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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.
September 21, 2005
05-38
______________________________
PRODUCT
Sweet potato slice, net wt. 6 oz. (170g). Product of China. The product is
packaged in a heat-sealed, flexible plastic bag, UPC barcode # 6 932692 200014,
Recall # F-634-5
CODE
No code.
RECALLING FIRM/MANUFACTURER
Sunny Lake Trading, Inc., Brooklyn, NY, by press release on May 24, 2005.
Firm initiated recall is complete.
REASON
The product contained undeclared sulfites based on sampling & analysis
by the New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
100 cartons (100 plastic bags per carton)
DISTRIBUTION
NY
______________________________
PRODUCT
Deli Express Turkey Club Sandwich. Made with Butterball Turkey. Ingredients:
White bread, Oven roasted turkey breast with white turkey, smoked ham --
water added, pasteurized process American cheese. Net wt. 4.4 oz. (125g).
Sandwich is packaged in a modified atmosphere small wedge plastic container
with a flexible plastic sealed cover which contains the labeling information.
Product code # 157, Recall # F-643-5
CODE
Date code 652091
RECALLING FIRM/MANUFACTURER
Sween, E.A., Company, Eden Prairie, MN. by letter on August 23, 2005 and
by press release on August 24, 2005. Firm initiated recall is ongoing.
REASON
Turkey Club sandwiches are contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
13,087 sandwiches
DISTRIBUTION
Nationwide
______________________________
PRODUCT
King Koku Brand Dried Mushroom, net wt. 3 oz., servings per packet about
9. The product is packed in a heat-seal, flexible plastic package, UPC bar
code # 6 933309 700125, Recall # F-633-5
CODE
No coding
RECALLING FIRM/MANUFACTURER
Recalling Firm: Starway, Inc., Brooklyn, NY, by letters dated August 24,
2005.
Manufacturer: Xiamen Sunmore Food Corporation Ltd, Xiamen, China. Firm initiated
recall is complete.
REASON
The product contained undeclared sulfites based on sampling & analysis
by the New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
2,500 packages
DISTRIBUTION
NY
______________________________
PRODUCT
a) Product is Boquerones Vinagre (Anchiovies in Vinegar)
contained in 7 oz, 3.5 oz, and 17 oz packages.
Product is labeled in part: "*Boquerones en
Vinagre Elaboracion Artesanal*Boquerones *LEVANTE*",
UPC code 8 410880 000038, Recall # F-635-5;
b) Product is Boquerones Aceite Oliva (Anchiovies in
Olive Oil) contained in 7 oz packages. Product is
labeled in part: "*Boquerones en Aceite de Oliva*
Elaboracion Artesanal*BOQUERONE LEVANTE*",
Recall # F-636-5;
c) Product is Boquerones Ajillo (Anchiovies in Garlic)
contained in 7 oz packages. No labeling available,
Recall # F-637-5;
d) Product is Boquerones Banderillas (Anchiovies in
Little Flags) contained in 7 oz. packages,
Recall # F-638-5;
e) Product is Pincho Bacalao (Bacalao Kabobs) contained
in 3.5 oz packages. No labeling available,
Recall # F-639-5;
f) Product is Pincho Salmon (Salmon Kabobs) contained
in 3.5 oz. packages. Product is labeled in part:
"*Pincho de Salmon con Piquillo*Elaboracion Artesanal
*SALMON APPETIZERS*", Recall # F-640-5;
g) Product is Salpicon Mariscos (Mixed Seafood) contained
in 7 oz packages. No labeling available,
Recall # F-641-5;
h) Product is Sardinas Albahaca (Sardines in Herbs)
contained in 7 oz packages. No labeling available,
Recall # F-642-5
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Hispamer Distributors, Inc., Miami, Fl, by letter on or about June 17, 2005.
Firm initiated recall is ongoing.
REASON
Vacuum-packaged seafood products were improperly stored resulting in the
potential for the formation of clostridium botulinum toxin due to temperature
abuse.
VOLUME OF PRODUCT IN COMMERCE
130 cases
DISTRIBUTION
The products have been delivered to restaurants, liquor stores, and delis,
which are direct accounts of the recalling firm.
_______________________________
PRODUCT
Lotrimin AF, Antifungal (Miconazole Nitrate 2%), Net wt. 100g (3.5 oz.) and
133g (4.6 oz.), OTC, NDC 11523-1272-1, Recall # D-481-5
CODE
3B03CC, exp. Feb 2006; 4B09CC, exp. Feb 2007; 4G03CC, exp. Jun 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Schering-Plough HealthCare Products, Inc., Memphis, TN, by
letter on August 29, 2005.
Manufacturer: Kik Custom Mfg, Cumberland, RI. Firm initiated recall is ongoing.
REASON
Subpotency: The analytical results for Miconazole Nitrate were below specification
for the 12 month stability point.
VOLUME OF PRODUCT IN COMMERCE
479,148 units
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
Butorphanol Tartrate Nasal Spray, 10 mg/mL in a 2.5 mL metered-dose spray
pump bottle; a schedule C-IV narcotic analgesic; NDC 60505-0813-1, Recall
# D-482-5
CODE
Lot numbers GN0487, GP4074, GP8357, GP9401, GP9403, GT3173, GT6213, GT6211,
GT6215, GV0501, GV0499, GV0503
RECALLING FIRM/MANUFACTURER
Recalling Firm: Apotex Corp., Lincolnshire, IL, by letter dated August 30,
2005.
Manufacturer: Apotex Inc., Toronto, Ontario, Canada. Firm initiated recall
is ongoing.
REASON
Degradation Products: di-butorphanol oxide degradation product levels above
the specification limit at 9 month stability testing for the impurity.
VOLUME OF PRODUCT IN COMMERCE
160,244 units
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Red Blood Cells, Recall # B-1789-5
CODE
Unit number: 6911461
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile dated May 9,
2004. 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
CO.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1975-5;
b) Recovered Plasma, Recall # B-1976-5
CODE
a) and b) Unit number: 4899321
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by
facsimile dated October 18, 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
2 units
DISTRIBUTION
OK and Switzerland
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1977-5;
b) Platelets, Recall # B-1978-5;
c) Fresh Frozen Plasma, Recall # B-1979-5
CODE
a), b) and c) Unit numbers: 4532542
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by
facsimile dated July 9, 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
OK, PA, and FL
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1999-5;
b) Recovered Plasma, Recall # B-2000-5
CODE
a) and b) Unit number: 020E30735
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Lewis and Clark Region, Boise,
ID, by telephone, and by facsimile dated April 9, 2004.
Manufacturer: American National Red Cross, Salt Lake City, UT. Firm initiated
recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2001-5;
b) Platelets, Recall # B-2002-5;
c) Cryoprecipitated AHF, Recall # B-2003-5
CODE
a) Unit numbers: 50G52170, 50F76576;
b) Unit number: 50F76576;
c) Unit number: 50G52170
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH,
by facsimile dated July 30, 2004, or by letter dated August 3, 2004. Firm
initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Hodgkinís Lymphoma,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OH, IN, MN, CA, and Switzerland
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
Recall # B-2047-5;
b) Red Blood Cells Leukocytes Reduced
Irradiated, Recall # B-2048-5;
c) Red Blood Cells Leukocytes Reduced
Washed, Recall # B-2049-5;
d) Apheresis Red Blood Cells,
Recall # B-2050-5;
e) Platelets Pheresis Leukocytes Reduced,
Recall # B-2051-5;
f) Platelets Pheresis Leukocytes Reduced
Irradiated, Recall # B-2052-5;
g) Plasma frozen, Recall # B-2053-5;
h) Fresh Frozen Plasma Apheresis,
Recall # B-2054-5;
i) Liquid Plasma, B-2055-5;
j) Recovered Plasma, Recall # B-2056-5
CODE
a) Unit numbers: 084Q00017, 084Q00030, 084Q00048,
084Q00071, 084Q00073, 084Q00093, 084Q00120,
084Q00171, 084Q00185, 084Q00243, 084Q00246,
084Q00249, 084Q00267, 084Q00290, 084Q00298,
084Q00305, 084Q00318, 084Q00332, 084Q00337,
084Q00348, 084Q00380, 084Q00385, 084Q00389,
084Q00392, 084Q00443, 084Q00463, 084Q00467,
084Q00485, 084Q00489, 084Q00512, 084Q00529,
084Q00535, 084Q00579, 084Q00609, 084Q00622,
084Q00642, 084Q00652, 084Q00656, 084Q00675,
084Q00693, 084Q00699, 084Q00712, 084Q00716,
084Q00737, 084Q00742, 084Q00750, 084Q00784,
084Q00808, 084Q00818, 084Q00819, 084Q00824,
084Q00833, 084Q00849, 084Q00892, 084Q00914,
084Q00918, 084Q00947, 084Q00952, 084Q00978,
084Q01060, 084Q01078, 084Q01080, 084Q01123,
084Q01139, 084Q01147, 084Q01212, 084Q01213,
084Q01217, 084Q01218, 084Q01226, 084Q01246,
084Q01279, 084Q01306, 084Q01308, 084Q01348,
084Q01355, 084Q01365, 084Q01389, 084Q01399,
084Q01400, 084Q01421, 084Q01513, 084Q01524,
084Q01529, 084Q01591, 084Q01597, 084Q01613,
084Q01616, 084Q01622, 084Q01649, 084Q01660,
084Q01668, 084Q01674, 084Q01676, 084Q01678,
084Q01699, 084Q01709, 084Q01715, 084Q01763,
084Q01770, 084Q01796, 084Q01807, 084Q01810,
084Q01830, 084Q01885, 084Q01886, 084Q01912,
084Q01921, 084Q01966, 084Q02008, 084Q02025,
084Q02028, 084Q02032, 084Q02038, 084Q02060,
084Q02098, 084Q02099, 084Q02109, 084Q02119,
084Q02120, 084Q02140, 084Q02146, 084Q02148,
084Q02184, 084Q02195, 084Q02206, 084Q02224,
084Q02232, 084Q02235, 084Q02253, 084Q02275,
084Q02279, 084Q02298, 084Q02302, 084Q02320,
084Q02322, 084Q02337, 084Q02349, 084Q02360,
084Q02367, 084Q02368, 084Q02386, 084Q02394,
084Q02413, 084Q02438, 084Q02444, 084Q02481,
084Q02497, 084Q02519, 084Q02523, 084Q02526,
084Q02531, 084Q02575, 084Q02608, 084Q02611,
084Q02679, 084Q02691, 084Q02699, 084Q02738,
084Q02759, 084Q02808, 084Q02815, 084Q02851,
084Q02857, 084Q02866, 084Q02916, 084Q02943,
084Q02954, 084Q02976, 084Q02979, 084Q02999,
084Q03027, 084Q03051, 084Q03052, 084Q03055,
