OCTOBER 2007
WEEK ENDING OCTOBER 6
PRODUCT Red
Blood Cells,
CODE Unit:
029KC67762
RECALLING FIRM/MANUFACTURER American National
Red Cross Mid Atlanta, Norfolk, VA,
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 VA and
CA
PRODUCT
a)
Red Blood Cells, Leukocytes Reduced,
b) Platelets,
CODE
027GS07188
RECALLING
FIRM/MANUFACTURER ARC Greater Alleghenies, Johnstown, PA
REASON
Blood products, which were collected
from a donor in which donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION OH, WV and
CA
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Units: 019FZ31873 and
019LV36559
RECALLING FIRM/MANUFACTURER American Red Cross
Blood Services Tennessee Valley Region, Nashville, TN
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 TN
PRODUCT Platelets,
CODE
Unit:
1124187
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood product, which was
collected from a donor who had taken aspirin prior to the donation, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Units: 5822417, 5823702, 5823715, 5822420,
5823717, 5823735, 5823739, 5823716, 5823670, 5823743, 5822423, 5822421, 5823482,
5821508, 5822276, 5796481, 5790966, 5796876, 5824765, 5823573, 5790968, 5823567,
5823603, 5824382, 5822288, 5796797, 5796440, 5823232, 5824364, 5824432, 5824367,
5824371, 5824435, 5824404, 5822304, 5822410, 5822387, 5822418, 5823660, 5822422,
5823704, 5823740, 5822418, 5823595, 5823582, 5822419 (split unit), 5790985,
5823289, and 5791486
RECALLING
FIRM/MANUFACTURER LifeShare Blood Centers, Alexandria, LA
REASON
Blood products, which may have been
stored under unacceptable storage conditions were distributed.
VOLUME
OF PRODUCT IN COMMERCE 50
units
DISTRIBUTION LA and
AZ
PRODUCT Platelets,
CODE
Unit:
1124767
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood product, which was not
quarantined after receipt of information regarding post-donation illness,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION VA
PRODUCT Red
Blood Cells (Apheresis) Leukocytes Reduced,
CODE Unit: 19GG76493, split product, two
units
RECALLING FIRM/MANUFACTURER American Red Cross
Blood Services Tennessee Valley Region, Nashville, TN
REASON
Blood
products, collected without complete documentation of the apheresis process,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TN
PRODUCT Platelets,
CODE
Unit:
3938837
RECALLING FIRM/MANUFACTURER Lifesource, Glenview, IL
REASON
Blood product, which was collected from
a donor who had taken aspirin Prior to the donation, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT
a)
Cryoprecipitated AHF,
b) Red Blood Cells,
CODE
a) Unit: 4057297;
b) Units: 4032050 and
4058425
RECALLING FIRM/MANUFACTURER The Blood Connection,
Inc., Piedmont, SC
REASON Blood products,
associated with units that contained clots, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION NC and
SC
PRODUCT Fresh
Frozen Plasma,
CODE Unit:
0240885
RECALLING FIRM/MANUFACTURER The Blood Connection,
Inc., Piedmont, SC
REASON Blood product,
associated with a Red Blood Cell unit that contained clots, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION SC
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 71X348661
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL
REASON Blood product, associated with a unit of
Platelets that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets,
CODE
Unit:
71Q706365
RECALLING FIRM/MANUFACTURER LifeSouth Community
Blood Centers, Inc., Gainesville, FL
REASON Blood product, with
a low platelet count, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Plataelets
Pheresis, Leukocytes Reduced,
CODE Unit: 71X140825
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL
REASON Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Ampilink
Software versions 1.1, 1.3, 1.4, 2.41 and 2.42 [COBAS AmpliPrep/COBAS Amplicor
HIV-1 Monitor v1.5 test; COBAS Amplicor HIV-1 Monitor test v1.5; COBAS
AmpliScreen HBV Test; COBAS AmpliScreen HCV Test, version 2; COBAS AmpliScreen
HIV-1 Test, version 1.5], CODE Catalog
number 03309401018; working probe suspension/SM PS1-SM4; Working substrate
SB3-SB; Catalog number 03155935018; working Probe Suspension/IM PS1-IM4; Working
substrate SB3-SB; Catalog number 03599779190 Working Substrate SB3-SB; Catalog
number 03302563018, Working Substrate SB3-SB; Catalog number 03322114018,
Working Substrate SB3-SB.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Roche Molecular Systems, Inc.,
Somerville, NJ
Manufacturer: Roche
Instrument Center AG, Rotkreuz, Switzerland.
REASON For select COBAS AMPLICOR tests run on the COBAS
AMPLILINK software, a discrepancy has been identified between the onboard
working reagent stability information reported by AMPLILINK Software (versions
1.1, 1.3, 1.4, and 2.41) and the stability information provided in the test kit
package inserts/method manual.
