MARCH 2007
WEEK ENDING MARCH 3
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced,
b) Fresh Frozen Plasma
(Apheresis),
c) Red Blood Cells Leukocytes Reduced,
d) Fresh Frozen Plasma,
CODE
a) Unit: 5253220;
b) Units: 5253220,
4482296;
c) and d) Unit: 5202821
RECALLING
FIRM/MANUFACTURER Sylvan N. Goldman Center, Oklahoma Blood Institute, OK
REASON
Blood products, collected from a donor considered
to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION
OK, FL, and LA
PRODUCT Platelets, Pooled
Leukocytes Reduced,
CODE Units: 033FY02069,
033GJ91810, 033GL66664, 033GL66669 and 033GV89310
RECALLING
FIRM/MANUFACTURER American National Red Cross, Connecticut Region,
Farmington, CT,
REASON Blood products,
possibly contaminated with Staphylococcus epidermidis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION CT
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Red Blood Cells,
c) Red Blood Cells, Leukocytes Reduced, Irradiated,
d) Whole Blood,
e) Cryoprecipitated
AHF,
f) Platelets, Leukocytes Reduced,
g) Fresh Frozen Plasma,
h) Plasma, Frozen,
i) Plasma, Cryoprecipitate Reduced,
CODE
a) Units: 022FQ39509, 022FQ39511, 022FQ39512, 022FQ39521,
022FQ39523, 022FX29477, 022FX29479, 022FX29486, 022FX29488, 022FX29491,
022FX29492, 022FX29494, 022FX29498, 022FX29502, 022FX29642, 022FX29643,
022FX29648, 022FX29654, 022FX29662, 022FX29791, 022FX29823, 022FX29828,
022GE94306, 022GE94307, 022GE94308, 022GE94312, 022GE94313, 022GE94318,
022GE94320, 022GE94322, 022GE94431, 022GQ15902, 022GQ15903, 022GQ15909,
022GQ16061, 022GQ16067, 022GQ16070, 022GQ16072, 022GQ16075, 022GQ16077,
022GQ16197, 022GQ16198, 022GQ16203, 022GQ16204, 022KC88954, 022KC88956,
022KC88981, 022KC88984, 022KE32587, 022KE32603, 022KN70992, 022KN70994,
022KN70998, 022LZ11657, 022LZ11658, 022LZ11705, 022LZ11712, 022LZ11719,
022LZ11731, 022LZ11732, 022FM03535, 022FM03539, 022FM03543, 022FM03544,
022FM03547, 022FM03549, 022FQ39741, 022FQ39744, 022FQ39747,
022FQ39748,
022FQ40042, 022FQ40043, 022FQ40045, 022FQ40046, 022FQ40047,
022FQ40049, 022FQ40050, 022FQ40053, 022FQ40237, 022FQ40241, 022FQ40262,
022FQ40269, 022FQ40271, 022FQ40275, 022FQ40277, 022FS46066, 022FX29589,
022FX29592, 022FX29593, 022FX29601, 022GE94405, 022GE94407, 022GE94408,
022GE94411, 022GE94412, 022GG04735, 022GG04739, 022GG04752, 022GG05229,
022GG05231, 022GG05233, 022GG05235, 022GL35092, 022GL35096,
022GL35099,
022KE33679, 022KE33682, 022KE33688, 022KE33690, 022KE33700, 022KE33704, 022KE33708, 022KE34322, 022KK81693, 022KK81696, 022KK81698, 022KK81702,
022KK81707, 022KK81729, 022KK81737, 022KK81742, 022KK81974, 022KK81978,
022KN71049, 022KN71091, 022KN71100, 022KX82833, 022KX83055, 022KX83057,
022KX83058, 022KX83072, 022KX83078, 022KX83091, 022LP16718, 022LP16723,
022LP16726, 022LP16728, 022LP16729, 022LP16734,
022LP16735, 022LP16736;
b)
Units: 022FR00429, 022FX29475, 022KN70990, 022KN70991, 022LP14682;
c) Units:
022GG04749, 022KE34336;
d) Units: 022FR00428, 022FR00430, 022GQ16186,
022GQ16189, 022LL22957, 022LL22961, 022LL22963, 022LL22964, 022LL22966,
022LL22967, 022LL22969, 022LL22970, 022LL22975;
e) Units: 022FC38307,
022FC38312, 022FC38314, 022FC38315, 022FM01476, 022FM01881, 022FM01889,
022FM01908, 022FM01909, 022FQ39521,022FQ39523, 022FX28471, 022FX28472, 022FX28481, 022FX28482, 022FX28486, 022FX29488, 022GM04902, 022GM04910,
022GM04912, 022GQ15264, 022GS23715, 022GS23721, 022GS23722,022KE32603,
022KL30670, 022KL30708, 022KL30715, 022KL30722, 022KL30739, 022KN69595,
022KN69598, 022KN69600, 022KN69604, 022KN70050, 022KN70051, 022KV87386,
022KV87388, 022KV87392, 022KW74309, 022KW74312, 022KW74315, 022KW74326,
022KW74329, 022LP14689, 022LP14693, 022LP14884, 022LP14887,
022LW87979,
022LW87980, 022LW87988, 022LZ11229, 022LZ11658;
f) Units: 022GL35419,
022GL35422, 022GL35424, 022GL35426, 022KE34322, 022KE34336, 022KE34338,
022KE34339;
g) Units (123 units) 022FM01477, 022FM01500, 022FM01503,
022FM01505, 022FM02910, 022FM02914, 022FM03535, 022FM03539, 022FM03544,
022FM03547, 022FM03549, 022FQ37539, 022FQ37543, 022FQ39737, 022FQ39741,
022FQ39742, 022FQ39744, 022FQ39747, 022FQ39748, 022FQ40043, 022FQ40045,
022FQ40046, 022FQ40047, 022FQ40049, 022FQ40050, 022FQ40053, 022FQ40237,
022FQ40241, 022FQ40275, 022FQ40277, 022FS46066, 022FX28427, 022FX28433,
022FX28469, 022FX29185, 022FX29589, 022FX29592, 022FX29823, 022FZ24827,
022FZ24831, 022GE93467, 022GE93470, 022GE93471, 022GE94405, 022GE94407,
022GE94408, 022GE94409, 022GE94411, 022GG04735, 022GG04749, 022GG04752,
022GG05231, 022GG05233, 022GG05235, 022GL35092, 022GL35096, 022GL35099,
022GS22281, 022GS22288, 022KE33459, 022KE33462, 022KE33469, 022KE33471,
022KE33474, 022KE33688, 022KE33690, 022KE33704, 022KE33708,
022KK79489,
022KK79495, 022KK79499, 022KK79511, 022KK79515, 022KK79520, 022KK79522, 022KK79526, 022KK79905, 022KK81693, 022KK81696, 022KK81729, 022KK81737,
022KK81742, 022KK81973, 022KK81976, 022KN69672, 022KN69679, 022KN70019,
022KN70029, 022KN70047, 022KN70048, 022KN71047, 022KN71049, 022KN71052,
022KN71058, 022KN71091, 022KV87019, 022KV87077, 022KV87091, 022KX83055,
022KX83057, 022KX83058, 022KX83072, 022KX83078,
022KX83091, 022LP14694,
022LP14753, 022LP14764, 022LP14772, 022LP14875, 022LP16718, 022LP16723,
022LP16726, 022LP16728, 022LP16729, 022LP16734, 022LP16735, 022LP16736, 022LW87999, 022LZ10913, 022LZ11340, 022LZ11341, 022LZ11508,
022LZ11514;
h) Units: 022FQ39331, 022FQ40267, 022FQ40269, 022FX29662,
022FZ24825, 022FZ24829, 022GM06103, 022KE31972, 022KE31976, 022KK79879,
022KK79885, 022KK81698, 022KK81702, 022KK81707, 022KN68979, 022KV87063,
022KV87067, 022KV87078, 022KV87086, 022KW74283, 022KW74302, 022LP14679,
022LP14745, 022LP14787, 022LP14852, 022LP14853, 022LP14856, 022LP14857,
