216473, 90211096, 78858015, 78852815, 79013048, 77529305, 75088736, 75087616, 75085285, 75082888, 75080556, 60997685, 60994059, 62980258, 62977692, 62976305, 63388169, 63383041, 63381733, 63099560, 63097979, 93095067, 63094145, 60844743, 59707967, 59705871, 59704096, 59702924, 59700807, 59076704, 59074885, 59073697, 59071891, 59069584, 59068471, 59066804, 59064220, 59063155, 57551302, 57150116, 57148267, 57146928, 57144382, 57142562, 55530453, 55529266, 55524711, 55523554, 55521413, 45319457, 45318146, 45316081, 45314971, 45311451, 45200076, 45197833, 45196799, 46199508, 46197399, 46195449, 46192752, 46192073, 44779412, 44776367, 44773519, 44772789
RECALLING FIRM/MANUFACTURER
Plasma Biological Services Inc., Asheville, NC, by letter dated April 30, 2004, firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
89 units
DISTRIBUTION
CA

______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0957-6
CODE
Unit: 0887057
RECALLING FIRM/MANUFACTURER
The Blood Connection Inc, Greenville, SC, by telephone and letter on October 24, 2005, firm initiated recall is complete.
REASON
Blood product, associated with a corresponding product that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

______________________________
PRODUCT
Platelets Pheresis Leukoreduced Irradiated, Recall # B-0959-6
CODE
Units: C213190 (split product)
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by telephone on October 1, 2003, firm initiated recall is complete.
REASON
Blood products, labeled as leukoreduced, but which did not meet the requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA

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PRODUCT
Source Plasma, Recall # B-0960-6
CODE
Units: 0050255215, 0050254198, 0050253962, 0050252884, 0050250512, 0050245535, 0050243987, 0050243436, 0050243214, 0050242853, 0050242635, 0050242313, 0050241996, 0050241725, 0050241224, 0050240927, 0050240668, 0050239810
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma Inc, Beloit, WI, by fax on January 16, 2002, firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo applied within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
UK, Germany and Korea.

______________________________
PRODUCT
Platelets Pheresis, Recall # B-0961-6
CODE
Units: 36P79188, 36P79192
RECALLING FIRM/MANUFACTURER
The American National Red Cross, South Carolina Region, Columbia, SC, by telephone on August 23, 2005 and by letter dated August 25, 2006, firm initiated recall is complete.
REASON
Blood products, exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
SC and GA

______________________________
PRODUCT
Recovered Plasma, Recall # B-0962-6
CODE
Unit: 12FR82817
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone or fax on March 27, 2004 and by letter on March 28, 2004, firm initiated recall is complete.
REASON
Blood product, collected from a female donor who had sex with a male who had sex with another male, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Source Plasma, Recall # B-1028-6
CODE
Units N-61050-014, N-61075-014, G-73129-014, G-74477-014, G-74668-014, G-76730-014, G-77290-014, G-79890-014, G-80261-014, G-80879-014, G-81141-014, G-83876-014, G-84386-014, G-84795-014, & G-86341-014
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, National City, CA, by fax on July 22, 2002, firm initiated recall is complete.
REASON
Source Plasma, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
CA and Spain

______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1029-6
CODE
Unit: 71M655699
RECALLING FIRM/MANUFACTURER
Life South Community Blood Center, Dunwoody, GA, by telephone on October 15, 2004, firm initiated recall is complete.
REASON
Blood product, associated with a red blood cell product that failed filtration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

______________________________
PRODUCT
Recovered Plasma, Recall # B-1032-6
CODE
Units: 12K76696, 12X00935
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by fax on January 24, 2004, firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

______________________________
PRODUCT
Source Plasma, Recall # B-1033-6
CODE
Unit: 02lWID2565
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Onalaska, WI, by fax on August 6, 2002, firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN

______________________________
PRODUCT
Source Plasma, Recall # B-1034-6
CODE
Units: LF233198, LF232462, LF232072, LF231399, LF230818, LF230570, LF229890, LF229469, LF229041, LF228669, LF228290, LF227855, LF227466, LF227007, LF226578, LF226072, LF225814, LF225206, LF224831, LF224322, LF223845, LF223151, LF222813, LF221751, LF221142, LF220730, LF220307, LF219841, LF219454, LF217167, LF216345, LF215844, LF215589, LF215103, LF214836, LF214393, LF212872
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Lakeland, FL, by fax on January 10, 2005, firm initiated recall is complete.
REASON
Blood products, collected from a donor previously deferred for a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
37 units
DISTRIBUTION
NC