VOLUME OF PRODUCT IN
COMMERCE 5,806 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT Software
used by Blood Collection Centers and Blood Banks for donor screening. Product
Title: Blood Bank Control System Funtion/File/Callable: 087 Title: Donor Room
Management Release: 5.0, 5.1, 5.2, 5.2.1, 5.2.2, and 5.3 (POD0001) DPP #: 4012E,
CODE
Product Title: Blood Bank Control
System Funtion/File/Callable: 087 Title: Donor Room Management Release: 5.0,
5.1, 5.2, 5.2.1, 5.2.2, and 5.3 (POD0001) DPP #: 4012E
RECALLING
FIRM/MANUFACTURER Blood Bank Computer Systems, Inc., Auburn, WA,
REASON
Software, containing a glitch
or defect related to donor deferral, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 193
CD’s
DISTRIBUTION Nationwide
PRODUCT Misys
Encompass Versions 2.2.1, 2.3 and 2.4,
CODE Versions 2.2.1, 2.3 and
2.4
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems
dba Misys Hospital Systems, Tucson, AZ,
REASON Software, with a
glitch or defect, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 17 units
DISTRIBUTION PA, NJ, OH,
GA, AL, NY, OK, IL, MA,
NM
PRODUCT Red
Blood Cells Pheresis, Leukocytes Reduced,
CODE Unit: 314872051 (Parts 1 &
2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems Inc., Tupelo, MS.
REASON
Blood products, which failed to meet the
minimum requirement for total hemoglobin, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION MS
and
AL
PRODUCT
a)
Level 1 Normothermic IV Administration Sets, Disposable Sets: (D-60HL / DI-60HL
Maximum normothermic flow rate: 500 mL/min; Disposable
D-50 / DI-50 M
aximum normothermic flow rate: 300 mL/min;
D-100 / DI-100 Maximum
normothermic flow rate: 800 mL/min; D-300 / DI-300 Maximum normothermic
flow rate:
1000 mL/min; D-70 Maximum Flow Rate 525ml/min,
b) Level
1 Normothermic Irrigating Set IR-500, IR-600 & IRI 600 IRI 600B, IR-700,
IR-40,
CODE a) and b) All lots prior
to the Expiration Date of July 2011 or earlier and not labeled
with "Helium tested"
RECALLING
FIRM/MANUFACTURER Smiths Medical ASD, Inc., Rockland, MA,
REASON
Heat exchanger may leak in the inner
lumen contaminating the blood/solutions being infused or the recirculating
solution.
VOLUME OF PRODUCT IN COMMERCE 900,000
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Level 1 H-1200 Fast Flow Fluid Warmer equipped with H-31B Air
Detector/Clamp 510K=BK020043,
b)
Level 1 H-331B Air Detector accessory,
CODE Units with a plastic door latch are
affected.
RECALLING FIRM/MANUFACTURER Smiths Medical ASD,
Inc., Rockland, MA,
REASON Fluid Warmers, if the door latch is
broken or bent, the Air Detector door will not close properly and the presence
of air is detected and an audible and visual alarm sounds.
VOLUME OF
PRODUCT IN COMMERCE 1,388
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 4360136
RECALLING
FIRM/MANUFACTURER Central Jersey Blood Center, Shrewsbury, NJ,
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 and
SC
PRODUCT Red
Blood Cells (Apheresis) Leukocytes Reduced,
CODE Unit: 307744683
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ,
Manufacturer: Blood Systems, Inc., Fargo,
ND.
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 CA
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Unit: 307744734
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ,
Manufacturer: Blood Systems, Inc., Fargo,
ND.
