NOVEMBER 2006
WEEK ENDING NOVEMBER 4
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets,
CODE a) and b) Unit: 53FW36330
RECALLING
FIRM/MANUFACTURER American National Red Cross, Greater Chesapeake &
Potomac Region, Baltimore, MD
REASON Blood products, collected from an ineligible donor
due to use of the medication Diltiazem, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION MD and D.C.
PRODUCT
a) Platelets,
b) Platelets,
Irradiated
CODE
a)
Units: 53FF72565, 53FF72571, 53G75857, 53G75861, 53G75866, 53GC60848, 53GC60850,
53GC60852, 53GE91007, 53GR66304, 53GR66315, 53GR66346, 53GE90546, 53GE90549,
53GE90559, 53GE90575, 53GE90541, 53GE90583, 53GE90587, 53GE90594, 53GE90595,
53GE90597, 53GE91003, 53GE91004, 53GC60843, 53GE90562, 53GE90563, 53GE90570,
53GE90581, 53GE90584, 53G75846, 53G75854, 53G75864, 53GR66303, 53GR66309,
53GR66323, 53FF72558, 53FF72566, 53FF72569, 53FF72570, 53FF72572, 53FF72576,
53FF72577, 53GC60842, 53GC60845, 53GE90542, 53GE90543, 53GE90544, 53GE90547,
53GE90556, 53GE90557, 53GE90560, 53GE90566, 53GE90571, 53GE90572, 53GE90574,
53GE90576, 53GE90580, 53GE90590, 53GE90591, 53GE90596, 53GE90599, 53GE91009,
53GE91010, 53FF72561, 53FF72562, 53FF72563, 53FF72567, 53FF72573, 53FF72574,
53G75865, 53G75871, 53GC60847, 53GC60849, 53GE90565, 53GE90568, 53GE90577,
53GE90578, 53GE90579, 53GE90585, 53GE90586, 53GE90588, 53GE90592, 53GE90593,
53GE91002, 53GE91011, 53GR66301, 53GR66316, 53GR66336, 53GR66344, 53G75859,
53GR66313, 53GR66335, 53GR66342, 53M10639, 53M10656, 53G75855, 53G75878,
53G75879, 53GR66332, 53GR66340, 53M10633, 53G75863, 53G75842, 53G75847,
53G75850, 53G75851, 53G75860, 53G75867, 53G75870, 53G75873, 53G75882, 53GR66302,
53GR66318, 53GR66337, 53GR66338, 53M10626, 53M10630, 53M10634, 53M10635,
53M10640, 53M10641, 53M10655, 53GR66334, 53G75856, 53G75868, 53GR66310,
53GR66319, 53GR66320, 53GR66321, 53GR66322, 53GR66325, 53GR66328, 53M10628,
53M10629, 53M10637, 53M10642, 53M10657;
b) Units: 53GE90554, 53GE90558, 53GR66308, 53GR66311, 53GR66330, 53GV62772,
53GV62776, 53GV62792, 53GV62795, 53GV62796, 53GV62803, 53GV62805, 53GV62809,
53GV62818, 53GV62819, 53GV62820, 53GV62823, 53M10627, 53M10632, 53M10636,
53M10648, 53G75849, 53GE90550, 53GE90551, 53GR66326
RECALLING
FIRM/MANUFACTURER American National Red Cross, Greater Chesapeake &
Potomac Region, Baltimore, MD
REASON Blood products,
with a low platelet count, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 163 units
DISTRIBUTION MD, PA, and D.C.
PRODUCT Plasma, Frozen,
CODE
Unit: 53J99062
RECALLING
FIRM/MANUFACTURER American National Red Cross, Greater Chesapeake &
Potomac Region, Baltimore, MD,
REASON Blood
product, possibly contaminated with Klebsiella, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION D.C.
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE
a) Units: 13GE37321, 13GE37341, 13GW51393 and
13GW51403;
b) Units: 13GE37321, 13GE37331, 13GE37341 and
13GW51403
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southeastern Michigan Region, Detroit, MI
REASON Blood products, possibly contaminated with
Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8
units
DISTRIBUTION MI and CA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Red Blood Cells, Rejuvenated,
Washed,
c) Red Blood Cells, Deglycerolized,
d) Platelets,
e) Platelets, Irradiated,
f)
Cryoprecipitated, AHF,
g)
Cryoprecipitated AHF, Pooled,
h) Fresh Frozen Plasma,
CODE
a) Units: 18GF42971, 18GF42973, 18GF42974,
18GF42975, 18GF42977, 18GF42979, 18GF42987, 18GG56741, 18GG56754, 18GG56760,
18GG56762, 18GG56767, 18GF42926, 18GF42929, 18GF42930, 18GF42935, 18GF42938,
18GF42945, 18GF42948, 18GF42950, 18GF42951, 18GF42953, 18GG56672, 18GG56676, 18GG56704, 18GG56713, 18GF42880, 18GF42884, 18GF42904, 18GF42906,
18GF42845, 18GF42849, 18GF42867, 18GF42794, 18GF42796, 18GF42821, 18GF42767, 18GF42771, 18GF42776, 18GF42779, 18GF42782, 18GF42788,
18GF42789, 18GG56528, 18GG56534, 18GG56535, 18GG56552, 18GG56555, 18GG56559, 18GG56564, 18GG56410, 18GG56422, 18GG56437, 18GG56440,
18GG56450, 18GF42682, 18GF42684, 18GF42689, 18GK28136, 18GK28137, 18GK28140, 18GK28141, 18GK28148, 18GK28154, 18GK28106, 18GK28108,
18GK28111, 18GK28116, 18GK28126, 18GK28045, 18GK28047, 18GK28048, 18GK28050, 18GK28064, 18GK28067, 18GK28071, 18GK28084,
18GK28086, 18GK28088, 18GK28089, 18GK28091, 18GK27962, 18GK27971, 18GK27972, 18GK27973, 18GK27975, 18GK27929, 18GK27941, 18GK27943, 18GK27948,
18GK56232, 18GG56233, 18GG56234, 18GG56238, 18GG56250, 18GG56253, 18GG56264, 18GG56265, 18GF42481, 18GF42492, 18GK27744, 18GK27750,
18GK27752, 18GK27753, 18GK27764, 18GK27711, 18GK27714, 18GK27715, 18GK27717, 18GK27718, 18GK27721, 18GK27723, 18GK27727, 18GK27728,
18GK27730, 18GG56014, 18GG56015, 18GG56022, 18GK27507, 18GK27513, 18GK27485, 18GK27486, 18GK27492, 18GK27474, 18GK27481, 18GK27484,
18GK27470, 18GH89842, 18GH89837, 18GH89839, 18GH89830, 18GH89833, 18GG55868, 18GG55852, 18GG55853, 18GG55862, 18GG55832,
18GG55848, 18GG55827, 18GG55829, 18GH89540, 18GH89535, 18GH89536, 18GH89529, 18GH89531, 18GH89532, 18GH89520, 18GH89522, 18GH89512, 18GH89515,
18GH89517, 18GH89510, , 18GK27236, 18GK27238, 18GK27240, 18GK27219, 18GK27221, 18GK27214, 18GK27133, 18GK27135, 18GK27104, 18GK27099,
18GK27100, 18GF41961, 18GF41956, 18GF41958, 18GF41960, 18GF41949, 18GF41950, 18GF41954, 18GF41946, 18GF41948, 18GF41929, 18GF41931,