______________________________
PRODUCT
Human Corneas for Transplantation Tissues, Recall # B-1057-6
CODE
16435-OD and 16435-OS
RECALLING FIRM/MANUFACTURER
Central Ohio Lions Eye Bank, Columbus, OH, by telephone on July 13, 2005, firm initiated recall is complete.
REASON
Human Corneas, collected from a donor who subsequently tested positive for HBsAg, by another tissue procurement organization, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
OH

______________________________
PRODUCT
Human Cornea for Transplantation Tissue, Recall # B-1058-6
CODE
16461-OD
RECALLING FIRM/MANUFACTURER
Central Ohio Lions Eye Bank, Columbus, OH, by telephone on July 21, 2005, firm initiated recall is complete.
REASON
Human Cornea, that was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBcore) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
OH

______________________________
PRODUCT
Human OS Cornea for Transplantation Tissue, Recall # B-1059-6
CODE
06-0022-200
RECALLING FIRM/MANUFACTURER
Rocky Mountain Lions Eye Bank, Aurora, CO, by telephone and letter on March 1, 2006, firm initiated recall is complete.
REASON
Human cornea, stored in a storage container that may have been leaking, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
CO

______________________________
PRODUCT
Source Plasma, Recall # B-1060-6
CODE
G-90885-077, G-91404-077, G-91821-077, G-92536-077, G-93011-077, G-93703-077, G-93895-077, G-94984-077, G-95623-077, G-97291-077
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Riverside, CA, by fax dated October 16, 2002, firm initiated recall is complete.
REASON
Source Plasma, that was not properly quarantined after the receipt of post donation information from the donor relating to recent body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Spain

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1061-6
CODE
Units: 71W54151-8 (split unit)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Dunwoody, GA, by letter dated January 29, 2004, firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Pseudomonas aeruginosa, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1063-6;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1064-6
CODE
a) T71902, T71906, T71909, T71911, T71916, T71922, T71939, T71907, T71917,
T71918, T71923, T71924, T71925, T71926, T71927, T71929, T71933, T71934,
T71935, T71936, T71937, T71938, T71940 and T71944;
b) Units: T71915. T71919, T71920
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI, by fax on January 11, 2006, firm initiated recall is complete.
REASON
Red Blood Cells, collected from donors with inaccurate hemoglobin determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
MI

______________________________
PRODUCT
Source Plasma, Recall # B-1077-6
CODE
Units: 85454064, 85455146, 85458765, 85460621, 6010243927, 010245170, 6010245719, 6010245961, 6010246552, 6010246862, 6010249234, 6010250030
RECALLING FIRM/MANUFACTURER
Nabi Biopharmaceuticals, San Antonio, TX, by fax on January 14, 2004, firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo applied within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
CA, Israel and Korea

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1078-6;
b) Plasma Frozen, Recall # B-1079-6
CODE
a) and b) Unit: 003GF22932
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern Region, Atlanta, GA, by telephone on October 25, 2006 and by letter on October 27, 2006, firm initiated recall is complete.
REASON
Blood products, collected from a donor previously deferred due to a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA

______________________________
PRODUCT
Source Plasma, Recall # B-1080-6
CODE
Units: 05MINC3458, 05MINC3722, 05MINC4328, 05MINC4581, 05MINC5438, 05MINC8389, 05MINC8676, 05MINC9234, 05MINC9537, 05MIND0351, 05MIND0949, 05MIND1241, 05MIND1830, 05MIND2145, 05MIND2776, 05MIND3085, 05MIND3743, 05MIND4714, 05MIND5031, 05MIND5661, 05MIND6010, 05MIND6657, 05MIND6966, 05MIND7636, 05MIND7958, 05MIND8607, 05MIND8947
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P, Muncie, IN, by fax on January 5, 2006, firm initiated recall is complete.
REASON
Blood products, collected from a donor who disclosed a history of brain surgery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
CA

______________________________
PRODUCT
Source Plasma, Recall # B-1081-6
CODE
Units: 7030230707, 7030228844, 7030228223, 7030227756, 7030226416, 7030226058, 7030223186, 7030222702, 7030222265, 7030221773, 7030221321, 7030220821, 7030220345, 7030219989, 7030219107, 7030218783, 7030213753, 7030210907, 7030210603, 7030209484, 7030209166, 7030208194, 7030207999, 7030207057, 7030206672, 7030206102, 7030205184, 7030204837, 7030203092, 7030202673, 7030202278, 7030201888, 7030201185, 7030200760, 7030200099, 7030199580, 7030197836, 7030195948, 7030195576, 7030194907, 7030194297, 7030192321, 7030191715, 7030191137, 7030190524, 7030189407, 7030188819, 7030186097, 7030185447
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma Inc, San Antonio, TX, by fax on August 8, 2002, firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a body piercing within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
49 units
DISTRIBUTION
UK

