APRIL 2008
WEEK ENDING APRIL 5
PRODUCT Platelets Leukocytes Reduced,
CODE
Lot: 0898605
RECALLING
FIRM/MANUFACTURER West Tennessee Regional Blood Center Inc.,
Jackson, TN
REASON Blood product, for which there was
incomplete documentation of the irradiation process, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN
PRODUCT Source Plasma,
CODE
Lot
#’s: 04EWIA4081, 04EWIA5031, 04EWIB0977, 04EWIC3433, 04EWIC8797, 04EWIE0078,
04EWIE0618, 04EWIE1384, 04EWIB1527, 04EWIC8373
RECALLING
FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP,
Deerfield, IL,
Manufacturer: BioLife
Plasma Services, LP, Eau Claire, WI.
REASON Blood products, which tested negative
for hepatitis but were collected from a donor who disclosed a previous positive
test for hepatitis, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 10 units
DISTRIBUTION CA and Vienna,
Austria
PRODUCT Source Plasma,
CODE
Lot
#’s: 04SWIF8138, 04SWIF9259
RECALLING
FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP,
Deerfield, IL,
Manufacturer: BioLife Plasma
Services, LP, Sheboygan, WI.
REASON Blood products, collected from a donor
who engaged in multiple high risk behaviors, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION Austria
PRODUCT Source Plasma,
CODE
Lot
#: 3870001174
RECALLING FIRM/MANUFACTURER International
BioResources LLC, Springfield, IL,
REASON Blood product, which
was not properly quarantined after receiving post donation information
concerning a history of incarceration, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Austria
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Lot
#: 72C215027
RECALLING FIRM/MANUFACTURER LifeSouth
Community Blood Centers, Inc., Brooksville, FL,
REASON
Blood
product, with a low platelet count, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Lot #: 72C244662
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
a) Red Blood Cells,
b) Platelets,
c) Fresh Frozen Plasma,
;
d) Red Blood Cells
Leukocytes Reduced,
e) Red Blood Cells Leukocytes Reduced
Irradiated,
CODE
a) Lot #’s: 4179859,
4179857, 4179873, 4179872, 4179870, 4179854, 4179869,
4179868, 4179867, 4179866, 4179860, 3545301, 3100147, 3099786, 4150515, 4150520, 4150524, 4150528, 4150531, 4150532,
4150535, 4150538, 4150542,
4150547, 4150521, 4150509,
3086262, 3086261, 3086260, 3086263;
b) Lot #’s: 4179857, 4179873, 4179860,
3545301, 3099786, 4150515, 4150520, 4150524, 4150531,
4150535, 4150547, 4150521, 4150509;
c) Lot #’s: 1275435, 3545301, 3100147,
3099786;
d) Lot #’s: 4179871, 4179848, 8532307, 4150543, 4150544,
4150546;
e) Lot #: 1275435
RECALLING
FIRM/MANUFACTURER Community Blood Center, Dayton, OH,
REASON
Blood products, collected using expired
arm scrub supplies, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 54 blood components
DISTRIBUTION OH,
IN, NY
PRODUCT
a) Fresh Frozen Plasma,
b) Red Blood Cells
Leukocytes Reduced,
c) Platelets Leukocytes Reduced,
d) AS-1 Red Blood Cells Leukocytes Reduced Irradiated,
e) Red Blood Cells,
f) Whole Blood
CPD,
g) Whole Blood CPDA-1,
h)
Cryoprecipitated AHF,
i) Platelets Pooled Leukocytes
Reduced,
j) Plasma Frozen within 24 hours after
phlebotomy,
k) Plasma Cryoprecipitate Reduced,
CODE
a) Lot #’s: 22GE00283, 22LW93606,
22FC47659, 22FC47665, 22FS54856, 22GG14987, 22GS32434,
22KN78220, 22GS32241, 22GS32424, 22LP25387, 22LW93026,
22KK88507, 22KK88513, 22GG14986, 22FS54842, 22GL42310,
22GS32432, 22LW92884, 22GL42313, 22GE00281, 22GE00926, 22GS32641, 22FS54850, 22GE00956, 22GL42316, 22FQ48053, 22FQ48070,
22FQ48084, 22FQ48311, 22FS54857, 22FX40629, 22GL42315,
22GL42317, 22KX88782, 22LP25558, 22LZ15445, 22GG12789,
22GS32648, 22GS32649, 22GS32653, 22FC47680, 22FQ48088,
22FS54846, 22KV94704, 22FC47674, 22GL44036, 22GE00290,
22GS32426, 22LW93042, 22LW92883, 22FQ48063, 22FS54863, 22GE00939, 22GE00274, 22LW93049,
22GG14982, 22FC47697, 22GG14986, 2LW93054,
22FX40646, 22GL44034, 22KN78225, 22KT91690, 22KT91692,
22KX88779, 22LP25381, 22LP25385, 22LW93056, 22GS32428, 22GS32430, 22FS54852, 22FX40630, 22GS32420, 22GS32423, 22KN78213,
22KT91684, 22LP25390, 22FS54845, 22LW93039, 22LW93604,
22GG15355, 22LW93047, 2GE00280, 22GE00929, 22GE00277,
22GE00943, 22FC47669, 22GG14984, 22GG15369, 22GS32417
22LP25388, 22LP25394, 22LP25395, 22LP25519, 22LW93030,
22LP25380, 22LP25391, 22LW93033, 22LW93034, 22GL42311,
22GL42311, 22GL42311, 22GL42311, 22GS32663, 22GS32663, 22GS32663, 22GS32663;
b) Lot #’s: 22FQ47133,
22KN77820, 22GG12789, 22GS32236, 22LW93939, 22LW93948,
22KK88513, 22LZ15174, 22GS32671, 22FC47809, 22FS53589,
22FS53595, 22FC47614, 22KH18119, 22FC47609, 22GS32241, 22LZ15445, 22FC47836, 22GS32257, 22FC47838, 22GS32245, 22GS32295,
22FC47602, 22KT91461, 22GS32262, 22LW93595, 22LZ15375,
22LZ15377, 22GS32255, 22KT91473, 22LW93673, 22LZ15017,
22LZ15019, 22LZ15378, 22FC47803, 22KK88519, 22LW93671,
22KF71878, 22KX88752, 22KX88753, 22KX88756, 22KX88758,
22KX88759, 22GQ20897, 22KL40950, 22GS32290, 22GQ20900,
22KH18121, 22KT91465, 22LW93940, 22LZ15355, 22LZ15356, 22GQ20895, 22GS32240, 22KL40958, 22GS32222, 22KK88512, 22LW93362,
22LW93364, 22GS32258, 22LW93942, 22FC47845, 22GG14970,
22KF71862, 22KK88505, 22LZ15180, 22FQ48015, 22FC47600,
22LZ15021, 22LZ15380, 22GS32275, 22GS32663, 22LW93355,
22LZ15181, 22LZ15612, 22FC47665, 22FQ48084, 22GL42310,
22GL42315, 22GS32417, 22GS32432, 22KL40965, 22KT91696,
22KX88779, 22LC40546, 22FS54847, 22FS54852, 22FS54856, 22FS54858, 22GS32434, 22LW93056, 22FX40629, 22GE00280, 22GE00927,
22GE00929, 22GG14987, 22GL44034, 22GL44036, 22KN78220,
22GG14982, 22GS32653, 22LW93049, 22FC47697, 22FQ48053,
22GL42317, 22LP25381, 22LP25395, 22LP25399, 22LW93047,
22GE00926, 22KC98113, 22KC98118, 22KK88515, 22LW93042,
22FQ48063, 22GE00283, 22FQ48311, 22FC47710, 22KT93259,
22LW9303, 22GE00281, 22GS32426, 22KT91702, 22LP25558, 22LW93660, 22FC47669, 22FS54845, 22GG14984, 22GG15355, 22LP25388,
