NOVEMBER 2004
WEEK ENDING NOVEMBER 6
PRODUCT
Platelets, Pheresis, Leukocytes Reduced.
CODE
Units 71W178307.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL.
Manufacturer: LifeSouth Community Blood Centers, Civitan Regional Blood, Montgomery,
AL.
REASON
Platelets, that were below specification for platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units-split.
DISTRIBUTION
AL.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 12813-6293.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Albuquerque, New Mexico.
REASON
Blood products, collected from a donor who did not have a complete medical history
interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ and Switzerland.
PRODUCT
Human Corneal Tissue for Transplantation.
CODE
Tissues 04-1238-100 and 04-1238-200.
RECALLING FIRM/MANUFACTURER
Rocky Mountain Lions Eye Bank, Aurora, Colorado.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior to
distribution, but was subsequently found to test repeated reactive for the Hepatitis
B Surface Antigen (HBsAg) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
CO, and Ireland.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE
Units 71W326702- split 1 and split 2.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL.
Manufacturing Firm: LifeSouth Community Blood Centers, Inc., Montgomery
Region, Montgomery, AL.
REASON
Blood products, which yielded a platelet count that was below the acceptable
limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL.
PRODUCT
Human Tissue for Transplantation of the following types:
Corneas,
a) Various musculoskeletal tissues;
b) Skin.
CODE
Numbers SL01-11-017R1 and SL01-11-017L1;
a) and b) Donor number 11001709.
RECALLING FIRM/MANUFACTURER
Mid-American Transplant Service, Olivette, MS.
REASON
Human tissue for transplantation was incorrectly tested for viral markers in
that the blood sample used for testing was likely hemodiluted.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
CO, NJ, and Mexico.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units 71M587987, 71M580384, and 71M580360.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Inc., Huntsville, AL.
REASON
Blood products, which were manufactured from overweight whole blood units, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AL.
PRODUCT
Fresh Frozen Plasma.
CODE
Unit 71J08471.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Inc., Huntsville, AL.
REASON
Blood product, which was collected from a donor who was at risk for Creuztfeldt
Jakob Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Platelets
CODE
a) and b) Unit 127924587.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Albuquerque, NM.
REASON
Blood products, which were collected from a donor who had lived in a malarial
endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
New Mexico.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Red Blood Cells Leukocytes Reduced Irradiated.
CODE
Units 128003536 and 127966397;
Unit 127992878.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Albuquerque, NM.
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
TX and CO.
PRODUCT
a) Red Blood Cells, Irradiated.
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
c) Platelets Pheresis, Leukocytes Reduced, Irradiated.
CODE
a) Unit 71L00739;
b) Unit 71L231174;
c) Unit 71W14396X.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, Fl.
Manufacturer: LifeSouth Community Blood Centers, Inc., Birminham, AL.
REASON
Blood products, that lacked assurance of proper storage temperatures due to
inaccurate documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AL.
PRODUCT
Recovered Plasma.
CODE
Unit 12813-6293.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Albuquerque, New Mexico.
REASON
Blood products, collected from a donor who did not have a complete medical history
interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ and Switzerland.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 71H689903.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Gainesville, FL.
Manufacturer: LifeSouth Community Blood Centers, North Alabama Region
- Huntsville, Huntsville, AL. .
REASON
Blood product, collected from a donor whose body temperature was not properly
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
PRODUCT
Red Blood Cells Leukocytes Reduced
CODE
Unit 71L336433.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Inc., Huntsville, AL.
REASON
Blood product, which did not meet acceptable hematocrit specifications, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
WEEK ENDING NOVEMBER 13
PRODUCT
a) Whole Blood.
b) Red Blood Cells.
c) Red Blood Cells, Leukocytes Reduced.
d) Platelets.
e) Fresh Frozen Plasma.
f) Recovered Plasma.
CODE
a) Unit number: 31125-5240;
b) Unit numbers: 31124-8554, 31124-4362, 31125-4944, 31125-5241,
31125-5242, 31125-5980, 31125-6145, 31125-6873, 31125-7189,
31125-7666, 31125-7674, 31125-7675, 31125-7678, 31125-9026, 31125-9028, 31125-9057,