______________________________
PRODUCT
Source Plasma, Recall # B-1082-6
CODE
Units: 7030219244, 7030218377, 7030217992, 7030217335, 7030216978, 7030216056, 7030215648, 7030214745, 7030214304, 7030213838
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma Inc, San Antonio, TX, by fax on July 21, 2003, firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo applied within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
UK

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1097-6
CODE
Unit 17KM55247
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by letter dated February 10, 2004, firm initiated recall is complete.
REASON
Blood product, manufactured from an overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ME

______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1098-6
CODE
Units 6850271, 7014004
RECALLING FIRM/MANUFACTURER
HemaCare Corporation, Sherman Oaks, CA, by letter dated January 15, 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
2 units
DISTRIBUTION
CA

______________________________
PRODUCT
Source Plasma, Recall # B-1101-6
CODE
Units 05MINA8244, 05MINA8587, 05MINA9587
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Muncie, IN, by fax on January 18, 2006, 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
3 units
DISTRIBUTION
CA

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1102-6
CODE
Unit 8465133
RECALLING FIRM/MANUFACTURER
Atlanta Blood Services, Atlanta, GA, by telephone on October 17, 2005, firm initiated recall is complete.
REASON
Blood product, which tested positive for West Nile Virus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1112-6
CODE
Unit number 463298 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on April 23, 1999, firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Staphylococcus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1113-6
CODE
Unit number 17FJ63423
RECALLING FIRM/MANUFACTURER
American National Red Cross Blood, North Central Region, ST. Paul, MN, by fax and letter on June 25, 2004, 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
MN

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1114-6
CODE
Unit number 6663284
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on March 28, 2005, firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Recall # B-1115-6
CODE
Unit number 7092187
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on March 10, 2005, firm initiated recall is complete.
REASON
Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1116-6
b) Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-1117-6
CODE
a) Unit numbers 6593091 and 6596354
b) Unit number 9020737
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on March 8, 2005, firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Recall # B-1118-6
CODE
Unit number 9014146
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on April 5, 2005, firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Red Blood Cells, Recall # B-0958-6
CODE
Unit: 0887306
RECALLING FIRM/MANUFACTURER
The Blood Connection Inc. Greenville, SC, by telephone and letter on October 24, 2005, firm initiated recall is complete.
REASON
Blood product, associated with a corresponding product that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

______________________________
PRODUCT
Red Blood Cells (for further manufacture), Recall # B-0963-6
CODE
Unit: 12FR82817
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone or fax on March 27, 2004 and by letter on March 28, 2004, firm initiated recall is complete.
REASON
Blood products, collected from a female donor who had sex with a male who had sex with another male, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

______________________________
PRODUCT
a) Platelets, Recall # B-1013-6
b) Platelets, Irradiated, Recall # B-1014-6
CODE
a) Unit: 4360514
b) Unit 4340736
RECALLING FIRM/MANUFACTURER
Florida Blood Services Inc., St. Petersburg, FL, by fax on February 28, 2005, firm initiated recall is complete.
REASON
Blood products, processed from Whole Blood units with extended collection times, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL and MA

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1035-6
CODE
Unit 12X05179
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated December 20, 2002, firm initiated recall is complete.
REASON
Problem: Blood product, incorrectly identified as Jka antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

______________________________
PRODUCT
Capture R-Ready ID Test, Recall # B-1056-6
CODE
Lot Number: 21415
Expiration: June 21, 2002
RECALLING FIRM/MANUFACTURER
Immucor, Inc, Norcross, GA, by letter dated May 30, 2002, firm initiated recall is complete.
REASON
Capture-R Ready ID Test kits, packaged with an incorrect masterlist, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 lot
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Recovered Plasma, Recall # B-1083-6
CODE
Unit: 4832101
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers Inc., Orlando, FL, by fax on May 10, 2002, firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of ulcerative colitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1095-6
CODE
Unit 0627624
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on September 24, 1999, firm initiated recall is complete.
REASON
Blood product, possibly out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1096-6
CODE
Unit 0678628
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on March 3, 2000, firm initiated recall is complete.
REASON
Blood product, for which there was no documentation of weld acceptability for the sterile docking of pedi-packs, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1099-6
CODE
Unit 06LM38602
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by telephone on February 2, 2005 and by letter dated February 5, 2005, firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood with an extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Platelets Pheresis, Irradiated, Recall # B-1109-6
CODE
Units 040P96359, 040P96368, 06KP18918, 06KS38801, 06KT30580, 211J90266, 211J90267 (split unit)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by fax on November 12, 2003, firm initiated recall is complete.
REASON
Blood products, which were not returned to controlled storage within the allowable time frame after irradiation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
CA

