DECEMBER 2006
WEEK ENDING DECEMBER 2
PRODUCT BD Procount Progenitor
Cell Enumeration Kit, Part Number: 340498,
CODE Lot Number: 45602
RECALLING
FIRM/MANUFACTURER BD Biosciences, San Jose, CA
REASON Progenitor Cell Enumeration Kits, which may produce false
results, were distributed.
VOLUME OF PRODUCT IN COMMERCE 799
kits
DISTRIBUTION Nationwide and Internationally
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
71P126152
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Centers, Inc., Gainesville, FL
REASON Red Cells, mislabeled as to the Rh
antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT
a) Red Blood Cells,
b) Plasma,
CODE
a) Units:
53GJ28938, 53KN29412;
b) Unit: 53GJ28938
RECALLING
FIRM/MANUFACTURER American National Red Cross, Greater Chesapeake &
Potomac Region, Baltimore, MD,
REASON Blood products, which tested negative for the
antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected
from a donor who provided post donation information regarding having a prior
false positive test for HIV, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION MD and D.C.
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
261215931
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fort
Smith, AR
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 AK
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Red Blood Cells,
CODE
a) Units: 11FJ09817, 11LC60924, 11LC62210, 11LC63383,
11LC64773,
11LC75829, 11LC76977, 11LC78281, 11LC79571, 11LC81747;
b)
Units: 11LC42821, 11LV96347, 11LY34374
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Missouri-Illinois
Region, Saint Louis, MI
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 13 units
DISTRIBUTION IL, MO, GA, MD,
PA, and SC
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
11GT46514
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Missouri-Illinois Region, Saint Louis, MI
REASON Blood product, collected from a donor who had
lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced
b) Red Blood Cells, (Apheresis)
Leukocytes Reduced
CODE
a) Unit:
268357972;
b) Units: 268347619 -- parts 1 and 2
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., Fort Smith, AR
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 3 units
DISTRIBUTION AK
and OK
PRODUCT Source Plasma
CODE
Units: OE649210, OE648418, OE647213, OE643893,
OE643376, OE642504, OE642066, OE635257, OE634840, OE633148, OE631978, OE629871,
OE629376, OE628358, OE627851, OE625979, OE625188, OE624437, OE623886, OE622759,
OE622255, OE621470, OE620971, OE619874, OE619393, OE618264, OE617874, OE615737,
OE615254, OE614082, OE613458, OE612866, OE612266, OE609086, OE608755, OE606669,
OE605689, OE605346, OE604358, OE603875, OE602820, OE602457, OE601237, OE600896,
OE599638, OE599326, OE598083, OE597845, OE596513, OE596188, OE594667, OE593446,
OE593085, OE591890, OE591511, OE590288, OE589951, OE588606, OE588294, OE586955,
OE586663, OE585431, OE585147, OE584031, OE583607, OE582291, OE581917, OE580652,
OE579959, OE578739, OE578131, OE577073, OE576559, OE575326,
OE574793
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P.,
Eagle Pass, TX,
REASON Source Plasma, was not properly quarantined after
receipt of post-donation information related to recent tattoos.
VOLUME OF
PRODUCT IN COMMERCE 75 units
DISTRIBUTION NC and NY
PRODUCT Source Plasma
CODE
Units: OE569967, OE569704, OE568497, OE568158,
OE566950, OE566575, OE565377, OE563777, OE563543, OE562237, OE562038, OE560690,
OE560255, OE559137, OE558656, OE557579, OE557055, OE554419, OE554115, OE552640,
OE551346, OE550866, OE548242, OE547939, OE546717, OE545318, OE543926, OE543421,
OE542235, OE541813, OE540572, OE540282, OE537686, OE537007, OE636240, OE535311,
OE534688, OE533666, OE533334, OE532565, OE532178, OE531191, OE530791, OE529773,
OE529327, OE528311, OE527875, OE526854, OE526441, OE525282, OE524863, OE523640,
OE523191, OE522053, OE521626, OE520517, OE520076, OE519010, OE518642, OE516540,
OE515089, OE514575, OE513641, OE513107, OE512142, OE511624, OE510653, OE510131,
OE509192, OE508630, OE507667, OE507143, OE506171, OE505633, OE504680, OE504131,
OE503060, OE502516, OE501577, OE501079, OE500172, OE499333, OE498761, OE498119,
OE497464, OE496839, OE496406, OE495741, OE495000, OE494346
RECALLING
FIRM/MANUFACTURER BioLife Plasma Services, L.P., Eagle Pass, TX,
REASON
Source Plasma, was not properly quarantined after
receipt of post-donation information related to recent piercing.
VOLUME OF
PRODUCT IN COMMERCE 90 units
DISTRIBUTION NC
WEEK ENDING DECEMBER 9
PRODUCT Source Plasma,
CODE
Units: 05FIND3352, 05FIND3662, 05FIND4719,
05FIND5250
RECALLING FIRM/MANUFACTURER BioLife Plasma Services
L.P., Fort Wayne, IN,
REASON Blood products, collected from a donor who
acquired body piercings within twelve months of donating, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Unit: 4037982
RECALLING
FIRM/MANUFACTURER Lifeshare Blood Centers, Beaumont, TX, REASON Blood
products, collected from a donor considered to be at increased risk for variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION TX and Switzerland
PRODUCT Platelet Pheresis,
Leukocytes Reduced,
CODE Unit:
5711514
RECALLING FIRM/MANUFACTURER Lifeshare Blood Centers,
Beaumont, TX, REASON Blood product, labeled with the incorrect product
code, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Source Plasma,
CODE
Units: BY0137688, BY0138347
RECALLING
FIRM/MANUFACTURER DCI Biologicals Bryan LLC, Bryan, TX, REASON Blood products, collected from a donor who had a
tattoo applied within twelve months of donating, were distributed
VOLUME
OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NC
PRODUCT
a) Fresh Frozen Plasma
(Apheresis)
b) Platelets Pheresis Leukocytes Reduced,
CODE
a) Unit: R61749;
b) Units: R61749
(distributed as split product)
RECALLING FIRM/MANUFACTURER Coastal
Bend Blood Center, Corpus Christi, TX,
REASON Blood products, collected from a
donor whose health history screening was not adequately performed, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION TX
PRODUCT Red Blood Cells,
CODE
Unit: 7389553
RECALLING
FIRM/MANUFACTURER Marquette General Hospital Inc., Marquette, MI,
REASON
Blood product, collected from a donor who had
previously tested reactive for hepatitis C (HCV), was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MI
PRODUCT
a) Red Blood Cells,
b) Fresh Frozen Plasma,
CODE
a) and b) Unit: 7400061
RECALLING
FIRM/MANUFACTURER Marquette General Hospital, Inc., Marquette, MI,
REASON
Blood products, collected from a donor who
provided a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION MI
PRODUCT Source Plasma,
CODE
Units: 05FINC0735, 05FINC2158, 05FINC3109,
05FINC4494, 05FINC4876, 05FINC9417, 05FIND0383, 05FIND1013, 05FINE3104,
05FINE3414, 05FINE4088, 05FINE4559, 05FINC8351, 05FIND3928, 05FIND4258,
05FIND5784, 05FIND6840
RECALLING FIRM/MANUFACTURER BioLife Plasma
Services L.P., Fort Wayne, IN,
REASON Blood products, collected from donors who had body
piercings within twelve months of donating, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 17 units
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
268347415
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fort
Smith, AR
REASON Blood product, collected from a donor whose
medical history screening was incomplete, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT Platelet Pheresis,
Leukocytes Reduced,
CODE Units: 04P60766
(distributed as split product)
RECALLING FIRM/MANUFACTURER The
American National Red Cross, New England Region, Dedham, MA
REASON Blood products, possible contaminated with
coagulase negative staphylococcus, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION NY
PRODUCT
a) Red Blood Cells,
b) Cryoprecipitated
AHF,
c)
Recovered Plasma,
CODE a), b), and c) Unit:
5575374
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview,
IL.
Manufacturer: LifeSource Oak Lawn, Oak Lawn, IL.
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 IL and Switzerland
PRODUCT Platelets,
CODE
Units: 6217779
RECALLING
FIRM/MANUFACTURER Florida’s Blood Center, Inc., Orlando, FL,
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 FL
PRODUCT Recovered Plasma,
CODE
Unit: 6972331
RECALLING
FIRM/MANUFACTURER Florida’s Blood Center, Inc., Orlando, FL,
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 Austria
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma
CODE a) and b) Unit: 3243882
RECALLING
FIRM/MANUFACTURER Florida’s Blood Center, Inc., Orlando, FL
REASON
Blood products, collected from a donor who was at
increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION FL and Austria
PRODUCT Red Blood Cells Pheresis,
Leukocytes Reduced,
CODE Units: 12631-8827 (Split
unit)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc, Albuquerque, NM..