084Q03056, 084Q03081, 084Q03088, 084Q03121,
084Q03134, 084Q03167, 084Q03187, 084Q03227,
084Q03249, 084Q03254, 084Q03260, 084Q03266,
084Q03276, 084Q03294, 084Q03307, 084Q03352,
084Q03372, 084Q03407, 084Q03411, 084Q03446,
084Q03494, 084Q03578, 084Q03608, 084Q03636,
084Q03674, 084Q03713, 084Q03747, 084Q03776,
084Q03818, 084Q03826, 084Q03832, 084Q03838,
084Q03845, 084Q03846, 084Q03851, 084Q03943,
084Q03948, 084Q03953, 084Q03970, 084Q03975,
084Q04003, 084Q04078, 084Q04097, 084Q04106,
084Q04107, 084Q04110, 084Q04112, 084Q04114,
084Q04154, 084Q04225, 084Q04228, 084Q04238,
084Q04248, 084Q04313, 084Q04343, 084Q04354,
084Q04370, 084Q04372, 084Q04374, 084Q04401,
084Q04412, 084Q04452, 084Q04458, 084Q04470,
084Q04483, 084Q04514, 084Q04540, 084Q04541,
084Q04552, 084Q04566, 084Q04579, 084Q04583,
084Q04613, 084Q04615, 084Q04620, 084Q04629,
084Q04640, 084Q04676, 084Q04678, 084Q04735,
084Q04749, 084Q04756, 084Q04779, 084Q04785,
084Q04795, 084Q04837, 084Q04838, 084Q04849,
084Q04857, 084Q04858, 084Q04865, 084Q04874,
084Q04885, 084Q04897, 084Q04935, 084Q04940,
084Q04959, 084Q04975, 084Q05010, 084Q05030,
084Q05072, 084Q05099, 084Q05100, 084Q05117,
084Q05133, 084Q05134, 084Q05171, 084Q05247,
084Q05277, 084Q05349, 084Q05363, 084Q05371,
084Q05382, 084Q05400, 084Q05436, 084Q05477,
084Q05478, 084Q05480, 084Q05553, 084Q05580,
084Q05595, 084Q05601, 084Q05607, 084Q05608,
084Q05611, 084Q05638, 084Q05639, 084Q05648,
084Q05658, 084Q05708, 084Q05718, 084Q05763,
084Q05775, 084Q05782, 084Q05793, 084Q05866,
084Q05885, 084Q05939, 084Q06003, 084Q06038,
084Q06041, 084Q06043, 084Q06044, 084Q06050,
084Q06080, 084Q06091, 084Q06108, 084Q06162,
084Q06183, 084Q06205, 084Q06207, 084Q06212,
084Q06239, 084Q06245, 084Q06278, 084Q06279,
084Q06288, 084Q06290, 084Q06308, 084Q06354,
084Q06363, 084Q06375, 084Q06386, 084Q06392,
084Q06416, 084Q06417, 084Q06424, 084Q06429,
084Q06431, 084Q06440, 084Q06444, 084Q06468,
084Q06472, 084Q06500, 084Q06512, 084Q06513,
084Q06518, 084Q06527, 084Q06552, 084Q06576,
084Q06590, 084Q06610, 084Q06627, 084Q06684,
084Q06685, 084Q06705, 084Q06749, 084Q06759,
084Q06774, 084Q06819, 084Q06821, 084Q06827,
084Q06828, 084Q06838, 084Q06856, 084Q06871,
084Q06899, 084Q06906, 084Q06969, 084Q06975,
084Q06981, 084Q07078, 084Q07093, 084Q07123,
084Q07124, 084Q07144, 084Q07148, 084Q07158,
084Q07174, 084Q07186, 084Q07192, 084Q07223,
084Q07225, 084Q07283, 084Q07299, 084Q07320,
084Q07345, 084Q07347, 084Q07362, 084Q87322,
084Q87324, 084Q87341, 084Q87344, 084Q87350,
084Q87395, 084Q87412, 084Q87423, 084Q87451,
084Q87463, 084Q87487, 084Q87490, 084Q87495,
084Q87531, 084Q87557, 084Q87565, 084Q87612,
084Q87632, 084Q87639, 084Q87640, 084Q87681,
084Q87696, 084Q87744, 084Q87757, 084Q87782,
084Q87795, 084Q87815, 084Q87820, 084Q87901,
084Q88000, 084Q88026, 084Q88072, 084Q88089,
084Q88092, 084Q88155, 084Q88253, 084Q88290,
084Q88295, 084Q88303, 084Q88308, 084Q88332,
084Q88392, 084Q88566, 084Q88584, 084Q88601,
084Q88664, 084Q88694, 084Q88718, 084Q88748,
084Q88753, 084Q88759, 084Q88838, 084Q88841,
084Q88850, 084Q88880, 084Q88901, 084Q88928,
084Q88937, 084Q88995, 084Q89013, 084Q89024,
084Q89077, 084Q89101, 084Q89114, 084Q89150,
084Q89206, 084Q89248, 084Q89336, 084Q89382,
084Q89400, 084Q89415, 084Q89473, 084Q89475,
084Q89503, 084Q89550, 084Q89626, 084Q89673,
084Q89692, 084Q89725, 084Q89735, 084Q89737,
084Q89738, 084Q89750, 084Q89757, 084Q89759,
084Q89773, 084Q89789, 084Q89793, 084Q89798,
084Q89810, 084Q89828, 084Q89857, 084Q89858,
084Q89893, 084Q89903, 084Q89910, 084Q89922,
084Q89923, 084Q89929, 084Q89937, 084Q89975,
084Q90016, 084Q90021, 084Q90044, 084Q90063,
084Q90088, 084Q90096, 084Q90100, 084Q90135,
084Q90136, 084Q90141, 084Q90142, 084Q90143,
084Q90156, 084Q90160, 084Q90180, 084Q90205,
084Q90212, 084Q90226, 084Q90274, 084Q90283,
084Q90291, 084Q90298, 084Q90303, 084Q90318,
084Q90356, 084Q90370, 084Q90377, 084Q90378,
084Q90395, 084Q90396, 084Q90405, 084Q90406,
084Q90408, 084Q90415, 084Q90422, 084Q90431,
084Q90477, 084Q90505, 084Q90532, 084Q90567,
084Q90573, 084Q90635, 084Q90699, 084Q90704,
084Q90710, 084Q90747, 084Q90748, 084Q90769,
084Q90797, 084Q90821, 084Q90822, 084Q90838,
084Q90876, 084Q90879, 084Q90896, 084Q90962,
084Q90970, 084Q90998, 084Q91010, 084Q91058,
084Q91061, 084Q91065, 084Q91070, 084Q91080,
084Q91081, 084Q91091, 084Q91095,
084Q91099, 084Q91103, 084Q91107, 084Q91141,
084Q91181, 084Q91191, 084Q91203, 084Q91279,
084Q91297, 084Q91322, 084Q91337, 084Q91357,
084Q91398, 084Q91488, 084Q91522, 084Q91563,
084Q91581, 084Q91585, 084Q91608, 084Q91614,
084Q91647, 084Q91662, 084Q91673, 084Q91678,
084Q91696, 084Q91703, 084Q91740, 084Q91809,
084Q91941, 084Q91944, 084Q91959, 084Q91968,
084Q91989, 084Q91999, 084Q92015, 084Q92029,
084Q92076, 084Q92077, 084Q92098, 084Q92099,
084Q92112, 084Q92114, 084Q92116, 084Q92167,
084Q92212, 084Q92233, 084Q92237, 084Q92273,
084Q92282, 084Q92283, 084Q92294, 084Q92318,
084Q92387, 084Q92847, 084Q92849, 084Q92873,
084Q92892, 084Q92910, 084Q92949, 084Q92966,
084Q92991, 084Q93008, 084Q93023, 084Q93042,
084Q93078, 084Q93111, 084Q93128, 084Q93132,
084Q93143, 084Q93158, 084Q93160, 084Q93177,
084Q93186, 084Q93262, 084Q93270, 084Q93280,
084Q93282, 084Q93297, 084Q93324, 084Q93343,
084Q93376, 084Q93377, 084Q93394, 084Q93400,
084Q93401, 084Q93402, 084Q93404, 084Q93416,
084Q93439, 084Q93446, 084Q93447, 084Q93455,
084Q93475, 084Q93482, 084Q93487, 084Q93494,
084Q93505, 084Q93509, 084Q93515, 084Q93522,
084Q93547, 084Q93557, 084Q93567, 084Q93579,
084Q93603, 084Q93609, 084Q93628, 084Q93657,
084Q93661, 084Q93719, 084Q93734, 084Q93751,
084Q93781, 084Q93804, 084Q93817, 084Q93847,
084Q93857, 084Q93859, 084Q93863, 084Q93881,
084Q93888, 084Q93891, 084Q93965, 084Q94025,
084Q94054, 084Q94098, 084Q94124, 084Q94136,
084Q94144, 084Q94152, 084Q94175, 084Q94181,
084Q94204, 084Q94216, 084Q94235, 084Q94275,
084Q94301, 084Q94312, 084Q94315, 084Q94337,
084Q94351, 084Q94361, 084Q94400, 084Q94802,
084Q94824, 084Q94868, 084Q94869, 084Q94887,
084Q94892, 084Q94893, 084Q94899, 084Q94917,
084Q94980, 084Q95019, 084Q95021, 084Q95027,
084Q95028, 084Q95049, 084Q95103, 084Q95130,
084Q95149, 084Q95154, 084Q95163, 084Q95166,
084Q95178, 084Q95203, 084Q95218, 084Q95225,
084Q95231, 084Q95269, 084Q95276, 084Q95364,
084Q95377, 084Q95382, 084Q95389, 084Q95437,
084Q95440, 084Q95465, 084Q95475, 084Q95478,
084Q95509, 084Q95511, 084Q95546, 084Q95548,
084Q95551, 084Q95552, 084Q95571, 084Q95576,
084Q95588, 084Q95597, 084Q95632, 084Q95633,
084Q95662, 084Q95672, 084Q95723, 084Q95760,
084Q95779, 084Q95821, 084Q95828, 084Q95831,
084Q95833, 084Q95851, 084Q95882, 084Q95883,
084Q95932, 084Q95962, 084Q96005, 084Q96022,
084Q96033, 084Q96062, 084Q96117, 084Q96119,
084Q96123, 084Q96129, 084Q96135, 084Q96163,
084Q96145, 084Q96154, 084Q96159, 084Q96359,
084Q96228, 084Q96335, 084Q96348, 084Q96367,
084Q96388, 084Q96415, 084Q96450, 084Q96468,
084Q96485, 084Q96545, 084Q96554, 084Q96591,
084Q96640, 084Q96641, 084Q96648, 084Q96700,
084Q96715, 084Q96733, 084Q96740, 084Q96747,
084Q96794, 084Q96863, 084Q96871, 084Q96879,
084Q96935, 084Q96937, 084Q96957, 084Q96970,
084Q97064, 084Q97075, 084Q97108, 084Q97163,
084Q97164, 084Q97166, 084Q97168, 084Q97173,
084Q97209, 084Q97218, 084Q97276, 084Q97299,
084Q97360, 084Q97375, 084Q97392, 084Q97393,
084Q97393, 084Q97405, 084Q97406, 084Q97437,
084Q97438, 084Q97466, 084Q97579, 084Q97607,
084Q97617, 084Q97670, 084Q97673, 084Q97683,
084Q97730, 084Q97763, 084Q97769, 084Q97775,
084Q97782, 084Q97853, 084Q97861, 084Q97919,
084Q97942, 084Q98004, 084Q98011, 084Q98016,
084Q98048, 084Q98051, 084Q98092, 084Q98100,
084Q98115, 084Q98135, 084Q98162, 084Q98165,
084Q98173, 084Q98175, 084Q98227, 084Q98230,
084Q98243, 084Q98278, 084Q98294, 084Q98301,
084Q98340, 084Q98344, 084Q98355, 084Q98369,
084Q98373, 084Q98391, 084Q98409, 084Q98433,
084Q98459, 084Q98469, 084Q98477, 084Q98494,
084Q98524, 084Q98531, 084Q98541, 084Q98589,
084Q98633, 084Q98638, 084Q98667, 084Q98706,
084Q98707, 084Q98730, 084Q98743, 084Q98764,
084Q98765, 084Q98784, 084Q98807, 084Q98825,
084Q98839, 084Q98921, 084Q98926, 084Q98936,
084Q98941, 084Q98957, 084Q98983, 084Q98986,
084Q99051, 084Q99057, 084Q99094, 084Q99118,
084Q99135, 084Q99208, 084Q99213, 084Q99259,
084Q99260, 084Q99263, 084Q99306, 084Q99311,
084Q99376, 084Q99377, 084Q99382, 084Q99413,
084Q99434, 084Q99437, 084Q99456, 084Q99458,
084Q99486, 084Q99519, 084Q99537, 084Q99546,
084Q99547, 084Q99553, 084Q99585, 084Q99587,
084Q99599, 084Q99601, 084Q99607, 084Q99641,
084Q99645, 084Q99648, 084Q99688, 084Q99699,
084Q99704, 084Q99746, 084Q99800, 084Q99816,
084Q99818, 084Q99858, 084Q99867, 084Q99880,
084Q99906, 084Q99966, 084Q99982,
b) Unit numbers: 084Q01366, 084Q01456, 084Q01984,
084Q03796, 084Q04268, 084Q04367, 084Q04970, 084Q05236,
084Q05701, 084Q05754, 084Q06119, 084Q06337, 084Q06793,
084Q87816, 084Q89339, 084Q89474, 084Q90969, 084Q90984,
084Q91397, 084Q93217, 084Q95167, 084Q96614, 084Q97192,
084Q98036, 084Q98949, 084Q98960, 084Q99167;
c) Unit number: 084Q92252;
d) Unit numbers: 084Q04198, 084Q04198, 084Q04199;
e) Unit numbers: 084C31123, 084C31123, 084C31138,
084C31138, 084C31140, 084C31140, 084C31160, 084C31160, 084C31178, 084C31178,
084C31183, 084C31183, 084C31198, 084C31198, 084C31202, 084C31202, 084C31222,
084C31227, 084C31244, 084C31244, 084C31274, 084C31274, 084C31297, 084C31297,
084C31315, 084C31315, 084C31334, 084C31334, 084C31354, 084C31354, 084C31371,
084C31382, 084C31382, 084C31422, 084C31422, 084C31432, 084C31432, 084C31434,
084C31435, 084C31435, 084C31450, 084C31453, 084C31453, 084C31480, 084C31480,
084C31515, 084C31515, 084C31547, 084C31565, 084C31565, 084C31582, 084C31599,