31125-9059, 31125-9089, 31125-9090, 31125-9092, 31125-9880, 31125-9884, 31125-9889,
31125-9891, 31125-9893, 31125-9895, 31125-9896, 31126-0110, 31126-0112, 31126-0230,
31126-0231, 31126-0233, 31126-0241, 31126-0242, 31126-0246, 31126-0248, 31126-0250,
31126-0251, 31126-0252, 31126-0266, 31126-0271, 31126-0272, 31126-0274, 31126-0277,
31126-0278, 31126-0279, 31126-0282, 31126-0283, 31126-0286, 31126-0288, 31126-0425,
31126-0428, 31126-0431, 31126-0435, 31126-0438, 31126-0457, 31126-0459, 31126-0461,
31126-0465, 31126-0470, 31126-0515, 31126-0518, 31126-0950, 31126-1188, 31126-1190,
31126-1194, 31126-1196, 31126-1425, 31126-1427, 31126-1428, 31126-1534, 31126-1537,
31126-1538, 31126-1652, 31126-1669, 31126-1704, 31126-1707, 31126-1711, 31126-1713,
31126-1714, 31126-1719, 31126-1721, 31126-1723, 31126-1727, 31126-1731, 31126-1733,
31126-1736, 31126-1973, 31126-1974, 31126-1992, 31126-1996, 31126-1998, 31126-2000,
31126-2004, 31126-2180, 31126-2223, 31126-2225, 31126-2227, 31126-2362, 31126-2363,
31126-2364, 31126-2366, 31126-2370, 31126-2374, 31126-2375, 31126-2376, 31126-2602,
31126-2606, 31126-2637, 31126-2683, 31126-2711, 31126-3024, 31126-3028, 31126-3037,
31126-3060, 31126-3071, 31126-3074, 31126-3075, 31126-3076, 31126-3078, 31126-3079,
31126-3080, 31126-3135, 31126-3138, 31126-3139, 31126-3162, 31126-3202, 31126-3204,
31126-3206, 31126-3210, 31126-3211, 31126-3214, 31126-3217, 31126-3219, 31126-3383,
31126-3385, 31126-3387, 31126-3620, 31126-3625, 31126-3633, 31126-3636, 31126-3638,
31126-3641, 31126-3644, 31126-3654, 31126-3695, 31126-3696, 31126-3697, 31126-3698,
31126-3700, 31126-3701, 31126-3702, 31126-3705, 31126-3707, 31126-3708, 31126-3709,
31126-3710, 31126-4128, 31126-4135, 31126-4136, 31126-4140, 31126-4556, 31126-4557,
31126-4558, 31126-4559, 31126-4563, 31126-4564, 31126-4567, 31126-4586, 31126-4588,
31126-4590, 31126-4593, 31126-4595, 31126-4596, 31126-4597, 31126-4598, 31126-4600,
31126-4695, 31126-4868, 31126-4875, 31126-4881, 31126-4917, 31126-4924, 31126-5080,
31126-5601, 31126-5604, 31126-5605, 31126-5607, 31126-5608, 31126-5609, 31126-5612,
31126-5613, 31126-6685, 31126-6689, 31126-6693, 31126-6697, 31126-6700, 31126-6704,
31126-6709, 31126-6712, 31126-6713, 31126-6725, 31126-7136. 31126-7507, 31126-7509,
31126-7511, 31126-7513, 31126-7515, 31126-7518, 31126-7521, 31126-7524, 31126-7527,
31126-7528, 31126-7531, 31126-7534, 31126-7536, 31126-7537, 31126-7540, 31126-7901,
31126-7903, 31126-7904, 31126-7908, 31126-7909, 31126-7923, 31126-8253, 31126-8254,
31126-8255, 31126-8257, 31126-8258, 31126-8259, 31126-8260, 31126-8273, 31126-8274,
31126-8275, 31126-8276, 31126-8277, 31126-8278, 31126-8297, 31126-8300, 31126-8301,
31126-8344, 31126-8345, 31126-8346, 31126-8352, 31126-8364, 31126-8372, 31126-8373,
31126-8374, 31126-8376, 31126-8377, 31126-8552, 31126-8553, 31126-8562, 31126-8564,
31126-8566, 31126-8567, 31126-8568, 31126-8569, 31126-8571, 31126-8572, 31126-8573,
31126-8774, 31126-8784, 31126-8791, 31126-9124, 31126-9126, 31126-9127, 31126-9234,
31126-9236, 31126-9241, 31126-9242, 31126-9244, 31126-9245, 31126-9248, 31126-9249,
31126-9519, 31126-9602, 31126-9605, 31126-9617, 31126-9618, 31126-9619, 31126-9623,
31126-9628, 31126-9633, 31126-9635, 31126-9636, 31126-9656, 31126-9661, 31126-9663,
31126-9667, 31126-9669, 31126-9681, 31126-9689, 31126-9748, 31126-9751, 31126-9752,
31126-9753, 31126-9754, 31126-9758, 31126-9759, 31126-9761, 31127-0144, 31127-0154,
31127-0155, 31127-0166-01, 31127-0166-02, 31127-0166-03, 31127-0279, 31127-0282,
31127-0318, 31127-0327, 31127-0328, 31127-0331, 31127-0332, 31127-0715, 31127-0717,
31127-0718, 31127-0720, 31127-0721, 31127-0722, 31127-0723, 31127-0724, 31127-0725,
31127-0727, 31127-0728, 31127-0729, 31127-0730, 31127-0731, 31127-0733, 31127-0734,
31127-0736, 31127-1062, 31127-1064, 31124-1065, 31127-1068, 31127-1070, 31127-1074,
31127-1075, 31127-1086, 31127-1102, 31127-1265, 31127-1268, 31127-1270, 31127-1275,
31127-1279, 31127-1280, 31127-1284, 31127-1288, 31127-1289, 31127-1825, 31127-1828,
31127-1829, 31127-1831, 31127-1833, 31127-1835, 31127-1837, 31127-1838, 31127-1843,
31127-1846, 31127-1847, 31127-1848, 31127-1899, 31127-1900, 31127-1906, 31127-1909,
31127-1910, 31127-1913, 31127-1917, 31127-1918, 31127-1921, 31127-1922, 31127-1926,
31127-1928, 31127-1930, 31127-2175, 31127-2177, 31127-2178, 31127-2181, 31127-2186,
31127-2189, 31127-2190, 31127-2194, 31127-2195, 31127-2197, 31127-2198, 31127-2341,
31127-2342, 31127-2344, 31127-2346, 31127-2347, 31127-2350, 31127-2354, 31127-2499,
31127-2529, 31127-2666, 31127-2814, 31127-2841, 31127-2846, 31127-2850, 31127-3003,
31127-3006, 31127-3011, 31127-3013, 31127-3023, 31127-3024, 31127-3025, 31127-3026,
31127-3104, 31127-3105, 31127-3107, 31127-3109, 31127-3110, 31127-3112, 31127-3116,
31127-3117, 31127-3118, 31127-3119, 31127-3122, 31127-3124, 31127-3125, 31127-3490,