REASON
Blood products, collected from
an ineligible donor due to use of the medication Avodart, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NC and TX
PRODUCT Source Plasma,
CODE
Unit: 05HMSA9164
RECALLING
FIRM/MANUFACTURER BioLife Plasma Services L.P., Hattiesburg, MS,
REASON
Source Plasma, collected from a donor for whom
donor suitability was not adequately determined, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
5758049
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N. Goldman Center Oklahoma, Oklahoma City, OK
REASON Blood product,
collected from an ineligible donor due to use of Antibiotic medication, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OK
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit: 12KJ21108 (part 1
and 2)
RECALLING FIRM/MANUFACTURER American National Red Cross,
Carolina Region, Charlotte, NC,
REASON Platelets, which were possibly
contaminated with Staphylococcus species, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION NC
PRODUCT Recovered Plasma,
CODE
Unit: 03KP25041
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta,
GA,
REASON Blood product, which was collected from an
unsuitable donor based on risk factors for variant Creutzfeldt - Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1
unit
DISTRIBUTION Switzerland
PRODUCT Source Plasma,
CODE
Units: 372002294, 372001398, 372000776, I65091427,
I65084568, I65084057, I65082855, I65078367, I65077953, I65063100, I65062271,
I65061851, I65061036 , I65050804, I65049273, I65048306, I65047223, I65046689,
I65045133, I65044631, I65045517, I65043902, I65043283, I65042672, I65042154,
I65041743, I65040747, I65040363, I65038830, I65038313, and
I65030232
RECALLING FIRM/MANUFACTURER International BioResources, LLC, El Paso, TX,
REASON
Blood products, which were collected from a donor
who had engaged in multiple high risk behavior activities, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 31
units
DISTRIBUTION NC
PRODUCT Fresh Frozen Plasma
CODE
Unit: 16459-9747
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ,
Manufacturer: Blood Systems, Inc.,
dba United Blood Services, Meridian, MS.
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 MS
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
2063531
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN
REASON
Blood product, which was not properly quarantined
after being confidentially identified by the donor to be excluded for donation,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
2066386
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN
REASON
Blood product, which was possibly contaminated
with Corynebacterium species, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION TN
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
2066003
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN
REASON
Platelets, possibly contaminated with Micrococcus
species, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN
PRODUCT
a) Platelets Pheresis,
Leukocytes Reduced,
b) Platelets Pheresis, Leukocytes
Reduced, Irradiated,
CODE
a) Unit: 2064961 (Part
B);
b) Unit: 2064961
RECALLING FIRM/MANUFACTURER Medic, Inc.,
Knoxville, TN
REASON Platelets, possibly contaminated with
Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TN
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Units: 9039563 (Parts 1
& 2)
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO, .
REASON Platelets, which were contaminated with
Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION CO
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit: 49GP22247 (Part
2)
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southwest Region, Tulsa, OK,
REASON Platelets, which were contaminated with
Lactobacillus species, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT Red Blood Cells,
Leukocytes Reduced, Irradiated,
CODE Unit:
KC04519
RECALLING FIRM/MANUFACTURER Blood Center of Southeastern
Wisconsin, Milwaukee, WI,
REASON Red Cells. collected from a
donor who relayed a history of hepatitis, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells
(Apheresis) Leukocytes Reduced,
c) Platelets Pheresis Leukocytes Reduced,
d) Fresh Frozen Plasma
(Apheresis),
CODE
a) Unit: 4547142;
b) Unit: 4786424, 4757201,
4650003 and 4658564;
c) Unit: 4947135 (parts 1 and 2);
d) Unit: 4786424,
4757201, 4650003, 4663954, 4652404, 4658564 and 4547142
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center,
Oklahoma City, OK
REASON Blood products, which were collected from a donor
who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 14
units
DISTRIBUTION OK and NY
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Unit: 4957648
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center,
Oklahoma City, OK,
REASON Blood products, which were collected from a donor
who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CA and Switzerland
PRODUCT Source Plasma,
CODE
Unit numbers: CZ002370, CZ002228, CZ002075, CZ001939,
CZ001815, CZ001606, CZ001446, CZ001321, CZ001174, CZ001023, CZ000429, 05BOH8576,
05BOHB8345, 05BOHB7973, 05BOHB7506, 05BOHB7237, 05BOHB6811, 05BOHB6587,
05BOHB2953, 05BOHA9332, 05BOHA8899, 05BOHA8411, 05BOHA7656, 05BOHA7425,
05BOHA6814, 05BOHA6254, 05BOHA5564, 05BOHA4492, 05BOHA4107, 05BOHA3933,
05BOHA3374, 05BOHA2517, 05BOHA1831, 05BOHA1470, 05BOHA1244, 05BOHA0819, and
05BOHA0324
RECALLING FIRM/MANUFACTURER Bio-Blood Components, Inc.,
Mankato, MN,
REASON Blood products, collected from a donor who was at
increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 37
units
DISTRIBUTION CA and Austria
PRODUCT Platelets
Pheresis,
Leukocytes Reduced, Irradiated7
CODE Unit:
17FP06364
RECALLING FIRM/MANUFACTURER American National Red Cross,
North Central Region, St. Paul, MN,
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 WI
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Units: 22GM05973,
22GM05976, 22GM05980, 22GM05983, 22GM06991, 22GM06978, 22GM06969, 22GM06985,
22GM06977, 22GM06993, 22GM06981 22GM06990
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Philadelphia, PA,
REASON
Blood products, collected on
a trip scale for which there was no documented daily QC, were distributed.
VOLUME OF PRODUCT IN COMMERCE 12
units
DISTRIBUTION PA and NJ
PRODUCT Red Blood Cells, Frozen,
Irradiated,
CODE Units: 3764382 (Parts 1, 2, and
3), 3860440 (Parts 1, 2, and 3), 3764381 (Parts 1, 2, and 3), 3860487 (Parts 1,
2, and 3)
RECALLING FIRM/MANUFACTURER Florida’s Blood Centers,
Inc., Orlando, FL,
REASON Blood products, which were not treated with
rejuvenating solution prior to freezing, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 12 units
DISTRIBUTION FL
PRODUCT Source Plasma,
CODE
Unit: HP142301
RECALLING
FIRM/MANUFACTURER Interstate Blood Bank, Inc., Chicago, IL, REASON Blood
product, which was not properly quarantined after receiving post donation
information concerning high-risk behavior, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit: 9317166
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc.,
Orlando, FL,
REASON Blood product,
which was labeled leukoreduced, but had an unacceptable white blood cell count,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Red Blood Cells,
CODE
Unit: FJ14121
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Aurora Area Blood Bank,
Heartland Blood Centers, Aurora, IL
Manufacturer: Heartland Blood Centers, Naperville, IL.
REASON
Blood product, collected in an
expired collection bag, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION IL
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
12W05886
RECALLING FIRM/MANUFACTURER American National Red Cross,
Carolinas Region, Charlotte, NC, .
REASON Platelets, which was possibly
contaminated with coagulase negative Staphylococcus, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
4140793
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood
Center, Inc., Indianapolis, IN
REASON Platelets,
which were possibly contaminated with Propionibacterium acnes, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IN
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Units: 71X136302 (3
splits)
RECALLING FIRM/MANUFACTURER
Recalling Firm:
LifeSouth Community Blood Centers, Inc., Gainesville, FL,
Manufacturer: LifeSouth Community Blood Centers,
Inc., Birmingham, AL.
REASON Blood products, which were not processed according
to specifications, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION AL
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
71X13829X
RECALLING FIRM/MANUFACTURER
Recalling Firm:
LifeSouth Community Blood Centers, Inc., Gainesville, FL,
Manufacturer: LifeSouth Community Blood Centers, Inc.,
Birmingham, AL
REASON Blood
product, which were not processed according to specifications, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets Pheresis, Leukocytes
Reduced, Irradiated,
c) Platelets Pheresis, Leukocytes
Reduced,
CODE
a) and b) Unit: 163821175;
c)
Unit: 163821175 (split unit)
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ
Manufacturer: Blood Systems, Inc.,
dba United Blood Services, Meridian, MS.