084C31599, 084C31621, 084C31621, 084C31623, 084C31623, 084C31644, 084C31664,
084C31682, 084C31682, 084C31687, 084C31687, 084C31726, 084C31726, 084C31731,
084C31731, 084C31783, 084C31801, 084C31836, 084C31836, 084C31864, 084C31864,
084C31935, 084C31958, 084C31958, 084C31984, 084C32005, 084C32005, 084C32013,
084C32013, 084C32061, 084C32061, 084C32078, 084C32078, 084C32093, 084C32093,
084C32155, 084C32155, 084C32159, 084C32163, 084C32177, 084C32205, 084C32213,
084C32213, 084C32233, 084C32233, 084C32245, 084C32245, 084C32252, 084C32252,
084C32283, 084C32283, 084C32293, 084C32293, 084C32296, 084C32296, 084C32312,
084C32312, 084C32320, 084C32320, 084C32341, 084C32341, 084C32345, 084C32345,
084C32356, 084C32356, 084C32377, 084C32380, 084C32380, 084C32394, 084C32394,
084C32401, 084C32420, 084C32432, 084C32432, 084C32443, 084C32471, 084C32473,
084C32481, 084C32481, 084C32495, 084C32515, 084C32533, 084C32563, 084C32569,
084C32602, 084C32604, 084C32604, 084C32615, 084C32663, 084C32691, 084C32707,
084C32770, 084C32770, 084C32779, 084C32783, 084C32794, 084C32794, 084C32840,
084C32874, 084C32874, 084C32925, 084C32925, 084C32958, 084C32958, 084C32961,
084C32988, 084C33009, 084C33030, 084C33030, 084C33035, 084C33035, 084C33039,
084C33039, 084C33042, 084C33042, 084C33063, 084C33063, 084C33082, 084C33102,
084C33179, 084C33214, 084C33214, 084C33235, 084C33235, 084C33251, 084C33251,
084C33267, 084C33267, 084C33273, 084C33292, 084C33325, 084C33325, 084C33336,
084C33336, 084C33348, 084C33348, 084C33361, 084C33361, 084C33384, 084C33415,
084C33426, 084C33450, 084C33450, 084C33456, 084C33456, 084C33516, 084C33523,
084C33527, 084C33527, 084C33530, 084C33530, 084C33546, 084C33546, 084C33554,
084C33558, 084C33574, 084C33580, 084C33601, 084C33601, 084C33604, 084C33604,
084C33628, 084C33628, 084C33644, 084C33656, 084C33695, 084C33745, 084C33801,
084C33801, 084C33810, 084C33810, 084C33831, 084C33851, 084C33856, 084C33856,
084C33883, 084C33893, 084C33907, 084C33910, 084C33910, 084C33922, 084C33922,
084C33937, 084C33937, 084C33964, 084C34013, 084C34038, 084C34070, 084C34070,
084C34076, 084C34076, 084C34081, 084C34081, 084C34089, 084C34106, 084C34106,
084C34158, 084C34168, 084C34168, 084C34212, 084C34214, 084C34214, 084C34220,
084C34220, 084C34300, 084C34322, 084C34340, 084C34340, 084C34351, 084C34446,
084C34446, 084C34528, 084C34528, 084C34531, 084C34531, 084C34542, 084C34542,
084C34553, 084C34556, 084C34558, 084C34558, 084C34568, 084C34590, 084C34590,
084C34608, 084C34608, 084C34612, 084C34612, 084C34620, 084C34628, 084C34638,
084C34638, 084C34663, 084C34672, 084C34672, 084C34683, 084C34707, 084C34708,
084C34817, 084C34817, 084C34838, 084C34838, 084C34843, 084C34846, 084C34847,
084C34902, 084C34902, 084C34905, 084C34905, 084C34906, 084C34906, 084C34914,
084C34914, 084C34917, 084C34917, 084C34925, 084C34953, 084C34953, 084C34955,
084C34963, 084C35002, 084C35005, 084C35005, 084C35011, 084C35011, 084C35049,
084C35050, 084C35098, 084C35099, 084C35099, 084C35101, 084C35101, 084C35110,
084C35111, 084C35111, 084C35112, 084C35112, 084C35127, 084C35127, 084C35128,
084C35128, 084C35162, 084C35169, 084C35169, 084C35218, 084C35224, 084C35224,
084C35240, 084C35240, 084C35255, 084C35255;
f) Unit numbers: 084C31371, 084C31582, 084C31935,
084C32205, 084C32443, 084C32495, 084C32615, 084C32691,
084C32845, 084C32866, 084C32919, 084C33175, 084C33179,
084C33292, 084C33523, 084C33645, 084C33851, 084C34600,
084C34683, 084C34737, 084C34956, 084C34956, 084C35049,
084C35098, 084C35162;
g) Unit numbers: 084Q00071, 084Q00073, 084Q00093,
084Q00243, 084Q00246, 084Q00249, 084Q00267,
084Q00290, 084Q00298, 084Q00305, 084Q00318,
084Q00332, 084Q00337, 084Q00348, 084Q00380,
084Q00385, 084Q00389, 084Q00392, 084Q00443,
084Q00463, 084Q00467, 084Q00512, 084Q00529,
084Q00535, 084Q00579, 084Q00609, 084Q00622, 084Q00642, 084Q00652, 084Q00656,
084Q00693, 084Q00699, 084Q00712, 084Q00716, 084Q00737, 084Q00914, 084Q00947,
084Q01912, 084Q02349, 084Q02360, 084Q02368, 084Q02386, 084Q02394, 084Q02413,
084Q02438, 084Q02444, 084Q02463, 084Q02481, 084Q02497, 084Q02523, 084Q02526,
084Q02738, 084Q02759, 084Q02808, 084Q02815, 084Q02866, 084Q02943, 084Q02954,
084Q02976, 084Q02979, 084Q02999, 084Q03027, 084Q03352, 084Q04078, 084Q04676,
084Q04678, 084Q04735, 084Q04749, 084Q04756, 084Q04779, 084Q04785, 084Q04795,
084Q04935, 084Q05277, 084Q05349, 084Q05363, 084Q05371, 084Q05400, 084Q05477,
084Q05478, 084Q05480, 084Q06205, 084Q06207, 084Q06212, 084Q06239, 084Q06245,
084Q06278, 084Q06288, 084Q06294, 084Q06308, 084Q06337, 084Q06354, 084Q06375,
084Q06527, 084Q06552, 084Q06576, 084Q06590, 084Q06610, 084Q06627, 084Q06684,
084Q06685, 084Q06705, 084Q06749, 084Q06759, 084Q06774, 084Q06793, 084Q07362,
084Q87322, 084Q87324, 084Q87341, 084Q87344, 084Q87395, 084Q87423, 084Q87451,
084Q87463, 084Q87487, 084Q87495, 084Q87531, 084Q87557, 084Q87565, 084Q87612,
084Q87639, 084Q87681, 084Q87696, 084Q87744, 084Q87757, 084Q87815, 084Q88155,
084Q88253, 084Q88290, 084Q88295, 084Q88303, 084Q88308, 084Q88332, 084Q88362,
084Q88392, 084Q88566, 084Q88806, 084Q88841, 084Q89114, 084Q89150, 084Q89206,
084Q89248, 084Q89336, 084Q89382, 084Q89400, 084Q89415, 084Q89473, 084Q89475,
084Q89503, 084Q89550, 084Q89923, 084Q90016, 084Q90021, 084Q90063, 084Q90088,
084Q90142, 084Q90477, 084Q90635, 084Q90647, 084Q90704, 084Q90710, 084Q90748,
084Q90769, 084Q90797, 084Q90821, 084Q90822, 084Q90838, 084Q90876, 084Q90879,
084Q90896, 084Q90962, 084Q90969, 084Q90970, 084Q90984, 084Q90998, 084Q91058,
084Q91061, 084Q91065, 084Q91070, 084Q91080, 084Q91081, 084Q91091, 084Q91095,
084Q91099, 084Q91103, 084Q91107, 084Q91337, 084Q91941, 084Q91944, 084Q92015,
084Q92029, 084Q92076, 084Q92077, 084Q92098, 084Q92099, 084Q92112, 084Q92114,
084Q92116, 084Q92233, 084Q92237, 084Q92294, 084Q92318, 084Q92387, 084Q92949,
084Q93078, 084Q93158, 084Q93177, 084Q93282, 084Q93401, 084Q93475, 084Q93515,
084Q93751, 084Q93781, 084Q94136, 084Q94181, 084Q94204, 084Q94216, 084Q94275,
084Q94301, 084Q94312, 084Q94315, 084Q94337, 084Q94351, 084Q94361, 084Q94400,
084Q94802, 084Q94824, 084Q94868, 084Q94869, 084Q94887, 084Q94892, 084Q94893,
084Q94899, 084Q94917, 084Q94980, 084Q95019, 084Q95021, 084Q95027, 084Q95028,
084Q95049, 084Q95103, 084Q95130, 084Q95149, 084Q95154, 084Q95163, 084Q95166,
084Q95167, 084Q95178, 084Q95203, 084Q95509, 084Q95633, 084Q95672, 084Q95834,
084Q95882, 084Q95932, 084Q95962, 084Q96005, 084Q96022, 084Q96033, 084Q96062,
084Q96117, 084Q96119, 084Q96123, 084Q96129, 084Q96145, 084Q96154, 084Q96159,
084Q96163, 084Q96228, 084Q96335, 084Q96367, 084Q96388, 084Q96485, 084Q96545,
084Q96641, 084Q96648, 084Q96700, 084Q96715, 084Q96733, 084Q96747, 084Q96871,
084Q96935, 084Q97075, 084Q97164, 084Q97166, 084Q97173, 084Q97209, 084Q97218,
084Q97437, 084Q97438, 084Q97579, 084Q97607, 084Q97617, 084Q97670, 084Q97673,
084Q97683, 084Q97763, 084Q97769, 084Q97775, 084Q97782, 084Q97853, 084Q97861,
084Q98373, 084Q98391, 084Q98409, 084Q98433, 084Q98459, 084Q98469, 084Q98494,
084Q98524, 084Q98633, 084Q98638, 084Q98706, 084Q98730, 084Q98743, 084Q98764,
084Q98765, 084Q98784, 084Q98807, 084Q98839, 084Q98936, 084Q98941, 084Q98949,
084Q98957, 084Q98960, 084Q98983, 084Q99051, 084Q99546, 084Q99607;
h) Unit numbers: 084C31547, 084C31801, 084C32377,
084C32401, 084C32533, 084C32866, 084C33175, 084C33273,
084C33964, 084C34061, 084C34755;
i) Unit number: 084Q90765;
j) Unit numbers: 084Q00017, 084Q00030, 084Q00048,
084Q00116, 084Q00120, 084Q00171, 084Q00185, 084Q00485,
084Q00489, 084Q00675, 084Q00742, 084Q00750, 084Q00784,
084Q00808, 084Q00818, 084Q00819, 084Q00824, 084Q00833,
084Q00849, 084Q00892, 084Q00918, 084Q00952, 084Q00978,
084Q01060, 084Q01078, 084Q01080, 084Q01123, 084Q01139,
084Q01147, 084Q01212, 084Q01213, 084Q01246, 084Q01279,
084Q01306, 084Q01308, 084Q01348, 084Q01355, 084Q01365, 084Q01366, 084Q01389,
084Q01399, 084Q01400, 084Q01421, 084Q01456, 084Q01513, 084Q01524, 084Q01529,
084Q01591, 084Q01597, 084Q01613, 084Q01616, 084Q01622, 084Q01649, 084Q01660,
084Q01668, 084Q01674, 084Q01676, 084Q01678, 084Q01699, 084Q01709, 084Q01715,
084Q01763, 084Q01770, 084Q01796, 084Q01807, 084Q01810, 084Q01830, 084Q01885,
084Q01886, 084Q01921, 084Q01966, 084Q01984, 084Q02008, 084Q02025, 084Q02028,
084Q02032, 084Q02038, 084Q02060, 084Q02098, 084Q02099, 084Q02109, 084Q02119,
084Q02120, 084Q02140, 084Q02146, 084Q02148, 084Q02184, 084Q02195, 084Q02206,
084Q02224, 084Q02232, 084Q02253, 084Q02275, 084Q02279, 084Q02298, 084Q02302,
084Q02320, 084Q02322, 084Q02337, 084Q02367, 084Q02519, 084Q02531, 084Q02575,
084Q02608, 084Q02611, 084Q02679, 084Q02691, 084Q02699, 084Q02851, 084Q02857,
084Q02916, 084Q03052, 084Q03055, 084Q03056, 084Q03081, 084Q03088, 084Q03121,
084Q03134, 084Q03167, 084Q03187, 084Q03227, 084Q03249, 084Q03254, 084Q03260,
084Q03266, 084Q03276, 084Q03294, 084Q03307, 084Q03372, 084Q03407, 084Q03411,
084Q03446, 084Q03494, 084Q03578, 084Q03608, 084Q03636, 084Q03674, 084Q03713,
084Q03747, 084Q03776, 084Q03796, 084Q03818, 084Q03826, 084Q03832, 084Q03838,
084Q03845, 084Q03846, 084Q03851, 084Q03943, 084Q03948, 084Q03953, 084Q03970,
084Q03975, 084Q04003, 084Q04097, 084Q04106, 084Q04107, 084Q04110, 084Q04112,
084Q04114, 084Q04154, 084Q04225, 084Q04228, 084Q04238, 084Q04248, 084Q04268,
084Q04313, 084Q04343, 084Q04354, 084Q04367, 084Q04370, 084Q04372, 084Q04374,
084Q04401, 084Q04412, 084Q04452, 084Q04458, 084Q04470, 084Q04483, 084Q04514,
084Q04540, 084Q04541, 084Q04552, 084Q04566, 084Q04579, 084Q04583, 084Q04613,
084Q04615, 084Q04620, 084Q04629, 084Q04640, 084Q04837, 084Q04838, 084Q04849,