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 ND
PRODUCT
a)
Red Blood Cells, Leukoreduced,
b) Platelets Leukocytes
Reduced,
c) Frozen Plasma,
d)
Recovered plasma,
CODE
a) Units:
17FG29694, 17FG33256, 17FG36181, 17FG39281, 17FG45007,
17FG49548, 17KC58352.;
b) Units: 17FG29694, 17FG33256, 17FG39281, 17FG45007,
17FG49548;
c) Units: 17FG33256, 17FG45007;
d) Units: 17FG29694, 17FG36181,
17FG39281, 17FG49548, 17KC58352
RECALLING
FIRM/MANUFACTURER The American National Red Cross, North Central
Region, Saint Paul, MN,
REASON Blood products,
collected from an ineligible donor, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 19 units
DISTRIBUTION MA,
MN, VA, WI and
DC
PRODUCT
a)
Red Blood Cells,
b) Cryoprecipitated AHF,
c) Plasma Cryoprecipitate Reduced,
CODE
a) Units: J30241 and J30005;
b) and c)
Unit: J30241;
RECALLING FIRM/MANUFACTURER Virginia Blood
Services, Inc., Richmond, VA
REASON Blood products, collected from donors
whose suitability to donate was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
components
DISTRIBUTION VA and
Switzerland
PRODUCT Recovered
Plasma,
CODE Unit:
4340416
RECALLING FIRM/MANUFACTURER Central Jersey Blood
Center, Shrewsbury, NJ
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 SC and
CA
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Unit: 4343919
RECALLING
FIRM/MANUFACTURER Central Jersey Blood Center, Shrewsbury, NJ
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 Fresh
Frozen Plasma,
CODE Unit:
71Q584413
RECALLING FIRM/MANUFACTURER LifeSouth Community
Blood Centers, Inc., Gainesville, FL
REASON Blood product, which
was manufactured from a whole blood unit in which an associated blood component
contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT Recovered
Plasma,
CODE Unit:
029KC67762
RECALLING FIRM/MANUFACTURER American National
Red Cross Mid Atlanta, Norfolk, VA
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 VA and
CA
PRODUCT Recovered
Plasma,
CODE 027GS07188
RECALLING
FIRM/MANUFACTURER ARC Greater Alleghenies, Johnstown, PA
REASON
Blood products, which were collected
from a donor in which donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH, WV and
CA
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Units: 1717623, 6149458, 6149525, 6149570,
6149613, 1717619, 1717832, 1717838, 1717839, 1717844, 1717853, 1805099, 2339808,
2339902, 3233362, 2339805, 1717388, 1717392, 1717393, 2339139, 1407292, 2339278,
6148601, 6148609, 1804909, 2339276, 1804953, 3232837, 3232839, 6148375, 6148599,
6148608, 6148611, 6148613, 6148614, 6148615, 1717723, 3233105, 6149199, 1664232,
2339382, 2339401, 2339403
RECALLING
FIRM/MANUFACTURER Central Texas Regional Blood and Tissue Center,
Austin, TX
REASON Blood products, which may have been
exposed to unacceptable temperatures during storage, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 43
units
DISTRIBUTION TX and
AZ
PRODUCT
a)
Red Blood Cells
b) Red Blood Cells (Apheresis)
Leukocytes Reduced Irradiated,
CODE
a)
Unit: 1113285;
b) Units: 1113288 (double collection) and
1113290
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood product, which may have been
stored under unacceptable storage conditions, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION MN
PRODUCT Red
Blood Cells
CODE Unit:
1382182538
RECALLING FIRM/MANUFACTURER American Red Cross
Blood Services Tennessee Valley Region, Nashville, TN
REASON
Blood product, lacking assurance being
maintained at an acceptable temperature during shipping, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN\
PRODUCT Pneumovax
23 (Pneumococcal Vaccine Polyvalent) single Dose Vial. 25mcg/ml, 10 vials per
pack. NDC number 0006-4943-00; Pneumovax 23 (Pneumococcal Vaccine Polyvalent)
25mcg/ml, multi dose vial. NDC number 0006-4739-00
CODE Lot number 1004F expiration 12/8/08; Lot
number 0988F expiration 11/3/08
RECALLING
FIRM/MANUFACTURER
Recalling Firm: AmeriSource Bergen,
Chesterbrook,
PA,
Manufacturer: Merck and Co., Inc., West Point, PA.
REASON
Vaccines, lacking assurance of proper
temperatures during transit, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 474 vials
DISTRIBUTION CT, MA, ME,
NH, NY, and
RI
PRODUCT Ortho
Ficin Panel System Resolve Panel C A qualitative test for the identification of
unexpected blood group antibodies. Untreated For in Vitro Diagnostic Use Package
contains: Eleven 3 ml. vials red blood cells One 2 ml. vial Reagent Red Blood
Cell Diluent. Product code 719410 (US), Product code 6901867 (ex-US),
CODE
Lot # RC329
RECALLING
FIRM/MANUFACTURER Ortho Clinical Diagnostics, Inc., Raritan, NJ
REASON
Resolve Panel C, demonstrating unexpected
reactivity with untreated Cell 16, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 393 kits
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
a)
Recombivax HB (Hepatitis B Vaccine [recombinant]) 40mcg/ml, single dose vials.