REASON Platelets, which were possibly contaminated with
Penicillium species, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION MS
PRODUCT Cryoprecipitated AHF,
CODE
Units: FH21897, FH21898, FH23288,
FH23307
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank,
Heartland Blood Centers, Aurora, IL,
REASON Blood
products, which were not manufactured according to specifications, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION IL
WEEK ENDING DECEMBER 16
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Red Blood Cells, Leukocytes Reduced,
Irradiated,
c) Fresh Frozen Plasma,
CODE
a) Units: 26730-7953, 26730-7964, 26731-8556,
26731-2251, 26731-2272, 26731-2288, 26731-2290, 26731-2327, 26731-2393,
26731-2400, 26731-2408, 26731-2413, 26731-2419, 26731-2425, 26731-2451,
26731-2462, 26731-2514, 26731-2529, 26731-2538, 26731-2603, 26731-2610,
26731-2626, 26731-2661, 26731-2671, 26731-2797, 26731-2804, 26731-2808,
26731-2811, 26731-2818, 26731-2828, 26731-2841, 26731-2845, 26731-2847,
26731-2848, 26731-2903, 26731-2948, 26731-2954, 26731-2957, 26731-2984,
26731-2988, 26731-2997, 26731-2998, 26731-3062, 26731-3063, 26731-3071,
26731-3075, 26731-3137, 26731-3138, 26731-3153, 26731-3159, 26731-3166,
26731-3173, 26731-3186, 26731-3292, 26731-3368, 26731-3371, 26731-3381,
26731-3432, 26731-3602, 26731-3603, 26731-3610, 26731-3621, 26731-3675,
26731-3685, 26731-3689, 26731-3701, 26731-3708, 26731-3735, 26731-3766,
26731-3769, 26731-3841, 26731-3842, 26731-3846, 26731-3857, 26731-3873,
26731-3893, 26731-3918, 26731-3977, 26731-3988, 26731-3998, 26731-4000,
26731-4007, 26731-4015, 26731-4046, 26731-4054, 26731-4071, 26731-4116,
26731-4144, 26731-4181, 26731-4189, 26731-4208, 26731-4223, 26731-4280,
26731-4283, 26731-4286, 26731-4331, 26731-4366, 26731-4405, 26731-4416,
26731-4446, 26731-4494, 26731-4509, 26731-4515, 26731-4516, 26731-4521,
26731-4522, 26731-4524, 26731-4526, 26731-4531, 26731-4671, 26731-4695,
26731-4709, 26731-4717, 26731-4756, 26731-4820, 26731-4949, 26731-4988,
26731-5169, 26731-6212, 26731-6244, 26731-6255;
b) Unit:
26731-3641;
c) Units: 26731-2288, 26731-2290, 26731-2425,
26731-2696
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fort
Smith, AR
REASON Blood products, that lacked
assurance of sterility, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 126 units
DISTRIBUTION AK, PA, OK, and TX
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
2066003
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN
REASON
Platelets, possibly contaminated with Micrococcus
species, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN
PRODUCT
a) Fresh Frozen Plasma,
b) Recovered Plasma,
CODE
a) Unit: R27179;
b) Unit: S84014
RECALLING
FIRM/MANUFACTURER Michigan Community Blood Center, Saginaw, MI,
REASON
Blood products, collected from a donor considered
to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION I and Switzerland
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
5861366
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute -
Sylvan N Goldman Center, Oklahoma City, OK
REASON Red
Cells, collected from an ineligible donor, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OK
PRODUCT Source Plasma,
CODE
Units: HZ024794, HP138660, HZ024592, HZ024508,
HP137286, HZ023858, HZ023775, HZ023592, HP135652, HZ023308, HP135126, HZ022929,
HZ022491, HZ022172, 05CILB9740, 05CILB9484, 05CILB9159, 05CILB8981, HZ021146,
HZ021005, HZ020704, 05CILB7848, 05CILB7359, 05CILB7136, HZ019764, HZ019461,
05CILB6266, HZ018758, HZ018181, 05CILB5410, HZ017615, HZ017067, HZ016612,
HZ015958, HZ015553, HZ015417, HZ014730, HZ014327, HZ014171, HZ013700, HZ013169,
HZ013001, HZ012487, HZ011487, HZ011261, HP132094, HZ010325, HZ009494,
05CILB0589, HZ008563, HZ008239, HZ008058, HZ007530, 05CILA9418, 05CILA9229,
HP129912, HP129685, HP129429, HP129315, HP129164, HP129058, HP128972, HP128810,
HP128675, HP128399, HP128224, HP128105, HP127874, HP127749, HP127629, HP127335,
HP127192, HP126977, HP12686
RECALLING FIRM/MANUFACTURER Interstate
Blood Bank of Chicago, Chicago, IL,
REASON Source Plasma, collected from a donor with a history of having tested
positive for Hepatitis B, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 74 units
DISTRIBUTION CA, Austria, and
Germany
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Units: 0272734,
0274726, 0235248, 0244250, 0267730, 0268749, and 0264369
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA, REASON Blood products,
which may have been exposed to unacceptable storage temperatures, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 7
units
DISTRIBUTION MS
PRODUCT Red Blood Cells
Irradiated,
CODE Unit: 0341727
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA, REASON Blood
product, which was labeled with an incorrect expiration date, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Red Blood Cells
CODE
Unit: 0312982
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA, REASON Blood
product, which tested initially reactive for the hepatitis B surface antigen (HBsAg), but was not subsequently retested in duplicate, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Red Blood Cells,
CODE
Unit: 0203452
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA, REASON Blood
product, which was manufactured from a whole blood unit in which a corresponding
blood product contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION LA
PRODUCT Fresh Frozen Plasma,
CODE
Units: 9962690 and 9960828
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA, REASON Blood products, which were manufactured from whole
blood units in which collection extended beyond the allowable time limits, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION LA
PRODUCT Platelets,
CODE
Units: 0204724, 0231729, 0200733, 0200735, 023280,
022470, 022471, 0232378, 0232379, 0230887, 0230889, and 0230894
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA, REASON Blood
products, which may have been stored at unacceptable temperatures, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 12
units
DISTRIBUTION LA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Units: 177359570,
177359054, 177359029
RECALLING FIRM/MANUFACTURER Blood Systems,
Inc. Mcallen, TX
REASON Red Cells, lacking assurance of proper storage
temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION TX
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Unit:
22FQ36985
RECALLING FIRM/MANUFACTURER American National Red Cross,
Penn-Jersey Region, Philadelphia, PA
REASON Red Cells, mislabeled for the
‘C’ antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NJ
WEEK ENDING DECEMBER 23
PRODUCT Red Blood
Cells, Leukocytes Reduced,
CODE Unit
269722020
RECALLING FIRM/MANUFACTURER Blood Systems,
Inc., Fort Smith, AR
REASON Red Cells, collected from donors with
unacceptable hematocrits, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1unit
DISTRIBUTION TX
PRODUCT Platelets
Pheresis Leukocyte Reduced Irradiated,
CODE Unit: 2066349
RECALLING
FIRM/MANUFACTURER Medic Inc., Knoxville, TN
REASON Blood product, labeled as
leukoreduced,
but which did not meet the requirements for a leukoreduced product, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN
PRODUCT
a)
Red Blood Cells,
b) Red Blood Cells, Leukocytes Reduced,
c) Platelets,
d) Fresh Frozen Plasma,
e) Recovered Plasma,
CODE
a) Units 20281734 and 204007629
b) Unit
207265268
c) Units 20281734 and 204007629
d) Unit 202817535
e) Units
204007629 and 207265268
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Lafayette, LA
REASON Blood products,
collected from an ineligible donor due to a history of jaundice, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 8
units
DISTRIBUTION LA, VA, TX and
Switzerland
PRODUCT
a)
Red Blood Cells,
b) Red Blood Cells, Leukocytes Reduced,
c) Platelets, Leukocytes Reduced,
d) Fresh Frozen Plasma,
CODE
a)
Units 22GH27742, 22GH27756
b) Units 22LP14611, 22FX27910, 22FZ25495,
22FZ25493, 22FZ25484, 22FZ25491, 22FZ25488, 22FQ37529, 22FQ37175, 22FQ37531,
22FQ37511, 22FQ37186, 22GG02764, 22GG02765, 22GG02759, 22GG02758, 22GH28058,
22GH28057, 22GH27100, 22GH28069, 22GH28072, 22GH28062, 22GQ14442, 22GS22279,
22GS22298, 22KN68386, 22KN69321, 22KT81095, 22KT81098, 22KT81091, 22KT81067,
22KT81064, 22KT81063, 22KT81061, 22KT81069
c) Units 22FQ37175, 22FQ37186,
22FQ37513, 22FQ37511, 22FZ25488, 22FZ25491, 22FZ25493, 22FZ25495, 22GG02758,
22KT81061, 22KT81064, 2KT81069, 22KT81095, 22KN68386, 22LP14611;
d) Units
22KN68386, 22KT81063, 22KT81069, 22KT81091, 22GG02758, 22FZ25493, 22FZ25495,
22FQ37513, 22KT81067, 22FQ37175, 22FQ37186, 22FX27963
RECALLING
FIRM/MANUFACTURER American National Red Cross, Penn-Jersey Region,
Philadelphia, PA
REASON Blood products, lacking assurance of sterility
due to an inadequate arm rub were distributed.