022LZ10904;
i) Units: 022FM01476, 022FM01886, 022FX29189, 022GM04902,
022KE32587, 022KW74309, 022KW74312
RECALLING FIRM/MANUFACTURER American National Red Cross, Penn-Jersey Region, Philadelphia, PA,
REASON
Blood products, collected from donors whose arm
scrubs may have been incorrectly performed, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 379 units
DISTRIBUTION Pa, NJ, DL, MI,
MD, D.C., VA, and CA
PRODUCT Platelets,
CODE
Units: Y54955, Y53849
RECALLING
FIRM/MANUFACTURER Blood Assurance, Inc., Chattanooga, TN,
REASON
Platelets, manufactured with an incorrect second
spin setting, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TN
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets,
CODE a) and b) Unit: Y49726
RECALLING
FIRM/MANUFACTURER Blood Assurance, Inc., Chattanooga, TN,
REASON Blood
products, collected from a donor for whom donor suitability was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TN
PRODUCT Red Blood Cells,
CODE
Unit: 2506931
RECALLING
FIRM/MANUFACTURER
Recalling Firm: New York Blood Center,
Inc., New York, NY
Manufacturer: New York Blood Center, Inc., Elmsford, NY.
REASON
Blood product, with an
unacceptable hemoglobin value, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NY
PRODUCT
a) Red Blood Cells,
b) Recovered Plasma,
CODE
a) and b) Unit: 4148197
RECALLING
FIRM/MANUFACTURER LifeSource, Glenview, IL,
REASON Blood products, collected from a donor who had
received a body piercing within twelve months of donating, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION IL and Austria
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Fresh Frozen Plasma,
c)
Cryoprecipitated, AHF,
CODE a), b), and c) Unit: KS07332
RECALLING
FIRM/MANUFACTURER Inova Health Care Services, Sterling, Va.,
REASON
Blood products, which tested negative for
hepatitis, but were collected from a donor with a history of Hepatitis A, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION VA
PRODUCT Recovered Plasma,
CODE
Unit: 5202821
RECALLING
FIRM/MANUFACTURER Sylvan N. Goldman Center, Oklahoma Blood Institute, OK
REASON
Blood product, collected from a donor considered
to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OK, FL, and LA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced, Irradiated
b) Recovered Plasma,
CODE a) and b) Unit: 5422863
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center,
Oklahoma City, OK,
REASON Blood products, collected from a donor for whom
donor suitability was not adequately determined, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OK and
Switzerland,
PRODUCT
a) Red Blood Cells,
b) Fresh Frozen Plasma,
CODE
a) and b) Unit: 8304864
RECALLING
FIRM/MANUFACTURER New York Blood Center, Inc. New York, NY,
REASON
Blood products, associated with a unit
of Platelets that was possibly contaminated with gram positive rods, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NY
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Units: 5001707,
5001709, 5001694
RECALLING FIRM/MANUFACTURER Coral Blood Services,
Inc., Scarborough, ME,
REASON Blood
products, which were not leukoreduced within the appropriate time period after
collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION ME
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
9723797
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON
Platelets, which were possibly contaminated with
Bacillus species, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
b) Platelets
Pheresis,
Leukocytes Reduced, Irradiated,
CODE a) and b)
Unit: 040FP26080
RECALLING FIRM/MANUFACTURER American National Red
Cross, Heart of America, Peoria, IL
REASON Platelets, which were possibly
contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION IL
WEEK ENDING MARCH 10
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets,
c) Recovered Plasma,
CODE
a) Units:
4759943, 4677574, 4555912;
b) Units: 4759943, 4555912;
c) Units: 4677574,
4555912
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood products, collected from
a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7
units
DISTRIBUTION MA, OK, TX, and Switzerland
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets,
c) Recovered Plasma,
CODE a), b), and c)
Unit: 5249546
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N, Goldman Center, Oklahoma City, OK
REASON Blood products, collected
from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease
(nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION OK, NB, and Switzerland
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Unit: 5218775
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N, Goldman Center,
Oklahoma City, OK
REASON Blood products, collected from a donor who was at
increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION OK and Switzerland
PRODUCT Platelets, Pheresis,
Leukocytes Reduced,
CODE Unit:
J41312
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA
REASON Blood product, collected in a manner that may
compromise the sterility of the product, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION VA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE Unit: 2157929
RECALLING
FIRM/MANUFACTURER New York Blood Center, Inc., New Brunswick, NJ
REASON
Blood products, collected from a donor who had a
non-confidential health history screening, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION NY
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets,
c) Fresh Frozen Blood,
d) Recovered Plasma,
CODE
a) Units: 5250527, 4901850, 4517058;
b) Units:
4901850, 4517058;
c) Unit: 4517058;
d) Units: 5250527,
4901850
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N.