31127-3491, 31127-3492, 31127-3493, 31127-3494, 31127-3495, 31127-3497, 31127-3498,
31127-3499, 31127-3500, 31127-3502, 31127-3504, 31127-3509, 31127-3511, 31127-3514,
31127-4002, 31127-4003, 31127-4005, 31127-4007, 31127-4008, 31127-4009, 31127-4010,
31127-4012, 31127-4014, 31127-4015, 31127-4017, 31127-4018, 31127-4227, 31127-4230,
31127-4232, 31127-4233, 31127-4237, 31127-4238, 31127-4240, 31127-4241, 31127-4507,
31127-4507, 31127-4510, 31127-4513, 31127-4514, 31127-4515, 31127-4516, 31127-4517,
31127-4519, 31127-4524, 31127-4530, 31127-4534, 31127-4535, 31127-4539, 31127-4542,
31127-4543, 31127-4545, 31127-4564, 31127-4565, 31127-4568, 31127-4570, 31127-4571,
31127-4573, 31127-4575, 31127-4576, 31127-4580, 31127-4686, 31127-4695, 31127-4958,
31127-4959, 31127-4960, 31127-4961, 31127-4962, 31127-4963, 31127-4965, 31127-4966,
31127-4967, 31127-4968, 31127-4969, 31127-4970, 31127-4971, 31127-4973, 31127-4974,
31127-4975, 31127-4976, 31127-4978, 31127-4979, 31127-5226, 31127-5227, 31127-5229,
31127-5230, 31127-5231, 31127-5232, 31127-5233, 31127-5235, 31127-5236, 31127-5237,
31127-5238, 31127-5239, 31127-5240, 31127-5241, 31127-5242, 31127-5243, 31127-5245,
31127-5247, 31127-5249, 31127-5251, 31127-5252, 31127-5264, 31127-5353, 31127-5441,
31127-5442, 31127-5454, 31127-5458, 31127-5461, 31127-5863, 31127-5876, 31127-5877,
31127-5879, 31127-5884, 31127-5886, 31127-5896, 31127-5900, 31127-5901, 31127-5903,
31127-5929, 31127-5930, 31127-5931, 31127-5932, 31127-5938, 31127-5941, 31127-5944,
31127-5945, 31127-5946, 31127-5948, 31127-5951, 31127-5952, 31127-5957, 31127-5958,
31127-5959, 31127-6056, 31127-6057, 31127-6058, 31127-6060, 31127-6061, 31127-6063,
31127-6066, 31127-6067, 31127-6068, 31127-6070, 31127-6072, 31127-6073, 31127-6074,
31127-6076, 31127-6785, 31127-6790, 31127-6791, 31127-6792, 31127-6796, 31127-7029,
31127-7042, 31127-7043, 31127-7044, 31127-7085, 31127-7096, 31127-7130, 31127-7131,
31127-7132, 31127-7133, 31127-7136, 31127-7137, 31127-7138, 31127-7139, 31127-7141,
31127-7142, 31127-7145, 31127-7146, 31127-7149, 31127-7150, 31127-7152, 31127-7155,
31127-7156, 31127-7452, 31127-7550, 31127-7551, 31127-7552, 31127-7553, 31127-7554,
31127-7556, 31127-7557, 31127-7560, 31127-7561, 31127-7563, 31127-7564, 31127-7565,
31127-7568, 31127-7569, 31127-7570, 31127-7571, 31127-7572, 31127-7578, 31127-7579,
31127-7581, 31127-7584, 31127-7585, 31127-7586, 31127-7591, 31127-7603, 31127-7604,
31127-7629, 31127-7801, 31127-7802, 31127-7805, 31127-7807, 31127-7808, 31127-7809,
31127-7810, 31127-7812, 31127-7814, 31127-7815, 31127-7816, 31127-7818, 31127-7819,
31127-7820, 31127-7821, 31127-7823, 31127-7824, 31127-7825, 31127-7826, 31127-7828,
31127-7829, 31127-7936, 31127-7941, 31127-7943, 31127-7944, 31127-7945, 31127-7946,
31127-7947, 31127-7948, 31127-7949, 31127-7950, 31127-7951, 31127-7952, 31127-8036,
31127-8037, 31127-8038, 31127-8039, 31127-8040, 31127-8041, 31127-8042, 31127-8044,
31127-8111, 31127-8224, 31127-8225, 31127-8226, 31127-8231, 31127-8232, 31127-8233,
31127-8234, 31127-8235, 31127-8236, 31127-8239, 31127-8240, 31127-8242, 31127-8243,
31127-8244, 31127-8246, 31127-8247, 31127-8248, 31127-8249, 31127-8250, 31127-8253,
31127-8276, 31127-8278, 31127-8279, 31127-8281, 31127-8282, 31127-8283, 31127-8287,
31127-8294, 31127-8296, 31127-8298, 31127-8300, 31127-8301, 31127-8305, 31127-8311,
31127-8312, 31127-8314, 31127-8315, 31127-8319, 31127-8320, 31127-8323, 31127-8453,
31127-8456, 31127-8462, 31127-8464, 31127-8465, 31127-8466, 31127-8467, 31127-8473,
31127-8476, 31127-8477, 31127-8479, 31127-8482, 31127-8484, 31127-8490, 31127-8492,
31127-8495, 31127-8496, 31127-8499, 31127-8502, 31127-8503, 31127-8505, 31127-8506,
31127-8507, 31127-8515, 31127-8516, 31127-9202, 31127-9203, 31127-9205, 31127-9207,
31127-9209, 31127-9211, 31127-9214, 31127-9502, 31127-9530-01, 31127-9530-02,
31127-9530-03, 31127-9547, 31127-9554, 31127-9561, 31127-9565, 31127-9566, 31127-9567,
31127-9572, 31126-3655, 31126-4328, 31126-4686, 31126-9683, 31127-5225;
c) Unit numbers: 31125-4161, 31125-4950, 31125-5978, 31125-
7673, 31125-9887, 31126-0386, 31126-0463, 31126-0517, 31126- 1186, 31126-1527,
31126-1532, 31126-1536, 31126-1542,
31126-1677, 31126-1680, 31126-1718, 31126-2094, 31126-2095, 31126-2179, 31126-2211,
31126-2639, 31126-2641, 31126-2643, 31126-2645, 31126-2648, 3126-2649, 31126-2693,
31126-2719, 31126-2720, 31126-3015, 31126-3030, 31126-3116, 31126-3199, 31126-3381,
31126-3384, 31126-3647, 31126-3658, 31126-3659, 31126-3694, 31126-3699, 31126-3704,
31126-4161, 31126-4394, 31126-4397, 31126-4560, 31126-4561, 31126-4569, 31126-4589,
31126-4591, 31126-4592, 31126-4594, 31126-4607, 31126-4688, 31126-4689, 31126-4690,
31126-4691, 31126-4693, 31126-5078, 31126-5079, 31126-5602, 31126-5603, 31126-5606,
31126-5814, 31126-5815, 31126-5839, 31126-5840, 31126-5846, 31126-5848, 31126-6604,
31126-6687, 31126-6692, 31126-6699, 31126-6710, 31126-6715, 31126-6719, 31126-9125,