22LW93033, 22KL40961, 22KL40963, 22KL40969, 22FS54857,
22LP25380, 22FC47685, 22GS32424, 22KC98109, 22GL42313,
22GS32420, 22KC98111, 22KC98121, 22FX40635, 22LW93054,
22FQ48070, 22FS54846, 22FS54854, 22KX88782, 22LW93656,
22FC47674, 22FS54863, 22LW93604, 22LW93026, 22GE00956,
22GS32637, 22GS32648, 22GS32649, 22FC47716, 22FS54850, 22LW92884, 22LP25390, 22FQ48057, 22FX40646, 22KT91684, 22FS54851,
22GL42316, 22FQ48088, 22GS32641, 22LC40549, 22LP25394,
22LP25519, 22LW93606, 22KT91692, 22GE00290, 22LP25387,
22FC47659, 22FS54842, 22FX40630, 22GE00274, 22GE00277,
22GS32428, 22KN78213, 22GE00939, 22GS32423, 22KT91690,
22LW93030, 22LW93039, 22LW92883, 22GE00943, 22GL42305,
22LW93658;
c) Lot #’s: 22FQ48053, 22LP25399, 22GE00274, 22GG15369, 22FX40646, 22KN78225, 22FQ48311, 22GE00277, 22GG15447, 22GS32432,
22KN78220, 22KT91684, 22LP25380, 22LP25381, 22LP25385,
22LP25390, 22LP25394, 22LW93604, 22GL42316, 22KC98109,
22GH44105, 22FQ48070, 22FQ48088, 22FS54845, 22GS32417,
22KT91690, 22LW92884, 22LW93047, 22GL42315, 22FS54856,
22FS54863, 22GE00927, 22KC98121, 22KC98113, 22FX40630,
22FQ48063, 22FQ48084, 22FS54852, 22FX40629, 22GE00929, 22GE00943, 22GL44034, 22GS32648, 22GS32653, 22KC98111, 22LW93026,
22LW93030, 22LW93049, 22FS54846, 22GE00280, 22GS32426,
22LW93042, 22LW93054, 22GS32434, 22LW92883, 22LW93056,
22GG15355, 22GL44036, 22KN78213, 22FS54850, 22GE00956,
22GL42316, 22KC98109, 22KT93259, 22LP25388, 22GS32641,
22KT91692, 22GS32430, 22GE00283, 22GE00290, 22LP25558,
22KT93232, 22FS54842, 22FS54858, 22KC98118, 22LW93033, 22GS32423, 22GG14987, 22LW93034, 22GL42310;
d) Lot #’s:
22LZ15371, 22LZ15455, 22GS32247, 22FC47680, 22GS32430,
22GL42311, 22LP25391;
e) Lot #’s: 22LZ15441, 22LZ15443,
22LZ15444, 22GG14965, 22LW93933, 22LW93954,
22KH18129;
f) Lot #’s: 22GG14969, 22KX88750, 22LW93937, 22LZ15360;
g) Lot
#’s: 22LL34477, 22LL34479, 22LL25381, 22LL34481, 22LL28330,
22LL34486;
h) Lot #’s: 22GS32275, 22LZ15355, 22GS32671,
22KT91461, 22FC47836, 22FC47838, 22FQ48015, 22GS32222,
22GS32236, 22GS32262, 22KT91465, 22LZ15612, 22GQ20900,
22LW93362, 22LZ15371, 22GS32290, 22KT91463, 22LZ15380,
22LZ15377, 22LZ15375, 22LW93670, 22LZ15356, 22KF71878,
22KL40963, 22KL40965, 22LW93671, 22LZ15180, 22KK88519, 22KK88512, 22KK88515, 22LZ15174, 22FC47845, 22GS32245, 22GS32247,
22GS32255, 22GS32257, 22GS32258, 22GS32295, 22KL40969,
22KT91473, 22LZ15181, 22LZ15455, 22LZ15378,
22LW93673;
i) Pool numbers: 891, 901, 1240, 1247, 747, 886, 1197, 1050, 1288,
739, 791, 962;
j) Lot #’s: 22KC98113, 22KC98111, 22LW93656, 22KL40950,
22KF71861;
k) Lot #: 22LW93670
RECALLING
FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region,
Philadelphia, PA,
REASON Blood
products, collected in a manner that may have compromised the sterility of the
collection system, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 560 components
DISTRIBUTION PA, NJ,
NY, VA, MD, and PR
PRODUCT Platelets Leukocytes Reduced,
CODE
Lot #: 71X598268
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Lecanto, 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
Lot #: 5210627
RECALLING
FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., Long
Island City, NY,
Manufacturer: New York Blood
Center, Inc., Westbury, NY.
REASON Blood product, which was collected from
a donor who traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT Platelets Pheresis Leukocytes Reduced Irradiated,
CODE Lot #’: 1543472 Part 1 and
2
RECALLING FIRM/MANUFACTURER Indiana Blood Center,
Indianapolis, IN,
REASON Blood products, which did not meet the
acceptable product specifications, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2
units
DISTRIBUTION IN
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Lot #: 71X576713
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL
REASON Blood product, labeled “Leukocyte
Reduced” but which failed to meet the criteria for a leukoreduced unit, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Source Plasma,
CODE
Lot
#’s: TA2074378, TA2074623, TA2080224, TA2080431, TA2083653, TA2083938,
TA2090794
RECALLING FIRM/MANUFACTURER DCI Biologicals
Texarkana, LLC, Texarkana, AR
REASON Blood products, collected from
a donor who provided post donation information regarding a history of receiving
a tattoo and being incarcerated, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 7 units
DISTRIBUTION NC and
UK
PRODUCT
a)
Cryoprecipitated AHF,
b) Plasma Cryoprecipitate Reduced,
c) Red Blood Cells Leukocytes Reduced,
d) Platelets,
CODE
a),
b), c), and d) Lot #: 2545816
RECALLING
FIRM/MANUFACTURER South Texas Blood & 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 4
units
DISTRIBUTION TX,
WI
PRODUCT Platelets Pheresis Leukocytes
Reduced
CODE Lot #: 1678319 (3
units)
RECALLING FIRM/MANUFACTURER The Blood Center of
New Jersey, East Orange, NJ,
REASON Blood products, which were labeled as
leukoreduced, but exceeded the acceptable limit for white blood cell count, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION NJ
PRODUCT Cornea,
CODE
Tissue #:
2008013038
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Heartland Lions Eye Bank, Kansas City, MO,
Manufacturer: Heartland Lions Eye
Bank, Springfield, MO.
REASON Ineligible cornea was mislabeled and
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
cornea
DISTRIBUTION KS
PRODUCT Red Blood
Cells, Leukocytes Reduced,
CODE Unit:
766187
RECALLING FIRM/MANUFACTURER Florida’s Blood
Centers, Inc, Orlando, FL
REASON Blood product, collected from
a donor with an elevated temperature, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT
a) Red Blood Cells Leukocytes Reduced Irradiated,
b) Red Blood Cells
(Apheresis) Leukocytes Reduced Irradiated, CODE
a) Lot #: GJ123791;
b) Lot #:
GJ123792
RECALLING FIRM/MANUFACTURER The Blood Center,
New Orleans, LA,.