084Q04857, 084Q04858, 084Q04865, 084Q04874, 084Q04885, 084Q04897, 084Q04940,
084Q04959, 084Q04970, 084Q04975, 084Q05010, 084Q05030, 084Q05072, 084Q05099,
084Q05100, 084Q05117, 084Q05133, 084Q05134, 084Q05171, 084Q05236, 084Q05247,
084Q05382, 084Q05553, 084Q05580, 084Q05595, 084Q05601, 084Q05607, 084Q05608,
084Q05611, 084Q05638, 084Q05639, 084Q05648, 084Q05658, 084Q05708, 084Q05718,
084Q05754, 084Q05793, 084Q05866, 084Q05885, 084Q05939, 084Q06003, 084Q06038,
084Q06041, 084Q06043, 084Q06044, 084Q06050, 084Q06080, 084Q06091, 084Q06108,
084Q06119, 084Q06162, 084Q06183, 084Q06279, 084Q06290, 084Q06386, 084Q06392,
084Q06416, 084Q06417, 084Q06424, 084Q06429, 084Q06431, 084Q06440, 084Q06444,
084Q06468, 084Q06472, 084Q06500, 084Q06819, 084Q06821, 084Q06827, 084Q06828,
084Q06838, 084Q06856, 084Q06871, 084Q06899, 084Q06906, 084Q06969, 084Q06975,
084Q06981, 084Q07078, 084Q07093, 084Q07123, 084Q07124, 084Q07144, 084Q07148,
084Q07158, 084Q07174, 084Q07186, 084Q07192, 084Q07223, 084Q07225, 084Q07283,
084Q07299, 084Q07320, 084Q07345, 084Q07347, 084Q87782, 084Q87795, 084Q87816,
084Q87820, 084Q87901, 084Q87951, 084Q88000, 084Q88026, 084Q88089, 084Q88092,
084Q88584, 084Q88601, 084Q88664, 084Q88694, 084Q88718, 084Q88748, 084Q88753,
084Q88759, 084Q88838, 084Q88850, 084Q88880, 084Q88901, 084Q88928, 084Q88937,
084Q88995, 084Q89013, 084Q89019, 084Q89024, 084Q89077, 084Q89101, 084Q89857,
084Q89858, 084Q89893, 084Q89903, 084Q89910, 084Q89922, 084Q89929, 084Q89937,
084Q89975, 084Q90096, 084Q90100, 084Q90135, 084Q90136, 084Q90141, 084Q90143,
084Q90156, 084Q90160, 084Q90180, 084Q90205, 084Q90212, 084Q90226, 084Q90274,
084Q90283, 084Q90291, 084Q90298, 084Q90303, 084Q90356, 084Q90370, 084Q90376,
084Q90377, 084Q90378, 084Q90395, 084Q90396, 084Q90405, 084Q90406, 084Q90408,
084Q90415, 084Q90422, 084Q90431, 084Q90505, 084Q90532, 084Q90567, 084Q90573,
084Q90699, 084Q91141, 084Q91181, 084Q91191, 084Q91203, 084Q91279, 084Q91297,
084Q91322, 084Q91357, 084Q91397, 084Q91398, 084Q91488, 084Q91522, 084Q91563,
084Q91581, 084Q91585, 084Q91614, 084Q91647, 084Q91662, 084Q91673, 084Q91678,
084Q91696, 084Q91703, 084Q91740, 084Q91809, 084Q91959, 084Q91968, 084Q91989,
084Q91999, 084Q92026, 084Q92167, 084Q92252, 084Q92273, 084Q92282, 084Q92283,
084Q92847, 084Q92849, 084Q92873, 084Q92892, 084Q92910, 084Q92966, 084Q92991,
084Q93008, 084Q93023, 084Q93042, 084Q93043, 084Q93111, 084Q93128, 084Q93132,
084Q93143, 084Q93160, 084Q93186, 084Q93217, 084Q93262, 084Q93270, 084Q93280,
084Q93297, 084Q93324, 084Q93343, 084Q93376, 084Q93377, 084Q93400, 084Q93402,
084Q93404, 084Q93416, 084Q93439, 084Q93446, 084Q93447, 084Q93455, 084Q93482,
084Q93487, 084Q93494, 084Q93505, 084Q93509, 084Q93522, 084Q93547, 084Q93557,
084Q93567, 084Q93579, 084Q93603, 084Q93609, 084Q93628, 084Q93657, 084Q93661,
084Q93719, 084Q93734, 084Q93804, 084Q93817, 084Q93847, 084Q93857, 084Q93859,
084Q93863, 084Q93881, 084Q93888, 084Q93891, 084Q93965, 084Q94025, 084Q94054,
084Q94098, 084Q94124, 084Q94152, 084Q94175, 084Q95218, 084Q95225, 084Q95231,
084Q94235, 084Q95269, 084Q95276, 084Q95364, 084Q95377, 084Q95382, 084Q95389,
084Q95437, 084Q95440, 084Q95465, 084Q95475, 084Q95478, 084Q95511, 084Q95546,
084Q95548, 084Q95551, 084Q95552, 084Q95571, 084Q95576, 084Q95588, 084Q95597,
084Q95632, 084Q95662, 084Q95723, 084Q95779, 084Q95821, 084Q95828, 084Q95831,
084Q95833, 084Q95851, 084Q95883, 084Q96348, 084Q96359, 084Q96415, 084Q96450,
084Q96468, 084Q96591, 084Q96614, 084Q96640, 084Q96740, 084Q96781, 084Q96794,
084Q96863, 084Q96879, 084Q96937, 084Q96957, 084Q96970, 084Q97064, 084Q97108,
084Q97163, 084Q97168, 084Q97192, 084Q97276, 084Q97299, 084Q97360, 084Q97375,
084Q97392, 084Q97393, 084Q97405, 084Q97406, 084Q97466, 084Q97730, 084Q97919,
084Q97942, 084Q98004, 084Q98011, 084Q98016, 084Q98036, 084Q98048, 084Q98051,
084Q98092, 084Q98100, 084Q98115, 084Q98135, 084Q98162, 084Q98165, 084Q98173,
084Q98175, 084Q98227, 084Q98230, 084Q98243, 084Q98262, 084Q98278, 084Q98294,
084Q98301, 084Q98340, 084Q98344, 084Q98355, 084Q98369, 084Q98477, 084Q98531,
084Q98541, 084Q98589, 084Q98825, 084Q98921, 084Q98926, 084Q89438, 084Q89474,
084Q89626, 084Q89673, 084Q89692, 084Q89725, 084Q89735, 084Q89737, 084Q89738,
084Q89750, 084Q89757, 084Q89759, 084Q89773, 084Q89789, 084Q89793, 084Q89798,
084Q89810, 084Q89828, 084Q98986, 084Q99057, 084Q99094, 084Q99118, 084Q99135,
084Q99167, 084Q99208, 084Q99213, 084Q99259, 084Q99260, 084Q99263, 084Q99306,
084Q99311, 084Q99376, 084Q99377, 084Q99413, 084Q99434, 084Q99437, 084Q99456,
084Q99458, 084Q99486, 084Q99519, 084Q99537, 084Q99547, 084Q99585, 084Q99587,
084Q99599, 084Q99601, 084Q99641, 084Q99645, 084Q99648, 084Q99688, 084Q99699,
084Q99704, 084Q99746, 084Q99800, 084Q99816, 084Q99818, 084Q99858, 084Q99867,
084Q99880, 084Q99906, 084Q99966, 084Q99982
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern California Region, Oakland, CA,
by letters dated April 1, 2004, April 27, May 3, May 21, June 6, June 11,
August 10, August 27, and September 29, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose medical history screening did
not include questioning regarding certain risk factors for variant Creutzfeldt-Jackob
Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2,314 units
DISTRIBUTION
CA and Switzerland
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2081-5;
b) Recovered Plasma, Recall # B-2082-5
CODE
a) and b) Unit number: 55FN224372
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock,
AR, by telephone and letter on October 7, 2003. Firm initiated recall is
complete.
REASON
Blood products, collected from a donor who engaged in multiple high risk
behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AR, and Switzerland
_______________________________
PRODUCT
Source Plasma, Recall # B-2097-5
CODE
Unit numbers: NG0041263 and NG0041587
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and facsimile
on January 16, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor whose suitability pertaining
to risk factors for Creutzfeldt-Jakob Disease (CJD) was not adequately determined,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY
_______________________________
PRODUCT
Source Plasma, Recall # B-2098-5
CODE
Unit numbers: NG0042056, NG0042192, NG0042536, NG0042653, and NG0043315
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and facsimile
on January 14, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor whose suitability pertaining
to risk factors for Creutzfeldt-Jakob Disease (CJD) was not adequately determined,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
KY
_______________________________
PRODUCT
Granulocytes Pheresis, Recall # B-2108-5
CODE
Unit number: 22KG86650
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone
on June 10, 2005 and by letter dated June 13, 2005. Firm initiated recall
is complete.
REASON
Blood product, which was found to contain clots during collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2115-5;
b) Red Blood Cells (Apheresis), Leukocytes
Reduced, Recall # B-2116-5;
c) Recovered Plasma, Recall # B-3117-5
CODE
a) and c) Unit number: 4490272;
b) Unit numbers: 4926463 and 4864343 (both units distributed as two split
products)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma
City, OK, by facsimile on January 20, 2005.
Manufacturer: Oklahoma Blood Institute, Midwest City Donor Center, Midwest
City, OK. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of travel
to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob
Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
OK, NY, and Switzerland
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2130-5
CODE
Unit numbers: 6877726 and 6874169
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on August 24, 2004.
Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an
area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO and FL
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2131-5;
b) Red Blood Cells, Leukocytes
Reduced, Recall # B-2132-5
CODE
a) Unit number: 7065977;
b) Unit number: 7077577
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on August 28, 2004.
Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an
area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO and FL
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2133-5;
b) Red Blood Cells, Leukocytes
Reduced Irradiated, Recall # B-2134-5;
c) Platelets, Recall # B-2135-5
CODE
a) Unit numbers: 4772170, 4700592, 4640562;
b) Unit number: 4715188;
c) Unit numbers: 47721701, 4640562
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by
fax on march 3, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the drug Sulfazine,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
OK, TX, TN, NY, and Switzerland
_______________________________
PRODUCT
Source Plasma, Recall # B-2139-5
CODE
Unit numbers: 0141124187, 0141123722, 0141122896, 0141122168, 0141121831,
0141121191, 0141120772, 0141120285, 0141119865, 0141118983, 0141118505, 0141118052,
0141117499, 0141116526, 0141116116, 0141115633, 0141115276, 0141114762, 0141114345,
0141113743, 0141112868, 0141111085, 0141110809, 0141110204, 0141109779, 0141109263,
0141108818, 0141108306, 0141107986, and 0141107431
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Tulsa, OK, by facsimile on May 29, 2003. 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
30 units
DISTRIBUTION
England
_______________________________
PRODUCT
Red Blood Cells (Apheresis), Recall # B-2140-5
CODE
Unit number: 4754992 (distributed as two split units)
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on June 25, 2004.
Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose health history screening was
inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2141-5;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-2142-5;
c) Red Blood Cells, Leukocytes Reduced
Washed, Recall # B-2143-5;
d) Red Blood Cells (Apheresis), Leukocytes
Reduced, Recall # B-2144-5;
e) Platelets, Leukocytes Reduced,
Recall # B-2145-5;
f) Fresh Frozen Plasma, Recall # B-2146-5;
g) Plasma, Recall # B-2147-5
CODE
a) Unit numbers 042FX34551, 042FX35398,
042FY58190, 042L19070, 042R76479,
and 042R77693;
b) Unit numbers 042FX33846, 042FH30779, 042FH30780, 042FH30782, 042X94568,
042X94570, 042X94602, 042X94614, 042T30464, 042FH31276, 042FH31284, 042R77086,
042FX36022, 042R77591, 042R77621, 042R77624, 042R77625, 042R77685, 042X96838,
042GE15875, 042S02669, 042FZ06199, 042R78472, 042X98880, 042R76223, 042K73988,
042K73992, 042K73993, 042GC09745, 042GC09768, 042FR09981, 042GC09750, 042GC09765,
042FR09994, 042K74143, 042K74169, 042GC09747, 042GC09761, 042FG09487, 042FG09488,
042FH30762, 042FH30765, 042FH30771, 042FH30774, 042FG09483, 042FH30767, 042FP02721,
042FP02725, 042FH30754, 042FH30769, 042X94592, 042X94610, 042X94618, 042FX33838,
042X94560, 042X94624, 042FG09492, 042FX33831, 042R76481, 042R76482, 042T30425,
042T30436, 042T30437, 042FH31105, 042FT49513, 042G52046, 042FX34580, 042FT49721,
042FH31270, 042FX34554, 042FX34561, 042FG10078, 042FT49748, 042FH31282, 042FH31313,
042FP03348, 042FP03354, 042FP03358, 042GC10428, 042FP03343, 042FG10089, 042FG10097,
042GC10425, 042GE15009, 042GE15010, 042FH31404, 042FH31409, 042FX34601, 042GC10503,
042K75109, 042GC10482, 042GC10484, 042GC10485, 042GC10487, 042GC10490, 042GC10492,
042GC10495, 042K75111, 042FX35176, 042FX35212, 042FX35220, 042FX35229, 042FJ27049,
042FX35494, 042FX35456, 042FY56777, 042FY56782, 042FY56786, 042FY56792, 042FP03829,
042FY56816, 042R77203, 042R77213, 042L18833, 042L18835, 042L18836, 042GE15440,
042FP04063, 042FP04066, 042FP04069, 042J54665, 042FX35858, 042FX35862, 042L19078,
042FP04067, 042FX36064, 042FX36070, 042FX36035, 042FX36042, 042FX36046, 042FX36047,
042FX36053, 042FX36055, 042FH32372, 042FH32358, 042FH32384, 042X96405, 042FY57453,
042FY57460, 042R77587, 042X96674, 042X96682, 042FZ05962, 042FZ05974, 042L19493,
042R77683, 042FZ05959, 042FZ05965, 042X96824, 042X96827, 042H43423, 042H43425,
042H43427, 042H43429, 042H43438, 042H43439, 042H43440, 042GC11286, 042H43422,
042FH32827, 042FH32829, 042GE15865, 042GC11285, 042GC11287, 042FX36783, 042FR12454,
042FR12467, 042FR12461, 042FR12465, 042FR12495, 042T32288, 042T32293, 042T32311,
042T32400, 042S02594, 042S02579, 042FY58195, 042FY58201, 042FY58205, 042FZ06209,
042X97413, 042X97445, 042X97457, 042X97471, 042FG11467, 042FG11468, 042GC11767,
042GC11771, 042FH33486, 042K76804, 042GC11757, 042K76801, 042K76806, 042K76808,
042L20495, 042L20510, 042L20514, 042L20535, 042X98875, 042X98896, 042X98925,
042X98944, 042GC10214, 042H42916, 042R77075, 042FX36033, 042J54813, 042J54817,
042J54822, 042X97403, 042K76799, 042GC11415, 042GC10411, 042R77060, 042FP03870,
042R77700, 042GE15851, 042FH32831, 042FY58220, 042FZ06200, 042GC09763, 042R76496,
042T30454, 042T30456, 042GC10417, 042GC10426, 042GC10430, 042GC10432, 042FX35181,
042FX35453, 042FX35462, 042FX35463, 042FX35473, 042GE15434, 042R77688, 042R77689,
042S02574, 042S02586, 042FH33491, 042GC11765, 042R78490, 042FP05068, 042K74146,
042FX34582, 042FG10076, 042GC10422, 042FP03869, 042R77214, 042R77221, 042L18826,
042L18830, 042J54604, 042J54606, 042X96609, 042FZ05971, 042X96785, 042GE15868,
042GE15872, 042FH32865, 042S02654, 042L20492, 042R78474, 042X98878, 042FT49719,
042FH31306, 042K75122, 042FH32360, 042R77218, 042X96616, 042L20506, 042FY56784,
042X96628, 042FR10012, 042X94571, 042X94608, 042FY56157, 042J54663, 042X97452,
042GC11407, 042FR10001, 042J54816, 042J54820, 042X96699, 042X97476, 042X94562,
042X94575, 042X94579, 042X94499, 042FR09988, 042T30422, 042T30460, 042T30463,
042FH31295, 042FH31300, 042FH31383, 042FH31390, 042R77050, 042R77053, 042FP03830,
042FP03860, 042R77225, 042FW26094, 042R77593, 042X96834, 042X96835, 042G53376,
042FX33669, 042R76486, 042FT49543, 042FP03338, 042FX35201, 042FX35199, 042FX35226,
042R77079, 042FX35460, 042FX35475, 042FP03826, 042FP03841, 042R77215, 042L18834,
042FX35895, 042J54667, 042FX36027, 042FW26097, 042X96658, 042FZ05966, 042FZ05967,
042L19496, 042X96789, 042H43428, 042T32372, 042S02583, 042FP04807, 042FP04783,
042FP04786, 042FP04792, 042R76222, 042R76225, 042FR09977, 042FG09782, 042FH31107,
042FY56155, 042FH31403, 042FH31400, 042FX35209, 042FY56794, 042FX35866, 042FX35867,
042FP04048, 042R77709, 042R77702, 042T32395, 042K76431, 042S02589, 042GC11409,
042FH33515, 042FR09990, 042FH30749, 042T30431, 042FG10082, 042GC10494, 042J54597,
042FW26116, 042FX36802, 042FH33488, 042K74024, 042K74025, 042FR09982, 042K74178,
042T30423, 042FR10009, 042FR10017, 042K73990, 042K74176, 042FG09477, 042FG09486,
042FG09490, 042FH30759, 042FP02722, 042FX33664, 042FX33840, 042FG09789, 042FG09787,
042T30434, 042FT49527, 042FY56150, 042FY56151, 042FY56163, 042FX34584, 042FH31308,
042FP03359, 042FP03345, 042FP03346, 042FH31280, 042FH31387, 042R77059, 042R77092,
042R77093, 042H42922, 042FJ27048, 042R77223, 042GE15443, 042R77230, 042FP04049,
042FH32370, 042FW26095, 042FW26119, 042X96670, 042X96689, 042L19487, 042H43437,
042FH32825, 042FH32833, 042GE15867, 042GE15870, 042FR12501, 042FY58193, 042X97449,
042FZ06208, 042J55718, 042R78494, 042R78488, 042L20623, 042L20615, 042X98939,
042X98915, 042GC09754, 042FX33661, 042FP02724, 042FX33843, 042FR10019, 042T30406,
042T30407, 042FG09791, 042FG09793, 042FY56116, 042T30542, 042FX34609, 042FX34619,
042FH31286, 042FH31288, 042FH31292, 042FH31287, 042FT49521, 042K75113, 042K75120,
042FX35207, 042R77054, 042R77072, 042FJ27041, 042T30473, 042FX35391, 042FX35399,
042FX35401, 042FY56818, 042FJ27039, 042FX35459, 042FX35476, 042R77456, 042R77458,
042R77460, 042R77465, 042R77466, 042FW26088, 042X96667, 042R77692, 042L19495,
042L19509, 042FG10978, 042FX36759, 042FX36766, 042FX36771, 042FR12476, 042FR12498,
042FX36805, 042S02592, 042GC11412, 042X97417, 042FP04788, 042FP04791, 042FZ06210,
042FH33507, 042G53375, 042FH33494, 042K76825, 042GC11753, 042L20459, 042L20470,
042L20539, 042FR13595, 042FR09984, 042GC09752, 042GC09756, 042GC09769, 042FX33678,
042FH30761, 042GC09748, 042X94511, 042T30439, 042T30448, 042T30462, 042T30466,
042T30452, 042FT49646, 042FT49751, 042FT49755, 042FH31394, 042K75115, 042T30428,
042FX35210, 042FX35215, 042FX35217, 042FX35219, 042FX35221, 042R77089, 042R77098,
042H42915, 042FJ27032, 042FJ27036, 042FJ27040, 042R77227, 042FX36075, 042FH32362,
042FY56788, 042X96414, 042R77704, 042FG10981, 042H43432, 042FX36782, 042S02644,
042FG10984, 042GE15855, 042G53378, 042GC11748, 042L20555, 042FR13606, 042FY58198,
042T30430, 042FX34586, 042GC10419, 042FX35165, 042T30467, 042FX34600, 042FH32378,
042FR12504, 042T32362, 042S02611, 042S02626, 042G53380, 042FZ06211, 042L20483,
042X98886, 042FT49760, 042FX34615, 042FZ05972, 042GE15447, 042GE15438, 042FH32383,
042X96686, 042X96781, 042FG10979, 042FH32380, 042S02655, 042X97462, 042X97467,
042X97483, 042GC11760, 042FR09996, 042FR09998, 042X94495, 042T30446, 042T30458,
042T30472, 042FX34546, 042FH31298, 042FX35163, 042R77085, 042FP03827, 042FP03832,
042FP04068, 042FX36072, 042FH32364, 042GC11283, 042FY58214, 042K76810, 042L20541,
042X98931, 042X98940, 042FT49549, 042FH31272, 042FP03857, 042FP03864, 042FH32375,
042FW26102, 042FW26106, 042FW26108, 042FW26112, 042X96773, 042FY58203, 042FX36061,
042FX36063, 042K74140, 042X94507, 042FP03341, 042FP03352, 042FP03353, 042FH31406,
042FG10080, 042R77063, 042FP03866, 042FP03867, 042H43433, 042FH30776, 042FX33848,
042K73986, 042T30411, 042T30413, 042T30424, 042GC10431, 042FP03362, 042FP03363,
042K75116, 042R77101, 042R77102, 042FP03859, 042J54523, 042FZ05960, 042GE15858,
042FR12464, 042GE15874, 042K76423, 042K76419, 042S02647, 042FY58199, 042FG11465,
042FH33512, 042GC11759, 042X98891, 042X98935, 042FY56160, 042FP03350, 042FT49757,
042FR10825, 042T32300, 042J55715, 042GC10216, 042GE15449, 042X94587, 042T30539,
042T30541, 042K75107, 042FX35202, 042R77057, 042FX35395, 042J54648, 042FX36076,
042X96660, 042X96661, 042FY57458, 042H43426, 042FP04782, 042FP04787, 042FP04790,
042FH33497, 042L18824, 042L20503, 042FH30772, 042FH30757, 042T30404, 042FG09796,
042FG09797, 042T32307, 042K76426, 042K74017, 042K74018, 042T30440, 042FX34548,
042K75124, 042GE15455, 042X96625, 042K74020, 042K74023, 042FG09784, 042GC10213,
042FT49531, 042FX34589, 042FX34606, 042T30426, 042FH31316, 042FP03339, 042FG10073,
042FG10086, 042R77082, 042R77088, 042FJ27038, 042L18846, 042GE15436, 042X96620,
042R77690, 042R77713, 042H43435, 042X96777, 042FX36051, 042H43419, 042S02666,
042G53379, 042GC11756, 042L20531, 042FR13638, 042L18828, 042X98911, 042FP03862,
042FX35496, 042R76494, 042FX35853, 042FW26091, 042FX33836, 042J54609, and
042J54610;
c) Unit number 042R77707;
d) Unit numbers 042C18623, 042C18624, 042C18625,
042C18928, 042C18984, 042C18992, 042C19002,
042C19009, 042C19015, 042C19016, 042C19019,
042E47449, 042E51634, 042E51999, 042E52000,
042E52003, 042E52126, 042E52128, 042N24042,
042N24257, 042N24263, 042Y50552, 042Y50558,
042Y50600, 042Y50601, and 042Y50602
(all units except 042N24042 and 042N24263
distributed as two split products);
e) Unit numbers 042FX33678, 042FR09977, 042FR09990, 042FR10009, 042FR10012,
042FR10017, 042GC09768, 042K74140, 042K74143, 042K74146, 042FH30761, 042FH30762,
042FH30767, 042FH30769, 042FH30771, 042FH30772, 042FH30774, 042FH30779, 042FH30780,
042FH30782, 042X94495, 042X94499, 042X94507, 042X94511, 042R76494, 042R76496,
042T30425, 042T30439, 042T30440, 042T30448, 042T30458, 042T30462, 042T30464,
042T30472, 042T30473, 042FT49513, 042FT49521, 042FT49527, 042FT49531, 042FT49543,
042FT49748, 042FT49755, 042FT49757, 042FX34580, 042FX34582, 042FX34584, 042FH31308,
042FG10078, 042FH31394, 042K75113, 042K75115, 042K75116, 042K75122, 042K75124,
042GC10503, 042R77079, 042R77082, 042R77088, 042R77092, 042R77093, 042R77098,
042R77101, 042R77102, 042R77230, 042FP03869, 042GE15455, 042FX35858, 042FP04066,
042FP04068, 042FX36022, 042FX36076, 042FH32360, 042FH32372, 042FH32375, 042FH32378,
042FH32380, 042FH32384, 042FW26088, 042FW26091, 042X96414, 042FY57453, 042FY57458,
042FY57460, 042FZ05967, 042FZ05971, 042FZ05972, 042FZ05974, 042X96824, 042X96834,
042X96835, 042GE15874, 042GC11283, 042GC11285, 042GC11286, 042GE15870, 042FH32865,
042FX36802, 042FX36805, 042T32288, 042T32293, 042T32300, 042T32307, 042K76419,
042K76431, 042S02626, 042FY58214, 042FP04807, 042X97417, 042X97445, 042X97449,
042X97452, 042FH33507, 042K76825, 042R78486, 042R78487, 042R78488, 042R78490,
042R78494, 042X98915, 042T30426, 042S02669, 042R76222, 042R76225, 042R76223,
042FX35207, 042FX35210, 042FX35212, 042FX35217, 042R77057, 042R77059, 042FJ27041,
042X96660, 042X96674, 042FH33515, 042X98925, 042FH32358, 042FH32364, 042FH32370,
042GE15868, 042GE15872, 042GE15875, 042X94571, 042FR09982, 042K74023, 042X94560,
042X94587, 042X94614, 042FH31105, 042FR10825, 042R77704, 042R77709, 042T32400,
042K76423, 042FH33512, 042X98918, 042X98939, 042GC09769, 042T20454, 042T30446,
042T30460, 042FW26108, 042L19509, 042FZ06211, 042X96405, 042FW26102, 042FW26112,
042FR10007, 042FR10019, 042GC09767, 042FX33846, 042X94562, 042R77060, 042R77089,
042FJ27051, 042FY56818, 042J54663, 042FX36027, 042X96827, 042T32362, 042S02666,
042X98935, 042X98944, 042K74020, 042FR09994, 042FR09995, 042FR09996, 042K74178,
042X94602, 042X94608, 042T30452, 042FX34609, 042FX34615, 042FX34619, 042FX35219,
042FX35221, 042FX35866, 042FX35867, 042FP04069, 042FH32362, 042FW26094, 042FW26095,
042FW26097, 042X96689, 042L19493, 042L19495, 042L19496, 042G53380, 042L20615,
042X98922, 042FX33682, 042J54665, 042X96682, 042X96699, 042FX35853, 042FR12504,
042K74025, 042FH30776, 042X94618, 042FX35895, 042R77713, 042FX35215, 042FX35220,
042FX35226, 042FX35229, 042FT49721, 042X94579, 042FH30749, 042FP04067, 042K74017,
042K74018, 042X94610, 042X94582, 042FX34586, 042FX34600, 042FH31313, 042FX35209,
042R77086, 042FY56816, 042FP03866, 042FP03867, 042G53379, 042GC11770, 042X98910,
042X98911, 042X98940, 042FR13635, 042FH30759, 042FH31306, and 042FX34601
f) Unit numbers: 042FG10078, 042FH30749, 042FH30754, 042FH30757, 042FH30759,