31126-9129, 31126-9136, 31126-9137, 31127-0272, 31127-0275, 31127-0278, 31127-0315,
31127-0326, 31127-1099, 31127-2458, 31127-2459, 31127-2460, 31127-2462, 31127-2466,
31127-2469, 31127-2473, 31127-2668, 31127-2675, 31127-2680, 31127-2683, 31127-2684,
31127-2685, 31127-2687, 31127-3506, 31127-3510, 31127-5012, 31127-5540, 31127-5541,
31127-5546, 31127-5547, 31127-5548, 31127-5549, 31127-5833, 31127-5842, 31127-5846,
31127-5850, 31127-5860, 31127-5862, 31127-7140, 31127-7144, 31127-7153, 31127-8561,
31127-8562, 31127-8565, 31127-8567, 31127-8574, 31127-8578, 31127-9541;
d) Unit numbers: 31125-4944, 31126-0230;
e) Unit numbers: 31125-6873, 31125-7666, 31125-7673, 31125-7674,
31125-7678, 31125-1677, 31126-1680, 31126-1704, 31126-1707, 31126-1711, 31126-1713,
31126-1714, 31126-1718, 31126-1719, 31126-1721, 31126-3620, 31126-3625, 31126-3633,
31126-3636, 31126-3638, 31126-3641, 31126-3644, 31126-3647, 31126-3655, 31126-3697,
31126-4161, 31126-6685, 31126-6687, 31126-6689, 31126-6692, 31126-6693, 31126-6710,
31126-6712, 31126-6713, 31126-6715, 31126-6719, 31126-8345, 31126-8364, 31126-8372,
31126-8373, 31126-8374, 31126-8377, 31126-8562, 31126-8564, 31126-9236, 31127-0155,
31127-0332, 31127-2197, 31127-5225, 31127-5226, 31127-5227, 31127-5228, 31127-5229,
31127-5230, 31127-5231, 31127-5232, 31127-5233, 31127-5235, 31127-5236, 31127-5237,
31127-5238, 31127-5239, 31127-5240, 31127-5242, 31127-5243, 31127-5245, 31127-5247,
31127-7042, 31127-7043, 31127-7044, 31127-7130, 31127-7131, 31127-7133, 31127-7136,
31127-7137, 31127-7138, 31127-7139, 31127-7140, 31127-7141, 31127-7143, 31127-7144,
31127-7150, 31127-7152, 31127-7554, 31127-7556, 31127-7564, 31127-7569, 31127-7585,
31127-7807, 31127-7809, 31127-7810, 31127-7812, 31127-8036, 31127-8037, 31127-8477,
31127-9205, 31127-9207, 31127-9211;
f) Unit numbers: 31125-4161, 31125-4362, 31125-4944, 31125-
4950, 31125-5242, 31125-5978, 31125-5980, 31125-6145, 31125- 7189, 31125-9026,
31125-9028, 31125-9057, 31125-9059, 31125-9089, 31125-9090, 31125-9092, 31125-9880,
31125-9884, 31125-9887, 31125-9889, 31125-9891, 31125-9893, 31125-9895, 31125-9896,
31126-0110, 31126-0112, 31126-0230, 31126-0231, 31126-0233, 31126-0241, 31126-0242,
31126-0246, 31126-0248, 31126-0250, 31126-0251, 31126-0252, 31126-0266, 31126-0271,
31126-0272, 31126-0274, 31126-0277, 31126-0278, 31126-0279, 31126-0282, 31126-0283,
31126-0286, 31126-0288, 31126-0386, 31126-0425, 31126-0428, 31126-0431, 31126-0435,
31126-0438, 31126-0457, 31126-0459, 31126-0461, 31126-0463, 31126-0465, 31126-0470,
31126-0515, 31126-0517, 31126-0518, 31126-0950, 31126-1186, 31126-1188, 31126-1190,
31126-1194, 31126-1196, 31126-1427, 31126-1428, 31126-1527, 31126-1532, 31126-1534,
31126-1536, 31126-1537, 31126-1538, 31126-1542, 31126-1652, 31126-1669, 31126-1723,
31126-1727, 31126-1731, 31126-1733, 31126-1736, 31126-1973, 31126-1974, 31126-1992,
31126-1996, 31126-1998, 31126-2000, 31126-2004, 31126-2094, 31126-2095, 31126-2179,
31126-2180, 31126-2223, 31126-2225, 31126-2227, 31126-2362, 31126-2363, 31126-2364,
31126-2366, 31126-2370, 31126-2374, 31126-2375, 31126-2376, 31126-2602, 31126-2606,
31126-2637, 31126-2639, 31126-2641, 31126-2643, 31126-2645, 31126-2648, 31126-2649,
31126-2683, 31126-2693, 31126-2711, 31126-2719, 31126-2720, 31126-3015, 31126-3024,
31126-3028, 31126-3030, 31126-3037, 31126-3060, 31126-3071, 31126-3074, 31126-3075,
31126-3076, 31126-3078, 31126-3079, 31126-3080, 31126-3116, 31126-3135, 31126-3138,
31126-3139, 31126-3162, 31126-3199, 31126-3202, 31126-3204, 31126-3206, 31126-3210,
31126-3211, 31126-3214, 31126-3217, 31126-3219, 31126-3381, 31126-3383, 31126-3384,
31126-3385, 31126-3387, 31126-3654, 31126-3658, 31126-3659, 31126-3694, 31126-3695,
31126-3696, 31126-3698, 31126-3699, 31126-3700, 31126-3701, 31126-3702, 31126-3704,
31126-3705, 31126-3707, 31126-3708, 31126-3709, 31126-3710, 31126-4124, 31126-4128,
31126-4135, 31126-4136, 31126-4140, 31126-4328, 31126-4394, 31126-4397, 31126-4556,
31126-4557, 31126-4558, 31126-4559, 31126-4560, 31126-4561, 31126-4563, 31126-4564,
31126-4567, 31126-4569, 31126-4586, 31126-4588, 31126-4589, 31126-4590, 31126-4591,
31126-4592, 31126-4593, 31126-4594, 31126-4595, 31126-4596, 31126-4597, 31126-4598,
31126-4600, 31126-4607, 31126-4686, 31126-4688, 31126-4689, 31126-4690, 31126-4691,
31126-4693, 31126-4868, 31126-4875, 31126-4881, 31126-4917, 31126-4924, 31126-5078,
31126-5079, 31126-5080, 31126-5601, 31126-5602, 31126-5603, 31126-5604, 31126-5606,
31126-5607, 31126-5608, 31126-5609, 31126-5612, 31126-5613, 31126-5814, 31126-5815,
31126-5839, 31126-5840, 31126-5846, 31126-5848, 31126-6604, 31126-6697, 31126-6699,
31126-6700, 31126-6704, 31126-6709, 31126-6725, 31126-7136, 31126-7507, 31126-7509,
31126-7511, 31126-7513, 31126-7515, 31126-7518, 31126-7521, 31126-7524, 31126-7527,
31126-7528, 31126-7531, 31126-7534, 31126-7536, 31126-7537, 31126-7540, 31126-7901,
31126-7903, 31126-7904, 31126-7908, 31126-7909, 31126-7923, 31126-8253, 31126-8254,