NDC number 0006-4992-00; Recombivax HB Adult Formulation
(Hepatitis B
Vaccine [recombinant]) 10mcg/ml, 10 vials
per pack. NDC number 0006-4995-41;
Recombivax HB
Pediatric/Adolescent (Hepatitis B Vaccine [recombinant])
5mcg/0.5ml, 10 vials per pack. NDC number 0006-4891-00,
b) VAQTA (Hepatitis A Vaccine [inactivated]) 50mcg/ml (Adult),
single dose vials,
10 vials per pack. NDC number
0006-4841-41,
c) Pedvax HIB (Haemophilus b Conjugate
Vaccine [Meningococcal Protein
Conjugate]) 7.5mcg HIB/125mcg Neisseria
Meningitidis/225mcg aluminum
per
0.5ml, 0.5 ml single dose vials, 10 vials per pack. NDC number 0006-4897-00,
d) COMVAX (Haemophilus b
conjugate[meningococcal protein conjugate] and
Hepatitis
B [recombinant] Vaccine) 7.5mcg HIB/125mcg Neisseria Meningitidis/
5mcg HBsAG per 0.5ml, 0.5 ml single dose
vials, 10 vials per pack. NDC number
0006-4898-00,
CODE
a) Lot number 0650F expiration 11/28/08,
Lot number 1160F expiration 7/6/09,
Lot number 1246F expiration 2/3/09;
b) Lot number
1278F expiration 10/12/09;
c) Lot number 1272F expiration 4/13/09;
d) Lot
number 1158F expiration 4/4/09
RECALLING
FIRM/MANUFACTURER
Recalling Firm: AmeriSource Bergen,
Chesterbrook,
PA,
Manufacturer: Merck and Co., Inc., West Point, PA.
REASON
Vaccines, lacking assurance of
appropriate storage temperatures during transit, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 578
vials
DISTRIBUTION CT, MA, NH, NY, and
RI
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 9064530 (Parts 1 &
2)
RECALLING FIRM/MANUFACTURER The Blood Connection,
Inc., Piedmont, SC,
REASON Blood
products, which were possibly contaminated with Diptheroid bacilli, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION SC
PRODUCT Platelets
Pheresis Leukocytes Reduced
CODE Unit: 9052874
RECALLING
FIRM/MANUFACTURER The Blood Connection, Inc., Piedmont, SC,
REASON
Blood product, which reached an
unacceptable temperature during shipment, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Unit: 107919113
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ,
Manufacturer: Blood Systems, Inc.,
Lafayette, LA.
REASON Blood product, which did not have
written documentation of the temperature at the time of receipt, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Recovered
Plasma,
CODE Units: 17GM50664,
17GM50665, 17KC85092, 17KC85125, 17GM50662, 17KE08664, 17KE08665, 17KE08669,
17KE08671, 17KE08656, 17KE08657, 17KE08663, 17KE08670, 17KE08672, 17KE08655,
17KE08658, 17KE08659, 17KE08660, 17KE08661, 17GR37518, 17KM54938, 17KT86784,
17KV49187, 17KZ51923
RECALLING FIRM/MANUFACTURER American
National Red Cross, North Central Region, Saint Paul, MN,
REASON
Blood products, which may have reached
unacceptable temperatures during storage, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 24
units
DISTRIBUTION CA
PRODUCT Red
Blood Cells Irradiated,
CODE Unit:
71R485316
RECALLING FIRM/MANUFACTURER LifeSouth Community
Blood Centers, Inc., Gainesville, FL
REASON Blood product, possibly
labeled with an extended expiration date, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Recovered
Plasma
CODE Unit: J30005
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Inc., Richmond, VA
REASON Blood product, collected from donors whose
suitability to donate was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
component
DISTRIBUTION VA and Switzerland
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Unit: 71R64066X
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Dunwoody, GA
REASON
Blood product, which was manufactured
from a whole blood unit in which an associated blood component contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
WEEK ENDING OCTOBER 13
PRODUCT Red
Blood Cells Pheresis, Leukocytes Reduced
CODE Unit: 318636324
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ,
Manufacturer: Blood Systems, Inc/dba
United Blood Services, Tupelo, MS,
REASON Blood product, which failed to meet the
minimum requirement for total hemoglobin, was distributed.