REASON Blood
products, which was out of controlled storage for an undocumented length of
time, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION LA
PRODUCT
a) Cryopreserved Allograft Skin, Non-Meshed and Cryopreserved
Allograft Skin, Meshed,
b)
AlloDerm GBR, 2x4 cm, .46-.86 (mm); 2x2 cm, .46-.86 (mm); 1x4 cm, .46-.86 (mm),
c) AlloDerm Graftable, 2x4
cm, 6-12 (1/1000 in.); AlloDerm Graftable (Non Meshed),
14-20 (1/1000 in.); AlloDerm Graftable (Meshed 1:1), 14-20 (1/1000 in.);
AlloDerm Graftable (Meshed 1:1), 9-13 (1/1000 in.),
d) AlloDerm, Oral Plastic Surgery, 1x4 cm, .89-1.65
(mm); 2x4 cm, .89-1.65 (mm); 1x2 cm, .89-1.65 (mm); 1x1
cm, .89-1.65 (mm),
e) AlloDerm
Implantable, 3x7 cm,
.79-1.27 (mm); 2x4 cm, .33-.76 (mm); 3x7 cm, .53-.76 (mm);
4x7 cm, .53-.76 (mm); 2x4 cm, .79-1.78 (mm); 4x7 cm, .53-.76 (mm); 3x7 cm, 1.14-1.78 (mm); 4x7 cm., .79-1.02(mm),
f) AlloDerm Implantable (Abdominal Wall Repair), 4x12 cm, .79-2.03
(mm); 4x16 cm, .79-2.03 (mm); 6x16 cm, .79- 2.03 (mm), g) GRAFTJACKET, 5x10 cm, .89-1.40 (mm); 5x5 cm, .89-1.52
(mm); 4x7 cm, .89 - 1.40 (mm),
h) Repliform, 5x10 cm, .9-1.6 (mm), 35-65 (1/1000 in.); 6x12 cm, .9-1.6 (mm), 35-65 (1/1000 in.); 2x7 cm, .9-1.6 (mm), 35-65 (1/1000 in.);
3x7 cm, .9-1.6 (mm), 35-65 (1/1000 in.); 4x7 cm, .9-1.6
(mm), 35-65 (1/1000 in.),
i) GRAFTJACKET, Maximum Force,
4x7 cm, 1.27-1.78 (mm); Maximum Force, 5x5 cm, 1.40 -
1.91 (mm); Maxforce Extreme, 4x7 cm, 1.80-2.29 (mm),
j) GRAFTJACKET, Ulcer Repair, 4x4 cm,
.38-1.02 (mm) and 4x8 cm, .38-1.02 (mm),
CODE
a) Lot # 20788C; sublots 001, 002, 003,
004, 005, 006, 007, 008, 009, 010, 011;
Expiration: 04/26/09; Lot # 21607C;
sublots: 001, 002, 003, 004. Expiration 6/29/09. Lot # 21745C; sublots: 001,
002, 003, 004, 005, 006, 007, 008, 009. Expiration: 7/8/09. Lot # 26039C,
sublots: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014.
Expiration: 03/06/10. Lot # 27278C: sublots: 001, 002, 003, 004, 005, 006, 007,
008, 009, 010, 011,. Expiration: 04/22/10. Lot # 29398C: sublots: 001, 002, 003,
004, 005, 006, 007, 008, 009, 010, 011. Expiration: 07/10/10. Lot 33219C;
sublots: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014.
Expiration: 11/09/10. Lot # 44269C; sublots: 001, 002, 003, 004, 005, 006, 007,.
Expiration: 09/05/11. Lot # 45291C; sublots: 001, 002, 003, 004, 005, 006.
Expiration: 10/03/11. Lot # 46811C; sublots: 001, 002, 003, 004,. Expiration:
11/06/11. Lot # 47609C; sublots: 001, 002, 003, 004, 005, 006, 007, 008.
Expiration: 11/28/11. Lot number: 21186C, sublots: 001, 002, 003, 004, 005, 006,
007, 008, 009, 010, 011, 012; Expiration: 5/24/09. Lot 22357C: sublots: 001,
002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013. Expiration: 8/18/09.
Lot 48179C; sublots: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012,
013, 014, 015, 016, 017,. Expiration: 12/13/11;
b) Lot #
B13646; sublots: 002. 004, 005, 011, 012, 020, 022. Expiration: 02/17/08; Lot: B20823:
Sublots: 024, 026. Expiration: 05/29/09. Lot #
B14441; sublot: 009; Expiration: 04/16/08: Lot B20823: sublots: 005, 006, 007, 008, 009, 010, 012, 013, 014,
015, 016, 017, 018, 019, 022, 023. Expiration: 05/29/09. Lot: B20823;
sublot: 002. Expiration: 05/29/09;
c)
Lot # B13646; sublot: 009, Expiration: 02/17/08. Lot # B16057; sublot: 034. Expiration: 7/30/08; Lot B161718; sublot 004, 007.
Expiration: 9/4/08. Lot # B16057; sublot: 034.
Expiration: 7/30/08 Lot B16057; sublot: 501. Expiration:
7/30/08 Lot B17809; sublots: 601, 603, 606, 607, 609, 610, 612, 613, 614, 616,
617, 620, 622, 623, Expiration 11/7/08. Lot B17809, sublots: 602, 604, 605, 608, 611, 615, 618, 619,.
Expiration: 11/07/08.; Lot B20286; sublots: 601, 602, 604; Expiration: 04/23/09;
d) Lot # B14441;
sublots:
001, 003, 005. ExpirationL 04/16/08. Lot # B16057; sublots: 029, 030, 031,
032. Expiration: 7/30/08 Lot B16718; sublot 001. Expiration: 09/04/08 Lot #
B14441; sublot: 017. Expiration 04/16/08. Lot B16718; sublot: 002. Expiration:
09/04/08; Lot B16718; sublot: 006. Expiration: 9/04/08 Lot: B18489, sublots:
004, 005. Expiration: 01/03/09. Lot 18767; sublots: 003, 004. Expiration:
01/21/09. Lot B19197; sublots: 004, 005, 006, Expiration 02/13/09. Lot B19213,
sublots: 001, 003, 006. Expiration 02/14/09. Lot B19322; sublot: 033, 037, 038.
Expiration# 02/21/09: Lot B19350; sublots: 003, 004, 005, 007, 008; Expiration:
02/22/09 Lot B19928; sublots: 031, 032, 034, 035; Expiration: 03/29/09; Lot
B20054: sublots: 033,, 034, 037, 038; Expiration: 04/08/09; Lot B20109; sublots:
003,004, 005; Expiration: 04/11/09; Lot B20510: sublots:001,005, 006;
Expiration: 05/08/09. Lot # B14441; sublot: 017. Expiration 4/16/08. Lot B16718;
sublot:002. Expiration: 9/4/08. Lot B16718; sublot: 006. Expiration 9/4/08. Lot
B16057: sublots:001, 002, 003, 004, 006, 007, 008, 009, 010, 011, 012, 013, 014,
015, 016, 017, 018, 019, 020, 021, 023, 024, 025, 026, 027, 028. Expiration:
7/30/08. Lot B16991: sublots: 001, 002, 003, 005, 006, 008, 009, 010, 011, 012,
013, 014, 015, 016, 017, 021, 022, 023,. Expiration: 09/18/08 Lot B19322; sublot: 001, 002, 003, 004, 005, 007, 008, 009, 010, 011, 013, 016, 020, 023,
024, 025, 026, 028, 029, 030, 031,. Expiration: 02/21/09 Lot: B19928; sublots:
001, 002, 003, 004, 005, 006, 007, 008, 009, 011, 012, 013, 016, 017, 018, 019,
020, 021, 022, 023, 024, 025, 026, 027, 028, 029, 030; Expiration: 03/29/09. Lot
B20054; sublots: 001, 003, 004, 005, 007, 011, 012, 013, 014, 016, 017, 018,
019, 020, 021, 026, 027, 028, 030, 031,. Expiration:
04/08/09;
e) Lot B14441; sublot: 019. Expiration 04/16/08.
Lot B16057; sublot: 043. Expiration:07/30/08 Lot B16718; sublot 003.