31126-8255, 31126-8257, 31126-8258, 31126-8259, 31126-8260, 31126-8273, 31126-8274,
31126-8275, 31126-8276, 31126-8277, 31126-8278, 31126-8297, 31126-8301, 31126-8344,
31126-8346, 31126-8352, 31126-8376, 31126-8552, 31126-8553, 31126-8566, 31126-8567,
31126-8568, 31126-8569, 31126-8571, 31126-8572, 31126-8573, 31126-9234, 31126-9241,
31126-9242, 31126-9245, 31126-9248, 31126-9249, 31126-9635, 31127-0144, 31127-0154,
31127-0166, 31127-0272, 31127-0275, 31127-0278, 31127-0318, 31127-0326, 31127-0715,
31127-0717, 31127-0718, 31127-0720, 31127-0721, 31127-0722, 31127-0723, 31127-0724,
31127-0725, 31127-0727, 31127-0728, 31127-0729, 31127-0730, 31127-0731, 31127-0733,
31127-0734, 31127-0736, 31127-1062, 31127-1064, 31127-1065, 31127-1068, 31127-1070,
31127-1074, 31127-1075, 31127-1086, 31127-1099, 31127-1102, 31127-1265, 31127-1268,
31127-1270, 31127-1275, 31127-1279, 31127-1280, 31127-1284, 31127-1288, 31127-1289,
31127-1825, 31127-1828, 31127-1829, 31127-1831, 31127-1833, 31127-1835, 31127-1837,
31127-1838, 31127-1843, 31127-1846, 31127-1847, 31127-1848, 31125-6873, 31125-7666,
31125-7673, 31125-7674, 31125-7678, 31125-1677, 31126-1680, 31126-1704, 31126-1707,
31126-1711, 31126-1713, 31126-1714, 31126-1718, 31126-1719, 31126-1721, 31126-3620,
31126-3625, 31126-3633, 31126-3636, 31126-3638, 31126-3641, 31126-3644, 31126-3647,
31126-3655, 31126-3697, 31126-4161, 31126-6685, 31126-6687, 31126-6689, 31126-6692,
31126-6693, 31126-6710, 31126-6712, 31126-6713, 31126-6715, 31126-6719, 31126-8345,
31126-8364, 31126-8372, 31126-8373, 31126-8374, 31126-8377, 31126-8562, 31126-8564,
31126-9236, 31127-0155, 31127-0332, 31127-2197, 31127-5225, 31127-5226, 31127-5227,
31127-5228, 31127-5229, 31127-5230, 31127-5231, 31127-5232, 31127-5233, 31127-5235,
31127-5236, 31127-5237, 31127-5238, 31127-5239, 31127-5240, 31127-5242, 31127-5243,
31127-5245, 31127-5247, 31127-7042, 31127-7043, 31127-7044, 31127-7130, 31127-7131,
31127-7133, 31127-7136, 31127-7137, 31127-7138, 31127-7139, 31127-7140, 31127-7141,
31127-7143, 31127-7144, 31127-7150, 31127-7152, 31127-7554, 31127-7556, 31127-7564,
31127-7569, 31127-7585, 31127-7807, 31127-7809, 31127-7810, 31127-7812, 31127-8036,
31127-8037, 31127-8477, 31127-9205, 31127-9207, 31127-9211.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Tupelo, MS.
REASON
Blood products, collected in a manner that may have compromised the sterility
of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,327 units.
DISTRIBUTION
AL, CA, MS, TN, TX, VA, and Switzerland.
PRODUCT
Red Blood Cells, Irradiated.
CODE
Units 71Z805952, 71Z814752.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc. Gainesville, FL.
Manufacturing Firm: LifeSouth Community Blood Centers, Inc., Birmingham
Region, Birmingham, AL. .
REASON
Blood products, for which documentation of irradiation was incomplete, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL.
PRODUCT
a) Red Blood Cells, Irradiated.
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE
a) Unit 71M208421;
b) Units 71Z746216, 71L351184.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc. Gainesville, FL.
Manufacturing Firm: LifeSouth Community Blood Centers, Inc., Birmingham
Region, Birmingham, AL.
REASON
Blood products, for which documentation of irradiation was incomplete, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AL.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number 71W152771.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc. Gainesville, FL.
Manufacturing Firm: LifeSouth Community Blood Centers, Inc., Birmingham
Region, Birmingham, AL.
REASON
Blood product with an insufficient plasma volume was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
PRODUCT
Platelets Pheresis.
CODE
Unit numbers 38P81644 and 38P82244.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN.
REASON
Platelets Pheresis with elevated platelet counts were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 18235-3908.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Cheyenne, WY.
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
WY.
PRODUCT
Source Plasma.
CODE
Unit numbers 6010206699, 6010206273, 6010206038, 6010204919, 6010201829, and
6010200249.
RECALLING FIRM/MANUFACTURER
Nabi Biopharmaceuticals, San Antonio, TX.
REASON
Blood products, that tested negative for viral markers, but were not properly
quarantined after the receipt of post donation information from the donor related
to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
Korea.
PRODUCT
Platelet Pheresis Leukocytes Reduced.
CODE
Unit 21KP46496.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR.
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
OR.
PRODUCT
Recovered Plasma.
CODE
Unit 7404324.
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR.
REASON
Blood product, which was collected from a donor who was at risk for Creutzfeldt-Jakob
Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.