042FH30761, 042FH30762, 042FH30769, 042FH30774, 042FH30776, 042FH31306, 042FH31308,
042FH31313, 042FH31394, 042FH32358, 042FH32360, 042FH32364, 042FH32865, 042FP04066,
042FP04067, 042FP04069, 042FP04807, 042FR09990, 042FR09994, 042FR09995, 042FR09996,
042FR09998, 042FR10825, 042FT49513, 042FT49521, 042FT49527, 042FT49531, 042FT49543,
042FT49549, 042FT49748, 042FX35853, 042FX35858, 042FX35862, 042FX36022, 042FX36805,
042FY57458, 042FY58214, 042FZ05967, 042FZ06211, 042GC09767, 042GC09768, 042GC09769,
042GC11283, 042GC11285, 042GC11286, 042GC11287, 042K74140, 042K74143, 042K74146,
042K74169, 042K74176, 042K74178, 042K75113, 042K75115, 042K75116, 042K75122,
042K75124, 042K76419, 042K76423, 042K76426, 042K76431, 042L19493, 042L19495,
042L19496, 042L19509, 042R76223, 042R76225, 042R76494, 042R76496, 042R77057,
042R77059, 042R77060, 042R77063, 042R77072, 042R77079, 042R77082, 042R77086,
042R77087, 042R77088, 042R77089, 042R77092, 042R77093, 042R77095, 042R77098,
042R77101, 042R77102, 042S02626, 042S02666, 042T30464, 042T30467, 042T30472,
042T30473, 042T32288, 042T32293, 042T32300, 042T32307, 042X94495, 042X94499,
042X94507, 042X94511, 042X97417, and 042X98915
g) Unit numbers 042FR10007, 042FR10019,
042FX33682, 042GE15013, 042GE15855,
042J55716, 042K73986, 042L20506, 042R77217,
042R77588, 042R77593, 042R78487, 042S02654,
042T30452, and 042X94582
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by
facsimile on November 23, 2004, and by letter on December 15, 2004. Firm
initiated recall is complete.
REASON
Blood products, collected from donors whose health history screening was
inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1147 units
DISTRIBUTION
OH, MD, CA, and PA
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2149-5
CODE
Unit number: 6592193
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on September 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
1 unit
DISTRIBUTION
FL
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2150-5
CODE
Unit number: 6592192
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on September 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
1 unit
DISTRIBUTION
CO
_______________________________
PRODUCT
Source Plasma, Recall # B-2151-5
CODE
Unit numbers: GA0888307, GA0895379, GA0899593, GA0909357, GA0913068, GA0914597,
GA0923553, GA0923913, GA0924732, GA0925021, GA0926052, GA0926451, GA0927081,
GA0927438, GA0927951, GA0928221, GA0928904, GA0929223, GA0929728, GA0929988,
GA0930847, GA0931331, GA0931784, GA0932305, and GA0932878
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Gallup, NM, by facsimile on April 25, 2003. Firm initiated
recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk
factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
Austria
_______________________________
PRODUCT
Source Plasma, Recall # B-2152-5
CODE
Unit number: 04OUTB2722
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, LP, Ogden, UT, by facsimile on September 30, 2004.
Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had engaged in multiple
high risk behavior activities, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2153-5
CODE
Unit number: 6592459
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on September
21, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2154-5
CODE
Unit number: 6914771
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on October
4, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2155-5
CODE
Unit numbers: 6613656 and 7072988
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on September
21, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an
area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC and VA
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2156-5
CODE
Unit numbers: 6640114 and 6657864
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on September
21, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an
area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2157-5;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-2158-5
CODE
a) Unit number: 7066389;
b) Unit number: 7080480
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on October
26, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an
area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2159-5
CODE
Unit numbers: 7084752 and 6628334
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on November
10, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an
area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO and KS
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2160-5
CODE
Unit numbers: 6595207 and 6591328
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on November
11, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an
area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO and MS
_______________________________
PRODUCT
Red Blood Cells, Recall # B-2161-5
CODE
Unit number: 7087121
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on November
23, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2162-5
CODE
Unit number: 6896937
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on November
19, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2163-5;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-2164-5
CODE
a) Unit number: 7070904;
b) Unit number: 7085632
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on November
30, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an
area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO
_______________________________
PRODUCT
Red Blood Cells, Recall # B-2165-5
CODE
Unit number: 7079610
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on December
10, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2166-5
CODE
Unit numbers: 6597210, 6593687. and 6590895
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on December
21, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO, MS, and TN
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2167-5
CODE
Unit number: 6592017
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on October
21, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
_______________________________
PRODUCT
Platelets, Recall # B-2172-5
CODE
Unit number: 1635572
RECALLING FIRM/MANUFACTURER
Carter Blood Care, Bedford, TX, by telephone on March 7, 2005 and by letter
on March 15, 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
TX
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2188-5
CODE
Unit number: 4233197
RECALLING FIRM/MANUFACTURER
Carter Blood Care, Bedford, TX, by letter on July 19, 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
Red Blood Cells (Apheresis), Leukocytes Reduced, Recall # B-2189-5
CODE
Unit number: 9336486 (distributed as two split units)
RECALLING FIRM/MANUFACTURER
Carter Blood Care, Bedford, TX, by telephone on November 24, 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
TX
_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-2190-5
CODE
Unit number: 1150472
RECALLING FIRM/MANUFACTURER
Carter Blood Care, Bedford, TX, by letter on November 15, 2004. Firm initiated
recall is complete.
REASON
Blood product, corresponding to a unit of Red Blood Cells that was possibly
contaminated with coagulase negative Staphylococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2191-5;
b) Platelets, Recall # B-2192-5
CODE
a) Unit numbers: 6256276, 6206054,
and 2884640;
b) Unit number: 6256276
RECALLING FIRM/MANUFACTURER
Carter Blood Care, Bedford, TX, by letter on December 22, 2004. Firm initiated
recall is complete.
REASON
Blood products, that tested negative for the antibodies to human T lymphotropic
virus, types I and II (anti-HTLV-I/II), but were collected from an ineligible
donor due to previous positive testing for anti-HTLV-I/II, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX
_______________________________
PRODUCT
Red Blood Cells, Recall # B-2193-5
CODE
Unit number: 6911434
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 4, 2004.
Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2194-5
CODE
Unit number: 6952426
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 4, 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
MA
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2195-5
CODE
Unit number: 6535653
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on April 26,
2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2196-5
CODE
Unit number: 6535654
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on April 26,
2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2197-5
CODE
Unit number: 6891314
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on April 22,
2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2198-5
CODE
Unit number: 6644379
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on April 14,
2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
_______________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced, Recall # B-2201-5
CODE
Unit numbers: 6781472 (parts 1&2)
RECALLING FIRM/MANUFACTURER
Carter Blood Care, Bedford, TX, by telephone on July 28, 2005. Firm initiated
recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical
history questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2219-5
CODE
Unit number: 4678936
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on February 19,
2004. Firm initiated recall is complete.
REASON
Blood product, which failed to meet the minimum specifications for product
volume and red blood cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2221-5;
b) Platelets, Recall # B-2222-5;
c) Platelets, Irradiated, Recall # B-2223-5
CODE
a) Unit numbers: 4672445, 4672447, 4672448,
4672449, 4672450, 4672451, 4672453, 4672455;
b) Unit number: 4672448;
c) Unit number: 4672449
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on March 24,
2004. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility
of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
TX
_______________________________
PRODUCT
Recovered Plasma, Recall # B-2004-5
CODE
Unit numbers: 50E21305, 50G52170
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH,
by facsimile dated July 30, 2004, or by letter dated August 3, 2004. Firm
initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Hodgkinís Lymphoma,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH, IN, MN, CA, and Switzerland
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2099-5;
b) Platelets, Recall # B-2100-5;
c) Fresh Frozen Plasma, Recall # B-2101-5
CODE
a) Unit numbers: W1638220, 1640536,
and W1637065;
b) Unit number: W1637065;
c) Unit numbers: W1638220, 1640536,
and W1637065
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Inc., Trenton, NJ, by facsimile on
April 17, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had undergone a cornea
transplant, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
NJ
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2109-5
CODE
Unit number: 22KX73918
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone
on June 10, 2005 and by letter dated June 13, 2005. Firm initiated recall
is complete.
REASON
Blood product, which was incorrectly typed for C antigen, but was labeled
as negative for C antigen, was distribted.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
_______________________________
PRODUCT
Platelets Pheresis, Irradiated, Recall # B-2110-5
CODE
Unit number: 42KW00012
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northern Ohio Region, Cleveland, OH, by letter
dated June 17, 1999. Firm initiated recall is complete.
REASON
Blood product, which may have reached an unacceptable temperature during
shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
_______________________________
PRODUCT
Recovered Plasma, Recall # B-2136-5
CODE
Unit numbers: 4772170, 4715188, 4700592, 4640562
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by
fax on March 3, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the drug Sulfazine,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OK, TX, TN, NY, and Switzerland
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2137-5;
b) Red Blood Cells, Leukocytes Reduced
Irradiated, Recall # B-2138-5
CODE
a) Unit numbers: 7005400, 6995791,
7001489, and 7000207;
b) Unit numbers: 7001451
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on September 17, 2004. Firm initiated
recall is complete.