Expiration 09/04/08. Lot B16718; sublot: 012. Expiration: 09/04/08 Lot B16718.
sublot: 014. Expiration: 09/04/08. Lot 16991, sublot: 029. Lot B16991; sublot
027. Expiration: 9/18/08; Lot B192193, sublot: 007; Expiration: 02/14/09: Lot
B20605: sublot: 006; Expiration: 05/14/09. Lot B16991. sublot: 029. Expiration:
09/18/08. Lot B19213; sublot: 012; Expiration: 02/14/09. Lot B19350; sublot:
014; Expiration: 02/22/09;
f) Lot B14441; sublot: 022. 023.
Expiration: 04/16/08. Lot B16991; sublot: 031, 033.Expiration: 09/18/08;
Lot B19092; sublot 009., 010. Expiration: 02/07/09; Lot B19197; sublot: 007.
Expiration: 2/13/09; Lot B19322; sublot: 044; Expiration: 02/21/09; Lot B19350;
sublot: 018; Expiration: 02/22/09; Lot B19928; sublot: 046; Expiration:
03/29/09. Lot B18489; sublots: 021, 023, 024. Expiration: 01/03/09. Lot B18767,
sublot 016, 017. Expiration: 01/21/09; Lot B19092; sublot 011; Expiration:
02/07/09; Lot B19197; sublot: 011; Expiration: 02/13/09; Lot B19350: sublot:
022, 023; Expiration: 02/22/09 Lot B20054; sublot: 047; Expiration: 04/08/09;
Lot B20510; sublots: 015, 016, 020, 021; ExpirationL 05/08/09; Lot B20605:
sublots: 013, 014; Expiration: 05/14/09. Lot B18489; sublots: 043, 044.
Expiration: 1/03/09; Lot B19197' sublot 020; Expiration: 03/13/09; Lot B19213;
sublot: 020. Expiration: 02/14/09; Lot B19322: sublot: 054; Expiration:
02/21/09; Lot B19350; sublot: 033; Expiration: 02/22/09; Lot B20054; sublots:
066, 068, 069, 070; Expiration: 04/08/09;
g) Lot # B14441; sublot: 032. Expiration 04/16/08; Lot B16057;
sublots: 053, 055.Expiration:
07/30/08: Lot B19213; sublot: 018; Expiration: 02/14/09 Lot: B16057; sublot:
050. Expiration: 07/30/08; Lot B19322; sublot: 047; Expiration: 02/21/09: Lot
B18489; sublots: 026, 033. Expiration: 01/03/09: Lot B19350; sublot: 027;
Expiration: 02/22/09; Lot B20054: sublot: 050. 051; 052; Expiration: 04/08/09;
Lot B19350; sublot: 029; Expiration: 02/22/09; Lot B20054; sublots 043, 054,
055; Expiration: 04/08/09: Lot: B21696; sublot: 021; Expiration: 07/25/09. Lot
B16057; sublot: 050. Expiration 7/30/08; Lot B19322; sublot: 047; Expiration
02/21/09: Lot B18489; sublots: 026, 033. Expiration: 01/03/09: Lot B19350;
sublot:027; Expiration: 02/22/09; Lot B20054: sublot: 050, 051, 052; Expiration
4/8/09. Lot B19322: sublot: 041. Expiration: 02/21/09: Lot B19350; sublot: 012;
Expiration: 02/22/09;
h) Lot # B16057; sublot: 052.
Expiration: 07/30/08; Lot B19322; sublots: 048, 049, 050, 051, 052.
Expiration: 2/21/09. Lot B16057; sublots: 056, 058. Expiration: 07/30/08; Lot
B19322; sublot: 053. Expiration: 02/21/09; Lot B18489; sublot 035. Expiration:
01/03/09 Lot B19350: sublots: 031 032; Expiration: 02/22/09; Lot B20054: sublots: 062,063; Expiration: 04/08/09. Lot B21719;
sublot: 029; Expiration:
07/26/09. Lot B189489, sublot: 010. Expiration: 01/03/09; Lot B19213; sublots:
008, 009; Expiration: 02/14/09. Lot B18489; sublots: 013, 014. Expiration:
1/03/09. Lot B18489; sublot: 015. Expiration 1/03/09; Lot B19322; sublot: 042.
Expiration: 02/21/09; Lot B19350; sublot: 010, 17; Expiration: 02/22/09; Lot
B20054; sublots: 041, 042; Expiration 04/08/09;
i) Lot
B18489; sublot: 016, Expiration: 01/03/09. Lot B18767; sublot 010. Expiration:01/21/09. Lot B19092;
sublot: 008. Expiration: 02/07/09; Lot B19350; sublot:
013; Expiration: 2/22/09. Lot B19928; sublots: 044, 045; Expiration: 3/29/09.
Lot B20109; sublots: 009, 010; Expiration 4/11/09. Lot B18489; sublots: 025,
027, 028, 029, 031, 032. Expiration: 01/03/09. Lot B18767; sublot: 019.
Expiration: 01/21/09; Lot B19092; sublots: 013. 014. Expiration: 02/07/09. Lot
B19213; sublot 017.. Expiration 02/14/09; Lot: B20054; sublot 049; Expiration:
04/08/09. Lot B19350; sublot: 011; Expiration: 02/22/09;
j)
Lot: B20604; sublots: 007, 008, 009, 010, 011, 012, 013, 014, 015, 020, 024,
025, 027.Expiration: 05/14/09; Lot: B20823; sublots: 028, 041, 053, 065,
069, 070, 071. Expiration: 05/29/09. Lot: B20604: sublots: 032, 033, 034, 036,
037, 038, 039, 041, 047, 050, 051, 052, 053, 054, 055, 056, 057, 058, 059, 060.
Expiration: 05/14/09.
RECALLING
FIRM/MANUFACTURER LifeCell Corporation, Somerville, NJ
REASON
Human tissues from
donors, tested using diagnostic test kits rather than FDA licensed or cleared
screening tests for hepatitis B surface antigen (HBsAg) and total antibody to
hepatitis B core antigen (anti-HBc total), were distributed.
VOLUME
OF PRODUCT IN COMMERCE 46 product
lots
DISTRIBUTION Nationwide, Canada and
Korea
PRODUCT
Red
Blood Cells (Apheresis) Leukocytes Reduced Irradiated,
CODE
Lot #: 3824801 (split
unit)
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA
REASON Blood
products, which were out of controlled storage for an undocumented length of
time, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION LA
PRODUCT
a) Fresh Frozen Plasma, ;
b) Red Blood Cells
Leukocytes Reduced,
CODE a) and b) Lot
#: 71R694243
RECALLING FIRM/MANUFACTURER LifeSouth
Community Blood Centers, Inc. – Birmingham Region, Birmingham, AL.
REASON
Blood products, which were untested for
the human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the
Nucleic Acid Test (NAT), were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION AL
PRODUCT
Red Blood Cells Leukocytes Reduced,
CODE Lot #’s: GX41487, KM15911 and
KM15725
RECALLING FIRM/MANUFACTURER Indiana Blood Center,
Indianapolis, IN
REASON Blood
products, which were exposed to unacceptable temperatures during shipment, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION IN
PRODUCT
Red Blood Cells Leukocytes Reduced,
CODE Lot #: 2307581
RECALLING
FIRM/MANUFACTURER Florida Blood Centers, Inc., Orlando, FL
REASON
Blood product, collected from a donor
whose body temperature was not documented, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
WEEK ENDING APRIL 12
PRODUCT Red Blood
Cells Leukocytes Reduced Irradiated,
CODE Unit: FL24288
RECALLING
FIRM/MANUFACTURER Heartland Blood Centers, Aurora, IL,
REASON
Blood product, with incomplete
documentation of the irradiation process, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT Fresh Frozen Plasma,
CODE
Unit: 40KG08429
RECALLING
FIRM/MANUFACTURER American National Red Cross HOA Blood Services
Region, Peoria, IL
REASON Blood product,
collected from a donor who was previously deferred, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE
a) Unit: 123795411;
b) Units: 123795411
Split 1, 123795411 Split 2
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc.,
Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Albuquerque, NM.