Goldman Center, Oklahoma City, OK
REASON Blood products, collected from
a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
8
units
DISTRIBUTION OK, TX, Austria, and Switzerland
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Units: 5738052, 5275313,
4801421
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood products, collected
from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease
(nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units
DISTRIBUTION TX, OK, and Switzerland
PRODUCT Platelets, Pheresis,
Leukocytes Reduced,
CODE Unit:
53LP55010
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Baltimore, MD
REASON Blood
product, which did not meet acceptable product specifications, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Maryland
WEEK ENDING MARCH 17
PRODUCT
a) Platelets
Pheresis Leukocytes Reduced,
b) Platelets Pheresis
Leukocytes Reduced Irradiated,
CODE
a) Units:
4053617, 3798340, 5606869, 7685507-1, 7685507-2,
7677707, 7676672, and
7674878;
b) Unit: 4053617
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Beaumont,
TX
REASON Blood products, which
were collected from a donor who had traveled to a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 9
units
DISTRIBUTION TX and NY
PRODUCT FETALSCREEN, Product
Code 780540,
CODE
Lot Number: FS472 Exp. Date
Jan 16, 2007;
Lot Number: FS473 Exp. Date Feb 13, 2007
RECALLING
FIRM/MANUFACTURER Ortho Clinical Diagnostics, Inc., Raritan, NJ
REASON
FETALSCREEN test kits, demonstrating weak or
negative reactivity with the positive control, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Red Blood Cells
b)
Recovered Plasma
CODE a) and b) Unit: 0750553
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood products, collected from an ineligible
donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION VA and Switzerland
PRODUCT Platelets
CODE
Units: L57625, L62332, L56534, L62333, L62331,
L58708, L58711, L58709, L60377
RECALLING FIRM/MANUFACTURER Blood
Assurance Inc., Chattanooga, TN
REASON Platelets, processed in a manner that
may have caused the yield to be below the firm’s specified minimum, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 9
units
DISTRIBUTION GA and TN
PRODUCT
a) Red Blood Cells,
b) Platelets,
CODE
a) and
b) Unit: 6816046
RECALLING FIRM/MANUFACTURER LifeShare Community
Blood Services, Elyria, OH,
REASON Blood products, collected from a donor
with a history of jaundice, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION OH
PRODUCT Red Blood Cells
Leukocyte Reduced,
CODE Unit:
8865355
RECALLING FIRM/MANUFACTURER Florida’s Blood Centers, Inc.,
Orlando, FL,
REASON Blood product, collected from a donor who visited
an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis,
Leukocyte Reduced,
CODE Units: 9931218
(distributed as split product)
RECALLING
FIRM/MANUFACTURER Florida’s Blood Centers, Inc., Orlando, FL,
REASON
Blood products, labeled as leukoreduced, but which
did not meet the requirements for leukoreduced products, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION FL
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit:
113483855
RECALLING FIRM/MANUFACTURER Blood Systems Inc., El Paso,
TX,
REASON Blood product, collected without quality control
testing during apheresis machine validation, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT
a) Platelets
Pheresis Leukocytes Reduced,
b) Platelets Pheresis
Leukocytes Reduced, Irradiated,
CODE
a) Unit:
04GP64828, Part 2 ;
b) Unit: 04GP64828, Part 1
RECALLING
FIRM/MANUFACTURER The American National Red Cross, New England Region,
Dedham, MA
REASON Blood products, collected in a manner
that may have compromised the sterility of the collection system, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NH and NY
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Units: 1674391,
9594017
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood
Center, Indianapolis, IN,
REASON Blood products,
collected from a donor who was taking the drug Aricept, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION IN and Austria
PRODUCT Red Blood Cells,
Leukocytes Reduced, Irradiated,
CODE Units:
Y28792, Y33329
RECALLING FIRM/MANUFACTURER Blood Assurance Inc.,
Chattanooga, TN,
REASON Blood products, incorrectly labeled as irradiated,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION GA
PRODUCT Cryoprecipitated AHF,
CODE
Unit: LG46100
RECALLING
FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island
Blood Center, Providence, RI,
REASON Blood product, corresponding to a unit
of Red Blood Cells that was implicated in a transfusion reaction and possibly
contaminated with Staphylococcus aureus, was distributed,
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NY
PRODUCT Platelets,
CODE
Unit: N88070
RECALLING
FIRM/MANUFACTURER Michigan Community Blood Centers, Grand Rapids, MI
REASON
Blood product, associated with a unit of Red Blood
Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MI
PRODUCT
a) Red Blood Cells
Pheresis, Leukocytes Reduced,
b) Fresh Frozen Plasma Pheresis,