18GG55334, 18GG55336, 18GG55348, 18GG55323, 18GG55331, 18GG55281, 18GG55283, 18GG55285, 18GG55292, 18GG55306, 18GK26710, 18GK26714,
18GK26719, 18GK26720, 18GK26731, 18GK26733, 18GK26739, 18GK26742, 18GK26743, 18GG55172, 18GG55189, 18GG55084, 18GG55090, 18GG55091,
18GG55099, 18GG55100, 18GG55103, 18GG55112, 18GG55114, 18GH88692,18GH88695, 18GH88697, 18GH88707, 18GH88711, 18GH88713, 18GH88725,
18GH88727, 18GH88728, 18GH88730, 18GH88731, 18GH88733, 18GF41436, 18GF41449, 18GF41451, 18GH88653, 18GH88668, 18GH88673, 18GH88612,
18GH88619, 18GK26231, 18GK26233, 18GK26235, 18GK26239, 18GK26247, 18GK26249, 18GK26207, 18GF41245, 18GF41248, 18GF41260, 18GF41261,
18GF41269, 18GF41271, 18GF41193, 18GF41196, 18GF41207, 18GF41178, 18GF41180, 18GH88080, 18GH88100, 18GH88127, 18GH88133, 18GH88136,
18GK25984, 18GK25986, 18GK25987, 18GK25991, 18GK26004, 18GK26010, 18GH88005, 18GH87989, 18GH87986, 18GH87980, 18GG54273, 18GG54271,
18GG54248, 18GG54244, 18GH87840, 18GH87843, 18GH87848, 18GH87860, 18GH87865, 18GH87868, 18GH87870, 18GH87892, 18GF40937, 18GF40935,
18GF40933, 18GF40930 and 18GF40928;
b) Unit: 18GG56264;
c) Unit:
18GG54248;
d) Units: 18GG56410, 18GK27962, 18GH88080, 18GH88100 and
18GH88102;
e) Unit: 18GG56437;
f) Units: 18GK28111, 18GH89512, 18GH89515,
18GH87980, 18GH87860, and
18GH87865;
g) Unit: 18GK28050;
h) Units:
18GK28064, 18GG56232, 18GG56234, 18GG56236, 18GG56240,
18GG56015, 18GG56018,
18GG55323, 18GH88127, 18GH88001, 18GG54271,
18GG54270, 18GG54268 and
18GH87870
RECALLING FIRM/MANUFACTURER American National Red Cross,
Great Lakes Region, Lansing, MI,
REASON Blood products, collected from a donor in which
donor suitability was not adequately determined, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 301 units
DISTRIBUTION AL, CA, CT,
GA, IN, NV, OK, PA, SC, VA, OH, MD, MI, and MA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
53GR70769
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Chesapeake and Potomac Region, Baltimore, MD
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 MD
PRODUCT Recovered Plasma,
CODE
Unit: GR38567
RECALLING
FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI,
REASON
Blood product, collected from a donor who was at
increased risk for variant Creutzfeldt - Jakob disease (vCJD), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Switzerland
PRODUCT Source Plasma,
CODE
Units: 03LWID9056 03LWIE0563 03LWIE1438 03LWIE1703
03LWIE2881 03LWIE7822 03LWIF5263 03LWIF5709 03LWIF6162 03LWIF6703 03LWIF7544
03LWIF8839 03LWIG0019 04LWIA0693 04LWIA1413 04LWIA6459 04LWIA7250 04LWIB7909
04LWIC0795 04LWIC2962 04LWIC3881 04LWIC4249 04LWIC5138 04LWIC7988 04LWIC8464
04LWIC9002 04LWIC9487 03LWIS2936 03LWIS3052 03LWIS3082 03LWIS3114 03LWIS3204
03LWIS3554 03LWIS4083 03LWIS4116 03LWIS4147 03LWIS4185 03LWIS4239 03LWIS4334
04LWIS0036 04LWIS0127 04LWIS0262 04LWIS0545 04LWIS0600 04LWIS0616 04LWIS0850
04LWIS1717 04LWIS1784 04LWIS1810 04LWIS1874 04LWIS2074 04LWIS2110 04LWIS2149
04LWIS2179
RECALLING FIRM/MANUFACTURER BioLife Plasma Service
L.P., Onalaska, WI
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 54
units
DISTRIBUTION Austria
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
31137-2614
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., dba United Blood Services, Tupelo,
MS.
REASON Blood product,
collected from a donor who did not have a complete medical history interview,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MS
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE a) and b) Unit: 31136-6731
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ
Manufacturer: Blood Systems, Inc., dba United Blood Services, Tupelo,
MS.
REASON Blood product,
collected from a donor who did not have a complete medical history interview,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MS and UK
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Fresh Frozen Plasma,
c) Platelets
Pheresis, Leukocytes Reduced,
CODE
a) Units: 16375-9054, 16454-4031;
b) Unit:
16454-4031;
c) Units: 16375-9757 (Splits 1, 2, and 3)
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 who did not have a complete medical history
interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units
DISTRIBUTION AL and MS
PRODUCT Platelets Pheresis,
CODE
Units: W020004200121, W020005200003 (Split
A), W020005200003 (Split B), W020005200144, 4802037, W020004200013,
W020004200036, W020004200125, W020004200132, W020004200161, W020004200164,
W020004200182, W020004200192, W020005200052, W020005200072, W020005200094 (Split
A), W020005200094 (Split B), W020005200124, W020005200171, W020004200011,
W020004200029, W020004200033, W020004200055, W020004200056, W020004200263,
W020004200265, W020004200270 (Split A), W020004200270 (Split B), W020004200272,
W020005200144 (Split B), W020005200145 (Split B), W020005200157 (Split B),
W020005200159, W020005200171 (Split B), W020005200176, W020005200177,
W020005200178, W020005200174 (Split A), W020005200174 (Split B), W020004200031,
W020004200129, W020004200130, W020004200133, W020004200053
RECALLING
FIRM/MANUFACTURER Department of the Navy, National Naval Medical Center,
Bethesda, MD,
REASON Blood products, manufactured in a manner that may
compromise the sterility of the products, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 44 units
DISTRIBUTION MD and D.C.