REASON
Blood products, that were labeled leukoreduced but had an elevated white
blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
TX
_______________________________
PRODUCT
Recovered Plasma, Recall # B-2148-5
CODE
Unit numbers: 042L19487, 042FR09977, 042FR09982, 042FR09984, 042FR09988,
042FR10001, 042FR10009, 042FR10012, 042FR10017, 042GC09745, 042GC09747, 042GC09748,
042GC09750, 042GC09752, 042GC09754, 042GC09756, 042GC09763, 042GC09765, 042K73988,
042K73990, 042K73992, 042K73993, 042K73998, 042K74017, 042K74018, 042K74020,
042K74023, 042K74024, 042K74025, 042R76222, 042FX33661, 042FX33664, 042FX33669,
042FG09477, 042FG09483, 042FG09486, 042FG09487, 042FG09488, 042FG09490, 042FG09492,
042FH30767, 042FH30771, 042FH30772, 042FH30779, 042FH30780, 042FH30782, 042FP02721,
042FP02722, 042FP02724, 042FP02725, 042FR09981, 042FX33678, 042FX33831, 042FX33836,
042FX33840, 042FX33843, 042FX33846, 042R76481, 042R76482, 042R76486, 042T30428,
042T30430, 042T30431, 042T30434, 042T30436, 042T30437, 042T30439, 042T30440,
042T30446, 042T30448, 042T30454, 042T30456, 042T30458, 042T30460, 042T30462,
042T30463, 042T30466, 042X94560, 042X94562, 042X94568, 042X94570, 042X94571,
042X94575, 042X94579, 042X94587, 042X94592, 042X94602, 042X94608, 042X94610,
042X94614, 042X94618, 042X94624, 042FG09782, 042FG09784, 042FG09787, 042FG09789,
042FG09791, 042FG09793, 042FG09796, 042FG09797, 042FH31105, 042FH31107, 042FY56150,
042FY56151, 042FY56155, 042FY56157, 042FY56160, 042FY56163, 042GC10213, 042GC10214,
042GC10216, 042R76479, 042T30404, 042T30406, 042T30407, 042T30411, 042T30413,
042T30422, 042T30423, 042T30424, 042T30425, 042T30426, 042FG10073, 042FG10076,
042FH31272, 042FH31276, 042FH31280, 042FH31282, 042FH31284, 042FH31286, 042FH31287,
042FH31288, 042FH31292, 042FH31295, 042FH31298, 042FH31300, 042FH31316, 042FP03338,
042FP03339, 042FP03341, 042FP03343, 042FP03345, 042FP03346, 042FP03348, 042FP03350,
042FP03352, 042FP03353, 042FP03354, 042FP03358, 042FP03359, 042FP03362, 042FP03363,
042FT49646, 042FT49719, 042FT49721, 042FT49751, 042FT49755, 042FT49757, 042FT49760,
042FX34546, 042FX34548, 042FX34551, 042FX34554, 042FX34561, 042FY56116, 042G52046,
042T30539, 042T30541, 042T30542, 042FG10080, 042FG10082, 042FG10086, 042FG10089,
042FG10097, 042FH31270, 042FH31383, 042FH31387, 042FH31390, 042FX34580, 042FX34582,
042FX34584, 042FX34586, 042FX34589, 042FX34600, 042FX34601, 042FX34606, 042FX34609,
042FX34615, 042FX34619, 042GC10411, 042GC10417, 042GC10419, 042GC10422, 042GC10423,
042GC10425, 042GC10426, 042GC10428, 042GC10431, 042GC10432, 042GC10433, 042GE15009,
042GE15010, 042FH31400, 042FH31403, 042FH31404, 042FH31406, 042FH31409, 042FX35163,
042FX35165, 042FX35176, 042FX35181, 042FX35199, 042FX35201, 042FX35207, 042FX35209,
042FX35210, 042FX35212, 042FX35215, 042FX35217, 042FX35219, 042FX35220, 042FX35221,
042FX35226, 042FX35229, 042GC10482, 042GC10484, 042GC10485, 042GC10487, 042GC10490,
042GC10494, 042GC10495, 042GC10503, 042K75107, 042K75109, 042K75111, 042R77050,
042R77053, 042R77054, 042FJ27032, 042FJ27036, 042FJ27038, 042FJ27040, 042FJ27041,
042FJ27049, 042FJ27051, 042FP03827, 042FP03829, 042FP03830, 042FP03832, 042FP03841,
042FP03857, 042FP03859, 042FP03860, 042FP03864, 042FP03869, 042FX35391, 042FX35395,
042FX35398, 042FX35399, 042FX35453, 042FX35456, 042FX35459, 042FX35460, 042FX35462,
042FX35473, 042FX35475, 042FX35476, 042FX35494, 042FX35496, 042FY56777, 042FY56782,
042FY56784, 042FY56786, 042FY56788, 042FY56792, 042FY56794, 042FY56816, 042H42915,
042H42916, 042H42922, 042R77075, 042FP03866, 042FP03867, 042FP03870, 042FY56818,
042J54523, 042L18824, 042L18826, 042L18828, 042L18830, 042L18833, 042L18834,
042L18835, 042L18836, 042L18846, 042R77074, 042R77203, 042R77213, 042R77214,
042R77215, 042R77218, 042R77221, 042R77223, 042R77225, 042R77227, 042R77230,
042FP04049, 042FP04063, 042FP04068, 042FX35866, 042FX35867, 042FX35895, 042GE15434,
042GE15436, 042GE15438, 042GE15440, 042GE15443, 042GE15447, 042GE15449, 042GE15455,
042J54597, 042J54604, 042J54606, 042J54609, 042J54610, 042J54648, 042J54663,
042J54665, 042J54667, 042L19078, 042FH32370, 042FH32372, 042FH32375, 042FH32378,
042FH32380, 042FH32383, 042FH32384, 042FX36033, 042FX36035, 042FX36042, 042FX36046,
042FX36047, 042FX36051, 042FX36053, 042FX36055, 042FX36063, 042FX36064, 042FX36070,
042FX36072, 042FX36075, 042FX36076, 042J54813, 042J54816, 042J54817, 042J54820,
042J54822, 042L19070, 042R77456, 042R77458, 042R77460, 042R77465, 042R77466,
042FW26088, 042FW26091, 042FW26094, 042FW26095, 042FW26097, 042FW26102, 042FW26106,
042FW26108, 042FW26112, 042R77587, 042R77591, 042X96405, 042X96414, 042FY57453,
042FY57460, 042FZ05959, 042FZ05960, 042FZ05962, 042FZ05965, 042FZ05966, 042FZ05971,
042FZ05972, 042FZ05974, 042R77621, 042R77625, 042R77683, 042R77685, 042R77688,
042R77689, 042R77690, 042R77692, 042R77702, 042R77704, 042R77709, 042R77713,
042X96609, 042X96616, 042X96620, 042X96625, 042X96628, 042X96658, 042X96660,
042X96661, 042X96670, 042X96674, 042X96682, 042X96686, 042X96689, 042X96699,
042FG10978, 042FG10979, 042FG10981, 042GE15851, 042GE15858, 042GE15865, 042GE15867,
042GE15868, 042GE15870, 042GE15872, 042GE15874, 042GE15875, 042H43419, 042H43422,
042H43423, 042H43425, 042H43426, 042H43427, 042H43428, 042H43429, 042H43432,
042H43433, 042H43435, 042H43437, 042H43438, 042H43439, 042H43440, 042R77693,
042X96773, 042X96777, 042X96785, 042X96789, 042X96824, 042X96827, 042X96834,
042X96835, 042X96838, 042FH32825, 042FH32827, 042FH32829, 042FH32831, 042FH32833,
042FR12454, 042FR12464, 042FR12465, 042FR12467, 042FX36759, 042FX36766, 042FX36771,
042FX36782, 042FX36783, 042FX36802, 042T32301, 042T32311, 042T32362, 042T32372,
042T32400, 042FR12461, 042FR12476, 042FR12495, 042FR12498, 042FR12501, 042FR12504,
042FX36777, 042FY58193, 042FY58195, 042FY58198, 042FY58199, 042FY58201, 042FY58203,
042FY58205, 042FY58220, 042S02574, 042S02579, 042S02583, 042S02586, 042S02589,
042S02592, 042S02594, 042S02611, 042S02644, 042S02647, 042S02655, 042S02669,
042FP04782, 042FP04783, 042FP04786, 042FP04787, 042FP04788, 042FP04790, 042FP04791,
042FP04792, 042FY58190, 042FZ06199, 042FZ06200, 042FZ06208, 042FZ06209, 042FZ06210,
042G53375, 042G53376, 042G53379, 042G53380, 042GC11409, 042GC11412, 042GC11415,
042X97403, 042X97408, 042X97413, 042X97445, 042X97449, 042X97452, 042X97457,
042X97462, 042X97467, 042X97471, 042X97476, 042X97483, 042FG11465, 042FG11467,
042FG11468, 042FH33486, 042FH33488, 042FH33491, 042FH33494, 042FH33503, 042FH33507,
042FH33512, 042FH33515, 042K76799, 042K76801, 042K76804, 042K76806, 042K76808,
042K76810, 042K76825, 042GC11748, 042GC11753, 042GC11756, 042GC11757, 042GC11759,
042GC11760, 042GC11765, 042J55715, 042J55718, 042GC11407, 042GC11767, 042GC11770,
042GC11771, 042FP05068, 042L20459, 042L20470, 042L20483, 042L20492, 042L20495,
042L20503, 042L20510, 042L20514, 042L20531, 042L20535, 042L20539, 042L20541,
042L20615, 042L20623, 042R78472, 042R78486, 042R78488, 042R78490, 042R78494,
042FJ27051, 042T32301, 042FR10007, 042GC09767, 042FX33682, and 042X94582
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by
facsimile on November 23, 2004, and by letter on December 15, 2004. Firm
initiated recall is complete.
REASON
Blood products, collected from donors whose health history screening was
inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
585 units
DISTRIBUTION
CA, MI and Switzerland
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2180-5;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-2181-5;
c) Platelets, Recall # B-2182-5;
d) Fresh Frozen Plasma, Recall # B-2183-5
e) Recovered Plasma, Recall # B-2184-5
CODE
a) Unit numbers: 7556008;
b) Unit numbers: 5437982, 0187676, 2933715, 2924822,
6255808, and 0099106;
c) Unit numbers: 5437982, 0187676, and 6255808;
d) Unit numbers: 7556008, 2933715, 2924822,
and 6255808;
e) Unit numbers 5437982 and 0187676
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on January 10, 2005. Firm initiated
recall is complete.
REASON
Blood products, collected from an unsuitable donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
TX and Switzerland
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-2185-5;
b) Recovered Plasma, Recall # B-2186-5
CODE
a) and b) Unit numbers: 01KG60355
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, New York-Penn Region, West
Henrietta, NY, by letter on September 17, 2004, and by electronic mail on
October 4, 2004.
Manufacturer: American Red Cross Blood Services, Albany, NY. Firm initiated
recall is complete.
REASON
Blood products, collected from an unsuitable donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY and CA
_______________________________
PRODUCT
Platelets, Recall # B-2187-5
CODE
Unit number: 1598870
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and letter on January 28, 2005.
Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that had a discrepant
collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
In the August 24, 2005 Enforcement Report: Recall # Z-1112-05, PASV Central Venous Catheter was listed as a Class II Recall, it has been determined to be Class III.
_______________________________
PRODUCT
Custom Procedure Trays, containing various configurations of medical and
surgical devices, packed in plastic pouches, labeled in part ***Avid Medical,
The custom procedure tray company***Sterile~Disposable~Single Use Only***,
and further identified by the following catalog numbers: BOOZ001-01 CATARACT
PACK*** VMLR0009-05 FEM POP*** AZSS001-01 SINGLE SHOT EPIDURAL TRAY*** META026-01
SHOULDER*** MPOC002-02 ARTHROSCOPY PACK*** MMMC002 UNIVERSAL ARTHROSCOPY
PACK*** ORHS023-03 OBSTETRICAL PACK W/POUCH*** MSCB002-02 BASIC PACK*** ADVH002-08
OPEN HEART KLICH PACK*** ADVM005-02 PACEMAKER-IL MASONIC*** CILS004-03 EXTREMITY
PACK*** NOIN004 ARTHROGRAM PACK*** RMRI036-11 TOTAL JOINT PACK*** NRSC0003-06
ARTHROSCOPY PACK*** AV10584-03 COMMUNITY RETINAL DETACHMENT*** STJN030-02
HEART DRAPE TRAY*** STJN045 HEART OFF PUMP*** PHLS008-04 SPECIAL PROCEDURES
PACK*** UHSN035-02 TOTAL KNEE*** SLIZ004a-02 CATH TRAY*** NYOD008 Abdominal
Preservation Kit*** NYOD011 PEDIATRIC ABDOMINAL*** FAMC017-05 MAJOR BASIN
SET*** AGAK005-04 BASIN SET-SURGERY CENTER*** AV010773-02 C-SECTION PACK***
OSUM018-04 OPHTHALMOLOGY CUSTOM TRAY*** KENT005-01 CAROTID*** HVCCA-10 HEART
PACK*** SUMM004-04 Harris Basic*** MCVA0020-07 BUNDLE, EYE*** MCVA0025-04
BUNDLE, LOWER EXTREMITY*** MCVA0033-06 PDS, MAJOR EAR*** MCVA0039-06 PDS,
TOTAL KNEE*** MCVA0044-02 PACEMAKER PACK*** NAPO0014-04 LAP CHOLE CUSTOM
TRAY*** NAPO0025-05 HAND & PODIATRY TRAY*** NAPO0061-02 ABDOMINOPLASTY
CUSTOM TRAY*** LIFE0027-06 C.V. TRANSPORT BOX*** WIAS002-01 UNIVERSAL BLOCK
TRAY*** UMCW013-07 TOTAL KNEE PDS***, Recall # Z-1398-05
CODE
Lots: 385569 386370 388085 380910 385604 386873 386153 388558 387906 386224
385726 386714 386721 386142 387590 386731 386732 386337 385262 386756 383386
383385 385819 386706 385980 386074 386472 385660 386649 386409 384525 386543
386410 385493 386849 385945 387453 386357 388777 385542
RECALLING FIRM/MANUFACTURER
Avid Medical, Inc., Toano, VA, by letter on September 7, 2005. Firm initiated
recall is ongoing.