______________________________
PRODUCT
Red Blood Cells, Recall # B-1111-6
CODE
Unit number 443484
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on May 25, 1999, firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1168-6
CODE
Units 12X88143, 12X88171, 12X88125, 12X88162, 12X88165, 12LC37610, 12LC37609, 12LC37606, 12LC37602, 12LC37596, 12GC84472, 12LC37601, 12GC84470, 12GC84471, 12LC37607, 12LJ37185, 12GN57845, 12GN57880, 12GN57887, 12Z31666, 12GC84462, 12LJ37173, 12LJ37205, 12GC84456, 12GC84460, 12GC84464, 12GC84465, 12GC84468, 12GC84469, 12GE48555, 12GE48556, 12GN57841, 12LC37598, 12LC37603, 12LC37612, 12Z31682, 12Z31688, 12X88174, 12GE48541, 12F14117, 12LJ37208, 12Z31659, 12Z31665, 12Z31667, 12GE48568, 12GE48569, 12GE48539, 12GE48540, 12GE48565, 12LJ37213, 12LJ37170, 12LJ37174, 12LJ37204, 12LJ37169, 12LJ37207, 12LJ37202, 12GE48546, 12GE48547, 12GE48550, 12GE48552, 12GE48553, 12GE48554, 12GE48564, 12GE48531, 12Z31657, 12Z31662, 12GC84459, 12LC37611, 12X88127, 12X88138, 12GE48524, 12GE48525, 12GE48527, 12GE48528, 12GE48532, 12GE48534, 12GE48538, 12X88130, 12X88132, 12X88131, 12X88136, 12LJ37162, 12LJ37168, 12LJ37179, 12LJ37187, 12LJ37191, 12LJ37193, 12Z31673, 12Z31677, 12Z31683, 12Z31687, 12Z31672, 12X88166, 12X88169, 12X88170, 12Z31685, 12K49428, 12P10104, 12P10105, 12GE48543, 12GE48544, 12GE48545, 12GE48548, 12GE48557, 12GE48542, 12GC84476, 12GC84477, 12GC84478, 12GC84473, 12GC84475, 12LJ37164, 12X88173, 12GN57837, 12GN57875, 12GL52268, 12X88159, 12F14134, 12GE48551, 12GE48559, 12GE48522, 12GE48526, 12GE48529, 12GE48558, 12GE48563, 12GE48530, 12GE48533, 12GE48535, 12GE48536, 12E13628, 12F14073, 12GK30403, 12GL52248, 12GN57851, 12GN57874, 12F14072, 12GN57848, 12H33084, 12GE48567, 12Z31661, 12Z31671, 12Z31656, 12X88158, 12X88155, 12X88154, 12GC84474, 12GC84466, 12GC84461, 12GC84458, 12X88160, 12X88161, 12X88163, 12X88168, 12Z31668, 12Z31675, 12Z31676
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by telephone on June 23, 2000, firm initiated recall is complete.
REASON
Red Blood Cells, leukoreduced with a faulty filter, were distributed.
VOLUME OF PRODUCT IN COMMERCE
155 units
DISTRIBUTION
NC and SC