REASON
Blood products,
which tested negative for HIV, but was collected from a donor who previously
tested positive for HIV, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3
units
DISTRIBUTION NM
PRODUCT Recovered Plasma,
CODE
Unit # LE77385
RECALLING
FIRM/MANUFACTURER Blood Center of Wisconsin, Inc.,
Milwaukee, WI,
REASON Blood product,
collected from a donor considered to be at increased risk for variant
Creutzfeldt - Jakob disease (vCJD), was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Switzerland
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b)
Platelets Pheresis Leukocytes Reduced,
CODE
a) Units: 2802438; and 2689590;
b)
Units: 7089263 Part 1; and 7089263 Part 2;
RECALLING
FIRM/MANUFACTURER South Texas Blood & Tissue Center, San
Antonio, TX
REASON Blood products, which were collected
from a donor who traveled to a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION TX
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Units: 0441884
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA,
REASON
Blood product, which
was labeled as leukoreduced, but exceeded the acceptable limit for white blood
cell count, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Red Blood Cells
(Apheresis) Leukocytes Reduced, CODE Unit: 3825816 (split
unit)
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA,
REASON Blood products, which were labeled as
leukoreduced, but were not tested to verify the White Blood Cell count, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION LA
PRODUCT Red Blood Cells
(Apheresis) Leukocytes Reduced, CODE Units: 2679092 (split unit), 2675308
(split unit)
RECALLING FIRM/MANUFACTURER South Texas
Blood & Tissue Center, San Antonio, TX
REASON Blood
products, which were labeled as leukoreduced, but were not tested to verify the
White Blood Cell count, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4
units
DISTRIBUTION TX
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 033GL69350
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services,
Farmington, CT
REASON Blood product, manufactured from a Whole
Blood unit that was overweight, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT
a) Platelets Pheresis Leukocytes Reduced,
b)
Platelets Pheresis Leukocytes Reduced Irradiated,
CODE
a) Units: 49GP24201 (2 units), 49GP20688
(2 units), 49GP24612 (2 units), 49GP23239 (2 units),
49GP22095, 49GP23844, 49GP21536, 49GP22735 (2 units),
49GP24850 (2 units), 49GP23293, 49GP23091, 49GP21559 (2 units), 49GP23183 (2 units), 49GP24619 (2 units), 49GP23146 (2 units),
49GP22681 (2 units), 49GP17400 (2 units), 49GP23242,
49GP23243 (2 units), 49GP23588 (2 units), 49GP24141,
49GP23809, 49GP23238 (2 units), 49GP24446 (2 units), 49GP24477 (2 units);
b)
Units: 49GP25337, 49GP22095, 49GP18659 (2 units), 49GP24141
RECALLING
FIRM/MANUFACTURER American National Red Cross SW Region – HT,
Tulsa, OK
REASON Blood products, collected using
apheresis kits that had exceeded the acceptable time periods for use, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 47
units
DISTRIBUTION TX,
OK
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 72C179491
RECALLING
FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers,
Inc., Gainesville, FL,
Manufacturer:
LifeSouth Community Blood Centers - Wiregrass Region, Dothan, AL.
REASON
Blood product, which did not
meet acceptable product specifications, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 72C075235
RECALLING
FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers,
Inc., Gainesville, FL,
Manufacturer:
LifeSouth Community Blood Centers Inc., Huntsville, AL.
REASON
Blood product, which did not
meet acceptable product specifications, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 71X528371
RECALLING
FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers,
Inc., Gainesville, FL,
Manufacturer: LifeSouth
Community Blood Centers Inc., Huntsville, AL.
REASON
Blood product, which did not meet
acceptable product specifications, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 71X601185
RECALLING
FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers,
Inc., Gainesville, FL,
Manufacturer: LifeSouth
Community Blood Centers Inc., Huntsville, AL.
REASON
Blood product, which did not meet
acceptable product specifications, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 71X67149X
RECALLING
FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers,
Inc., Gainesville, FL,
Manufacturer:
LifeSouth Community Blood Centers - Wiregrass Region, Dothan, AL.
REASON
Blood product, which
did not meet acceptable product specifications, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Source Plasma,
CODE
Units: 05EWIE4335, 05EWIE5036,
05EWIE5864
RECALLING FIRM/MANUFACTURER
Recalling Firm:
BioLife Plasma Services LP, Deerfield IL,
Manufacturer: BioLife Plasma Services, L.P., Eau Claire, WI.
REASON
Blood products, collected from a donor
with high risk behavior, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION Vienna,
Austria
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Units: 160290025; 160290036; 160290026;
160290029
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 been shipped under unacceptable temperatures, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION MS
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 71M33896X
RECALLING
FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers,
Inc., Gainesville, FL,
Manufacturer:
LifeSouth Community Blood Centers Inc., Huntsville, AL.
REASON
Blood product, which was
collected from a donor with a history of malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Irradiated,
CODE
Unit: E31022
RECALLING
FIRM/MANUFACTURER Michigan Community Blood Centers, Saint Joseph, MI
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 MI
PRODUCT Red Blood Cells Leukocytes
Reduced
CODE Units: 4996088, 4996724,
4998468
RECALLING FIRM/MANUFACTURER Coral Blood Services,
Inc., Bangor, ME,
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 ME
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 160295445
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ,
Manufacturer: Blood Systems Inc/dba United
Blood Services, Meridian, MS.
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 MS
PRODUCT Platelets,
CODE
Unit:
W73661
RECALLING FIRM/MANUFACTURER Michigan Community
Blood Center, Traverse City, MI
REASON Blood product, which
did not meet acceptable product specifications, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MI
PRODUCT Platelet Pheresis Leukocytes Reduced,
CODE
Unit: 72C089725
RECALLING
FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers,
Inc., Gainesville, FL,
Manufacturer:
LifeSouth Community Blood Centers Inc., Huntsville, AL.
REASON
Blood product, which did not
meet acceptable product specifications, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelet Pheresis Leukocytes Reduced,
CODE
Unit: 72C347780
RECALLING
FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers,
Inc., Gainesville, FL,
Manufacturer:
LifeSouth Community Blood Centers Inc., Huntsville, AL.
REASON
Blood product, which did not
meet acceptable product specifications, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced,
b) Red Blood Cells
(Apheresis) Leukocytes Reduced Irradiated, CODE a) and b) Unit:
247491117
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Blood Systems Inc., Scottsdale, AZ,
Manufacturer: Blood Systems Inc., Rapid City, SD.
REASON
Blood products, which was collected
from a donor in which donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MS, SD
PRODUCT Red Blood
Cells,
CODE Unit:
71T859479
RECALLING FIRM/MANUFACTURER LifeSouth Community
Blood Centers, Inc., Dunwoody, GA.
REASON Blood product,
associated with a plasma component that contained clots, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells
Leukocytes Reduced,
CODE
a) Unit:
71V107612;
b) Unit: 71T724585
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, GA
REASON Blood products, which was manufactured
from a whole blood unit in which an associated blood component contained clots,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION GA
PRODUCT Red Blood Cells
(Apheresis) Leukocytes Reduced, CODE Unit: 314079473
RECALLING
FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems
Inc/dba United Blood
Services, Tupelo, MS.
REASON Blood product, which may have been
shipped under unacceptable temperatures, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MS
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 200400758
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ,
Manufacturer: Blood Systems Inc.,
Lafayette, LA.