PRODUCT Red Blood Cells,
Leukocytes Reduced, Irradiated,
CODE Unit:
032KE77458
RECALLING FIRM/MANUFACTURER American National Red Cross,
Badger-Hawkeye Region, Madison, WI
REASON Blood product, which was
manufactured from a unit of whole blood more than eight hours after collection,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WI
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit: 032GP23395 (Part
1)
RECALLING FIRM/MANUFACTURER American National Red Cross,
Badger-Hawkeye Region, Madison, WI,
REASON Platelets, inappropriately
prepared by splitting the product into two storage bags instead of one, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WI
PRODUCT Human Corneas for
Transplantation,
CODE CIO50081OS and
CIO50081OD
RECALLING FIRM/MANUFACTURER Michigan Eye Bank, Ann
Arbor, MI
REASON Human corneas, recovered from a donor who had not
been properly evaluated, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 tissue allografts
DISTRIBUTION NJ and OH
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Units: 032GE56561,
032GE58023
RECALLING FIRM/MANUFACTURER American National Red Cross,
Badger-Hawkeye Region, Madison, WI
REASON Blood products, which
tested negative for hepatitis, but were collected from an ineligible donor due
to a subsequent disclosure of previous positive hepatitis testing, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION CA, ME, and MA
PRODUCT Acellular Dermal Matrix
Grafts AlloDerm, Repliform and GraftJacket,
CODE
Lot # B14672 - (003, 004, 005, 006, 007, 008, 009,
010, 011, 012, 015, 017, 019, 021, 022, 023, 024, 025, 027, 029, 030, 031, 032,
034, 039, 040, 041, 042, 044, 045, 046, 048, 049, 050, 051, 052, 053, 054, 055,
056, 057, 058, 059, 060, 061, 063, 064, 065, 066, 067, 068, 069, 070, 071, 072,
074, 077, 078, 080, 083, 085, 088, 090, 092, 093, 094, 095, 096, 097, 098, 099,
100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115,
116, 117, 118, 119)
RECALLING FIRM/MANUFACTURER LifeCell
Corporation, Somerville, NJ
REASON Human tissues, collected from a donor who had not been
properly evaluated for hemo-dilution, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 91 tissue allografts
DISTRIBUTION Nationwide
PRODUCT Human Cornea,
CODE
NE2006-1-1-72, L-01
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Tissue Banks International,
Baltimore, MD
Manufacturer: New England Eye & Tissue
Transplant Bank, Boston, MA.
REASON Human Cornea, recovered from an ineligible donor, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
tissue
DISTRIBUTION MA
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
7220939
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Shreveport, LA, REASON Blood product, which did not meet acceptable
product specifications, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION LA
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit 4728726 (split)
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center,
Indianapolis, IN
REASON Blood products,
which were labeled with the incorrect platelet yield, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION IN
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit:
231518233
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Billings, MT
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 MT
PRODUCT Platelets,
CODE
Unit: H25683
RECALLING
FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, 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 VA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
164605491
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Meridian, MS
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 AL
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
200393452
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Lafayette, LA
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION LA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets Leukocytes Reduced,
CODE
a) and b) Unit: 22FZ20878
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Philadelphia, PA
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 PA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
42FG17318
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Cleveland, OH
REASON Blood
product, which was collected from a donor who had traveled to a malarial endemic
area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Units: 1673943, 1612186,
and 1182017
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, UC
Medical Center, Cincinnati, OH,
REASON Blood products, which were collected
from a donor who had traveled to a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION OH
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
42FQ26498
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Cleveland, OH,
REASON Blood
product, which was collected from a donor who had traveled to a malarial endemic
area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH
PRODUCT Platelets,
CODE
Unit: 5578508
RECALLING
FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON Platelets, with an
unacceptable pH, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
71X37821-1
RECALLING FIRM/MANUFACTURER Life Source Community Blood
Centers, Lecanto, FL
REASON Platelets, with a low pH, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT
a) Platelets,
b) Fresh Frozen Plasma,
c) Plasma,
d) Plasma Frozen,
e) Cryoprecipitated
AHF,
f) Cryoprecipitated AHF Pooled,
CODE
a) Units 17FZ15071, 17FZ17844, 17KH79866, 17KK64067,
and 17KP76411;
b) Units: 17FM09895, 17FR15623, 17FZ15071, 17KM41521,
17KQ58071,
17KX84529, and 17KH79866;
c) Unit: 17KE03007;
d) Units:
17KL98251 and 17KR90333;
e) Unit: 17KE03007;
f) Units: 17FZ620395,
17FV10750, 17FV10753, and 17FV10777
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, St. Paul, MN,
REASON
Blood products, which were manufactured from whole
blood units in which an associated blood component contained clots, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 20
units
DISTRIBUTION CA, MI, MN, OH, TN, and WI
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets,
CODE a), and b) Unit: 163603956
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., Meridian, MS,
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 AL, MS, and VA
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells Leukocytes Reduced,
c) Platelets,
d) Recovered Plasma,
CODE
a) Unit: 163430243;
b) Units: 163562690,
163703728, and 163728297;
c) Units: 163562690 and 163703728;
d) Unit:
163728297
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Meridian, MS
REASON Blood products, which were collected from a donor
who had lived in an area that was at high risk for group O HIV, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 7
units
DISTRIBUTION MS, AL, VA, and Switzerland
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
53GQ26187
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Chesapeake & Potomac Regions, Baltimore, MD
REASON Blood product,
which may have been exposed to unacceptable temperatures during shipment, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MD
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Unit: 53LL66797
RECALLING
FIRM/MANUFACTURER American National Red Cross, Greater Chesapeake &
Potomac Regions, Baltimore, MD,
REASON Blood products, collected from an ineligible donor due to a
history of Idiopathic Thrombocytopenic Purpura (ITP), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MD and CA
PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced,
CODE
Unit:
53FE18607 -- part A
RECALLING FIRM/MANUFACTURER American National