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
GE Signa Advantage nuclear magnetic resonance imaging system, Recall # Z-0858-06
CODE
All GE Signa Advantage MRI magnets with the model numbers 46-260805G1, 46-260805G2, 46-281380G1, 46-281380G2, 46-281380G3, 46-281380G4, 46-281380G5, 46-281380G6, 46-281380G7 and 46-281380G8
RECALLING FIRM/MANUFACTURER
General Electric Med Systems LLC, Waukesha, WI, by Urgent Safety Notification beginning September 1, 2005, firm initiated recall is ongoing.
REASON
During use of GE Signa nuclear magnetic resonance imaging system, a flexible Teflon tube that was part of the magnet vent system ruptured and allowed the magnet to vent into the scan room. Because of helium pressure inside the room, the scan room door could not be reopened after the patient was removed from the scan room.
VOLUME OF PRODUCT IN COMMERCE
644 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue. Product Number: CTRF117 and CTRF220, Recall # Z-0859-06
CODE
Lot numbers: C4K101C thru C4K122C, C4K126C thru C4K133C, C4L134C thru C4L147C, C5A148C thru C5A158C, C5B159C thru C5B174C, C5C175C thru C5C191C, C5D192C thru C5D199C, C5E200C thru C5E213C, C5F214C thru C5F231C, C5G232C thru C5G235C, C5H236C thru C5H241C, C5I242C thru C5I246C, C5J247C thru C5J263C, C5K264C thru C5K272C, C5L273C thru C5L282C, C6A283C thru C6A286C
RECALLING FIRM/MANUFACTURER
Valleylab, Boulder, CO, by telephone and fax on April 21, 2006, firm initiated recall is ongoing.
REASON
Electrosurgical ablation device may experience loss of power during use, when used with Cool-tip Switching controller in ablation mode.
VOLUME OF PRODUCT IN COMMERCE
137 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. The Konica REGIUS Image Manager Software (RIM) is used to receive and manage computerized X-Ray image file workflow, Recall # Z-0862-06
CODE
Units distributed between June 2003 and January 2006. Software version prior to January 31, 2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Konica Minolta Medical Imaging USA, Inc., Wayne, NJ, by telephone on February 6, 2006, followed with a fax, e-mail and letter.
Manufacturer: Konica Minolta Medical & Graphic, Inc., Tokyo, Japan, firm initiated recall is ongoing.
REASON
If the patient demographic data is entered into the CS-1 manually, and the user fails to enter any data in one of the demographic data fields labeled as Birthday, Sex, Name or Patient Comments, etc, the RIM will populate the fields where no data has been entered with data from the previous patient.
VOLUME OF PRODUCT IN COMMERCE
58 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Kimberly Clark * 20' Minibore Extension Line * Single Use * Sterile * Rx only *
This is a Pain Management Product that is sold in a wide variety of kits including both
standard tray configurations and custom kits, Product Code: 18938,
Recall # Z-0864-06;
b) Kimberly Clark * Facet Block Tray * Single Use * Sterile * Rx only *,
Product Code: 18146, Recall # Z-0865-06;
c) Kimberly Clark * Nerve Block Tray * Single Use * Sterile * Rx only * Product
Code: 18164, Product Code: 181027, Product Code: 181A040, Product Code:
181A108, Product Code: 181A144, Product Code: 181A170, Recall # Z-0866-06;
d) Kimberly Clark * Nerve Root Block Tray * Single Use * Sterile * Rx only *,
Product Code: 181236, Recall #Z-0867-06;
e) Kimberly Clark * Selective Nerve Block Tray * Single Use * Sterile * Rx only *,
Product Code: 181A236, Recall # Z-0868-06;
f) Kimberly Clark * Universal Block Tray * Single Use * Sterile * Rx only *,
Product Code: 181000, Product Code: 181053, Product Code: 181066,
Product Code: 181069, Product Code: 181126, Product Code: 181128, Product Code:
181167, Product Code: 181253, Product Code: 181255, Product Code: 181269,
Product Code: 181A055, Product Code: 181A088, and Product Code: 181A237,
Recall # Z-0869-06
CODE
a) Lot #321922;
b) Lot #330104;
c) Lot #330105, Lot #327294, Lot #324535, Lot #326465, Lot #327309, Lot #328365;
d) Lot #324523;
e) Lot #329218 and Lot #327315
f) Lot #324507, Lot #325536, Lot #327295, Lot #326447 & Lot #330094, Product Code: 181126, Lot #327296, Product Code: 181128, Lot #324516, Product Code: 181167, Lot #319874, Product Code: 181253, Lot #326455, Product Code: 181255, Lot #330100, Product Code: 181269, Lot #326456, Product Code: 181A055, Lot #329119, Product Code: 181A088, Lot #328354 and Product Code: 181A237, Lot #329220
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kimberly-Clark Corporation, Roswell, GA, by fax on/about March 15, 2006.
Manufacturer: Ballard Medical Products, Draper, UT, firm initiated recall is ongoing.
REASON
The Pain Management Procedural Trays may contain extension sets that do not meet USP specification requirements for non pyrogenicity (less than or equal to 2.25 EU/device (Endotoxin Units/device).
VOLUME OF PRODUCT IN COMMERCE
4,385 units from 25 lots
DISTRIBUTION
Nationwide