REASON Blood product, which was incorrectly
labeled with an extended expiration date, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Fresh Frozen Plasma,
CODE
Unit: 71M33896X
RECALLING
FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers,
Inc., Gainesville, FL,
Manufacturer:
LifeSouth Community Blood Centers Inc., Huntsville, AL.
REASON
Blood product, which was
collected from a donor with a history of malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Red Blood
Cells Leukocytes Reduced,
CODE Unit: 71V670447
RECALLING
FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers,
Inc., Gainesville, FL,
Manufacturer:
LifeSouth Community Blood Centers Inc., Huntsville, AL.
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 AL
PRODUCT Recovered Plasma,
CODE
Unit: 247492364
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale,
AZ,
Manufacturer: Blood
Systems Inc., Mitchell, SD.
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 Switzerland
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b)
Recovered Plasma,
CODE a) and b) Unit:
307446984
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 CA, Switzerland
WEEK ENDING APRIL 19
PRODUCT
a) Canc/Cort
(Spierings),
b) Flex HD Allogarfts,
c) Posterior Tibialis,
d) Radius/Ulna
Shaft, 4cm,
e) Femoral Head >=44mm,
f) BTB W/Quad, Hemi,
g) Anterior Tibialis
Tendon,
h) Achilles Tendon w/calc,
i) Cancellous Cervical Spacer,
CODE
a) Serial number: 005645311025P,
005645310026P;
b) (4cm x 7cm) 005645311007 (6 pieces); (6cm
x 16cm) 005645311001 (1 piece);
(4cm x 12cm) 005645311006
(3 pieces); (4cm x 16cm) 005645311005 (2 pieces);
(3cm x
12cm) 005645311008 (1 piece);
c) Serial number: 0056453110021P,
005645311016P;
d) Serial numbers: 0056453110037P, 0056453110036P;
e)
Serial numbers: 005645311038P, 005645311039P;
f) Serial number:
005645311018P;
g) Serial numbers: 005645311015P, 005645311020P;
h) Serial
numbers: 005645311017P, 005645311022P;
i) Serial number: 005645311042
RECALLING FIRM/MANUFACTURER Musculoskeleta Transplant
Foundation, Edison, NJ,
REASON Patient who received graft from MTF
developed an infection 12 days post surgery. Sample collected during second
surgery grew Clostridium Perfringens.
VOLUME OF PRODUCT IN
COMMERCE 28
allografts
DISTRIBUTION Nationwide
PRODUCT
a) AlloDerm Regenerative Tissue Matrix Oral Plastic Surgery 1x2cm,
.89-1.65 (mm)
and 1x4cm, .89-1.65 (mm),
b) AlloDerm Implantable Abdominal Wall Repair; 6x16 cm,. 79-2.03
(mm); 6x12 cm,
.79-2.03 (mm); 4x16 cm, .79-2.03 (mm);
5x12cm, .79-2.03 (mm); 4x12 cm, .79-2.03
(mm),
c) AlloDerm
Implantable, 4x16cm, 2.06-3.30 (mm) and 2x4cm, .33-.76
(mm),
d) AlloDerm, Oral Plastic
Surgery, 2x4 cm, .8901.65 (mm),
e) Graftjacket
Regenerative Tissue Matrix 5x5cm, .89-1.52 (mm).Non-meshed.
Inner package not sterile,
f)
Repliform Tissue Regeneration Matrix; Aseptically Processed; 4x7 cm,. 9-1.6 (mm)
35-65 (1/1000 in.); 5x10 cm,. 9-1.6 (mm), 35-65 (1/1000
in.); 6x12 cm,. 9-1.6 (mm)
35-65 (1/1000 in.),
CODE
a) Lot B16375, sublots 005, 006, 010, 012,
019, 020, 021, 023, 026, 029.
Lot 16375, sub lots 033,
034, 035, 036;
b) Lot B16375, sublots 071, 072, 078, 074, 075, 076, 077,
073. Lot B16375, sublots 067,
070; Lot B16375, sublots
056, 050, 051, 052, 054, 055, 049; Lot B16375, sublots 062,
063; Lot B16375, sublot 048;
c) Lot B16375, sublot 053
and Lot B16375, sublot 042;
d) Lot B16375, sub lot 040;
e) Lot B16375,
sublots 057, 058, 059;
f) Lot B16375, sublots: 043, 046; Lot B16375, Sublots:
060, 061;
Lot B16375, sublots: 064, 065, 066, 068,
069
RECALLING FIRM/MANUFACTURER LifeCell Corporation,
Somerville, NJ,
REASON Human tissues from donors, tested using
diagnostic test kits rather than FDA licensed or cleared screening tests for
hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core
antigen (anti-HBc total), were distributed.
VOLUME OF PRODUCT IN
COMMERCE 49 units (1 unit scrapped 6/7/07, 2 units in
quarantine)
DISTRIBUTION Nationwide
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells
Leukocytes Reduced,
c) Fresh Frozen Plasma,
CODE
a) Units:
04F59264; 04J95500;
b) Units: 04FS96202; 04J95741; 04LQ80645;
c) Units:
04F59264; 04J95500
RECALLING FIRM/MANUFACTURER ARC Blood
Services, New England Region, Dedham, MA,
REASON Blood products, which were collected
from donors in which donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 7
units
DISTRIBUTION CA, CT, MA, and
NY
PRODUCT Recovered Plasma,
CODE
Unit: 04KM69756
RECALLING
FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England
Region, Dedham, MA,
Manufacturer:
ARC/Manchester, NH.
REASON Blood product, collected from a donor
considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD),
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT
a) Fresh Frozen Plasma,
b) Red Blood Cells
Leukocytes Reduced,
CODE a) and b)
Unit: 012FS30908
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 a donor whose suitability to donate was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION NC
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 72C893625
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Dunwoody, GA,
REASON Blood product, which did not meet
acceptable product specifications, was distributed.
VOLUME OF PRODUCT
IN COMMERCE1
unit
DISTRIBUTION GA
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 030GV32963
RECALLING
FIRM/MANUFACTURER American Red Cross, Northeastern, Ashley, PA,
REASON
Blood product, which was collected from
a donor who traveled to malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Source Plasma,
CODE
Units: 05GWIG7642, 05GWIG8334, 05GWIG9440,
05GWIH0121, 05GWIH1171, 05GWIH1847, 05GWIH2969, 05GWIH3675, 05GWIH4747
,05GWIH5363, 05GWIH6431
RECALLING
FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP,
Deerfield, IL,
Manufacturer: BioLife
Plasma Services, LP, Green Bay, WI.
REASON Blood products, collected from a donor
for whom post donation information was provided regarding multiple high-risk
behaviors, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 11
units
DISTRIBUTION CA
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 3102000
RECALLING
FIRM/MANUFACTURER Indiana Blood Center, Indianapolis, IN,
REASON
Blood product, which was possibly
contaminated with Corynebacterium species, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IN
PRODUCT Platelets Leukocytes Reduced,
CODE
Unit: M56598
RECALLING
FIRM/MANUFACTURER Michigan Community Blood Centers, Saginaw, MI,
REASON
Blood product, associated with a red
cell unit that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION MI
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 4766018
RECALLING
FIRM/MANUFACTURER Indian Blood Center, Indianapolis, IN
REASON
Blood product, which
was collected in a manner that may have compromised the sterility of the
collection system, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION IN
PRODUCT Plasma
Cryoprecipitate Reduced,
CODE Unit:
71T736572
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 AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 4147235
RECALLING
FIRM/MANUFACTURER Indian Blood Center, Indianapolis, IN,
REASON
Blood product, which
was possibly contaminated with Corynebacterium species, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IN
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 0406767
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA,
REASON
Blood product, leukoreduced after the
allowable post collection time limit, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Units: 0353059;
0407472
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA,
REASON Blood products,
leukoreduced after the allowable post collection time limit, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION LA and
MS
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 0419588
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA,
REASON
Blood product, labeled leukoreduced
which did not meet the requirements for a leukoreduced product, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Red Blood
Cells Irradiated,
CODE Unit:
0408195
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA,
REASON Blood product,
documented as being out of controlled storage for more than 30 minutes, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Red Blood Cells,
CODE
Unit: 0355173
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA,
REASON
Blood product, associated with a unit of
platelets that contained clots, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 123797668
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ,
Manufacturer: Blood Systems, Inc.,
Albuquerque, NM.