CODE
a) and b) Unit:
5272834
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N. Goldman Center, Oklahoma City, OK,
REASON Blood products,
collected in a manner that may compromise the sterility of the products, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION OK
PRODUCT Red Blood Cells,
Leukocytes, Reduced,
CODE Unit:
H79738
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA,
REASON Blood product, collected from a donor with a
history of melanoma, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION VA
PRODUCT Red Blood Cells,
CODE
Unit: 5541829
RECALLING
FIRM/MANUFACTURER New York Blood Center, New Brunswick, NJ,
REASON
Blood product, which was not quarantined after
receiving post-donation information regarding a history of pneumonia, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT
a) Red Blood Cells
Pheresis, Leukoctyes Reduced,
b) Red Blood Cells,
c) Fresh Frozen Plasma
Pheresis,
d)
Recovered Plasma,
CODE
a) and c) Units:
4961587;
b) and d) Units: 4923250
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center,
Oklahoma City, OK,
REASON Blood products, collected from an ineligible donor
due to a history of a hepatitis and jaundice, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 4 units
DISTRIBUTION OK and
Switzerland
PRODUCT Source Plasma,
CODE
Unit: F-50100-072
RECALLING
FIRM/MANUFACTURER Alpha Therapeutic Corporation, Long Beach, CA,
REASON
Blood product, collected from a donor who was
previously deferred, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1unit
DISTRIBUTION Sweden
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
b) Platelets
Pheresis,
Leukocytes Reduced, Irradiated,
CODE
a) Units:
GS39540, GS39580 (2 units), GS39606, GS40880, GS39784 (3 units), GS40930,
GS40925, GS40978, GS40960, GS39806 (2 units), GS41033 (3 units), GS42764 (3
units), GS42833, GS42512 (3 units), GS42599 (3 units), GS42573 (3 units),
GS39913 (3 units), GS42990 (2 units), GS42773 (3 units), GS42596, GS42678 (2
units), GS42915 (2 units), GS42919 (3 units), GS39890 (3 units), GS41192 (3
units), GS42699, GS42592, GS42550, GS39967 (3 units), GS41183 (3 units), GS42718
(2 units), GS39972, GS42796 (3 units), GS39911 (2 units), GS42571 (2 units),
GS42475 (3 units), GS40000 (2 units), GS40037 (2 units), GS41136 (3 units),
GS42935 (3 units), GS40009, GS40017 (2 units), GS42835 (2 units), GS42768,
GS42828, GS40008 (2 units), GS39825 (3 units), GS41041 (2 units), GS42395 (2
units), GS39929 (2 units), GS42460, GS42441 (2 units), GS42707, GS40938, GS40028
(2 units) , GS40012 (3 units), GS39824, GS42603, GS42872 (2 units), GS42663,
GS40080, GS42623 (2 units), GS42821 (3 units), GS42963, GS41168, GS41087,
GS41082 (2 units), GS42704, GS42611, GS39998 (2 units), GS42856, GS42408,
GS42425, GS42784, GS41106, GS42482;
b) Units: GS40908 (2 units), GS42957 (3 units), GS40008, GS42395, GS42460,
GS39929, GS39957, GS42571, GS39973 (2 units), GS40009, GS40080 (2 units),
GS42623, GS39912 (2 units), GS42835
RECALLING
FIRM/MANUFACTURER Blood Bank of San Bernardino and Riverside Counties,
San Bernardino, CA
REASON Platelets Pheresis, with an elevated platelet
count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 158
units
DISTRIBUTION CA
PRODUCT Source Plasma,
CODE
Units: G-97942-077, G-97665-077,
N-65454-077, N-65425-077
RECALLING FIRM/MANUFACTURER Alpha
Therapeutic Corporation, Riverside, CA
REASON Blood products, which were not
properly quarantined after receiving post donation information concerning
high-risk behavior, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION Spain
PRODUCT Recovered Plasma,
CODE
Unit: V10665
RECALLING
FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA,
REASON Blood
product, collected from a donor who was at increased risk for variant
Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION Switzerland
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells, Leukocytes Reduced,
c) Platelets,
d) Fresh Frozen Plasma,
CODE
a) Units: H44634, H38812 and H52963;
b)
Unit: H23237;
c) Unit: H52963;
d) Units: H44634, H38812 and
H52963
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA,
REASON Blood products, collected from a donor whom donor
suitability was not adequately determined, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 8 units
DISTRIBUTION VA, WI and
Switzerland
PRODUCT Source Plasma,
CODE
Unit: 377023103
RECALLING
FIRM/MANUFACTURER Talecris Plasma Resources, Inc., dba International
BioResources, LLC, Anderson, IN,
REASON Blood product, which was
untested for viral markers, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NC
PRODUCT Platelets Pheresis
Leukocytes Reduced
CODE Units 172054103 (split
unit parts 1, 2, and 3)
RECALLING FIRM/MANUFACTURER Blood Systems,
Inc., McAllen, TX,
REASON Blood products, which did not meet acceptable
product specifications, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION TX
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Platelets Leukocytes Reduced,
c) Fresh Frozen Plasma,
d)
Recovered Plasma,
CODE
a) Units 32KY21202 and