Red Cross, Greater Chesapeake & Potomac Regions, Baltimore, MD,
REASON
Red Cells, possibly
contaminated with Corynebacterium, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MD
PRODUCT Red Blood Cells, (for
further manufacture-non-injectable),
CODE Unit:
18GK27222
RECALLING FIRM/MANUFACTURER American National Red Cross,
Great Lakes Region, Lansing, MI,
REASON Blood
product, collected from a donor in which donor suitability was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NB
PRODUCT Recovered Plasma,
CODE
Unit: 4715955
RECALLING
FIRM/MANUFACTURER Mary Greeley Medical Center, Ames, IA, REASON Blood
product, which tested negative for viral markers, but was collected from a donor
who previously tested repeatedly reactive for HIV-p24 antigen, Western Blot
indeterminate, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT Platelets (Apheresis),
Leukocytes Reduced, Irradiated,
CODE Unit:
0025467
RECALLING FIRM/MANUFACTURER Community Blood Center, Inc.,
Appleton, WI,
REASON Blood product, labeled with the incorrect
expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WI
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Units: 246303266 (2
units), 246303278 (2 units), 246303264
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., Rapid City, SD,
REASON Blood
products, which were out of controlled storage for more than 30 minutes, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION SD
PRODUCT Source Plasma,
CODE
Units: I61041070, I61041209, I61041283, I61041334,
I61041382, I61041412, I61041429, I61041512, I61041868, I61041879, I61042250,
I61042252, I61042318, I61042580, I61042658, I61042659, I61042807, I61042810,
I61042851, I61042852, I61042909, I61043107, I61043109, I61043158, I61043187,
I61043226, I61043238, I61043294, I61043312, I61043315, I61043366, I61043600,
I61043607, I61043614, I61043639, I61043697, I61043713, I61043815, I61043867,
I61043899, I61043929, I61043946, I61043991, I61044319, I61044364, I61044367,
I61044484, I61044507, I61044510, I61044559, I61044668, I61044695
RECALLING
FIRM/MANUFACTURER International BioResources, Eugene, OR, REASON Blood
products, collected from a donor in which donor suitability was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 52
units
DISTRIBUTION NC
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Units: 16454-5598 (split
unit), 16374-3305 (split unit), 16374-3328 (split unit)
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ
Manufacturer: Blood Systems,
Inc., dba United Blood Services, Meridian, MS.
REASON Blood products, collected from donors with
unacceptable hematocrit determinations, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 6 units
DISTRIBUTION MS
PRODUCT Recovered Plasma,
CODE
Unit: 31137-2614
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ
Manufacturer: Blood Systems, Inc.,
dba United Blood Services, Tupelo, MS.
REASON Blood product, collected from a donor who did not have a
complete medical history interview, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION Switzerland
PRODUCT
a) Platelets Leukocytes
Reduced
b) Platelets Pheresis Leukocytes Reduced,
c) Platelets Pheresis Leukocytes Reduced Irradiated,
CODE
a) Units 13GP21299 and 13GT14736;
b) Units
18KT03007, 18KT03019, 18KT03020, 18KT02996, 18KT02997,
18P66786, 18P66773,
18P66791, 18P66795, 32FP20252, 32GP37819,
32GP37820, 32KM54254 and
32KM54247;
c) Units 50KP03645, 50P45273 and 50KP03653
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Lansing, MI,
REASON
Blood products, which may have
been stored at unacceptable temperatures, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 19 units
DISTRIBUTION MI
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit:
164567957
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Meridian, MS
REASON Blood product, which did not meet acceptable
product specifications, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MS
PRODUCT Red Blood Cells
Irradiated,
CODE Unit: 71Q268115
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Birmingham,
AL,
REASON Blood product, which was labeled with an incorrect
expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit: 71X276034
(split)
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Centers, Inc., Birmingham, AL,
REASON Blood products, which did not meet
acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION AL
PRODUCT
a) Red Blood Cell,
b) Platelets,
c) Fresh Frozen Plasma,
CODE
a), b), and c) Unit: 0210611
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA
REASON Blood products, which were collected from a donor
in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION LA
and CA
PRODUCT Red Blood Cells,
CODE
Units 17FZ06057, 17FZ15071, 17KX42496, 17KG76458,
17KK64067, 17KR50804, and 17KF68595
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, St. Paul, MN,
REASON
Blood products, which were manufactured from whole
blood units in which an associated blood component contained clots, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 7
units
DISTRIBUTION CA, MI, MN, OH, TN, and WI
PRODUCT Recovered Plasma,
CODE
Unit: 163603956
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., Meridian, MS
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 AL, MS, and VA
WEEK ENDING NOVEMBER 11
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
53GX25624
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Chesapeake & Potomac Region, Baltimore, MD
REASON Blood product, collected from a donor for whom
documentation of a hematocrit test during the donor screening process was
discrepant, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MD
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
006KG42641
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Chesapeake & Potomac Region, Baltimore, MD
REASON Blood product,
which may have been exposed to unacceptable shipping temperatures, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MD
PRODUCT Source Plasma
CODE
Units: 0050254455, 0050253266, 0050252987,
0050252656, 0050252404, 0050252190, 0050251871, 0050251526, 0050251242,
0050250909, 0050250559, 0050250334, 0050247456, 0050247046, 0050246278,
0050245486, 0050242019, 0050236800
RECALLING FIRM/MANUFACTURER ZLB
Bioplasma, Inc., Beloit, WI,
REASON Source Plasma, collected
from a donor with participated in high risk behaviors, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 18
units
DISTRIBUTION UK
PRODUCT Source Plasma,
CODE
Units: 68664169, 68650124, 68648299,
68643454
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Duluth, MN
REASON
Source Plasma, collected from a donor whose
medical history screening did not include questioning regarding risk factors for
Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD),
was distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION CA
PRODUCT Source Plasma,
CODE
Units: 68621933, 68620080
RECALLING
FIRM/MANUFACTURER ZLB Bioplasma, Inc., Duluth, MN
REASON Source
Plasma, collected from a donor whose medical history screening did not include
questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and
variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA
PRODUCT Source Plasma,
CODE
Units: 68668877, 68664350, 68633875
RECALLING
FIRM/MANUFACTURER ZLB Bioplasma, Inc., Duluth, MN
REASON Source
Plasma, collected from a donor whose medical history screening did not include
questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and
variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF
PRODUCT IN COMMERCE 3 units
DISTRIBUTION CA
PRODUCT Source Plasma,
CODE