PRODUCT
Red Blood Cells.
CODE
Unit GE70804.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA.
REASON
Blood product, manufactured in a manner that may have compromised the sterility
of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 231494455.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Billings, MT.
REASON
Blood products, collected from a donor who did not have a complete medical history
interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WY and Switzerland.
PRODUCT
Platelets.
CODE
Unit number 2095359.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
PRODUCT
Platelets.
CODE
Unit number 2096266.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number 1222743 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH.
REASON
Blood products, that were labeled leukoreduced but had an elevated white blood
cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.
PRODUCT
Human Tissue for Transplantation of the following types:
a) Various musculoskeletal tissues (e.g., fascia, bone,
and tendon);
b) Various cardiovascular tissues (e.g., saphenous vein
and femoral vein).
CODE
Donor number 11099275.
RECALLING FIRM/MANUFACTURER
Mid-American Transplant Service, Olivette, MO.
REASON
Human Tissue for transplantation was incorrectly tested for viral markers in
that the blood sample used for testing was hemodiluted.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CO and GA.
PRODUCT
Human Corneas.
CODE
Units 041342100 and 041342200.
RECALLING FIRM/MANUFACTURER
Rocky Mountain Lions Eye Bank, Aurora, CO.
REASON
Human tissues, which were collected from a donor who was not adequately evaluated
for suitability, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CO, and OH.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit 171997240.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX..
REASON
Blood products, which were collected from a donor who was taking the medication
Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and Switzerland.
PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE
a) and b) Unit number 2028845.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY.
REASON
Blood products, that tested negative for hepatitis, but were collected from
an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KY and NJ.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Fresh Frozen Plasma. .
CODE
a), b), and c) Unit number 2081820.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY.
REASON
Blood products, collected from an ineligible donor due to medication with the
drug Tegison, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
KY.
PRODUCT
Source Plasma.
CODE
Unit numbers: F-41378-011, F-41035-011, F-40321-011, F-40010-011, F-39242-011,
F-38952-011, F-38231-011, and F-37848-011.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corp, Los Angeles, CA.
Manufacturing Firm: Alpha Therapeutic Corp, Portland, OR.
REASON
Blood products, collected from a donor who engaged in high risk behaviors, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
Spain.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit 231499645.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Billings, MT.
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, and Switzerland.
PRODUCT
Red Blood Cells.
CODE
Units 21FM93661 and 21FM85188.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR.
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
OR.
PRODUCT
Source Plasma.
CODE
Units G79835070, G80076070, G81405070, G81891070, G82054070, G82610070, G83079070,
G83218070, G83642070, G83929070, G84308070, G84519070, G84888070, G85152070,
G85602070, G85804070, G86346070, G87140070, G87522070, G87723070, G88208070,
G88411070, G88784070, G88966070, G89380070, G89579070, G89955070, G90187070,
G90559070, G90775070, G91129070, G91316070, G91672070, G91866070, G92287070,
G92627070, G92934070, G93279070, G93569070, G93916070, G94191070, G94527070,
G94892070, G95369070, G95615070, G95970070, G96279070, G96573070, G97012070,
G07409070, G07578070, G08026070, G08323070, G08700070, G11727070, G12022070,
and G12360070.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Vancouver, WA.
REASON
Blood products, which were collected from a donor who received a tattoo within
twelve months of the donations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
57 units
DISTRIBUTION
NC, Switzerland, and Spain.
PRODUCT
Source Plasma.
CODE
Units G77175001, G77343001, G78075001, G78924001, G79246001, G79522001, G83555001,
G84157001, F00486001, F00656001, F01484001, F01824001, F03552001, F03842001,
F04322001, F04794001, F05229001, and F05448001.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Portland, OR.
REASON
Blood products, which were collected from a donor in which donor suitability
was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
NC, and Spain.
PRODUCT
Platelets.
CODE
Unit M78793.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated
red blood cells contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
Red Blood Cells.
CODE
Unit S78529
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI.
REASON
Blood product, which was not leukoreduced but labeled as leukoreduced, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
Platelets.
CODE
Unit M78982.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated
red blood cells contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
Platelets.
CODE
Unit N09731.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated
red blood cells contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE
a) and b) Units K40576 and L52966.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI.
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
MI.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit 224320491.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV.
REASON
Blood product, which was collected in a manner that may have compromised the
sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NV.
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Unit 150233677.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX.
REASON
Blood product, which did not meet product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units 150225270 (2 units), 150220153 (2 units), 150220147 (2 units), 150220166
(2 units), 150212735 (2 units), 150212719 (2 units), 150220741 (2 units), 150220162
(2 units), 150220797, and 150225368.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX.
REASON
Blood products, which were collected in a manner that may have compromised the
sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
TX.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number: KE92184.
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA.
REASON
Blood product, with an unacceptable hematocrit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.
PRODUCT
a) Red Blood Cells, Irradiated.
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE
a) Unit 71J582870;
b) Units 71J40794X, 71L496281, 71L496293.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL.
Manufacturing Firm: LifeSouth Community Blood Centers, Inc., Birmingham Region,
Birmingham, AL.
REASON
Blood products, incorrectly labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
AL.
PRODUCT
a) Red Blood Cells, Irradiated.
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE
a) Units 71L61175X, 71L476927, 71J073111;
b) Units 71L52260X, 71W621660, 71W621715.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL.
Manufacturing Firm: LifeSouth Community Blood Centers, Inc., Montgomery
Region, Montgomery, AL.
REASON
Blood products, incorrectly labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
AL
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 71J232962.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Gainesville, FL.
Manufacturer: LifeSouth Community Blood Centers, Birmingham Region, Birmingham,
AL. .
REASON
Blood product, that was found to be out of specification for red blood cell
recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
PRODUCT
Recovered Plasma.
CODE
Unit 231494455.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Billings, MT.
REASON
Blood products, collected from a donor who did not have a complete medical history
interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WY and Switzerland.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units 172016433 and 172017798.
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
Red Blood Cells Leukocytes Reduced.
CODE
Units 172012277, 172012278, 172013624, 172013627 and 172013628.
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
5 units.
DISTRIBUTION
TX.
PRODUCT
Red Blood Cells (Apheresis).