VOLUME OF
PRODUCT IN COMMERCEN1
unit
DISTRIBUTION AL
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Recovered Plasma
Frozen within 24 hours,
CODE a) and b)
Unit #9102733
RECALLING FIRM/MANUFACTURER Blood Bank Of
Delmarva, Inc., Newark, DE,
REASON Blood product, collected from a donor
who was previously indefinitely deferred, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION MD
and
Austria
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Units: 7087269 (parts 1 and 2), 7088080
(parts 1 and 2), and 7088051
RECALLING
FIRM/MANUFACTURER South Texas Blood & Tissue Center, San
Antonio, TX
REASON Blood products, labeled as leukoreduced,
but which did not meet the criteria for leukoreduced products, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5
components
DISTRIBUTION TX and
AR
PRODUCT Platelets
Irradiated,
CODE Unit:
1141288
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood product, which was manufactured
from a whole blood unit in which the associated blood product contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT
a)
Red Blood Cells, Leukocytes Reduced,
b) Red Blood Cells Apheresis, Leukocytes Reduced,
c) Platelets
Pheresis,
Leukocytes Reduced,
CODE
a) Units:
318100168, 318100171, 318100173, 319100179, 318100183, 318100188,
318100190, 318100193, 318100195, 318100197, 318100199,
318100439,
318100442, 318100446, 318100450, 318100452,
318100454, 318100459,
318100550, 318100553, 318100555,
318100556, 318100557, 318100559,
318100562, 318100565,
318100568, 318100571, 318100746, 318100749,
318100752,
318100754, 318100756, 318100761, 318100768, 318100770,
318100772, 318100774, 318100858, 318100859, 318101029, 318101034,
318101043, 318101046, 318101049, 318101052, 318101057,
318101074,
318101077, 318101079, 318101082, 318101202,
318101204, 318101212,
318101214, 318101216, 318101219,
318101228, 318101232, 318101423,
318101427, 318101433,
318101438, 318101441, 318101447, 318101451,
318101454,
318101457, 318101459, 318101468, 318101484, 318101486,
318101488;
b) Units: 318100444 (2 units), 318100457 (2 units), 31801040,
318101060,
318101206 (2 units), 318101213 (2 units),
318101450, 318101419,
318101481 (2 units);
c) Units:
318100848 (2 units), 318100855 (2 units)
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ,
Manufacturer: Blood Systems, Inc/dba
United Blood Services, Tupelo, MS,
REASON Blood products, collected from a donor
who did not have a complete medical history interview, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 91
units
DISTRIBUTION MS and
AL
PRODUCT Platelets,
CODE
Unit:
71Q714691
RECALLING FIRM/MANUFACTURER LifeSouth Community
Blood Centers, Inc., Gainesville, FL,
REASON Blood product, with
a low platelet count, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Platelets,
CODE
Unit:
71Q481878
RECALLING FIRM/MANUFACTURER LifeSouth Community
Blood Centers, Inc., Gainesville, FL
REASON Blood product, with
a low platelet count, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Units: 2505490, 2741241, 2453744, and
2436827
RECALLING FIRM/MANUFACTURER South Texas Blood and
Tissue Center, San Antonio, TX
REASON Blood products,
collected from a donor who traveled to an area considered endemic for malaria,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION TX
PRODUCT
a)
Red Blood Cells,
b) Fresh Frozen plasma,
CODE a) and b) Unit:
LC38956;
RECALLING FIRM/MANUFACTURER Blood Center of
Wisconsin, Inc., Milwaukee, WI,
REASON Blood product, which
was collected from a donor who was taking the drug Lupron Depot, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION WI
PRODUCT
a)
Fresh Frozen Plasma Pheresis,
b) Fresh Frozen Plasma,
CODE
a) Units: 163879117, 163881683,
163881686;
b) Units: 163880681, 163880730, 163880743, 163881045, 163881079,
163881390,
163881427, 163881518, 163881523, 163881528,
163881584, 163881630
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ,
Manufacturer: Blood Systems, Inc/dba
United Blood Services, Meridian, MS,
REASON Blood products, which may have reached
an unacceptable temperature during storage, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 15
units
DISTRIBUTION MS
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Units: 1025560A,
1025562B
RECALLING FIRM/MANUFACTURER Community Blood
Council of New Jersey, Inc., Trenton, NJ,
REASON Blood products,
which were unlicensed and shipped in interstate commerce, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION PA
WEEK ENDING OCTOBER 20
PRODUCT
a)
Red Blood Cells,
b) Fresh Frozen Plasma,
CODE
a) and b) Units:
30GH04390
RECALLING FIRM/MANUFACTURER American Red Cross,
Northeastern, Ashley, PA,
REASON Blood products, collected from a donor
with a history of hepatitis exposure, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2
units
DISTRIBUTION PA
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 318646200
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ,
Manufacturer: Blood Systems Inc/dba
United Blood Services, Tupelo, MS.
REASON Blood product, labeled with an incorrect
expiration date, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Plasma,
CODE
a) and b) Unit: 19LS06714
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services Tennessee Valley Region, Nashville, TN,
REASON Blood product, collected from
a donor who resided in a HIV Group O risk area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TN &
NC
PRODUCT
a)
Packed Red Blood Cells,
b) Red Blood Cells for
Manufacturing,
c) Recovered Plasma,
d) Fresh Frozen Plasma,
CODE
a) Units: 55R96437 and 55S86094;
b)
Unit: 55S73527;
c) Units: 55S73527, and 55R96437;
d) Unit:
55S86094
RECALLING FIRM/MANUFACTURER American National
Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR
REASON
Blood products, collected from a donor
who was previously deferred, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 6 components
DISTRIBUTION TX, AR,
and
CA
PRODUCT Granulocytes
CODE
Unit:
LP02260
RECALLING FIRM/MANUFACTURER Central Blood Bank,
Pittsburgh, PA,
REASON Blood products, collected from a donor
who reported travel to a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Units: 5609800 and
7119735
RECALLING FIRM/MANUFACTURER LifeShare Blood
Centers, Alexandria, LA,.