REASON
Defect in packaging of medical devices may compromise sterility of these
products used in medical and surgical procedures.
VOLUME OF PRODUCT IN COMMERCE
4,281 kits
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Linvatec LS 7500, 300 Watt Xenon Light Source Catalog Numbers: LS7500, LS7500L
(loaner), LS7500R (refurbished), Recall # Z-1531-05
CODE
Lot/Serial Numbers: 43293 44784 45788 46207 46200 45794 44545 44546 44558
45809 41542 41544 44739 44810 44751 45791 46217 43316 44210 44271 44548 42025
42905 41487 40550 42914 42917 42919 44736 45850 46151 40533 45792 43271 46117
40580 40534 42878 42099 42899 46113 46243 46099 43243 45777 45855 45857 42902
46185 40572 43304 46204 45848 45852 45813 46216 45775 42891 46199 46202 46129
46143 44237 46127 40527 42885 40555 40582 44826 44777 44775 44803 44761 44802
40548 43283 40546 44262 44275 44267 44268 44785 44812 44770 44786 44788 44827
44791 44794 44778 43284 43971 43301 43973 43273 40570 42073 46209 46218 46159
46244 46240 44799 44809 42065 42054 42070 45764 44797 44783 44820 42895 42894
42892 42999 40579 42889 41560 41563 44753 42097 42106 42880 44547 41998 42017
42014 41993 44565 44570 41527 40565 42884 40568 42102 42888 46182 46164 46168
43254 41561 44549 43269 40528 42068 43312 43306 42006 43249 43238 43281 43282
44767 44764 44765 43285 43270 42069 40562 40549 44224 44220 42896 41517 41531
40560 40557 45782 40545 44218 46212 42071 41507 42088 42077 42105 42095 42094
42091 46184 44763 45801 42108 43977 43972 43311 44746 44208 46114 46121 43278
43297 43277 43300 43296 40581 41520 44573 41571 44266 44264 44269 44252 46192
46213 46205 46187 46220 44567 44572 44559 44279 44563 44560 44277 44281 44282
44569 44283 40563 45821 40577 41989 42013 46181 46179 46157 46180 41567 42067
42076 44738 41490 41482 41494 41546 44749 44755 44754 44231 44227 44229 44787
41554 42886 42033 42040 46102 46109 42064 41532 46103 45798 45808 45806 42012
42011 43288 43287 42007 42008 42027 42907 46123 46146 46156 41515 42001 46210
41565 44550 44553 44221 44228 43247 44251 44248 44234 41569 42890 43262 43250
44814 45787 44774 40573 45780 44552 41483 41479 41498 41488 42915 41997 44831
44798 44828 44773 46115 46124 46122 40541 45835 45828 45776 45826 45827 45804
45830 45823 45825 45829 45824 45810 44745 41547 43308 44209 44758 44766 41541
42909 42107 42096 42100 43970 40558 42913 42911 42875 42877 40532 40569 42883
41555 41574 44830 41533 41535 41506 41510 41513 44801 44813 44815 44795 40543
40544 46237 40535 44258 44233 44247 44244 44256 44250 44241 44259 41518 46155
46163 44272 44270 44273 41575 42066 43246 43266 44274 44808 44821 40523 44800
41529 42015 41994 42009 42021 46120 42109 40530 42910 41519 44780 44734 40529
44762 44574 44562 44554 44759 46174 45785 44816 44817 44748 45771 43242 43268
46171 46169 46176 40552 40553 41481 46119 46148 42897 43252 43251 43256 43253
45836 45838 45846 45847 45840 42089 46118 45795 46132 46137 45822 40559 44806
44771 45768 44807 44805 45770 45767 45831 42026 40531 43294 43305 43295 43299
43298 43307 43310 43263 43968 42041 42039 42049 42044 42056 42050 42038 42055
42057 42052 42045 42047 42053 42046 42048 42061 42062 41990 41987 42036 42035
42079 42090 42882 44811 45860 46107 45853 45861 46111 46105 46106 46101 45858
46104 46110 46098 42916 42904 44551 44561 44557 46152 45839 44796 44743 44285
42103 42893 45805 46224 43287 42004 40551 40554 42920 42922 42918 41525 40566
42037 42042 44235 44240 44236 44207 44239 43313 44238 44243 42873 43978 43976
46129 40547 42912 40571 44732 42104 43272 43303 45820 45819 44253 44257 45778
43244 46100 46226 42906 44818 45773 44284 45814 45807 45786 41566 40576 40567
46135 46112 46142 46140 42098 41540 44265 40540 41512 44556 44280 46130 46170
44768 40542 40561 40564 40034MF 41493
RECALLING FIRM/MANUFACTURER
Linvatec Imaging, Santa Barbara, CA, by letter on August 3, 2005. Firm initiated
recall is ongoing.
REASON
Surface contamination, stress, and excessive heat around the optical taper
surface may result in a low light output that can create poor illumination
of the surgical site.
VOLUME OF PRODUCT IN COMMERCE
810 units
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
a) Boston Scientific brand LeVeen Needle Electrode,
5.0/13/15; Model number M001262160, Ref 26-216,
Recall # Z-1541-05;
b) Boston Scientific brand LeVeen Needle Electrode,
5.0/13/25; Model number M001262170,Ref 26-217,
Recall # Z-1542-05
CODE
a) Lots 31804, 92702, 6538336, 6538341, 6556258,
6556462, 6556464, 6556634, 6826039, 7002067,
7021736, 7091482, 7108067, 7257089, 7356251,
7422492, 7457364, 7664972, 7667650, 21403R,
21703R and 92702R;
b) Lots 7417267, 7481332 and 7606569
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Spencer, IN, by letter dated July 29, 2005. Firm
initiated recall is ongoing.
REASON
Firm has received complaints of extended ablation times, lack of roll-off
and patient burns.
VOLUME OF PRODUCT IN COMMERCE
1,570 units
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test
strips for use with the Senova brand meter only. For in vitro diagnostics
use. Do not store strips outside vial. Discard 3 months after opening, Recall
# Z-1546-05
CODE
Lot numbers: 407061, 4071601, 4071901, 4071902, 4072001, 4072002, 4072201,
4072202, 4072801, 4072802, 4072901, 4072902, 4073001; 4080301, 4080302, 4080303,
4080401, 4080402, 4080601, 4081101, 4081102, 4081601, 4081901, 4082001, 4082002,
4082301, 4082501, 4082502, 4082701, 4083101, 4083102, 4090101, 4090201, 4091601,
4091702, 4092101, 4092201, 4092301, 4092401, 4092701, 4092801, 4092901, 4100101,
4100401, 4100402, 4100501, 4100601, 4101101, 4101201, 4101301, 4101401, 4101801,
4102201, 4102502, 4102601, 4102701, 4102801, 4102901, 4110401, 4110501, 4111101,
4111601 and 4111602
RECALLING FIRM/MANUFACTURER
Recalling Firm: CHdiagnostics, Plymouth, MN, by e-mail, Sales Representatives
visit, and letters on March 14, 2005.
Manufacturer: Cambridge Sensors Limited, Huntingdon, United Kingdom. Firm
initiated recall is ongoing.
REASON
A suspect material used in the manufacturer of the product has degraded over
time and consequently may cause falsely high readings when testing your blood
glucose level.
VOLUME OF PRODUCT IN COMMERCE
43,138 vials
DISTRIBUTION
Nationwide. Greece, Czech Republic, and Singapore
_______________________________
PRODUCT
a) Scanlan Premier Jacobson Micro Scissors, spring
style, flat handle, V-neck, 125-degree angled
micro fine blades, 6-1/4", 16 cm. Catalog Number
7007-449. Recall # Z-1532-05;
b) Scanlan Premier Jacobson Micro Scissors, spring
style, flat handle, V-neck, 125-degree angled micro
fine blades, 8î, 20 cm. Catalog Number 7007-449-8,
Recall # Z-1533-05;
c) SCANLAN Premier Jacobson Micro Scissors, Spring
Style, round handle, V-neck, 125-degree angled
micro fine blades, 6-1/2", 16.5 cm. Catalog no.
7007-499, Recall # Z-1534-05;
d) SCANLAN Premier Jacobson Micro Scissors, spring
style, round handle, V-neck, 125-degree angled
micro fine blades, 8", 20 cm. Catalog no. 7007-499-8,
Recall # Z-1535-05;
e) SCANLAN Premier Jacobson Micro Scissors, spring style,
flat handle, V-neck, 125-degree angled nano blades,
6-1/8", 15.5 cm. Catalog no. 7007-548,
Recall # Z-1536-05;
f) SCANLAN Premier Jacobson Micro Scissors, spring
style, round handle, 90-degree angled nano blades,
6-12", 16.5 cm. Catalog no. 7007-596,
Recall # Z-1537-05;
g) SCANLAN Premier Jacobson Micro Scissors, spring
style, round handle, V-neck, 125-degree angled
nano blades, 6-1/2", 16.5 cm. Catalog no. 7007-598,
Recall # Z-1538-05
CODE
a) Lot numbers: U7A, U7B, U7C, U7D, V7A, V7B, V7C, V7D,
and W7A. The lot numbers are located on the inside
shank of the instrument near the fulcrum. Please note:
If there is a ìTî on the inside shank of one of the
spring handles, the instrument is not included in
this recall;
b) Lot numbers: U7A, U7B, U7C, U7D, V7A, V7B, V7C, V7D
and W7A. The lot numbers are located on the inside
shank of the instrument near the fulcrum. Please note:
If there is a "T" on the inside shank of one of the
spring handles, the instrument is not included in
this recall;
c) Lot numbers: U7A, U7B, U7C, U7D, V7A, V7B, V7C, V7D
and W7A. The lot numbers are located on the inside
shank of the instrument near the fulcrum. Please note:
If there is a "T" on the inside shank of one of the
spring handles, the instrument is not included in
this recall;
d) Lot numbers: U7A, U7B, U7C, U7D, V7A, V7B, V7C, V7D,
and W7A. The lot numbers are located on the inside
shank of the instrument near the fulcrum. Please note:
If there is a ìTî on the inside shank of one of the
spring handles, the instrument is not included in
this recall;
e) Lot numbers: U7A, U7B, U7C, U7D, V7A, V7B, V7C, V7D,
and W7A. The lot numbers are located on the inside
shank of the instrument near the fulcrum. Please note:
If there is a ìTî on the inside shank of one of the
spring handles, the instrument is not included in this
recall;
f) Lot numbers: U7A, U7B, U7C, U7D, V7A, V7B, V7C, V7D,
and W7A;
g) Lot numbers: U7A, U7B, U7C, U7D, V7A, V7B, V7C, V7D,
and W7A
RECALLING FIRM/MANUFACTURER
Scanlan International, Inc., Saint Paul, MN, by letters on July 27, 2005.
Firm initiated recall is ongoing.
REASON
Some scissors purchased before May 1, 2005 may not perform properly. They
may have a crack in the blade that could break.
VOLUME OF PRODUCT IN COMMERCE
159 Scissors
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12,
Recall # Z-1539-05
CODE
Lot numbers 17270M100 and 18177M300
RECALLING FIRM/MANUFACTURER
Abbott Laboratories MPG, Abbott Park, IL, by letter on June 27, 2005. Firm
initiated recall is ongoing.
REASON
The XSYSTEMS Multiconstituent Controls accessory insert (commodity number
34-3067/R6) does not contain the correct control ranges for the AxSYM Opiates
assay.
VOLUME OF PRODUCT IN COMMERCE
4,151 kits
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
VersaTREK Myco AS, Recall # Z-1540-05
CODE
Lot code 144365, exp. date 2005/11
RECALLING FIRM/MANUFACTURER
Trek Diagnostic Systems, Cleveland, OH, by letter dated August 8, 2005. Firm
initiated recall is ongoing.
REASON
Invitro diagnostic test kit used for testing to confirm the presence of tuberculosis
contains interfering bioburden which can cause false positive results.
VOLUME OF PRODUCT IN COMMERCE
29 boxes
DISTRIBUTION
AL, IA, IL, MD, NJ, OH, PA, D.C., Mexico and India
END OF ENFORCEMENT REPORT FOR SEPTEMBER 21, 2005
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