CODE
Unit number 22KL07639 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA.
REASON
Blood products, collected on an apheresis machine where there was no documentation
of evaluation of the filter assemblies as required, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.
PRODUCT
Recovered Plasma.
CODE
Unit 231499645.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Billings, MT.
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, and Switzerland.
PRODUCT
Source Plasma.
CODE
Unit 498232.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Austin, 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
NC.
PRODUCT
Source Plasma.
CODE
Unit 498368.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Austin, 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
NC.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit numbers: 15021-6648, 15021-6726, 15021-3766, 15021-6508, 15021-3799, 15021-6772,
15021-7341, 15021-7320, and 15021-7538.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock Center, Lubbock, TX.
REASON
Blood products, which was shipped without documenting temperatures of shipping
containers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
TX.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit 150226353.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX.
REASON
Blood product, which was not stored at acceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
WEEK ENDING NOVEMBER 20
PRODUCT
Ortho Assay Protocol Diskette (OAPD) for the Vironostika® HTLV-I/II Microelisa
system; Revision 1 (For Use with the Ortho Summit™ Sample Handling System).
CODE
Serial # 6901871-001 thru --065 version 1.0, OAPD.
RECALLING FIRM/MANUFACTURER
Ortho Clinical Diagnostics, Raritan, NJ.
REASON
Defects in the design of instrument software where inconsistent liquid levels
occur while pipetting Human T-Lymphotropic Viruses Type I and Type II (HTLV-I/II)
microwell plates.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Nationwide.
PRODUCT
a) Red Blood Cells.
c) Red Blood Cells, Leukocytes Reduced.
d) Recovered Plasma.
CODE
a) Units 20FJ02869, 20FH04132;
b) Unit 20FH05645;
c) Units 20FJ02869, 20FH04132, 20FH05645.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lewis and Clark Region, Boise, ID.
REASON
Blood products, which tested negative for hepatitis, but were collected from
an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
CA and Switzerland.
PRODUCT
a) Amplicor [3] AV-HRP Avidin-HRP (Horseradish Peroxidase) BGG Conjugate;
b) Amplicor [3] AV-HRP Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.
CODE
a) Lot No. E09569, found in kit Lot No. E11360, Material No. 21118560018,
expiration January, 2005;
b) Lot No. E09569, found in kit Lot No. E11231, Material No. 21117750123,
expiration September, 2004 (This lot was only distributed to foreign consignees).
RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Inc., Belleville, NJ.
REASON
AMPLICOR HIV-1 MONITOR Test Kits, with an increased frequency of "blue
foci" that potentially can cause elevated A450 background in microwell
plate wells during PCR detection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 8,400 kits;
b) 1,256 kits.
DISTRIBUTION
IN, Japan and Germany.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number: KE72385.
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA.
REASON
Blood product, which was collected from a donor in which donor suitability was
not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
NY.
PRODUCT
Recovered Plasma.
CODE
Unit 2408046..
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX.
REASON
Blood product, collected from a donor with a history of taking anti-seizure
medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.
PRODUCT
Red Blood Cells.
CODE
Unit 2093926.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY.
REASON
Red Blood Cells, that may have contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
WEEK ENDING NOVEMBER 27
PRODUCT
Ortho a Assay Software; (For Use with the Ortho Summitä Sample Handling
System).
CODE
Version 2.0.
RECALLING FIRM/MANUFACTURER
Ortho Clinical Diagnostics, Inc, Raritan, NJ.
REASON
Defects in the design of instrument software where sample or reagent could be
dispensed twice.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Nationwide.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) Units 32GR59875, 32GR59876, 32GR59877, 32GR59878, 32GR59879,
32GR59880, 32GR59881, 32GR59882, 32GR59883, 32GR59884,
32GR59885, 32GR59886, 32GR59887, 32GR59888, 32GR59889,
32GR59901, 32GR59902, 32GR59903, 32GR59906, 32GR59908,
32GR59909, 32GR59911, 32GR59912, 32GR59914, 32GR59917,
32GR59918, 32GR59919, 32GR59921, 32GR59924, 32GL94842,
32GL94844, 32GL94845, 32GL94846, 32GL94847, 32GL94849,
32GL94905, 32GL94906, 32GL94909, 32GL94910, 32GL94911,
32GL94918, 32GL94920, 32GL94922, 32GL94927, 32GL94929,
32GL94932, 32GL94933, 32GL94936, 32GL94938, 32GL94940,
32GL94942, 32GL94948, 32GL94950, 32GL94952, 32GL94954,
32GL94957, 32GL94964, 32GL94966, 32GL94968, 32GL94970,
32GE47086, 32GE47087, 32GE47091, 32GE47095, 32GE47100,
32GE47103, 32GE47104, 32GE47114, 32GE47115, 32GE47132,
32GE47136, 32GE47137, 32GE47138, 32GE47143, 32GE47144,
32GE47145, 32GE47152, 32GR60226, 32GR60230, 32GR60235,
32GR60236, 32GR60240, 32GR60242, 32GR60245, 32GR60247,
32GR60250, 32GR60254, 32GR60259, 32GR60260, 32GR60262,
32GR60263, 32GR60267, 32GE47155, 32GE47165, 32GE47167,
32GE47168, 32GE47170, 32GE47173, 32GL94975, 32GL94976,
32GL94981, 32GF56324, 32GF56333, 32GF56341, 32GF56348,
32GL95038, 32GL95058, 32GL95060, 32GL95062, 32GR59891,
32GR59893, 32GR59896, and 32GR59897;
b) Units 32GR59874, 32GR59875, 32GR59876, 32GR59877,
32GR59878, 32GR59879, 32GR59880, 32GR59882, 32GR59884,
32GR59885, 32GR59886, 32GR59887, 32GR59888, 32GR59889,
32GR59901, 32GR59906, 32GR59907, 32GR59909, 32GR59910,
32GR59911, 32GR59912, 32GR59914, 32GR59915, 32GR59916,
32GR59919, 32GR59920, 32GR59922, 32GR59923, 32GR59924,
32GR59925, 32GL94843, 32GL94844, 32GL94846, 32GL94847,
32GL94848, 32GL94905, 32GL94907, 32GL94908, 32GL94910,
32GL94911, 32GL94912, 32GL94914, 32GL94916, 32GL94921,
32GL94924, 32GL94931, 32GL94933, 32GL94939, 32GL94941,
32GL94942, 32GL94947, 32GL94948, 32GL94970, 32GE47103,
32GL94954, 32GL94955, 32GL94960, 32GL94962, 32GL94963,
32GL94966, 32GE47104, 32GE47106, 32GE47108, 32GE47109,
32GE47113, 32GE47118, 32GE47120, 32GE47122, 32GE47124,
32GE47125, 32GE47128, 32GE47132, 32GE47135, 32GE47139,
32GE47141, 32GE47142, 32GE47144, 32GE47150, 32GE47151,
32GR60245, 32GR60253, 32GR60256, 32GR60261, 32GR60265,
32GR60266, 32GE47157, 32GE47160, 32GE47161, 32GE47162,
32GE47164, 32GE47165, 32GE47166, 32GE47168, 32GE47173,
32GE47178, 32GE47182, 32GE47183, 32GE47184, 32GL94971,
32GL94972, 32GL94973, 32GL94974, 32GL94977, 32GL94979,
32GL94982, 32GL94983, 32GL94985, 32GL94987, 32GL94988,
32GF56323, 32GF56333, 32GF56334, 32GF56335, 32GF56336,
32GF56341, 32GF56345, 32GF56346, 32GF56347, 32GF56348,
32GF56349, 32GF56350, 32GF56351, 32GF56352, 32GF56353,
32GF56357, 32GF56358, 32GF56360, 32GL95045, 32GR59890,
32GR59891, 32GR59892, 32GR59893, 32GR59894, 32GR59896,
32GR59897, 32GR59898, 32GR59899, and 32GR59900.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Service, Madison, WI.