Units: 68686871, 68683238, 68678425, 68674861,
68671037, 68665203, 68660994, 68658397, 68654276, 68650179, 68645830, 68639686,
68636920, 68621971, 68624392
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Duluth,
MN
REASON Source Plasma, collected from a donor
whose medical history screening did not include questioning regarding risk
factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob
Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 15
units
DISTRIBUTION CA
PRODUCT Source Plasma,
CODE
Units: 68684402, 68681876, 68679446, 68674588,
68671976, 68667474, 68665135
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Duluth, MN,
REASON
Source Plasma, collected from a donor
whose medical history screening did not include questioning regarding risk
factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob
Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 7
units
DISTRIBUTION CA
PRODUCT Source Plasma,
CODE
Unit: 68676056
RECALLING
FIRM/MANUFACTURER ZLB Bioplasma, Inc., Duluth, MN
REASON Source
Plasma, collected from a donor whose medical history screening did not include
questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and
variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT Source Plasma,
CODE
Units: 68648121, 68645663, 68641207, 68638559,
68625207, 68621063, 68618322, 68613846, 68611279
RECALLING
FIRM/MANUFACTURER ZLB Bioplasma, Inc., Duluth, MN,
REASON Source
Plasma, collected from a donor whose medical history screening did not include
questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and
variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF
PRODUCT IN COMMERCE 9 units
DISTRIBUTION CA
PRODUCT Source Plasma,
CODE
Units: 02HWVA6493, 02HWVA7104, 02HWVA7567,
02HWVA8654, 02HWVA8902, 02HWVA9129, 02HWVA9494, 02HWVA9745
RECALLING
FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services, L.P.,
Deerfield, IL,
Manufacturing Firm: BioLife
Plasma Services, L.P., Huntington, WV.
REASON Blood products, collected from a donor who was at
increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 8
units
DISTRIBUTION NC
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Unit: 29KJ25174
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Norfolk, VA,
REASON
Blood products, which were collected from a donor
with a history of multiple high risk behaviors, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NC and CA
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
71X134609
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Centers, Inc., Birmingham, AL,
REASON Blood product, which was not
manufactured in appropriately and did not meet product specifications, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
71X275904
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Centers, Inc., Birmingham, AL,
REASON Blood product, which was not
manufactured inappropriately and did not meet product specifications, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
71X275781
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Centers, Inc., Birmingham, AL,
REASON Blood product, which was not
manufactured inappropriately and did not meet product specifications, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Red Blood Cells,
Leukocytes Reduced, Irradiated
CODE Unit:
FJ13120
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank,
Heartland Blood Centers, Aurora, IL
REASON Blood product, which may have been exposed to
unacceptable storage temperatures, was distributed.
VOLUME OF PRODUCT IN
COMMERCE1 unit
DISTRIBUTION IL
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE a) and b) Unit: 040FG51387
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Peoria, IL,
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 IL
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Units: 6921729 and
6925030
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO,
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 CO and NJ
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
6901826
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO,
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells, Leukocytes Reduced,
CODE
a) Units: 6593702 and 6590860;
b) Units: 9020192
and 6596489
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial
Blood Center, Denver, CO,
REASON Blood products, which were collected
from a donor who had traveled to a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION CO, TN and KS
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
9012677
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO,
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
6593096
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO,
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO
PRODUCT Red Blood Cells,
CODE
Unit: 6898868
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO,
REASON
Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets,
CODE a) and b) Units: 5711363
RECALLING
FIRM/MANUFACTURER LifeShare Blood Centers, Beaumont, TX, REASON Blood
products, which were collected from a donor who had traveled to a malarial
endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TX
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Units: 7X428913,
71X459152, and 71X42582X
RECALLING FIRM/MANUFACTURER LifeSouth
Community Blood Centers, Inc., Dunwoody, GA,
REASON Blood products,
which did not meet acceptable product specifications, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION GA
PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced,
CODE
Units:
177340217 (split)
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
McAllen, TX
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 TX
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Red Blood Cells (Apheresis),
Leukocytes Reduced,
c) Recovered Plasma,
CODE
a) and c) Unit: 177338315;
b) Units: 172007146 and
172007416
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., McAllen,
TX.
REASON Blood products, which were collected
from a donor who had lived in an area that was high risk for group O HIV, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION TX, and Switzerland
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
177347693
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., McAllen, TX
REASON
Blood product, which may have been shipped under
unacceptable temperatures, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets,
c)
Fresh Frozen Plasma,
CODE a), b), and c) Unit:
16365-5991
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Meridian, MS.
REASON
Blood products, collected from a donor
for which donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION MS
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
172036155
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., McAllen, TX
REASON
Blood product, which was incorrectly labeled with
an extended expiration date, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT Human Cornea for
Transplantation,
CODE Tissue:
06-0137-200
RECALLING FIRM/MANUFACTURER East Tennessee Lions Eye
Bank, Knoxville, TN,
REASON Human tissue for transplantation, that tested
negative for hepatitis prior to distribution, was subsequently found to test
repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBcore) by
a different facility, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 tissue
DISTRIBUTION NC
PRODUCT Human Cornea for
Transplantation,
CODE Tissue:
06-0797-200
RECALLING FIRM/MANUFACTURER Rocky Mountain Lions Eye
Bank, Aurora, CO,
REASON Human Cornea,
mislabeled and distributed prior to completion of donor eligibility
determination.