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 LA
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 017FP08999
RECALLING
FIRM/MANUFACTURER The American National Red Cross, North Central
Region, Saint 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 MN
PRODUCT Red
Blood Cells (Apheresis) Leukocytes Reduced,
CODE Units: 17FS34587 (split unit), 17FS34588,
17FS34589 (split unit), 17FS34591 (split unit), 17FS34592 (split
unit)
RECALLING FIRM/MANUFACTURER The American National
Red Cross, North Central Region, Saint Paul, MN
REASON Blood products, lacking assurance of
sterility, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 9 units
DISTRIBUTION MD, DC, ME, NH,
MA, and
VA
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Units: 184281394 and
184284512
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Blood Systems Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Cheyenne, WY.
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 WY
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 19GE22811
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services Tennessee Valley
Region, Nashville, TN,
REASON Blood product, corresponding to a
unit of plasma that exhibited hemolysis was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 003E64866
RECALLING
FIRM/MANUFACTURER American National Red Cross, Douglasville, GA
REASON
Blood product, collected from donors
whose suitability to donate was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Red
Blood Cells Leukocytes Reduced, Irradiated,
CODE Unit: 040LF11663
RECALLING
FIRM/MANUFACTURER American National Red Cross Heart of American
Region, Peoria, IL
REASON Blood product, with incomplete
documentation of the irradiation process, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL\
PRODUCT Red
Blood Cells Pheresis, Leukocytes Reduced,
CODE Units: FC2012232A,
FC2012232B
RECALLING FIRM/MANUFACTURER Community Blood
Council of New Jersey, Inc., Trenton, NJ
REASON Blood products,
collected using an expired blood collection set, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NJ
PRODUCT Red
Blood Cells Apheresis, Leukocytes Reduced,
CODE Units: 318109417 (Parts 1 &
2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ,
Manufacturer:
Blood Systems, Inc/dba United Blood Services, Tupelo, 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 Leukocytes Reduced, Irradiated,
CODE Units: 203161787, 203167079, 203167080,
203168428
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Blood Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Lafayette, LA.
REASON
Blood products, labeled with
an extended expiration date, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4
units
DISTRIBUTION LA
PRODUCT Recovered
Plasma,
CODE Unit:
003E64866
RECALLING FIRM/MANUFACTURER American National
Red Cross, Douglasville, GA
REASON Blood product,
collected from donors whose suitability to donate was not adequately determined,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 9058245 (split unit)
RECALLING FIRM/MANUFACTURER The Blood Connection, Inc.,
Piedmont, SC,
REASON Blood products, which were identified as
being contaminated by the BacT/ALERT system, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NC and SC
WEEK ENDING OCTOBER 27
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Unit: 30GF40524
RECALLING
FIRM/MANUFACTURER American Red Cross, Northeastern, Ashley, PA
REASON
Blood product, collected from a donor
who reported travel to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Unit: 5864480
RECALLING
FIRM/MANUFACTURER Texoma Regional Blood Center, Sherman, TX
REASON
Blood product, collected from an
unsuitable donor based on travel to an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT
a)
Red Blood Cells,
b) Platelets,
CODE
a) Units: 71P93084X, 71Q397761, and
71Q887031;
b) Unit: 71Q397761
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL
REASON Blood products,
which were, collected from a donor who had traveled to a traveled to a malarial
area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION FL
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Fresh frozen
plasma,
CODE
a) and b) Unit:
1647163
RECALLING FIRM/MANUFACTURER Community Blood
Council of New Jersey, Inc., Trenton, NJ
REASON Blood products,
collected from a donor who lived in an area with increased risk for human
immunodeficiency virus (HIV) Group O, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2
units
DISTRIBUTION NJ
PRODUCT Platelets
Pheresis, Leukocytes Reduced, Irradiated,
CODE Unit: 120811239
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ,
Manufacturer: Blood Systems, Inc.,
Albuquerque, NM.