32KY20652;
b) and d) Unit: 32KY20652;
c) Unit 32KY21202
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Madison, WI,
REASON
Blood products, that tested negative for
the antibody to hepatitis C virus encoded antigen (anti-HCV), but were collected
from an ineligible donor based on the subsequent disclosure of a previous
positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 5 units
DISTRIBUTION IL, OH, and FL
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Unit: 7679080
RECALLING
FIRM/MANUFACTURER LifeShare Blood Centers, Beaumont, TX
REASON Blood products,
which were collected from a donor who had previously tested repeatedly reactive
for the antibody to the human immunodeficiency virus (anti-HIV), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION LA and Switzerland
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells,
Apheresis,
c)
Red Blood Cells, Leukocytes Reduced,
d) Red Blood Cells,
Leukocytes Reduced, Irradiated,
e) Platelets, Leukocytes
Reduced,
f) Platelets Pheresis, Leukocytes Reduced,
g) Fresh Frozen Plasma,
h)
Cryoprecipitate, AHF,
i) Plasma Frozen,
j) Plasma Frozen, Cryoprecipitate, Reduced,
CODE
a) Units: 022FN80287, 022FN80300, 022FN80387,
022FN80466,
022FN80475, 022FN80625, 022FN80628, 022FN80629, 022FN80634,
022FN80822, 022FN80824, 022FN80827, 022FN80843, 022FN80844,
022FN80845,
022FE98354, 022FE98570, 022FJ97459, 022FJ99446,
022FS35042, 022FS41308,
022FX19089, 022FZ13240, 022GE84970,
022KF56805, 022KF56806, 022KF56811,
022KF56899, 022KF60302,
022KF60303, 022KF60304, 022KF60305, 022KH10289,
022KK72529,
022KT72123, 022KW66117, 022LP09374, 022LW81415, and
022LZ09069;
b) Unit: 022LE14716;
c) Units: 022FN80757, 022FN80821,
022FN80330, 022FN80429,
022FN80453, 022FN80458, 022FN80542, 022FN80579,
022FN80582,
022FN80623, 022FN80644, 022FN80648, 022FN80669, 022FN80670,
022FN80671, 022FN80672, 022FN80750, 022FN80754, 022FN80783,
022FN80784,
022FN80792, 022FN80793, 022FN80796, 022FN80797,
022FN80798, 022FN80874,
022FN80875, 022FN81012, 022GL34871, and
022GL34873;
d) Unit:
022FN80837;
e) Units: 022FR01073 and 022LP17414;
f) Units: 022LE16844,
022LE16848, 022LE16849, 022LE16858, 022LE16862,
022LE16848, 022LE16858, and
022LE16858;
g) Units: 022FC30434, 022FC30437, 022FC30441, 022FC31017,
022FC31018,
022FC33170, 022FC34170, 022FC34516, 022FC34521, 022FC34526,
022FE99486, 022FE99682, 022FE99683, 022FE99685, 022FE99769,
022FE99770,
022FE99874, 022FN74787, 022FN75898, 022FN75905,
022FN75908, 022FN76431,
022FN76435, 022FN76436, 022FN76443,
022FN76450, 022FN76453, 022FN76456,
022FN76459, 022FN76610,
022FN76613, 022FN76687, 022FN76689, 022FN76705,
022FN76709,
022FN76710, 022FN76791, 022FN76807, 022FN77332, 022FN77334,
022FN77335, 022FN77336, 022FN77337, 022FN77368, 022FN77376,
022FN77378,
022FN77392, 022FN77457, 022FN77466, 022FN77470,
022FN77474, 022FN77856,
022FN77861, 022FN78425, 022FN78426,
022FN78430, 022FN79118, 022FN79127,
022FN80475, 022FN80783,
022FQ29133, 022FQ29138, 022FQ29143, 022FQ29144,
022FQ29145,
022FQ29146, 022FQ29792, 022FQ29803, 022FQ29827, 022FQ29951,
022FQ33507, 022FQ33509, 022FQ33510, 022FQ33512, 022FQ33514,
022FQ33515,
022FQ33516, 022FQ33526, 022FR01073, 022FS40156,
022FS40158, 022FS40161,
022FS40254, 022FS40255, 022FS40256,
022FS40257, 022FS40259, 022FS40260,
022FS40271, 022FS40272,
022FS40273, 022FS40275, 022FS40276, 022FS40277,
022FS40278,
022FS41308, 022FS41310, 022FS41313, 022FS41314, 022FS41317,
022FS41318, 022FX19090, 022FX19095, 022FX20683, 022FX20729,
022FX20730,
022FZ18364, 022FZ20163, 022FZ20164, 022FZ20165,
022FZ20166, 022FZ20168,
022GE88407, 022GE88414, 022GE88416,
022GE88425, 022GE88428, 022GE89025,
022GE89026, 022GE89028,
022GE89030, 022GE89031, 022GE89033, 022GE90295,
022GE90296,
022GE90303, 022GE90310, 022GE91551, 022GE92131, 022GE92132,
022GE92136, 022GE92137, 022GE92143, 022GE92152, 022GE92153,
022GE92154,
022GG00273, 022GG00286, 022GG02289, 022GH20751,
022GL28174, 022GL28440,
022GL28442, 022GL28462, 022GM01134,
022GM01136, 022GM01140, 022GM01147,
022GM04577, 022GM04633,
022GM05342, 022GM05353, 022GM05357, 022GM05360,
022GQ10059,
022GQ10060, 022GQ10063, 022GQ10066, 022GS15861, 022GS15863,
022GS15871, 022GS15872, 022GS15875, 022GS16471, 022GS17587,
022GS18004,
022GS18080, 022GS18085, 022GS18088, 022GS18089,
022GS18090, 022GS18093,
022GS18094, 022GS18099, 022GS18100,
022KC78883, 022KC78884, 022KC78887,
022KC78888, 022KC79971,
022KC79980, 022KC80832, 022KC80836, 022KC80839,
022KC80841,
022KC81561, 022KC81567, 022KC81569, 022KC81571, 022KC81572,
022KC81573, 022KC81578, 022KC81579, 022KC81580, 022KC81582,
022KC82886,
022KC82889, 022KC82898, 022KC82901, 022KC82909,
022KC82975, 022KC83429,
022KC83434, 022KC83437, 022KC83438,
022KC83440, 022KF59563, 022KF59564,
022KF59566, 022KF59577,
022KF59923, 022KF60721, 022KF60722, 022KF61014,
022KF61299,
022KF61300, 022KF61308, 022KF61528, 022KF61546, 022KF61547,
022KF61549, 022KF61553, 022KF61554, 022KF61555, 022KF61868,
022KF61869,
022KK74167, 022KK74168, 022KK74173, 022KK74175,
022KK74176, 022KK74184,
022KK74185, 022KK74186, 022KK74187,