VOLUME OF PRODUCT IN COMMERCE 1
tissue
DISTRIBUTION IL
PRODUCT Red Blood Cells,
Leukocyte Reduced,
CODE Unit:
16459-1747
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Meridian, MS
REASON Blood product, which was not quarantined after
receiving information regarding a post-donation illness, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MS
PRODUCT Source Plasma,
CODE
Unit: 68681142, 68677299, 68673321, 68670177,
68666446, 68663155, 68658694
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Duluth,
MN
REASON Blood products, collected from a donor
whose medical history screening was incomplete, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 7 units
DISTRIBUTION CA
PRODUCT Source Plasma,
CODE
Units: 68683818, 68682453, 68677725, 68673666,
68670320, 68667153, 68663476, 68660321, 68646646, 68642457, 68639785, 68634827,
68633011
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Duluth, MN
REASON
Blood products, collected from a donor whose
medical history screening was incomplete, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 13 units
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets, Leukocytes Reduced,
CODE
a) and b) Unit: 042W45670
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Cleveland, OH,
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
PRODUCT
a) Platelets Pheresis
Leukocytes Reduced,
b) Platelets Pheresis Leukocytes
Reduced Irradiated,
CODE
a) Units 038P98790
(split), 038P98783 (split), 038P98780 (split), 038P98785 (split), and 038P98782
(split);
b) Units 016KK13499 and 050KP02608 (split)
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Cleveland, OH
REASON
Blood products,
which may have been shipped under unacceptable temperatures, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 13
units
DISTRIBUTION OH
PRODUCT Platelets Pheresis,
Leukocytes Reduced, Irradiated,
CODE Unit:
006KC70764 (split)
RECALLING FIRM/MANUFACTURER American Red Cross
Blood Services, Cleveland, OH,
REASON Blood
products, which may have been shipped under unacceptable temperatures, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION OH
PRODUCT
a)
Red Blood Cells,
b) Fresh Frozen Plasma,
CODE a) and b) Unit: 7754703
RECALLING
FIRM/MANUFACTURER Suncoast Communities Blood Bank, Inc., Sarasota, FL
REASON
Blood products, which were collected from a donor
who had engaged in high risk behavior activities, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION FL
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
H79149
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Inc.,
Richmond, VA,
REASON Blood product, collected in a manner that may
compromise the sterility of the product, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION VA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Unit: 20728-0349
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ,
Manufacturer: Blood Systems, Inc., Lafayette, LA.
REASON
Blood products, which tested negative
for hepatitis, but were collected from a donor with a history of Hepatitis A,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION LA and Switzerland
PRODUCT Source Plasma,
CODE
Units: 68685676, 68679545, 68675752,
68672041
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Duluth, MN
REASON
Source Plasma, collected from a donor whose
medical history screening did not include questioning regarding risk factors for
Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD),
was distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced,
b) Platelets Pheresis
Leukocytes Reduced,
c) Platelets Pheresis Leukocytes
Reduced Irradiated,
CODE
a) Unit: 9007545;
b) Unit: 9002605 (parts 1 & 2);
c) Unit: 9002605 (part
3)
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center,
Denver, CO,
REASON Blood products, which were collected from a donor
who had traveled to a malarial endemic area, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 4 units
DISTRIBUTION CO
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Units: 6922389 and
6920225
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO,
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 CO
PRODUCT Red Blood Cells Pheresis,
Leukocytes Reduced,
CODE Units: 17FS32546 (2
units)
RECALLING FIRM/MANUFACTURER American National Red Cross,
North Central Region, St. Paul, MN
REASON Blood products, for which documentation
of an abnormal alarm during apheresis collection was discrepant, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MD and MA
PRODUCT Red Blood Cells,
Leukocytes Reduced, Irradiated,
CODE Unit:
16458-9990
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Meridian, MS.
REASON
Blood product, which contained a clot,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MS
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
16380-9558
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Meridian, MS.
REASON
Blood product, collected from a donor
whose body temperature was taken using unvalidated equipment, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MS
PRODUCT Red Blood Cells,
CODE
Unit: 3968118
RECALLING
FIRM/MANUFACTURER Department of the Army, Armed Services Blood Bank
Center, Landstuhl, Germany
REASON Blood product, collected from
an ineligible donor due to the use of an antibiotic, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Germany
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
20GZ16279
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Boise, ID,
REASON Blood product, which did not meet acceptable
product specifications, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MO
PRODUCT Red Blood Cells,
Leukocytes Reduced, Irradiated,
CODE Unit:
5578225 (split)
RECALLING FIRM/MANUFACTURER LifeSource, Glenview,
IL,
REASON Blood products, which may have been exposed to
unacceptable storage temperatures, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION IL
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells, Leukocytes Reduced,
CODE
a) Unit: 9153541;
b) Unit: 9154220
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO,
REASON
Blood products, which were not manufactured per
standard operating procedure, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION CO, and TN
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Units: 9016846 and
9029364
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO,
REASON Blood products, which were not manufactured per
standard operating procedure, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION CO and NB
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit: 9031995
(split)
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 and FL
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Plasma,
CODE a) and b) Unit: 29KH41430
RECALLING
FIRM/MANUFACTURER American National Red Cross, Mid-Atlanta Region,
Norfolk, VA
REASON Blood
products, collected from an ineligible donor, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION NC and VA
PRODUCT Red Blood Cells,
Apheresis, Leukocytes Reduced,
CODE Unit:
164584975
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Meridian, MA
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 MS
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Units: 050LW28693 and
018GP17967
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Cleveland, OH
REASON Blood products, which may have been shipped under
unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION OH
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
16460-9254
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., dba United Blood Services,
Meridian, MS.
REASON Blood
product, manufactured from a Whole Blood unit, which contained clots, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MS
WEEK ENDING NOVEMBER 18
PRODUCT
a) Red Blood Cells,
Leukocyte Reduced, 7;
b) Fresh Frozen Plasma,
CODE a) and b) Unit: LC29072
RECALLING
FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI,
REASON
Blood products, collected from a donor who was
taking the drug Proscar, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION WI
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit:
71X308036
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Centers, Inc., Brooksville, FL,
REASON Blood product, which did not meet
acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis
CODE
Unit: 1038424 (split)
RECALLING
FIRM/MANUFACTURER Walter L. Shepeard Community Blood Center, Inc.,
Augusta, GA,
REASON Blood products, which did not meet acceptable
product specifications, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION GA and SC
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit:
71X383190
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Centers, Inc., Brooksville, FL,
REASON Blood product, which did not meet
acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT Red Blood Cells,
CODE
Units: 71P675257, 71Q028316, and 71Q867855
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers,
Inc., Brooksville, FL,
REASON Blood products, which were collected from a donor
who had traveled to a malarial endemic area, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 3 units
DISTRIBUTION FL
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells,
Apheresis,
c)
Platelets,
d) Platelets, Irradiated,
CODE
a) Units: L22560 and L23663;
b) Units: L24646 (split
units);
c) Unit: L23663;
d) Unit: L22560
RECALLING
FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA,
REASON Blood products, which were collected from a donor in which
donor suitability was not adequately determined, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION VA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
29KY26570
RECALLING FIRM/MANUFACTURER American National Red Cross,
Mid-Atlantic Region, Norfolk,
REASON Blood
product, collected from a donor who did not have a hematocrit test during the
donor screening process, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION VA
PRODUCT Platelets Pheresis, Leukocytes Reduced,
CODE
Unit:
71X279927
RECALLING FIRM/MANUFACTURER
Recalling Firm:
LifeSouth Community Blood Centers, Inc., Gainesville, FL,
Manufacturer: LifeSouth Community Blood Centers,
Inc., Birmingham, AL.