VOLUME OF PRODUCT IN
COMMERCE 65 units
DISTRIBUTION MD, PA, NJ and
PR
PRODUCT Red Blood
Cells (Apheresis),
CODE Units 8950501
(A&B)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New
York Blood Center, Inc., New York, NY,
Manufacturer: New York Blood Center, Inc.,
Westbury, New York.
REASON Red Cells, that did not meet product
specifications, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION NY
PRODUCT Red
Blood Cells Leukocytes Reduced Irradiated,
CODE Units 0265082, 0273029, 0246062, and
0270566
RECALLING FIRM/MANUFACTURER The Blood Center,
New Orleans, LA, REASON Blood products, which were
incorrectly labeled as having been irradiated,
were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION LA
PRODUCT Source
Plasma,
CODE Units: 05YARD7596,
05YARD6714, 05YARD6337, 05YARD5797, 05YARD5454, 05YARD4525, 05YARD3946,
05YARD3616, 05YARD3092, 05YARD2762, 05YARD2222, 05YARD1921, 05YARD1383,
05YARD1041, 05YARD0469, 05YARD0152, 05YARC9586, 05YARC9286, 05YARC8149,
05YARC7595, 05YARC7259, 05YARC6686, 05YARC6304, 05YARC5700, 05YARC4661,
05YARC4360, 05YARC2648, 05YARC2024, 05YARC1666, 05YARC0864, 05YARC0249,
05YARB9972, 05YARB8503, 05YARB8186, 05YARB7699, 05YARB7354, 05YARB6851,
05YARB6514, 05YARB6037, 05YARB5732, 05YARB5250, 05YARB4931, 05YARB4375,
05YARB4042, 05YARB3510, 05YARB3176, 05YARB2633, 05YARB2270, 05YARB1748,
05YARB1419, 05YARB0846, 05YARB0504, 05YARA9997, 05YARA9683, 05YARA9226,
05YARA8961, 05YARA8465, 05YARA8122, 05YARA7581, 05YARA7260, 05YARA6755,
05YARA6443, 05YARA5983, 05YARA5652, 05YARA5165, 05YARA4856, 05YARA3570,
05YARA3270, 05YARA2749, 05YARA2189, 05YARA1923, 05YARA1397, 05YARA1118,
05YARA0625, 05YARA0359, 04YARD6410, 04YARD6001, 04YARD5753, 04YARC6289,
04YARC6013, 04YARC3786, 04YARB8591, 04YARB8147, 04YARB7895, 04YARB7453,
04YARB7193, 04YARB6640, 04YARB6057, 04YARB5812, 04YARB5359, 04YARB5107,
04YARB4695, 04YARB4410, 04YARB3806, 04YARB3364, 04YARB3148, 04YARB2763,
04YARB2530, 04YARB2152, 04YARB1733, 04YARB1285, 04YARB0995, 04YARB0532,
04YARB0219, 04YARA9752, 04YARA9224, 04YARA8973, 04YARA8561, 04YARA8297,
04YARA7839, 04YARA7558, 04YARA7114, 04YARA6775, 04YARA6582, 04YARA6205,
04YARA5773, 04YARA5505, 04YARA5074, 04YARA4803, 04YARA4460, 04YARA4122,
04YARA3772, 04YARA2800, 04YARA2503, 04YARA2163, 04YARA1203, 04YARA1085,
04YARA0595, 04YARA0327, 03YARD1159, 03YARD0878, 03YARD0655, 03YARD0326,
03YARD0095, 03YARC9788, 03YARC9575, 03YARC9191, 03YARC9031, 03YARC8542,
03YARC8236, 03YARC7907, 03YARC7580, 03YARC7348, 03YARC6762,
03YARC6433
RECALLING FIRM/MANUFACTURER BioLife Plasma
Services L.P., Fayetteville, AR,
REASON Source Plasma,
collected from a donor who was at increased risk for variant Creutzfeldt-Jakob
Disease (vCJD), was
distributed.
VOLUME OF PRODUCT IN
COMMERCE 145
units
DISTRIBUTION NC
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Unit number 5876975
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Oklahoma City, OK,
REASON Blood product, which was collected from a donor
who did not have a documented hematocrit, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OK
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Units 8716580 (split unit)
RECALLING
FIRM/MANUFACTURE Florida’s Blood Centers, Inc., Lake Park, FL
REASON Platelets, which were possibly contaminated with
bacteria, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION NY
PRODUCT Platelet
Pheresis Leukocytes Reduced,
CODE Unit
number 8507956
RECALLING FIRM/MANUFACTURER Florida’s
Blood Centers Inc., Orlando, FL,
REASON Blood product, with platelet yield below the
specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Red
Blood Cells Irradiated,
CODE Units:
71N566440, 71N566688
RECALLING FIRM/MANUFACTURER Life
South Community Blood Center, Birmingham, AL,
REASON Blood products, incorrectly labeled as
irradiated, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION AL
PRODUCT Fresh
Frozen Plasma,
CODE Units: 2233889,
2708213
RECALLING FIRM/MANUFACTURER Medic Inc.,
Knoxville, TN,
REASON Blood products,
associated with red cell components which contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TN
PRODUCT
a) Red Blood
Cells, Leukocytes Reduced,
b) Red Blood Cells (Apheresis)
Leukocytes Reduced,
CODE
a) Units:
17735-5133, 17735-5701, 17735-7219, 17735-7220, 17735-7223, 17735-7225,
17735-7226, 17735-7903, 17735-8302, 17735-8313, 17735-8316, 17735-8317,
17735-8314, 17735-8315, 17735-8740, 17735-9629, 17735-9227, 17735-9230,
17735-9231, 17735-9232, 17735-8876, 17735-8878, 17735-8882, 17735-9628,
17735-9237, 17735-9630, 17735-8901, 17735-8894, 17735-8898, 17735-9229,
17735-8891, 17735-9710, 17735-9233, 17735-9236, 17735-8881, 17735-8760,
17735-8753, 17735-8752, 17735-9082, 17735-9034, 17735-9029, 17735-9054,
17735-9055, 17735-9041, 17735-9046, 17735-9050, 17735-9066, 17735-9086,
17735-9051, 17735-9049, 17735-9039, 17735-9052, 17735-9057, 17735-8937,
17735-9635, 17735-9638, 17735-9634, 17735-8966, 17735-9285, 17735-8967,
17735-8976, 17736-0215, 17735-8978, 17735-8981, 17735-9442, 17735-9444,
17735-9478, 17735-9450, 17735-9509, 17735-9485, 17735-9437, 17735-9448,
17735-9472, 17736-0291, 17735-9436, 17735-9441, 17735-9452, 17735-9434,
17735-9438, 17735-9652, 17735-9651, 17735-9657, 17735-9655, 17735-9656,
17736-0249, 17736-0251, 17735-9543, 17735-9570, 17736-0351, 17735-9844,
17735-9549, 17735-9565, 17735-9571, 17736-0350, 17735-9538, 17735-9563,
17735-9566, 17736-0265, 17735-9904, 17735-9895, 17735-9881, 17736-0358,
17735-9882, 17735-9880, 17735-9902, 17736-0368;
b) Units: 17735-8883,
17735-9225(1), 17735-9225(2), 17735-9228(1), 17735-9228(2), 17735-9235(1),
17735-9235(2), 17735-8877(1), 17735-8877(2), 17735-8880, 17735-8902,
17735-9627(1), 17735-9627(2), 17735-9226(1), 17735-9226(2), 17735-9239(1),
17735-9239(2), 17735-9242(1), 17735-9242(2), 17735-9244(1), 17735-9244(2),
17735-9247(1), 17735-9247(2), 17735-9249(1), 17735-9249(2), 17735-8879(1),
17735-8879(2), 17735-8886(1), 17735-8886(2), 17735-8736(1), 17735-8736(2),
17735-8900(1), 17735-8900(2), 17735-9251(1), 17735-9251(2), 17735-9255(1),
17735-9255(2), 17735-9257(1), 17735-9257(2), 17735-9259, 17735-9260(1),
17735-9260(2), 17735-8735(1), 17735-8735(2), 17735-8893(1), 17735-8893(2),
17735-8889(1), 17735-8889(2), 17735-8883(1), 17735-8883(2), 17735-8885(1),
17735-8885(2), 17735-9030(1), 17735-9030(2), 17735-9031(1), 17735-9031(2),
17735-9045(1), 17735-9045(2), 17735-9081(1), 17735-9081(2), 17735-9060(1),
17735-9060(2), 17735-9062(1), 17735-9062(2), 17735-9080(1), 17735-9080(2),
17735-9067(1), 17735-9067(2), 17735-9076(1), 17735-9076(2), 17735-9022(1),
17735-9022(2), 17735-9038(1), 17735-9038(2), 17735-9042(1), 17735-9042(2),
17735-9056(1), 17735-9056(2), 17735-9024(1), 17735-9024(2), 17735-9047(1),
17735-9047(2), 17735-9059(1), 17735-9059(2), 17735-9061(1), 17735-9061(2),
17735-9074(1), 17735-9074(2), 17735-9083(1), 17735-9083(2), 17735-9058,
17735-9048(1), 17735-9048(2), 17735-9070(1), 17735-9070(2), 17735-9043(1),