______________________________
PRODUCT
ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, Recall # Z-0870-06
CODE
All Serial Numbers since 1996
RECALLING FIRM/MANUFACTURER
Excelsior Medical Corp, Neptune, NJ, by letter on March 22, 2006. Firm initiated recall is ongoing.
REASON
Potential for alarm failure when the 140 pump completes infusion and/or the pump encounters a mid-infusion occlusion, when used in the 140 mode with a 140cc syringe. The ESP Pump works correctly when used in 60 mode with a 60cc syringe or smaller.
VOLUME OF PRODUCT IN COMMERCE
3,695 units
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
Sterile empty vials, 10mL/20mm closure sold 25/case. Labels on case states CAUTION: For manufacturing, Processing or Repacking Rx only NON_RETURNABLE LOT, Recall # Z-0871-06
CODE
Lot # 6743, Item #s 7515ZA, 7515ZC, 7515ZD
RECALLING FIRM/MANUFACTURER
Hollister Stier Laboratories LLC, Spokane, WA, by letter on April 20, 2006, firm initiated recall is ongoing.
REASON
Potential for vials to be cracked at the vial stopper interface. This could compromise the sterility of the products compounded into the vials.
VOLUME OF PRODUCT IN COMMERCE
87,900 vials
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-049-50, Recall # Z-0872-06
CODE
Lot #'s 51198300, 51217200, 51234800, 51260000 and 51302600
RECALLING FIRM/MANUFACTURER
Pioneer Surgical Technology, Marquette, MI, by letters dated March 3, 2006 and March 10, 2006, firm initiated recall is ongoing.
REASON
There may be an obstruction in the cannula that will prevent the guide wire from passing through it. The obstruction in the cannula can force the guide wire to advance further into the patient than intended.
VOLUME OF PRODUCT IN COMMERCE
74 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824, Recall # Z-0886-06
CODE
Lot #'s M507219 and M511327
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc, Brea, CA, by letter on March 30, 2006, firm initiated recall is ongoing.
REASON
Beckman Coulter has received reports of patient samples and quality control recovery shifting low when using Vancomycin reagent lots M507219 and M11327. Internal QC recovery was as much as 15% lower than the assigned target value.
VOLUME OF PRODUCT IN COMMERCE
3147 units
DISTRIBUTION
Nationwide and Canada
 

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219), CONTAK RENEWAL 4 RF (models H230, H235) CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D), provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricualar tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with suden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. The device also uses accelerometer-based adaptive-rate bradycardia therapy. These CONTAK RENEWAL RF devices feature enhanced telemetry communication with wandless ZIP telemetry. Cardioversion/defibrillation therapies include a range of low- and high-energy shocks using either a biphasic or monophasic waveform, Recall # Z-0683-6
CODE
Issue affecting devices is a pre-implant issue. Serial number ranges listed below may also include devices not affected (i.e. implanted devices). Model H210 serial number 200031 thru 202462. Model H215 serial numbers 700016 thru 702646. Model H217 serial numbers 700006 thru 702543. Model H219 serial numbers 200021 thru 201747. Model H230 serial numbers 100012 thru 200526. Model H235 serial numbers 100018 thru 650559. Model H239 serial numbers 100018 thru 650272
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, St. Paul, MN, by press release on March 13, 2006 and by letter dated May 11, 2006.
Manufacturer: Guidant-Ireland, Clomel, Ireland, firm initiated recall is ongoing.
REASON
Guidant received 39 reports of devices that exhibited lower than expected battery voltage prior to implant; none of these devices were implanted.
VOLUME OF PRODUCT IN COMMERCE
Approximately 5,500 devices
DISTRIBUTION
Nationwide and Internationally
 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS I

______________________________
PRODUCT
Suther Feeds Inc. Expression Medicated, containing 22.7 g/ton decoquinate, packaged in 50-lb. bags, Recall # V-066-6
CODE
Lot #19305
RECALLING FIRM/MANUFACTURER
Recalling Firm: Suther Feeds Inc, Frankfort, KS, by telephone on August 13, 2005, and by press release on February 3, 2006.
Manufacturer: Garnavillo Mill Inc, Garnavillo, IA, firm initiated recall is complete.
REASON
Product contained high levels of monensin.
VOLUME OF PRODUCT IN COMMERCE
112/50-lb. bags
DISTRIBUTION
KS and NE

END OF ENFORCEMENT REPORT FOR MAY 24, 2006

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