REASON Platelets Pheresis, with an unacceptably low
volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Source Plasma,
CODE
Units: 68615598, 68611057
RECALLING
FIRM/MANUFACTURER ZLB Bioplasma, Inc., Duluth, MN,
REASON Source
Plasma, collected from a donor whose medical history screening did not include
questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and
variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells
Pheresis, Leukocytes Reduced,
b) Platelets Pheresis,
Leukocytes Reduced,
c) Fresh Frozen Plasma Pheresis,
CODE
a), b), and c) Unit:
16458-5185
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., dba United Blood Services,
Meridian, MA,
REASON Blood
products, which were possibly contaminated with Corynebacterium species, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION MS
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells Leukocytes Reduced,
CODE
a) Units: 9016659 and 9014813;
b) Unit: 9014308
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center,
Denver, CO,
REASON Blood products, which were collected from a donor
who had traveled to a malarial endemic area, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 3 units
DISTRIBUTION CO and IL
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
9150685
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO,
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TN
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Units: 9150583, 9044563,
and 6671207
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial
Blood Center, Denver, CO,
REASON Blood products, which was collected from a
donor who had traveled to a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION CO, and FL
PRODUCT Platelets Pheresis,
CODE
Unit: 3811179 (split)
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA,
REASON Blood products, which were collected from a donor
who had engaged in high risk behavior activities, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION MS
PRODUCT Red Blood Cells,
CODE
Unit: 9977993
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 and Switzerland
PRODUCT Red Blood Cells,
CODE
Unit: 0228954
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA,
REASON Blood product, which was collected from a donor in
which donor who had traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Red Blood Cells,
CODE
Unit: 0239281
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA
REASON Blood product, manufactured from a unit of Whole
Blood that was designated as a low volume collection, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE a) and b) Unit: H81780
RECALLING
FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA,
REASON Blood products, which
were collected from a donor with a history of hepatitis A, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION VA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
29FK62341
RECALLING FIRM/MANUFACTURER American National Red Cross,
Mid-Atlantic Region, Norfolk, VA,
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 VA
PRODUCT Fresh Frozen Plasma,
CODE
Unit: H94616
RECALLING
FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA,
REASON Blood
product, corresponding to a unit of clotted red blood cells, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION VA
PRODUCT Platelets
Pheresis,
Leukocytes Reduced,
CODE Unit:
7685031
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Beaumont, TX,
REASON Blood product, which did not meet acceptable
product specifications, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT Platelets
Pheresis,
Leukocytes Reduced,
CODE Unit:
3795586
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Beaumont, TX,
REASON Blood product, which did not meet acceptable
product specifications, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT Platelets,
CODE
Unit: 3799972
RECALLING
FIRM/MANUFACTURER LifeShare Blood Centers, Beaumont, TX,
REASON Blood
product, which was collected from a donor who had taken aspirin or an aspirin
product within three days of the donation, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Units: 4035970 and
7685655
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Beaumont, TX,
REASON Blood products, which were collected from a donor
who had traveled to a malarial endemic area, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX
PRODUCT Platelets
Pheresis,
Leukocytes Reduced,
CODE Units: 3798480 and
3799980
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Beaumont, TX,
REASON Blood products, which did not meet acceptable
product specifications, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION TX
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets,
CODE a) and b) Unit: 4037174
RECALLING
FIRM/MANUFACTURER LifeShare Blood Centers, Beaumont, TX,
REASON Blood
products, which were collected from a donor who had traveled to a malarial
endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MI
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
3796693
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Beaumont, TX,
REASON Blood product, which were collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT Platelets, Leukocytes
Reduced,
CODE Unit: 16GQ28697
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Columbus, OH,
REASON
Blood products, which did not meet
acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION OH
PRODUCT Red Blood Cells
Pheresis,
Leukocytes Reduced,
CODE Units: 16374-8427
(split)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., dba United Blood Services,
Meridian, MA,
REASON Blood
products, for which documentation of an abnormal alarm during apheresis
collection was incomplete, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION MS
PRODUCT Platelets
Pheresis,
Leukocytes Reduced,
CODE Unit:
53LF81748
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Chesapeake and Potomac Region, Baltimore, MD
REASON Blood product, collected from a donor who was at
risk for Leishmaniasis, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MD
PRODUCT Platelets
Pheresis,
Leukocytes Reduced,
CODE Units: 71X277203 (Parts
1 & 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm:
LifeSouth Community Centers, Inc., Gainesville, FL,
Manufacturer: LifeSouth Community Centers, Inc., Birmingham, AL.
REASON
Platelets, which were
possibly contaminated with coagulase negative Staphylococcus, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AL
PRODUCT Recovered Plasma,
CODE
Unit: 9977993
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 and Switzerland
PRODUCT
a) Red Blood Cells,
b) Platelets,
c) Fresh Frozen
Plasma,
CODE a), b), and c) Unit:
9999463
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 3
units
DISTRIBUTION LA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit: 5713905
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Beaumont, TX, 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 NOVEMBER 25
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets, Leukocytes Reduced,
CODE
a) and b) Unit: 032KE88517
RECALLING
FIRM/MANUFACTURER American National Red Cross, Badger-Hawkeye Region,
Madison, WI, .
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 WI
PRODUCT Red Blood Cells,
Leukocytes Reduced, Irradiated
CODE Units:
20727-0712, 20728-7723
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Blood Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Lafayette, LA.
REASON
Blood products, which were incorrectly
tested for Cytomegalovirus (CMV), were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION LA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
16455-4251
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Meridian, MS.