022KK74188, 022KK74192, 022KK74194,
022KK77686, 022KK77687,
022KK77698, 022KK77700, 022KK77703, 022KL26157,
022KL26160,
022KL26162, 022KL26694, 022KL26695, 022KL26709, 022KT74888,
022KT74892, 022KT74893, 022KV80323, 022KV80328, 022KV80334,
022KV80339,
022KV80349, 022KV80354, 022KV80355, 022KV80359,
022KV80370, 022KV80374,
022KV80415, 022KV80417, 022KV80418,
022KV80419, 022KV80422, 022KV80440,
022KV80471, 022KW68282,
022KW68288, 022KW68292, 022KW68296, 022KW68298,
022KW68300, 022KW68303, 022KW68305, 022KW69831, 022KW69837, 022KW69902, 022KW69903, 022KW69909, 022KW69910, 022KW70272, 022KW70273,
022KW70279,
022KW70286, 022KW70290, 022KW70292, 022KX78215,
022KX78577, 022KX80640,
022KX80641, 022KX80643, 022KX80646,
022KX80647, 022KX80651, 022KX80656,
022KX80670, 022KY97511,
022KY97512, 022KY97519, 022KY97549, 022KY99847,
022KY99867,
022KY99870, 022KY99877, 022KY99932, 022KY99942, 022KZ78282,
022KZ78284, 022KZ78286, 022KZ78287, 022KZ78301, 022KZ78306,
022KZ79455,
022KZ79864, 022KZ79875, 022KZ80478, 022KZ84986,
022KZ84993, 022KZ84995,
022KZ85003, 022KZ85010, 022KZ85064,
022KZ86479, 022KZ86480, 022KZ86481,
022KZ86669, 022LC26832,
022LC26833, 022LC26835, 022LC26836, 022LC26840,
022LC26843,
022LC26848, 022LC26854, 022LC26864, 022LJ94373, 022LJ94374,
022LJ94375, 022LJ94377, 022LJ94378, 022LJ94804, 022LJ94805,
022LJ94807,
022LJ94808, 022LJ94809, 022LJ94810, 022LJ94812,
022LJ94814, 022LJ94815,
022LJ95328, 022LJ95330, 022LJ98143,
022LJ98144, 022LJ98147, 022LJ98148,
022LJ98150, 022LJ98152,
022LJ98154, 022LJ98156, 022LP09360, 022LP09361,
022LP09369,
022LP09370, 022LP09374, 022LP10215, 022LP11298, 022LP11304,
022LP11305, 022LP11309, 022LW84869, 022LW84876, 022LW84890,
022LW84897,
022LW84902, 022LZ07966, 022LZ07975, 022LZ07986,
022LZ07988, 022LZ07989,
022LZ07990, 022LZ07991, 022LZ07992,
022LZ07998, 022LZ09049, 022LZ09062,
022LZ09063, 022LZ09064,
022LZ09065, 022LZ09066, 022LZ09067, 022LZ09069,
022LZ09073,
022LZ09077, 022LZ09528, 022LZ09530, 022LZ09532, 022LZ09533,
022KG92746, 022KG92749, 022KG93303, 022KG93330, 022KG93340,
022KG93429,
022KG93447, 022KG93451, 022KG93464, 022KG93468,
022KG93510, 022KG93515,
022KG93519, 022KG93530, 022KG94403,
022KG94565, 022KG94572, 022KG94662,
022KG95205, 022KG95258,
022KG95313, 022KG95358, 022KG95379, 022KG95383,
022KG95389,
022KG95541, 022KG96012, 022KG96016, 022KG96042, 022KG96047,
022KG96063, 022KG96312, 022KG96373, and 022KG97093;
h) Units: 022FC34522,
022FN74059, 022FN74062, 022FN74063,
022FN78969, 022FN78970, 022FN78973,
022FN78981, 022FN79384,
022FN79456, 022FN79526, 022FN80111, 022FN80162,
022FN80164,
022FN80230, 022FN80300, 022FN80330, 022FN80453, 022FN80458,
022FQ29837, 022FX20782, 022FX22200, 022FX23222, 022FX23225,
022FX23226,
022FX23228, 022FX23230, 022FX23231, 022FZ20172,
022FZ20173, 022FZ20174,
022FZ20175, 022FZ20178, 022GG02221,
022GG02227, 022GG02230, 022GG02237,
022GH18474, 022GH18480,
022GH18481, 022GH18500, 022GH18539, 022GH18545,
022GH18573,
022GH18598, 022GH20732, 022GL34873, 022GQ09770, 022GQ09777,
022GQ09941, 022GQ11495, 022GQ11497, 022GQ11503, 022GS16466,
022GS16519,
022KC82906, 022KF61042, 022KK74174, 022KK74191,
022KL24301, 022KL24303,
022KL24304, 022KL24305, 022KL24306,
022KT74881, 022KT74890, 022KW68307,
022KY97552, 022KY97557,
022KY97558, 022KY97571, 022KZ79849, 022LJ95337,
022LJ95342,
022LJ95478, 022LJ95479, 022LJ95481, 022LJ95482, 022LJ98178,
022LJ98182, 022LJ98184, 022LJ98186, 022LW84175, 022LW84190,
and
022LW84903;
i) Units: 022FC31021, 022FE99742, 022FE99879, 022FN76713,
022FN76716, 022FN77395, 022FN78419, 022FN78801, 022FN79528, 022FN80466, 022FZ18310, 022GG00275, 022GG00276, 022GG00277, 022GG00278,
022GG01458,
022GL28433, 022GM01142, 022GM01144, 022GQ09915, 022GQ09917, 022GS16478,
022KK77679, 022KK77681, 022KL26687, 022KL26688, 022KL26690, 022KV80424,
022KZ86425, 022KZ86450, 022KZ86670, 022LJ94368, 022LJ94439, 022LJ94442,
022LJ94444, 022LJ94456, 022LJ94462, 022LJ94465, 022LJ94806, 022LJ96794,
022LJ96795, and 022LJ96796;
j) Units: 022FQ29837, 022FX22200,
022FX23222, 022FX23226, 022FX23228, 022FX23230, 022FZ20173, 022FZ20175,
022FZ20178, 022GH18474, 022GH18480, 022GH18481, 022GH18598, 022GH20732,
022GQ09770, 022GQ11495, 022GQ11497, 022GQ11503, 022KC82906, 022KL24303, 022LJ98178, 022LJ98184, 022LJ98186, 022LW84190, and
022LW84903
RECALLING FIRM/MANUFACTURER American National Red Cross,
Penn-Jersey Region, Philadelphia, PA,
REASON Blood
products, collected from donors whose arm scrubs may have been incorrectly
performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 670
units
DISTRIBUTION PA, NJ, AZ, IL, CA, MD, MI, MA, MN, TN, TX and
WI
PRODUCT
a) Red Blood Cells,
b) Platelets,
CODE
a) and
b) Unit: L164243
RECALLING FIRM/MANUFACTURER Puget Sound Blood
Center, Seattle, WA,
REASON Blood products, which were collected from a donor
who had traveled to a malarial endemic area, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION WA
PRODUCT Red Blood Cells (Apheresis) Deglycerolized,
CODE
Units: 6970928
(Parts 1 and 2)
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial
Blood Center, Denver, CO.