REASON Blood product, collected under conditions where
the sterility of the products may have been compromised, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NM
PRODUCT Source Plasma,
CODE
Units: 04PWIF9366, 04PWIF9963,
04PWIG1143
RECALLING FIRM/MANUFACTURER
Recalling Firm:
BioLife Plasma Services LP, Deerfield, IL,
Manufacturer: Biolife Plasma Services, Stevens Point, WI.
REASON
Blood products,
which were not quarantined after the donor provided information concerning a
post-donation illness, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION CA
PRODUCT Recovered
Plasma,
CODE Units: 04FS96202;
04J95741; 04LQ80645
RECALLING FIRM/MANUFACTURER ARC Blood
Services, New England Region, Dedham, MA,
REASON Blood products, which were collected
from donors in which donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION CA
PRODUCT Source Plasma,
CODE
Unit:
364001990, I72034585, 364001842, I72053858, I72036569, 364003764, 364003693,
364004896, 364000177, I72058575, I72056802, I72039771, I72058884, I72050211, and
I72055055
RECALLING FIRM/MANUFACTURER International
BioResources, Llc, Fort Worth, TX,
REASON Blood products,
collected from a donor in which donor suitability was not adequately determined,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 15
units
DISTRIBUTION NC
PRODUCT Source Plasma,
CODE
Unit:
04VMNB3594, 04VMNB5382, 04VMNB5664
RECALLING
FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP,
Deerfield, IL,
Manufacturer: BioLife Plasma Services LP, Mounds View, MN.
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 CA
PRODUCT Red Blood Cells Leukocytes Reduced Irradiated,
CODE
Unit: 0441414; 0408355; 0359754; 0408387;
0373433; 0359768
RECALLING FIRM/MANUFACTURER The Blood
Center, New Orleans, LA,
REASON Blood products, documented as being out
of controlled storage for more than 30 minutes, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units
DISTRIBUTION LA and
AL
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Units:
0395918; 0406729; 0352085; 0354632; 0352124; 0339355; 0406720;
0353131
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA,
REASON Blood products, documented as being out
of controlled storage for more than 30 minutes, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 8
units
DISTRIBUTION LA
PRODUCT Source Plasma,
CODE
Unit
377030059
RECALLING FIRM/MANUFACTURER Talecris Plasma
Resources, Inc., Anderson, IN,
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 NC
WEEK ENDING APRIL 26
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: LL84167 – Part
2
RECALLING FIRM/MANUFACTURER Rhode Island Blood Center,
Providence, RI,
REASON Platelets, possibly contaminated with
Bacillus cereus, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION RI
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 5004923
RECALLING FIRM/MANUFACTURER Coral Blood Services, Inc., Scarborough, ME,
REASON
Blood product, which was collected from
a donor who traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Platelets,
CODE
Unit:
K28585
RECALLING FIRM/MANUFACTURER Michigan Community
Blood Centers, Grand Rapids, MI,
REASON Blood product, associated with
a red cell unit that contained a clot, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MI
PRODUCT Source Plasma,
CODE
Unit:
377041904
RECALLING FIRM/MANUFACTURER Talecris Plasma
Resources, Inc., Anderson, IN
REASON Blood product, collected from
a donor who had not had an annual physical performed, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Units: 04FH02001 (part 3), 04FH02003 (part
3), 04FH02007 (part 3), 04FH02012 (part 3), 04FH02021 (part 3), 04FH02026 (part
3), 04FH02028 (part 3), 04FH02032 (part 3), 04GJ26797 (part 3), 04GJ26864 (part
3), 04GJ26870 (part 3), 04GJ26885 (part 3), 04GJ26923 (part 3), 04GJ26995 (part
3), 04GJ27194 (part 3)
RECALLING FIRM/MANUFACTURER ARC
Blood Services, New England Region, Dedham, MA,
REASON
Platelets, lacking appropriate quality
control testing, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 15
units
DISTRIBUTION MA
PRODUCT Source Plasma,
CODE
Unit:
377035715
RECALLING FIRM/MANUFACTURER Talecris Plasma
Resources, Inc., Anderson, IN,
REASON Blood product, collected from
a donor who had not had an annual physical performed, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Recovered Plasma,
CODE
Unit:
0247162
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA,
REASON Blood product, collected from a donor
whose suitability to donate was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Switzerland
PRODUCT Red Blood Cells Deglycerolized,
CODE
Units: 5587095,
6456773
RECALLING FIRM/MANUFACTURER Lifesource, Glenview,
IL,
REASON Blood products, which may not
have been prepared in accordance with specifications, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION IL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 72C287441 (2
units)
RECALLING FIRM/MANUFACTURER
Recalling Firm:
LifeSouth Community Blood Centers, Inc., Gainesville, FL, .
Manufacturer: LifeSouth Community Blood Centers, Inc., Huntsville,
AL.
REASON Blood
products, with insufficient plasma volume, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AL
PRODUCT Source Plasma,
CODE
Units:
4260121910, 4260120669, 4260120273, 4260118970, 4260117783, 4260116796,
4260116368, 4260115486, 4260114711, 4260114320, 4260113171, 4260112855,
4260101319, 4260100753, 4260100158, 4260099740, 4260098989, 4260098455,
4260097718, 4260097439, 4260096788, 4260096382, 4260094914, 4260094362,
4260093627; 4260130253, 4260129805, 4260128270, 4260127956, 4260126242,
4260125759, 4260124557, 4260124163
RECALLING FIRM/MANUFACTURER
RECALLING
FIRM/MANUFACTURER ZLB Plasma,
Rock Island, IL,
REASON Blood products, collected using an
abbreviated screening process for which the donor was not eligible, were
distributed
VOLUME OF PRODUCT IN COMMERCE 33
units
DISTRIBUTION IL,
IN
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Units: 032GF80084, 032GF80085, 032GF80086,
032GF80087, 032GF80088, 032GF80092, 032GF80095, and
032GF80096
RECALLING FIRM/MANUFACTURER The American
National Red Cross, Madison, WI,
REASON Blood products, which were incorrectly
tested for syphilis, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 8 units
DISTRIBUTION CA, GA, IL, MA,
ME, MI, PR, VA,
WI
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE
Units: 032GE67986, 032GE67989, 032GE68005,
032GF68996, 032GM21467, 032GM21471, 032GN15305, 032GN15347, 032GN15355,
032KC45903, 032KC45911, 032KR36365, 032KS19508, 032KV36280, 032KV36292,
032LX64875, 032LX64883, 032LX64983, 032LX64987, 032LX64990,
032LX65144
RECALLING FIRM/MANUFACTURER The American
National Red Cross, Madison, WI
REASON Blood
products, in which the sample tubes for viral marker testing were not maintained
at an appropriate temperature, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 21 units
DISTRIBUTION GA, IL,
WI
PRODUCT Red
Blood Cells (Apheresis) Leukocytes Reduced,
CODE Unit: 307465992
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ,
Manufacturer: Blood Systems, Inc., Fargo,
ND.