17735-9043(2), 17735-9044(1), 17735-9044(2), 17735-9037(1), 17735-9037(2),
17735-9033(1), 17735-9033(2), 17735-8946(1), 17735-8946(2), 17735-8948(1),
17735-8948(2), 17735-9639(1), 17735-9639(2), 17735-8783(1), 17735-8783(2),
17735-8962(1), 17735-8962(2), 17735-8965(1), 17735-8965(2), 17735-9287(1),
17735-9287(2), 17735-9282(1), 17735-9282(2), 17735-9295(1), 17735-9295(2),
17735-9296(1), 17735-9296(2), 17735-9474(1), 17735-9474(2), 17735-9486(1),
17735-9486(2), 17735-9432(1), 17735-9432(2), 17735-9439(1), 17735-9439(2),
17735-9466(1), 17735-9466(2), 17735-9449(1), 17735-9449(2), 17735-9445(1),
17735-9445(2), 17735-9456(1), 17735-9456(2), 17735-9469(1), 17735-9469(2),
17735-9433(1), 17735-9433(2), 17735-9470(1), 17735-9470(2), 17735-9479(1),
17735-9479(2), 17735-9481(1), 17735-9481(2), 17735-9487(1), 17735-9487(2),
17735-9489(1), 17735-9489(2), 17735-9493(1), 17735-9493(2), 17735-9491(1),
17375-9491(2), 17735-9519(1), 17735-9519(2), 17735-9508(1), 17735-9508(2),
17735-9430(1), 17735-9430(2), 17735-9457(1), 17735-9457(2), 17735-9464(1),
17735-9464(2), 17735-9443(1), 17735-9443(2), 17735-9453, 17735-9468(1),
17735-9468(2), 17735-9496, 17735-9495, 17735-9501(1), 17375-9501(2),
17735-9496(1), 17735-9496(2), 17735-9516(1), 17735-9516(2), 17735-9463(1),
17735-9463(2), 17735-9482(1), 17735-9482(2), 17735-9514(1), 17735-9514(2),
17735-9454(1), 17735-9454(2), 17735-9480(1), 17735-9480(2), 17735-9446(1),
17735-9446(2), 17735-9467(1), 17735-9467(2), 17735-9490(1), 17735-9490(2),
17735-9502(1), 17735-9502(2), 17735-9505(1), 17735-9505(2), 17735-9547(1),
17735-9547(2), 17735-9593(1), 17735-9593(2), 17735-9586(1), 17735-9586(2),
17735-9856(1), 17735-9856(2), 17735-9541(1), 17735-9541(2), 17735-9551(1),
17735-9551(2), 17735-9555(1), 17735-9555(2), 17735-9552(1), 17735-9552(2),
17735-9554(1), 17735-9554(2), 17735-9561(1), 17735-9561(2), 17735-9588(1),
17735-9588(2), 17735-9852(1), 17735-9852(2), 17735-9853(1), 17735-9853(2),
17735-9546(1), 17735-9546(2), 17735-9583(1), 17735-9583(2), 17735-9599(1),
17735-9599(2), 17735-9548(1), 17735-9548(2), 17735-9897(1), 17735-98979(2),
17735-9899(1), 17735-9899(2), 17735-9898(1), 17735-9898(2),
17735-9900
RECALLING FIRM/MANUFACTURER Blood Systems,
Inc., McAllen, TX,
REASON Red Cells, held at an incorrect
temperature during component
preparation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 347
units
DISTRIBUTION TX
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Units:26836-3733(1), 26836-3733(2), 26836-3736(1),
26836-3736(2), 26836-4568(1), 26836-4568(2), 26836-4578(1), 26836-4578(2),
26836-5395(1), 26836-5395(2), 26836-5424(1), 26836-5424(2), 26836-5425(2),
26836-5429(1), 26826-5432(1), 26826-5432(2), 26836-5433(1), 26836-5433(2),
26836-5435(2), 26836-5444(1), 26836-5556(1), 26836-5556(2), 26836-5558(1),
26836-5558(2), 26837-0802(1), 26837-0802(2), 26971-2538(1), 26971-2538(2),
26971-2543(1), 26971-2543(2), 26971-2593(1), 26971-2593(2), 26971-2594(1),
26971-2594(2), 26971-2595(1), 26971-2595(2), 26971-2609(1), 26971-2609(2),
26971-2615(1), 26971-2615(2), 26971-2616(1), 26971-2616(2), 26971-3490(1),
26971-3490(2), 26971-3492(1), 26971-3492(2), 26971-3494(1), 26971-3494(2),
26971-3495(1), 26971-3495(2), 26971-3499(1), 26971-3499(2), 26836-3735,
36836-3738, 26836-3741, 26836-3742, 26836-4570, 26836-4573, 26836-5196,
26836-5197, 26836-5393, 26836-5394, 26836-5396, 26836-5397, 26836-5423,
26836-5446, 26836-5553, 26836-5563, 26837-0821, 26971-2589, 26971-2590,
26971-2591, 26971-2610, 26971-2612, 26971-2614, 26971-3488, 26971-3489,
26971-3491
RECALLING FIRM/MANUFACTURER Blood Systems,
Inc., Fort Smith, AR, REASON Red Cells, collected from donors who
were not properly qualified for donation, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 78 units
DISTRIBUTION AR,
OK and TX
PRODUCT Red
Blood Cells,
CODE Unit
0334827
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA, REASON Blood product, which was collected from
a donor in which donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION LA
WEEK ENDING DECEMBER 30
PRODUCT
Human Tissue for
Transplantation:
a) Achilles Tendon Frozen;
b) Patellar Ligament Hemi,
Frozen;
c) Cartilage in Saline Vacuum;
d) Tibialis Anterior Tendon,
Frozen
e) Tibialis Tendon Frozen;
f) Tibialis Tendon Posterior
Frozen;
Human Tissue for Transplantation:
a) Fascia Lyo 101-150 sq cm;
b) Pericardium
Lyo 26-50 sq cm;
c) ) Semitendonosus / Gracilis Frozen;
d) Patella
Ligament Whole Frozen,
CODE
a) 03-0178792,
03-0173682, 03-0168103, 03-0168104, 03-0162640, 03-0168841, 03-0181591,
03-0168302, 03-0179205, 03-0181592, 03-0042572, 03-0155372, 03-0182234,
03-0032401, 03-0174931, 03-0155371, 03-0161144, 03-0182782, 03-0182623,
03-0181628, 03-0182051, 03-0032400, 03-0168301, 03-0147962, 03-0173822,
03-0182235, 03-0181627, 03-0128130, 03-0162639, 03-0182783, 03-0182624,
03-0161143, 03-0182052, 03-0151503, 03-0147961, 03-0042571, 03-0179206,
03-0172621, 03-0135831, 03-0174932, 03-0173821, 03-0173681, 03-0172251,
03-0178791, 03-0173841, 03-0173842;
b) 03-0168842, 03-0181593, 03-0135832,
03-0181595, 03-0182781, 03-0178796, 03-0182625, 03-0182626, 03-0168844,
03-0173823, 03-0173825, 03-0179203, 03-0173826, 03-0182011, 03-0182049,
03-0179202, 03-0042574, 03-0139081, 03-0151502, 03-0147967, 03-0168102,
03-0162641, 03-0161142, 03-0128132, 03-0042575, 03-0168101, 03-0172618,
03-0181594, 03-0162643, 03-0168843, 03-0181438, 03-0172252, 03-0181596,
03-0178793, 03-0178794, 03-0032405, 03-0139084, 03-0179204, 03-0182047,
03-0181212, 03-0172620, 03-0182048, 03-0172617, 03-0172619, 03-0042573,
03-0042576, 03-0178795, 03-0139082, 03-0162644, 03-0173824, 03-0181213,
03-0172253, 03-0182050, 03-0151501, 03-0179201, 03-0181436, 03-0181437,
03-0032402, 03-00324404, 03-0162642, 03-0128131, 03-0128133, 03-0147968,
03-0181211;
c) 03-0014874, 03-0014871, 03-0014878, 03-0014875, 03-0014876,
03-0014877;
d) 03-0182053, 03-0182054, 03-0181621, 03-0179207, 03-0179208,
03-0181600, 03-0181599, 03-0168303, 03-0168304, 03-0155375, 03-0173846,
03-0173847, 03-0181622;
e) 03-0042582, 03-0042580, 03-0042581, 03-0178797,
03-0178798, 03-0178799, 03-0147963, 03-0147964, 03-0147965, 03-0147966;
f)
03-0155377, 03-0173845, 03-0182055, 03-0181623, 03-0155376, 03-0181598,
03-0181624, 03-0179209, 03-0181597, 03-0179210;
a) 03-0182237, 03-0182238, 03-0168105;
b) 03-0168845, 03-0173684,
03-168846, 03-0174935, 03-0174936, 03-0173683
c) 03-0147971;
d)
03-0182232, 03-0182233, 03-0155373, 03-0155374, 03-0179281, 03-0111812,
03-0174933, 03-0161141, 03-0173844, 03-0181625, 03-0173843
RECALLING
FIRM/MANUFACTURER DCI Donor Services Tissue Services Division, Nashville,
TN,
REASON Human tissue, which was either implicated in a
post-transplant bacterial infection, or was processed in the same manner as
tissue that was implicated in a post-transplant bacterial infection, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 170 tissue allografts
DISTRIBUTION New Mexico, TN, CA, NV, and AK.