REASON Blood product, which was possibly
contaminated with Corynebacterium species, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NM
PRODUCT Cornea
CODE
Unit:
01220701
RECALLING FIRM/MANUFACTURER Northeast Pa Lions
Eye Bank, Inc., Allentown, PA
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
cornea
DISTRIBUTION NY
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Fresh Frozen
Plasma,
CODE
a) Units: 2639818,
2673520, 2523984, 2605278;
b) Units: 2673520, 2605278
RECALLING
FIRM/MANUFACTURER South Texas Blood & Tissue Center, San
Antonio, TX
REASON Blood products, collected from a donor
taking the medication Sulfasalazine, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 6 units
DISTRIBUTION TX,
CA, and
Austria
PRODUCT Red
Blood Cells,
CODE Unit:
W012006000271
RECALLING FIRM/MANUFACTURER Department of
Army Blood Bank Center, Fort Hood, TX
REASON Blood product,
collected from a donor who traveled to areas considered at risk for exposure to
Creutzfeldt-Jakob disease (CJD) and malaria, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NJ
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Unit: 55FL22615
RECALLING
FIRM/MANUFACTURER American National Red Cross, Greater
Ozark-Arkansas Region, Little Rock, AK
REASON Blood product, which was incorrectly
tested for the antibody to human immunodeficiency virus-1/2 (anti-HIV-1/2), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AK
PRODUCT Fresh
Frozen Plasma,
CODE Unit:
6789717
RECALLING FIRM/MANUFACTURER Community Blood
Center of the Ozarks, Springfield, MO
REASON Blood product, for
which the sterility may have been compromised, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MO
PRODUCT
a)
Platelets Pheresis, Leukocytes Reduced, Irradiated,
b)
Red Blood Cells, Leukocytes Reduced, Irradiated,
CODE
a) Unit: 4313285;
b) Unit:
4342087
RECALLING FIRM/MANUFACTURER Central Jersey
Blood Center, Shrewsbury, NJ
REASON Blood products, which were
incompletely irradiated, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION NJ
PRODUCT Red
Blood Cells, Leukocytes Reduced
CODE Unit: 12C66419
RECALLING
FIRM/MANUFACTURER American Red Cross Carolinas Blood Services
Region, Charlotte, NC
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 and
NC
PRODUCT
a)
Fresh Frozen Plasma,
b) Red Blood Cells Leukocytes
Reduced,
c) Plasma Frozen,
CODE
a) Unit: 012GS73850;
b) Units:
012FW38955, 012GS73850;
c) Unit:
012FW38955
RECALLING FIRM/MANUFACTURER
Recalling
Firm: American Red Cross, Carolinas Blood Services Region, Charlotte, NC
Manufacturer:
American Red Cross Blood Service, Durham, NC.
REASON Blood products, collected from a donor
for whom donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION NC
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Plasma, Frozen,
CODE
a) and b) Unit:
03LE43457
RECALLING FIRM/MANUFACTURER American National
Red Cross, Douglasville GA
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 GA
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 12C72338
RECALLING
FIRM/MANUFACTURER American Red Cross Carolinas Blood Services
Region, Charlotte, NC
REASON Blood product, collected from a donor
who traveled to an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 71X375085
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Dunwoody, GA
REASON
Blood product, with a low pH, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 71X364384
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, GA
REASON Blood product, with a low pH, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 71X465355
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Dunwoody, GA
REASON
Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 71X459152
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Dunwoody, GA
REASON
Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 71X428913
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Dunwoody, GA
REASON
Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 71X42582X
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Dunwoody, GA
REASON
Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT
a)
Fresh Frozen Plasma,
b) Red Blood Cells, Leukocytes
Reduced,
c) Plasma Frozen,
CODE
a) Units: 12FT50604, 12FT50608;
b)
Units: 12FT50594, 12FT50611, 12FT50633, 12FT50634;
a) Unit:
12FT50606
RECALLING FIRM/MANUFACTURER
Recalling Firm:
American Red Cross Carolinas Blood Services Region, Charlotte, NC
Manufacturer:
American Red Cross Blood Services, Durham, NC.
REASON Blood products, collected from donors
whose arm scrubs may have been incorrectly performed, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 7
units
DISTRIBUTION AL and
NC
PRODUCT
a)
Cryoprecipitated AHF,
b) Red Blood Cells, Leukocytes
Reduced,
CODE Unit: a) and b)
012F76051
RECALLING FIRM/MANUFACTURER American Red Cross
Carolinas Blood Services Region, Charlotte, NC
REASON Blood products, collected from donors
whose suitability to donate was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NC and
CA
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Cryoprecipitated AHF,
c) Plasma Cryoprecipitated Reduced,
CODE
a), b) and c) Unit:
003FQ58722
RECALLING FIRM/MANUFACTURER American National
Red Cross, Douglasville, GA
REASON Blood Product, collected from a donor in
which donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION GA
PRODUCT BSource
Plasma,
CODE Units: 4460035937;
4460037761; 4460036704
RECALLING FIRM/MANUFACTURER ZLB
Plasma Services of Decatur, Decatur, IL
REASON Blood products,
collected from a donor in which donor suitability was not adequately determined,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION IL
PRODUCT Source
Plasma,
CODE Units: 4460041650;
4460038961; 4460038126; 4460037891; 4460035457
RECALLING
FIRM/MANUFACTURER ZLB Plasma Services of Decatur, Decatur, IL
REASON
Blood products, collected from a donor
in which donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION IL
PRODUCT Fresh
Frozen Plasma,
CODE Unit:
W020907000207
RECALLING FIRM/MANUFACTURER Regional Blood
Donor Center (UIC4304A), North Chicago, IL
REASON Blood product,
which was manufactured from a whole blood unit in which the associated blood
product contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT
a)
Red Blood Cells Pheresis Leukocytes Reduced,
b) Platelets
Pheresis Leukocytes Reduced,
CODE
a)
Unit: 7094370,
b) Unit: 7094370 (Parts 1 & 2)
RECALLING
FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX
REASON
Blood products, collected from a donor
who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION TX
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 5672735 (part
2)
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute –
Sylvan N Goldman Center, Oklahoma City, OK
REASON Blood product, which
was incorrectly labeled as to product type, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT Red
Blood Cells Pheresis, Leukocytes Reduced
CODE Unit: 12LY16498 (Parts 1 &
2)
RECALLING FIRM/MANUFACTURER American Red Cross
Carolinas Blood Services Region, Charlotte, NC,
REASON Blood products, collected using a
machine for which the monthly quality control testing was not performed, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NC
PRODUCT Red
Blood Cells (Apheresis), Leukocytes Reduced
CODE Unit: 306594899 (split
unit)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Fargo, ND.