REASON Blood products, labeled with extended
expiration dates, were distributed
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CO
PRODUCT Red Blood Cells
CODE
Unit: 5768891
RECALLING
FIRM/MANUFACTURER New York Blood Center, Inc., New York, NY,
REASON
Blood product, labeled with extended
expiration date, was distributed
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT Recovered Plasma
CODE
Units: 1674391, 9594017
RECALLING
FIRM/MANUFACTURER Central Indiana Regional Blood Center, Indianapolis,
IN,
REASON Blood products, collected from a donor
who was taking the drug Aricept, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION IN and Austria
PRODUCT Platelets Pheresis
CODE
Unit: Y02049
RECALLING
FIRM/MANUFACTURER Blood Assurance Inc., Chattanooga, TN
REASON Blood
product, lacking a verified platelet count, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT Red Blood Cells,
CODE
Unit: 4447265
RECALLING
FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON Platelets, which
were possibly contaminated with Diphtheroids, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL
PRODUCT
a) Platelets (for
further manufacturing),
b) Recovered Plasma,
CODE
a) Unit: H44634;
b) Unit: H23237
RECALLING
FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA
REASON Blood
products, collected from a donor whom donor suitability was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION VA, WI and Switzerland
WEEK ENDING MARCH 24
PRODUCT Cryoprecipitated AHF,
CODE
Unit: J39794
RECALLING
FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA,
REASON
Blood
product, associated with a unit of Red Blood Cells that contained clots, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION VA
PRODUCT Platelets,
CODE
Unit: J70002
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond,
VA,
REASON Blood product, associated with a unit of Red Blood
Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION VA
PRODUCT Source Plasma,
CODE
Units: 06DTXB4358, 06DTXB4657, 06DTXB5091,
06DTXB5342, 06DTXB6853, 06DTXB7028, 06DTXB7626, 06DTXB7969, 06DTXB8573,
06DTXB8889, 06DTXB9420, 06DTXC0057, 06DTXC0382
RECALLING
FIRM/MANUFACTURER BioLife Plasma Services, LP, Denton, TX,
REASON
Source Plasma, collected from a donor who did not
have a complete annual physical exam, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 13 units
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells, Irradiated,
c) Whole Blood,
CODE
a) Units:
LP10544, LP10545, LP10549, LP10558, LP10560, LP10564, LP10534, LP10522,
LP10542, LP10543, LP10539, LP10541, LP10538, LP10537, LP10536, LP10535, LP10533, LP10567, LP10561, LP10563, LP10555, LP10554, LP10556, LP10551,
LP10557, LP10548, LP10550, LP10566, LP10565, LP10559, LP10552;
b) Units:
LP10514, LP10547, LP10546, LP10515, LP10562, LP10553;
c) Units: LS12736,
LS12727, LS12732, LS12730, LS12717, LS12720, LS12718, LS12716, LS12725,
LS12724, LS12721, LS12726, LS12723, LS12719
RECALLING
FIRM/MANUFACTURER Southern California Permanente Medical Group, Woodland
Hills, CA
REASON Blood products, which were stored at an
unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 51 units
DISTRIBUTION CA
PRODUCT Source Plasma,
CODE
Units: 05RMID9123, 05RMID9292, 05RMIE0017,
05RMIE1072, 05RMIE1469, 06RMIA0084, 06RMIA1864, 06RMIC0541,
06RMID1828
RECALLING FIRM/MANUFACTURER BioLife Plasma Services,
L.P., Kentwood, MI,
REASON Blood products, collected from a donor for whom
post donation information was received regarding multiple high-risk behaviors,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 9
units
DISTRIBUTION CA and Austria
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Unit: 3862647
RECALLING
FIRM/MANUFACTURER Central Indiana Regional Blood Center, Indianapolis, IN
REASON
Blood products, collected from a donor who was
previously deferred for a tattoo, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION IN and Austria
PRODUCT Source Plasma,
CODE
Units: 91346483, 93216104, 90495328,
90490651
RECALLING FIRM/MANUFACTURER Interstate Blood Bank, Inc. of
Wisconsin, Milwaukee, WI,
REASON Blood products, collected from a donor who
received a piercing within 12 months of donation, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
2084324
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
REASON Blood product, collected from a donor for whom
donor suitability was not adequately determined, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT Source Plasma,
CODE
Units: 99JWIB9391, 99JWIB7846,
99JWIB7973
RECALLING FIRM/MANUFACTURER BioLife Plasma Services,
L.P., Janesville, WI,
REASON Blood products, collected from a donor who was at
increased risk for Creutzfeldt-Jakob Disease (CJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION MI and Austria
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
17KN69421
RECALLING FIRM/MANUFACTURER American National Red Cross,
North Central Region, St. Paul, MN,
REASON Blood product, collected from
an unsuitable donor based on travel to an area considered endemic for malaria,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Source Plasma,
CODE
Units: 03BNDD2327,
03BNDD3468
RECALLING FIRM/MANUFACTURER BioLife Plasma Services,
L.P., Bismarck, ND,
REASON Blood products, collected from a donor who had
received the MMR vaccine within two weeks of donation, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MI
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced, Irradiated,
b) Fresh Frozen
Plasma Pheresis,
CODE a) and b) Unit:
17FX67516
RECALLING FIRM/MANUFACTURER American National
Red Cross, North Central Region, St. Paul, MN,
REASON Blood products,
associated with a unit of platelets that was possibly contaminated with
Staphylococcus aureus, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION MN
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit: 17FX65572 (Part
2)
RECALLING FIRM/MANUFACTURER American National Red Cross, North
Central Region, St. Paul, MN,
REASON Platelets, which were possibly
contaminated with coagulase negative Staphylococcus species, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT Recovered Plasma,
CODE
Unit: W13604
RECALLING
FIRM/MANUFACTURER Blood Center of Northcentral Wisconsin, Inc., Wausau,
WI,
REASON Blood product, collected from a donor who had
received a body piercing within twelve months of donating, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT Red Blood Cells
CODE
Unit: D144018
RECALLING
FIRM/MANUFACTURER Puget Sound Blood Center, Seattle, WA.