REASON Blood
product, which failed Red Blood Cell QC testing, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b)
Fresh Frozen Plasma,
c) Platelets Leukocytes Reduced,
CODE
a), b) and c) Unit:
22FS54005
RECALLING FIRM/MANUFACTURER American National
Red Cross, Penn Jersey Region, Philadelphia, PA
REASON Blood products, collected from a
donor who provided post donation information regarding a history of multiple
high risk behaviors, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION NJ, PA,
VA
PRODUCT
a) Red
Blood Cells Leukocytes Reduced,
b) Platelets Leukocytes Reduced
CODE
a) and b) Unit:
22GS28387
RECALLING FIRM/MANUFACTURER American National
Red Cross, Penn Jersey Region, Philadelphia, PA,
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 PA
PRODUCT
a) Red Blood Cells,
b) Cryoprecipitated AHF,
CODE
a) and b) Unit:
22KR50724
RECALLING FIRM/MANUFACTURER American National
Red Cross, Penn Jersey Region, Philadelphia, PA,
REASON
Blood products, which tested negative
for hepatitis, but were collected from a donor who tested repeat reactive for
the antibody to hepatitis B core antigen (HBc) on two occasions, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION PA
PRODUCT Human Corneas,
CODE
Units:
FJ20070121, FJ20070122
RECALLING FIRM/MANUFACTURER The
National Eye Bank Center, Memphis, TN,
REASON Human
Corneal tissues, possibly recovered from a donor who tested repeatedly reactive
for antibodies to the hepatitis C virus and mislabeled, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
corneas
DISTRIBUTION MD, Damascus,
Syria
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 71S471696
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL,
REASON Blood product, manufactured from Whole
Blood that lacked the assurance of storage at the correct temperature, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 5999333
RECALLING
FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX,
REASON
Blood product, which was labeled as
negative for the Fyb antigen, but was collected from a donor who subsequently
tested positive for Fyb antigen, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Source Plasma,
CODE
Unit:
04PWIG2172
RECALLING FIRM/MANUFACTURER
Recalling Firm:
BioLife Plasma Services LP, Deerfield, IL,
Manufacturer: BioLife Plasma Services, Stevens Point, WI.
REASON
Blood product, which was not
quarantined after the donor provided information concerning a post-donation
illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Platelets Leukocytes Reduced,
CODE
Unit: 033GL72126
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Farmington, CT,
REASON
Blood product, prepared from a
unit of Whole Blood which may have exceeded the acceptable collection time, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CT
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells Leukocytes
Reduced,
c) Red Blood Cells (Apheresis) Leukocytes
Reduced,
d) Platelets Leukocytes Reduced,
e) Fresh Frozen Plasma,
CODE
a) 032KT68659 032KT68661 032KT68664
032KT68667 032KT68668 032KT68671
032KT68675 032KT68677 032KT68678 032KT68679
032KT68680 032KT68681
032KT68682 032KT68683 032KT68684 032KT68686 032KT68687
032KT68689
032KT68698 032KT68703 032KT68708;
b) Units: 032FC68122,
032FC68128, 032FC68130, 032FC68131, 032FC68132,
032FC68133, 032FC68137,
032GC29916, 032GC29917, 032GC29922, 032GC29925,
032GC29926, 032GC29927,
032GC29928, 032GC29930, 032GC29931,
032GC29932, 032GC29933, 032KL19586,
032KL19594, 032KL19597, 032KL19598,
032KL19601, 032KL19606, 032KR38619,
032KR38620, 032KR38621, 032KR38622,
032KR38623, 032KR38625, 032KR38629,
032KR38632, 032KR38634,
032KR38635, 032KR38636, 032KR38640, 032KR38645,
032KR38646,
032KR38647, 032KR38651, 032KR38655, 032KR38657, 032KR38660,
032KR38662, 032KR38664, 032KR38665, 032KR38667, 032KR38669,
032KR38670,
032KV38764, 032KV38768, 032KV38773, 032KV38776,
032KV38778, 032KX13610,
032KX13611, 032KX13612, 032KX13613,
032KX13614, 032KX13616, 032KX13619,
032KX13625, 032KX13626,
032KX13628, 032KX13631, 032KX13633, 032KX13635,
032KX13636,
032KX13637, 032KX13641, 032KX13643, 032KX13647, 032KX13650,
032KX13653, 032LX67413, 032LX67414, 032LX67417, 032LX67421,
032LX67422,
032LX67424, 032LX67425, 032LX67427, 032LX67430,
032LX67432, 032LX67433,
032LX67434, 032LX67435, 032LX67436,
032LX67437, 032LX67438, 032LX67439,
032LX67440, 032LX67444,
032LX67445, 032LX67446, 032LX67448, 032LX67449,
032LX67452,
032LX67454, 032LX67455, 032LX67456, and 032LX67458;
c) Units:
032KT68643, 032KT68645, 032KT68646, 032KT68647, 032KT68648,
032KT68649
(split unit), 032KT68650, 032KT68651, 032KX13596 (split unit),
032KX13597,
032KX13598 (split unit), 032KX13600, 032LX67394 (split unit),
032LX67395
(split unit), 032LX67396, 032LX67397, 032LX67398 (split unit),
032LX67399
(split unit), 032LX67400 (split unit), 032LX67404 (split unit),
032LX67405
(split unit), 032LX67406 (split unit), and 032LX67408 (split unit).
d)
Units: 032KL19587, 032KL19588, 032KL19589, 032KL19591, 032KL19592,
032KL19593, 032KL19598, 032KL19600, 032KR38623, 032KR38626, 032KR38627,
032KR38628, 032KR38630, 032KR38631, 032KR38634, 032KR38635,
032KR38638,
032KR38644, 032KR38649, 032KR38650, 032KR38652,
032KR38659, 032KR38663,
032KR38666, 032KR38667, 032KR38671, and
032KR38672;
e) Units:
032KL19595, 032KL19603, 032KR38624, 032KR38656, and
032KR38657
RECALLING FIRM/MANUFACTURER The American
National Red Cross, Madison, WI,
REASON Blood products, which were incorrectly
tested for syphilis, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 190 units
DISTRIBUTION CA, GA, IL,
MA, ME, MI, PR, VA,
WI
PRODUCT
a)
Fresh Frozen Plasma (Apheresis),
b) Platelets, Pheresis
Leukocytes Reduced, Irradiated,
CODE
a) Unit:
N72420;
b) Units: N72420 (2 units)
RECALLING
FIRM/MANUFACTURER Michigan Community Blood Centers, Grand Rapids,
MI,
REASON Blood products, collected from a donor
who received a bone graft within one year of donation, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION MI
PRODUCT
a) Recovered Plasma,
b) Red Blood Cells,
CODE
a) and b) Unit:
Q80218
RECALLING FIRM/MANUFACTURER Michigan Community
Blood Centers, Saginaw, MI,
REASON Blood
products, collected from a donor who received a bone graft within six months of
donation, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION MI and
Switzerland
PRODUCT
a) Red Blood Cells,
b) Platelets,
c) Fresh Frozen Plasma,
CODE
a), b) and c) Unit:
F90924
RECALLING FIRM/MANUFACTURER Michigan Community
Blood Centers, Grand Rapids, MI,
REASON Blood products,
collected from a donor who received a skin graft within one year of donation,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION MI
PRODUCT
a) Red Blood Cells,
b) Platelets,
c) Fresh Frozen Plasma,
CODE
a), b) and
c) Unit: F49028
RECALLING FIRM/MANUFACTURER Michigan
Community Blood Centers, Grand Rapids, MI,
REASON Blood products,
collected from a donor who had received a tendon transplant within one year of
donation, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3
units
DISTRIBUTION MI
PRODUCT Recovered Plasma,
CODE
Unit: 22GS28387
RECALLING
FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region,
Philadelphia, PA,
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