REASON
Blood products, which were collected
from a donor in which donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION ND
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Units: 5829622,
5830029
RECALLING FIRM/MANUFACTURER LifeShare Blood
Centers, Shreveport, LA,
REASON Blood products, mislabeled as
to antigen phenotype, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION LA
PRODUCT
a)
Recovered Plasma,
b) Source Leukocytes,
CODE
a) Unit: 2523984;
b) Unit:
2673520
RECALLING FIRM/MANUFACTURER South Texas Blood
& Tissue Center, San Antonio, TX
REASON Blood products,
collected from a donor taking the medication Sulfasalazine, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TX, CA, and
Austria
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Units: 55FF31298, 55FF31299, 55FF31301,
55FF31304
RECALLING FIRM/MANUFACTURER American National
Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR
REASON
Blood products, labeled with an extended
expiration date, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION AR and
TN
PRODUCT Red
Blood Cells, Leukocytes Reduced
CODE Units: 09KG23560, 09Q80087, 09Q80094,
09FF57030, 09FF57037, 09FV11739, 09FZ44861, 09GX48186, 09KG23475,
09KG23556
RECALLING FIRM/MANUFACTURER American National
Red Cross, Columbia, SC
REASON Blood products, which may have reached
an unacceptable temperature during shipment, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 10
units
DISTRIBUTION SC
PRODUCT Recovered
Plasma,
CODE Unit:
12C66419
RECALLING FIRM/MANUFACTURER American Red Cross
Carolinas Blood Services Region, Charlotte, NC
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 and
NC
PRODUCT
Red
Blood Cells, Leukocytes Reduced,
CODE Units: 03LN45780, 03LN45782,
03LN45784
RECALLING FIRM/MANUFACTURER American National
Red Cross, Douglasville, GA
REASON
Blood products, collected from donors
for whom a hemoglobin screening test was not performed, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION GA
PRODUCT
Red
Blood Cells, Leukocytes Reduced,
CODE Unit: 003LX37268
RECALLING
FIRM/MANUFACTURER American National Red Cross, Douglasville, GA
REASON
Blood product,
incorrectly labeled as to red cell antigen type, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT
Recovered
Plasma,
CODE Unit:
012F76051
RECALLING FIRM/MANUFACTURER American Red Cross
Carolinas Blood Services Region, Charlotte, NC
REASON Blood products, collected from donors
whose suitability to donate was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC and CA
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Unit: 9058558
RECALLING
FIRM/MANUFACTURER The Blood Connection, Inc., Piedmont, SC
REASON
Blood product, which was identified as
being contaminated by the BacT/ALERT system, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 9060113
RECALLING
FIRM/MANUFACTURER The Blood Connection, Inc., Piedmont, SC
REASON
Blood product, which was identified as
being contaminated by the BacT/ALERT system, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION SC
PRODUCT
a)
Red Blood Cells Deglycerolized Leukocytes Reduced
b) Red
Blood Cells Deglycerolized,
CODE
a)
Units: 03FJ88943, 03GP67267, 03GS68681, 03KQ33326, 03LN40710;
b) Units:
123GR63909, 123KK67834, 1256022389, 1428554688
RECALLING
FIRM/MANUFACTURER American National Red Cross, Douglasville, GA
REASON
Blood products, which did not
meet the minimum requirement for red blood cell recovery, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 9
units
DISTRIBUTION GA
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Units: 12FX03179, 12FX03183, 12FX03186,
12FX03189, 12FX03192, 12FX03195, 12FX03196, 12FX03198,
12FX03200
RECALLING FIRM/MANUFACTURER American Red Cross
Carolinas Blood Services Region, Charlotte, NC
REASON Blood products, which may have reached
unacceptable temperatures during shipment, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 9
units
DISTRIBUTION NC