PRODUCT Human Cadaveric
Unprocessed Tissue,
CODE A0501, A0502, A0503,
A0504, A0505, A0506, A0507, B0501, B0502, B0503,
B0504, B0505, C0501, C0502,
C0503, C0507, C0508, D0402, D0502, D0503,
D0504, D0505, D0509, E0401, E0402,
E0403, E0404, E0405, E0406, E0407,
E0410, E0411, E0412, E0413, E0502, E0503,
E0504, E0506, E0507, E0508,
E0509, E0510, E0511, F0401, F0402, F0405, F0407,
F0408, F0410, F0411,
F0502, F0503, G0402, G0403, G0404, G0405, G0406, G0407,
G0409, G0502,
G0503, H0401, I0401, I0402, I0403, J0401, J0402, J0403, J0404,
J0405, J0406,
J0407, J0408, J0409, J0501, J0503, K0401, K0402, K0403, K0404,
K0405,
K0501, K0502, K0503, K0504, K0505, L0401, L0403, L0404, L0405, L0406,
L0407, L0408, L0409, L0410, L0411, L0412, L0501
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Donor Referral Services,
Raleigh, NC,
Alternate
address: Hope of North Carolina, Raleigh, NC.
REASON Human Tissues, recovered from donors without
adequate donor eligibility determinations, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 99 units
DISTRIBUTION FL and TX
PRODUCT
Human Tissue for
Transplantation,
a) Achilles Tendon (various sizes), Fresh
Frozen, Irradiated;
b) Cancellous Chips, Crushed 1-4mm/15 & 30cc, Freeze
Dried, Irradiated;
c) Cancellous Chips 4-10mm/15cc, 30cc & 60cc, Freeze
Dried, Irradiated;
d) Cancellous, Cortical Chips 1-4mm/30cc, Freeze Dried,
Irradiated;
e) Cancellous Cubes 5-5mm/30cc, Freeze Dried, Irradiated;
f)
Cloward Dowel (various sizes), Freeze Dried, Irradiated;
g) Cortical Plate
2x20cm, Freeze Dried, Irradiated;
h) Cortical Button 12x9mm, Freeze Dried,
Irradiated;
i) Fascia Lata (various sizes), Freeze Dried, Irradiated;
j)
Femoral Head w/Neck (various sizes), Fresh Frozen, Irradiated;
k) Femoral
Ring 30mm, Fresh Frozen, Irradiated;
l) Femur Segment 6.0cm, Fresh Frozen,
Irradiated;
m) Femur Shaft, Split 23cm, Fresh Frozen, Irradiated;
n)
Fibula Ring 0.7cm, Freeze Dried, Irradiated;
o) Fibula Segment (various
sizes), Freeze Dried, Irradiated;
p) Gracilis 0.7x28cm, Fresh Frozen,
Irradiated;
q) Ilium Tricortical Block (various sizes), Freeze Dried,
Irradiated;
r) Patella Tendon, Bisected (various sizes), Fresh Frozen,
Irradiated;
s) Patella Tricortical 8x26mm, Freeze Dried, Irradiated;
t)
Semitendonosus (various sizes), Fresh Frozen, Irradiated;
u) Tibialis Tendon
Anterior (various sizes), Fresh Frozen, Irradiated;
v) Tibialis Tendon
Posterior (various sizes), Fresh Frozen, Irradiated;
w) Tibial Shaft, Split
(various sizes)
CODE
a) 05-0131-071, 05-0131-072, 05-0138-008,
06-0007-009, 06-0007-010,
06-0019-003;
b) 05-0129-001, 05-0129-002,
05-0129-004, 05-0129-005, 05-0129-007,
05-0129-008, 05-0131-040,
05-0131-041, 05-0131-042, 05-0131-043,
05-0131-044, 05-0131-045,
05-0131-046, 05-0131-047, 05-0131-048,
05-0131-049, 05-0138-023,
05-0138-024, 05-0138-025, 05-0138-026,
05-0139-014, 05-0139-016,
05-0139-017, 05-0139-018, 06-0007-015,
06-0007-016, 06-0007-017, 06-0007-018,
06-0019-017, 06-0019-018,
06-0019-020;
c) 05-0129-009, 05-0129-010,
05-0129-011, 05-0129-012, 05-0129-013,
05-0129-014, 05-129-015, 05-0129-016,
05-0129-017, 05-0131-019,
05-0131-020, 05-0131-021, 05-0131-022,
05-0131-023, 05-0131-024,
05-0131-025, 05-0131-026, 05-0131-027,
05-0131-028, 05-0131-029,
05-0131-030, 05-0131-031, 05-0138-027,
05-0138-029, 05-0138-030,
05-0138-032, 05-0139-019, 05-0139-020,
05-0139-021, 05-0139-022,
05-0139-023, 06-0007-019, 06-0007-020,
06-0007-021, 06-0007-022,
06-0007-023, 06-0007-024, 06-0019-022,
06-0019-023, 06-0019-024,
06-0019-025, 06-0019-026, 06-0019-027;
d)
05-0139-059, 05-0139-060, 05-0139-061, 05-0139-062, 05-0139-063,
05-0139-064, 05-0139-065, 05-0139-066, 05-0139-067, 05-0139-068;
e)
05-0131-014, 05-0131-015, 05-0131-016, 05-0131-017, 05-0131-018,
06-0007-025;
f) 05-0131-050, 05-0131-051, 05-0131-052, 05-0131-053,
05-0131-055,
05-0131-056, 05-0131-057, 06-0007-030;
g) 05-0138-011,
05-0138-012, 05-0138-013, 05-0139-001, 05-0139-002,
06-0007-035,
06-0007-037, 06-0019-016;
h) 05-0139-008;
i) 06-0007-013,
06-0007-014;
j) 05-0138-022, 05-0139-030, 05-0139-031, 06-0007-032,
06-0007-033;
k) 06-0019-009, 06-0019-010, 06-0019-011, 06-0019-012,
06-0019-013,
06-0019-014, 6-0019-015;
l) 05-0131-066, 05-0131-067,
05-0131-069, 05-0131-070;
m) 05-0129-025;
n) 05-0131-037, 06-0007-027,
06-0007-028;
o) 05-0131-036, 05-0138-018, 05-0138-020, 05-0138-021;
p)
06-0007-008;
q) 05-0131-032, 05-0131-033, 05-0131-034, 05-0131-075;
r)
05-0129-032, 05-0129-033, 05-0129-034, 05-0131-073, 05-0131-074,
06-0007-011, 06-0007-012;
s) 06-0007-031;
t) 05-0138-003,
06-0007-006;
u) 06-0007-001, 06-0007-002;
v) 06-0007-003,
06-0007-004;
w) 05-0139-003, 05-0139-005, 05-0139-006
RECALLING
FIRM/MANUFACTURER Alamo Tissue Services, Ltd., San Antonio, TX,
REASON
Human Tissues, recovered from donors without
adequate donor eligibility determinations, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 161
units
DISTRIBUTION Nationwide
PRODUCT Platelets Pheresis
Leukocytes Reduced Irradiated,
CODE Unit:
C51493
RECALLING FIRM/MANUFACTURER HCSC-Blood Center, Bethlehem,
PA, REASON Blood product, with no documentation to verify the
irradiation process, was distributed
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION PA
PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced,
CODE
Units:
26730-4974, 26730-5370, 26730-5569, 26730-5572, 26730-5834,
26730-5880,
26731-0691, 26731-0866, 26731-0962, 26731-1733,
26732-0271, 26732-0506,
26732-5191, 26732-5375, 26732-5381,
26732-5533, 26732-5573, 26732-5838,
26732-6222, 26732-6247,
26923-8476, 26923-8727, 26923-8883, 26923-9136,
26923-9152,
26923-9200, 26924-2377, 26924-2966
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., Fort Smith, AR, REASON Blood products, with undocumented quality control,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 28
units
DISTRIBUTION TX
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Units: 268352557,
268352564, 268352541, 268351736, 268351756
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., Fort Smith, AR, REASON Red
Cells, incorrectly tested for antibody to the Cytomegalovirus (CMV), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION AR
PRODUCT
a) Platelets Pheresis
Leukocytes Reduced,
b) Fresh Frozen Plasma (Apheresis),
CODE
a) Units: 71X27079-7 (distributed as split
product);
b) Unit: 71X27079-7
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers Inc., Brooksville,
FL,
REASON Blood Products, collected in an apheresis collection kit
which was not used within an acceptable time period, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION FL
PRODUCT
a) Red Blood Cells
Leukocyte Reduced,
b) Platelets,
CODE
a) and b) Unit: 9771326
RECALLING
FIRM/MANUFACTURER Florida’s Blood Centers Inc., Lake Park FL,
REASON
Blood products, collected
from the sexual partner of an immigrant from an HIV Group O risk area, were
distributed
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION FL
PRODUCT
a) Platelets Pheresis,
Leukocytes Reduced,
b) Platelets Pheresis, Leukocytes
Reduced, Irradiated,
CODE
a) Unit: 2060964-Part
B;
b) Unit: 2060964-Part A
RECALLING FIRM/MANUFACTURER Medic,