REASON
Blood product, collected from a donor
who was incorrectly tested for the antibody to the hepatitis B core antigen
(anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MS
PRODUCT Red Blood Cells,
CODE
Unit: 6273114
RECALLING
FIRM/MANUFACTURER New York Blood Center Inc., New York, NY,
REASON
Blood
product, collected from a donor whose health history screening was not
adequately performed, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NY
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Plasma Frozen,
CODE
a) Units: 042FF96397, 042FF96852;
b) Unit:
042FF96938
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Northern Ohio Region, Cleveland, OH,
REASON Blood products, collected in manner that may have
compromised the sterility of the units, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 3 units
DISTRIBUTION OH
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets Leukocytes Reduced,
CODE a) and b) Units: 042X08826,
042FP08598
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Northern Ohio Region, Cleveland, OH,
REASON Blood products, collected from a donor who visited
an area endemic for malaria were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION OH
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced
b) Platelets Leukoreduced,
CODE a) and b) Unit: 033GL59440
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Connecticut Region,
Farmington, CT
REASON Blood products, collected from a donor who visited
an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION CT
PRODUCT
a) Platelets Pheresis,
Leukocytes Reduced Irradiated,
b) Platelets Pheresis,
Leukocytes Reduced,
CODE
a) Units: 9000611 (split
product);
b) Unit: 6878287
RECALLING FIRM/MANUFACTURER Belle
Bonfils Memorial Blood Center, Denver, CO,
REASON Blood products, collected from
a donor who traveled to a malarial endemic area, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION CO
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Recovered Plasma,
(1 unit)
CODE a) and b) Unit: 7675411
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
a) Platelet Pheresis
Leukocytes Reduced,
b) Platelet Pheresis Leukocytes
Reduced Irradiated,
CODE a) and b) Unit:
035Z19202
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Greater Alleghenies Region, Johnstown, PA,
REASON Blood products, that did not meet QC specifications, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION VA
PRODUCT Source
Plasma,
CODE Units: 05FIND1700, 05FIND2073,
05FIND2700, 05FIND3659
RECALLING FIRM/MANUFACTURER BioLife Plasma
Services L.P., Fort Wayne, IN,
REASON Blood products, collected from a donor who had a
tattoo applied within twelve months of donating, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE
a) Units: 2234392, 2220342, 2172721;
b) Unit:
2172721
RECALLING FIRM/MANUFACTURER Blood Bank of Delmarva Inc.,
Newark, DE,
REASON Blood products,
collected from a donor who had previously been deferred after reporting a
positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION DE and MD
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
22LZ11336
RECALLING FIRM/MANUFACTURER American National Red Cross,
Penn-Jersey Region, Philadelphia, PA,
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 PA
PRODUCT Source Plasma,
CODE
Units: 04YARB6415, 04YARB7014,
04YARB7409
RECALLING FIRM/MANUFACTURER BioLife Plasma Services,
L.P., Fayetteville, AR,
REASON Blood products, collected from a donor who
provided post donation information regarding multiple high-risk behaviors, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION NC
PRODUCT
a) Red Blood Cells,
b) Platelets,
c) Recovered Plasma,
CODE
a), b), and c) Unit: 4434720
RECALLING
FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON Blood
products, collected from a donor who was previously deferred for a tattoo, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION IL, PA, and Switzerland
PRODUCT Source Plasma,
CODE
Unit: 6140070227
RECALLING
FIRM/MANUFACTURER ZLB Bioplasma, Inc., Evansville, IN
REASON Blood
product, collected from an ineligible donor, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
17203-5830
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
McAllen, TX,
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 TX
PRODUCT Source Plasma,
CODE
Units: 06FINA3067, 06FINA3669,
06FINA4072
RECALLING FIRM/MANUFACTURER BioLife Plasma Services,
L.P., Ft. Wayne, IN,
REASON Blood products, which tested negative for viral
markers, but were not properly quarantined after the receipt of post donation
information related to a recent tattoo, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 3 units
DISTRIBUTION CA
PRODUCT Source Plasma,
CODE
Units: 05FIND7561, 05FIND7950
RECALLING
FIRM/MANUFACTURER BioLife Plasma Services, L.P., Ft. Wayne, IN,
REASON
Blood products, collected from a doner who
received a tattoo and piercing within 12 months of donation, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
20729-7376
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Lafayette, 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
PRODUCT
a) Red Blood Cells,
Apheresis, Leukocytes Reduced,
b) Platelets, Pheresis,
Leukocytes Reduced,
CODE a), and b) Unit:
13X06144
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southeastern Michigan Region, Detroit, MI,
REASON Blood products, collected from a donor who
traveled to an area endemic for malaria, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION MI
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
2430074
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN
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 TN
PRODUCT Recovered Plasma,
CODE
Unit: 032KE88517
RECALLING
FIRM/MANUFACTURER American National Red Cross, Badger-Hawkeye Region,
Madison, WI,
REASON Blood products, collected from a donor for whom
donor suitability was not adequately determined, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION VA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Red Blood Cells Pheresis,
Leukocytes Reduced,
CODE
a) Unit:
20726-8478;
b) Units: 20726-0288 (split unit)
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ,
Manufacturing Firm: Blood Systems,
Inc., Lafayette, LA.
REASON Blood products, collected from an ineligible donor due to
the use of the medication, Isoniazid, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 3 units
DISTRIBUTION LA, and TX
PRODUCT Red Blood Cells,
CODE
Units: G56287, G56279, G56278, G56268, G56257,
G56265
RECALLING FIRM/MANUFACTURER Central Illinois Community Blood
Center, Springfield, IL,
REASON Blood products, collected
using a trip scale for which daily QC was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units
DISTRIBUTION IL
PRODUCT Recovered Plasma,
CODE
Unit: 6273114
RECALLING
FIRM/MANUFACTURER New York Blood Center Inc., New York, NY,
REASON
Blood
product, collected from a donor whose health history screening was not
adequately performed, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT Red Blood Cells,
CODE
Units: C40807, C40817
RECALLING
FIRM/MANUFACTURER HCSC Blood Center, Bethlehem, PA,
REASON Blood products,
processed at an unacceptable temperature were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION PA
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Units: 177342499,
177342500, 177342488, 177342496
RECALLING FIRM/MANUFACTURER Blood
Systems Inc., McAllen, TX,
REASON Blood products, lacking assurance of
acceptable temperatures during shipping, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 4
units
DISTRIBUTION TX
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Units: 4140956
(distributed as a split product)
RECALLING
FIRM/MANUFACTURER Central Indiana Regional Blood Center, Indianapolis,
IN,
REASON Blood products, possible
contaminated with Gram positive cocci, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2
units
DISTRIBUTION IN
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Units:
16383-7975 and 16383-9954
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Maridian, MS,
REASON Blood products, labeled with an extended
expiration time, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MS