REASON Blood
product, which was collected from a donor who had traveled to a malarial endemic
area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WA
PRODUCT Red Blood Cells,
Leukocytes Reduced, Irradiated
CODE Unit:
B323024
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center,
Seattle, WA
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WA
PRODUCT Red Blood Cells,
Leukocytes Reduced, Irradiated
CODE Unit:
D151836
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center,
Seattle, WA
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WA
PRODUCT
a) Red Blood Cells
b) Platelets Pooled
Irradiated
CODE
a) Unit: F159006;
b) Unit: UP15271 (from donation
unit # F159006)
RECALLING FIRM/MANUFACTURER Puget Sound Blood
Center, Seattle, WA
REASON Blood products, which were collected from a donor
who had traveled to a malarial endemic area, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION WA
PRODUCT Platelets Pheresis,
Leukocytes Reduced, Irradiated
CODE Unit:
F208076
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center,
Seattle, WA
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WA
PRODUCT Red Blood Cells
CODE
Units: X119492 and X118424
RECALLING
FIRM/MANUFACTURER Puget Sound Blood Center, Seattle, WA
REASON Blood
products, which were collected from a donor who had taken the medication Avodart, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2
units
DISTRIBUTION WA
PRODUCT
a) Red Blood Cells
b)
Platelets,Pooled
CODE
a) Units: B322679, U122123 and B315155;
b) Unit:
HP12205 (from donation unit # U122123)
RECALLING
FIRM/MANUFACTURER Puget Sound Blood Center, Seattle, WA
REASON Blood products, which were collected from a donor
who had traveled to a malarial endemic area, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 4 units
DISTRIBUTION WA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
LC32792
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin,
Inc., Milwaukee, WI
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
FW64296
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin,
Inc., Milwaukee, WI
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI
PRODUCT Red Blood Cells
CODE
Unit: LC35371
RECALLING
FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON
Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
LP58170
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin,
Inc., Milwaukee, WI.
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit:
J24057
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA
REASON Blood product, for which documentation of the
apheresis procedure was incomplete, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION VA
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit: S71021
RECALLING FIRM/MANUFACTURER Central Illinois Community Blood
Center, Springfield, IL
REASON Platelets, collected from an
ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT Source Plasma
CODE
Unit: 363004226
RECALLING
FIRM/MANUFACTURER International BioResources, LLC, Fort Worth, TX
REASON
Source Plasma, collected from a donor whose arm
inspection was not documented, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NC
PRODUCT Source Plasma
CODE
Unit: 06HINA6532
RECALLING
FIRM/MANUFACTURER Bio-Blood Components, Inc., Hammond, IN
REASON Blood product, collected from a donor who did not
have complete medical history interview, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA
WEEK ENDING MARCH 31
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets, Pooled,
CODE
a) Units: KZ59913 (double collection), KZ58041,
KZ55657, KZ52830;
b) Unit: KZ58041
RECALLING
FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI,
REASON
Blood products, collected from a donor who reported travel to an area
designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 6 units
DISTRIBUTION WI
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets,
CODE a) and b) Unit: K67198
RECALLING
FIRM/MANUFACTURER Blood Assurance Inc., Chattanooga, TN
REASON Blood products, collected from a donor with
polycythemia, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION GA and TN
PRODUCT Platelets,
CODE
Unit: L56640
RECALLING
FIRM/MANUFACTURER Blood Assurance Inc., Chattanooga, TN
REASON Blood
product, collected from a donor whose eligibility to donate was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
FW51925
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin,
Inc., Milwaukee, WI,
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 WI
PRODUCT Recovered Plasma,
CODE
Unit: LP50215
RECALLING
FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI,
REASON
Blood product, collected from a donor who was at
increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Switzerland
PRODUCT Human Cornea for
Transplantation
CODE Tissue:
07-0009-200
RECALLING FIRM/MANUFACTURER East Tennessee Lions Eye
Bank, Knoxville, TN
REASON Human tissue for transplantation, which tested
negative for hepatitis prior to distribution, but was subsequently found to test
repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
tissue
DISTRIBUTION NC
PRODUCT Human Cornea for
Transplantation
CODE Tissues: 07-0022-100,
07-0022-200
RECALLING FIRM/MANUFACTURER East Tennessee Lions Eye
Bank, Knoxville, TN,
REASON Human tissues for transplantation, which tested
negative for hepatitis prior to distribution, but were subsequently found to
test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc),
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
tissues
DISTRIBUTION NC
PRODUCT Human
Immunodeficiency Virus Type 1 (HIV-1), Vironostika® HIV-1, Microelisa System,
CODE
Lot number: 160354, expiration date:
4/10/2007
RECALLING FIRM/MANUFACTURER bioMerieux, Inc., Durham, NC, REASON
HIV-1 test kits, with a potential to cause false
negative test results, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 200 test kits
DISTRIBUTION Nationwide and
Canada
PRODUCT
a) Plasma,
Cryoprecipitate Reduced,
b) Cryoprecipitated AHF,
c) Platelets,
d) Fresh Frozen Plasma,
CODE
a) Unit: GV85431;
b) Units: GV85431,
KT11679;
c) and d) Unit: LR89955
RECALLING
FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA,
REASON
Blood
products, associated with units of Red Blood Cells that contained clots, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION PA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Red Blood Cells,
c) Platelets,
d) Cryoprecipitated
AHF,
e) Recovered Plasma,
CODE
a) Units: 2246252, 2221931, 2146330, 9222431,
9212327;
b) and c) Unit: 2012839;
d) Unit: 2146330;
e) Units: 2246252,
2221931, 2146330, 9222431, 9212327
RECALLING
FIRM/MANUFACTURER Blood Bank of Delmarva, Inc., Newark, DE,
REASON
Blood products, which tested
negative for hepatitis, but were collected from a donor who was previously
deferred for positive hepatitis testing, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 13 units
DISTRIBUTION DE, MD and NJ
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Whole Blood, Leukocytes Reduced,
CODE
a) Unit: FW49080;
b) Unit:
FW43972
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin,
Inc., Milwaukee, WI,
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 WI
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Units: FW62404,
LR89237
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin,
Inc., Milwaukee, WI
REASON Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were
distributed.
VOLUME OF PRODUCT IN COMMERCE2
units
DISTRIBUTION WI
PRODUCT Source Plasma,
CODE
Unit: 364014398
RECALLING
FIRM/MANUFACTURER International BioResources, LLC, dba Talecris Plasma
Resources, Inc., Fort Worth, TX
REASON Blood product, collected from a donor
who was at increased risk for new variant Creutzfeldt - Jakob Disease (nvCJD),
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Source Plasma,
CODE
Units: 363013686, 363005822, 363005839,
363005984, and 363006291
RECALLING FIRM/MANUFACTURER International
BioResources, LLC, Fort Worth, TX
REASON Source Plasma, collected from
donors whose eligibility to donate was not accurately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION NC
PRODUCT Platelets Pheresis
Leukocytes Reduced Irradiated,
CODE Unit:
32GP27476
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Madison, WI
REASON Blood product, which was not stored at
appropriate storage conditions, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION WI