Inc., Knoxville, TN
REASON Platelets,
possibly contaminated with Bacillus species, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION TN
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit number
5213589
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood product, which was
collected from an unsuitable donor based on risk factors for variant
Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION OK
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced
b) Recovered Plasma,
CODE a) and b) Unit: 4765590
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center,
Oklahoma City, OK,
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
2
units
DISTRIBUTION Oklahoma and Switzerland
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Unit number 4900925
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center,
Oklahoma City, OK,
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
2
units
DISTRIBUTION Oklahoma and Switzerland
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Unit number 5253844
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center,
Oklahoma City, OK
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 2
units
DISTRIBUTION Oklahoma and Switzerland
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
5418771
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N. Goldman Center, Oklahoma City, OK,
REASON Blood product, collected
from an unsuitable donor based on travel to an area considered endemic for
malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OK
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets,
CODE a) and b) Unit number 5427132
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center,
Oklahoma City, OK
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 OK and NY
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
5415359
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood product, collected
from an unsuitable donor based on travel to an area considered endemic for
malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NJ
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets,
CODE a)) and b) Unit number 5319038
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N Goldman Center,
Oklahoma City, OK
REASON Blood products, collected from an unsuitable
donor who had traveled to an area considered endemic for malaria, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION OK and NY
PRODUCT Red Blood Cells,
CODE
Unit: 0341802
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA, REASON Blood
product, which tested positive for syphilis, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION LA
PRODUCT
a) Red Blood Cells,
b) Recovered Plasma,
CODE a) and b) Unit: 0249958
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA, REASON Blood products, collected from a donor who was at
increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CA and LA
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Units: 9162127 (Parts 1,
2, & 3)
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial
Blood Center, Denver, CO
REASON Platelets, which were possibly contaminated
with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION CO
PRODUCT
a) Red Blood Cells,
b)
Platelets
c) Fresh Frozen
Plasma,
CODE
a) and b) Units: 0247462,
0247463;
c) Unit: 0247463
RECALLING FIRM/MANUFACTURER The Blood
Center, New Orleans, LA, REASON Blood products, collected from
donors for whom donor suitability was not adequately determined, were
distributed
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION CA, LA, and MS
PRODUCT Recovered Plasma,
CODE
Unit: 5595312
RECALLING
FIRM/MANUFACTURER Associated Regional and University Pathologists, Salt
Lake City, UT
REASON Blood product,
which tested positive for the antibody to the human immunodeficiency virus
(anti-HIV-1/2), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION UT
PRODUCT
a) Red Blood Cells,
b) Platelets,
c) Fresh Frozen
Plasma,
CODE a), b), and c) Unit
0253260
RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans,
LA, REASON Blood products, collected from a donor who may
have been at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD),
were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION CA and
LA
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
9038633
RECALLING FIRM/MANUFACTURE Belle Bonfils Memorial Blood Center,
Denver, CO,
REASON Platelets, possibly contaminated with Micrococcus
species, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CO
PRODUCT
a) Plasma, Frozen,
b) Platelets,
c) Platelets, Irradiated,
d) Fresh Frozen Plasma,
e)
Cryoprecipitated AHF,
f) Plasma, Cryoprecipitate Reduced,
CODE
a) Units: 053T00998, 053FJ60413,
053FL83759, 053GC33836, 053FJ69159,
053GQ90858, 053V06428, 053L23590,
053FL87405, 053V12793, 053GV34992,
053KY57797, 053LR23002, 053GE52626,
053GZ13730, 053FE66059,
053GV43928, 053GC38832, 053R98339, 053GZ17003,
053FL06621,
053FQ87008, 053GV45742, 053FH97803, 053FK82140, 053FH03266,
053FH03288, 053GM29315, 053GZ11433, 053FE68691, 053FJ82837,
053FH83821,
053FP33303, 053R83415, 053FK68503, 053Y93812,
053GM28932, 053FH83914,
053GL10553, 053GC44246, 053H99311,
053Y99652, 053G34726, 053GE44214,
053V99715, 053FH91752,
053H92766, 053GR48998, 053LR22299, 053KL61924,
053H67185,
053FP26683, 053R72881, 053FC89372, 053FL77885, 053FN54600,
053KF47635, 053T81186, 053FP30725, 053L17367, 053V94953,
053FH82403,
053Q81341, 053FJ67338, 053GM29314, 053C09625,
053H76442, 053GF33296,
053GR29463, 053FR77274, 053FN63645,
053FX78996, 053FX78998, 053Y87468,
053GN44015, 053L28694,
053FE61463, 053FL91240, 053J67589, 053GV41286,
053R89408,
053GN46125, 053GM32634, 053GE56938, 053GJ24563, 053FQ83600,
053H84739, 053FP37460, 053FR80659, 053GL11891, 053FH89425,
053GZ15052,
053FE66070, 053FJ76138, 053GN47695, 053GM34037,
053C16941, 053FL01123,
053GF40669, 053LW26041, 053FN80052, 053T96282, 053FE69466, 053H91325,
053GZ17298, 053L43275, 053H91610, 053FP42254, 053FL06857, 053F38635,
053FM54868, 053FL07100, 053FN83492, 053FN84893, 053FR84327, 053FJ79762,
053GL14881, 053GH56427, 053H94176, 053V08603, 053V09796, 053FN89460,
053G60746, 053FF62120, 053FP46295, 053FQ91377, 053H98542, 053H98544,
053G62481, 053H99837, 053H85377, 053FL09085, 053FK66692, 053FH85641,
053FH85645, 053FL04907, 053GN50099, 053FE63453, 053FW28904, 053L23591,
053FM52598, 053FX94252, 053FJ63319, 053L46162, 053GC41652, 053GC41653,
053L46614, 053FQ89246, 053GV49544, 053F30655,
053GR27969, 053L21402,
053FE58529, 053GL07735, 053GH51476, 053GJ09338, 053FL78363, 053C09454,
053FK67223, 053GJ22951, 053FQ85009, 053FC06615 053FL01071, 053GF26148,
053GH46211, 053T74939, 053V89571, 053KQ55835, 053T78386, 053GV34471,
053C05415, 053GQ77104, 053FL83769, 053H74356, 053GM28891, 053FN59832,
053FP33051, 053GR28777, 053FJ68022, 053FK64818,053F32149, 053LL51104,
053GQ82381, 053Q83103, 053H78663, 053FX79009, 053FK67232, 053G44419,
053FK67996, 053T87968, 053FQ81269, 053FJ70933, 053GL09797, 053GE52625,
053L31341, 053FM47975, 053FN69978, 053M97774,
053GJ24548, 053GQ87659,
053FL96032, 053H85218, 053FQ84675, 053Y91094,
053F35761, 053F36686,
053FN76951, 053GJ28178, 053H90216, 053FH93820,
053FN80230, 053GF41411,
053FW24422, 053GZ17478, 053GC41203, 053LW27784, 053FC12581, 053H93010,
053LW27811, 053FQ87614, 053J76052, 053FL09222, 053C21698, 053FM57891,
053Y97459, 053GL16671, 053Q98458, 053GJ37121, 053J81669, 053KE37678,
053GN41030, 053GF35035, 053GZ12835, 053L33097, 053Q86592, 053GJ27209,
053GR38281, 053FN76817, 053F25071, 053R72923, 053FN59048, 053L23822,
053F32156, 053GQ83622, 053V02563, 053Y93074, 053LW31327, 053Y91115,
053V89918, 053FF55825, 053GR30840, 053FH85671, 053J68109, 053GZ14946,
053FK80334, 053FL09890, 053K35790, 053C13074, 053GQ74140, 053KL64537,
053FN76124, 053GV46476, 053H98440, 053T72990, 053GV51308, 053GE56103,
053FM49193, 053KS40230, 053GS28868, 053C07442,
053FP33063, 053FQ80874,
053F33658, 053R88733, 053G49874, 053V02232,
053G51026, 053FQ84986,
053GL13105, 053LL56095, 053FR82296, 053GF40643, 053R98327, 053FP41397,
053Y94165, 053J76381, 053C21109, 053FE73321, 053FF61296, 053FJ85497,
053FC84490, 053GR26913, 053FM44094, 053R83261, 053FL95265, 053FL98529,
053GN47628, 053FL01041, 053H99753, 053GJ10619, 053FE55123, 053Q80987,
053Q81352, 053H93837, 053FC17232, 053FJ59510, 053V91042, 053KQ56499,
053FQ73909, 053GE47328, 053GL07862, 053FK67356,
053T87539, 053GM31417,
053GL11388, 053FN76819, 053GF39571, 053FJ77722, 053GC41200, 053GZ17796,
053FK80068, 053FR84423, 053FQ88070, 053GC42655, 053GQ03951, 053J59196,
053GL04920, 053GZ11961, 053FQ81966, 053G47708, 053V00535, 053Y92412,
053T97538, 053GE70103, 053GF43068, 053GV46476, 053FJ82840, 053V12813,
053GJ38167, 053GM29294, 053R95762, 053V06436, 053KX36398, 053R81953,
053FF55187, 053GR28857, 053GQ82386, 053FL01067, 053FH96325, 053J79757,
053Y99157, 053L36603, 053FE53486, 053GV35037,
053FK84053, 053LR22689,
053R95162, 053FE71521, 053GF26134, 053F32724,
053Q89114, 053FC19598,
053LW18453, 053GV39746, 053FL90658, 053Y88060, 053GC35908, 053FP38385,
053FL98082, 053FQ89238, 053FP24154, 053GF26132, 053FL85288, 053C11941,
053GJ21330, 053GE52343, 053GL09868, 053GC35914, 053FE63304, 053V01191,
053GR36327, 053GL13327, 053GM34039, 053GM34040,
053FN76880, 053GR39039,
053L42575, 053GZ17091, 053FE69796, 053R01863,
053FR84019, 053FE71650,
053FQ88080, 053GC42411, 053FL09745, 053GV49072, 053Q99340, 053GE75859,
053FJ67331, 053GM29295, 053GM29316, 053G42789, 053FK66097, 053GM43527;
b)
Units: 053GC33836, 053GJ16939, 053FF54505, 053LW18453, 053FX78703,
053FC96608, 053L33097, 053FN59048, 053LW24766, 053FK64818, 053GE56042, 053R83415, 053T72990, 053GZ11181, 053L25685, 053FC01547, 053GR34316,
053FK67996, 053T74939, 053FC03532, 053R95162, 053FL83759, 053FH83914, 053GC42212, 053J59130, 053H93188, 053L22043, 053G42789, 053R84150,
053J64133, 053Q86445, 053FC07547, 053FK67223, 053FK67232, 053Y91094, 053R01679, 053GE46489, 053FN68332, 053GM39065, 053GJ27209,
053GR28777, 053G47708, 053GE56938, 053FC03537, 053GE70103, 053R72881,
053KF47635, 053GV34992, 053C07442, 053F30655, 053Y94618, 053G58274,
053KQ55835, 053FN57710, 053GV39485, 053Y87054, 053R01863, 053GC41203,
053T81186, 053C09454, 053GM30775, 053FX85115, 053L46162, 053FM49798,
053GV49072, 053H85218, 053GZ11587, 053R88733, 053GL14881, 053FW28904,
053L43047, 053GZ10534, 053FC01389, 053Y94165, 053FX91370, 053GE65689,
053GV34471, 053GR27969, 053FL87033, 053KS40230, 053GJ10619, 053L17367,
053Q81855,
053FP33918, 053GE48706, 053H83477, 053GL11891, 053T92384,
053LW25299, 053FN83525, 053FL09890, 053FM57891, 053Y00020, 053KQ56499,
053R72923, 053GS28868, 053T82866, 053GJ15444, 053V94953, 053FC93750,
053L21402, 053GE47470, 053H77545, 053FF56365, 053L35849, 053FH93455,
053C20514, 053FM48806, 053FN69978, 053FL96032, 053GC37919, 053FX94476,
053LW15877, 053GJ09673, 053G60746, 053FH82403, 053LL53568, 053H93714,
053FN89460, 053GL00834, 053LW18690, 053K36217, 053J75215, 053L45359,
053GR48037,
053GR26913, 053FQ78134, 053G56599, 053GL09797;
c) Units:
053FN84893, 053Q82647, 053GJ30877;
d) Unit: 053FC89525;
e) Units:
053F28365, 053FC89525, 053FY23113, 053Q78528, 053C05631;
f) Unit:
053FC89525
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Chesapeake & Potomac Region, Baltimore, MD
REASON Blood
products, associated with units of Red Blood Cells that contained clots, were
distributed
VOLUME OF PRODUCT IN COMMERCE 543
units
DISTRIBUTION IL, MD, NY, NC, PA, VA, and D.C
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE a) and b) Unit: 22GS24166
RECALLING
FIRM/MANUFACTURER American National Red Cross, Penn-Jersey Region,
Philadelphia, PA,
REASON Blood
products, corresponding to a unit of Platelets that was possibly contaminated
with gram positive cocci, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION PA and NJ
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit:
172046504
RECALLING FIRM/MANUFACTURER Blood Systems Inc., McAllen, TX
REASON Blood product, with an un-verified platelet count, was
distributed
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Units: 71X183444
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth
Community Blood Centers, Inc., Gainesville, FL,
Manufacturer: LifeSouth Community Blood Centers, Inc.,
Huntsville, AL.
REASON Platelets, not manufactured according to
manufacturer’s specifications, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION AL
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
16GY05430
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Central Ohio Region, Columbus, OH,
REASON Blood product, mislabeled as to antigen phenotype, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH
PRODUCT
a) Platelets Pheresis,
Leukocytes Reduced,
b) Platelets Pheresis, Leukocytes
Reduced, Irradiated,
CODE Unit:
21KP60583
RECALLING FIRM/MANUFACTURER American National Red Cross,
Pacific Northwest Region, Portland, OR,
REASON Platelets, possibly contaminated with Staph
species, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION OR
PRODUCT Red Blood Cells Pheresis,
Leukocytes Reduced,
CODE Units 16383-2263 (split
unit)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturing Firm: Blood Systems, Inc., dba United Blood Services,
Meridian, MS.
REASON Blood
products, for which documentation of the apheresis procedure was incomplete,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MS
PRODUCT Red Blood Cells,
CODE
Unit: 4521100
RECALLING
FIRM/MANUFACTURER Florida Blood Services, Inc., St. Petersburg, FL,
REASON
Blood product, which was incorrectly tested for
human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic
acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Fresh
Frozen Plasma,
CODE Units: FE64838, FE68696,
FE65301, FG45140, FG27179, FG54292, FG53414, FG80202, FG73371, FH42762, FH40598,
FH29132, FH36123
RECALLING FIRM/MANUFACTURER Aurora Area Blood
Bank, Heartland Blood Centers, Aurora, IL,
REASON Blood products, manufactured
from units of Whole Blood with an extended collection time, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 13
units
DISTRIBUTION IL and IN
PRODUCT Platelets Pheresis
Leukocytes Reduced Irradiated,
CODE Units 9302197
(parts 1 & 2)
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO,
REASON Blood products, which did not meet
acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION CO