REASON
Blood products, which were manufactured from whole blood units that were collected
in 450 mL collection bags instead of 500 mL collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
251 units.
DISTRIBUTION
IA, WI, IL, CA, AL, GA, MI, and Switzerland.
PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE
a) and b) Unit 4201504.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK.
REASON
Blood products, which tested negative for the antibody to human T-lymphotropic
virus type I/II (anti-HTLV-I/II), but were collected from a donor who on two
occasions previously tested repeatedly reactive for anti-HTLV-I/II, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI and VT.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit 01FP29379.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, West Henrietta, NY.
REASON
Blood product, corresponding to a unit of Platelets that was implicated in a
transfusion reaction and found to be contaminated with Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Units 4904186 (parts A & B).
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL.
REASON
Platelets, possibly contaminated with Micrococcus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE
a) and b) Unit number FW20450.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA.
REASON
Blood products, corresponding to a unit of Fresh Frozen Plasma possibly contaminated
with coagulase negative Staphylococcus sp. Bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA and MA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit number 17199-8537.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX.
REASON
Blood products, collected from an ineligible donor due to a recent blood exposure,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and Switzerland.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number 27P69000.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA.
REASON
Blood product, that was labeled leukoreduced but was not tested to determine
the white blood cell count as required in the firmís standard operating procedures,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit numbers 27GE16810 and 27GE16868.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA.
REASON
Blood products, collected from an ineligible donor due to use of the medication
Feldene, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA and KY.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 15022-0687.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX.
REASON
Blood product, that initially tested negative for West Nile Virus (WNV), was
subsequently re-tested and found reactive for WNV.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
PRODUCT
Source Plasma.
CODE
Unit number: 04HWVA2021.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Huntington, WV.
REASON
Source Plasma was not properly quarantined and was distributed after the discovery
that the donor had been previously permanently deferred.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated.
CODE
Unit 4127437.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA.
REASON
Blood product, which was manufactured without a white blood cell count having
been performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated.
CODE
Unit 4129673.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit 102980283.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Platelets Leukocytes Reduced.
CODE
a) Units 27GM83140 and 27GS67070;
b) Unit 27GS67070.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, 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
3 units.
DISTRIBUTION
PA, OH, and WV.
PRODUCT
Platelets.
CODE
Unit V15595.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA.
REASON
Blood product, which was manufactured from a whole blood unit in which clots
were noted in the associated red blood cells unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
PRODUCT
Source Plasma.
CODE
Units 20522586, 20522401, 20522091, 20521926, 20521613, 20521425, 20521064,
20520898, 20520575, 20520432, 20519930, 20519825, 20519252, 20518996, 20517289,
20517049, 20516657, 20516073, 20515915, 20515558, 20514616, 20514383, 20514162,
20513892, 20513659, 20513427, 20513225, 20512900, 20512811, 20512518, 20512417,
20512131, 20511899, 20511720, 20511440, 20510948, 20509034, 20508794, 20508633,
20508322, 20508190, 20506224, 20506032, 20505734, 20505411, 20505163, 20505014,
and 20504745.
RECALLING FIRM/MANUFACTURER
Portsmouth Blood Plasma, LLC, Portsmouth, 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
48 units.
DISTRIBUTION
NC.
PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit # LX08901.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Annandale, 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
2 units.
DISTRIBUTION
MD and VA.
PRODUCT
a) Platelet Pheresis,
b) Platelets Pheresis Irradiated.
CODE
a) Units 35Z15187 (split units), 35Z15188, 35Z15189,
35Z15191 (split units), 35Z15196 (split units),
35Z15198 (split units), 35Z15199, 35Z15216 (split units),
35Z15217, 35Z15222, 35Z15227, 35Z15230 (split units),
35Z15231 (split units), 35Z15232 (split units),
35Z15233, 35Z15241 (split units), 35Z15242, 35Z15244,
35Z15247 (split units), 35Z15248 (split units),
35Z15254, 35Z15260 (split units), 35Z15264 (split units),
35Z15267 (split units), 35Z15270, 35Z15274 (split units),
35Z15277 (split units);
b) Units 35Z15189, 35Z15199, 35Z15217, 35Z15222, 35Z15227,
35Z15242, 35Z15244, 35Z15254, and 35Z15270.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Roanoke, VA.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
52 units.
DISTRIBUTION
PA, NJ, WV, VA, MD, GA, and D.C.
PRODUCT
Red Blood Cells.
CODE
Unit K91415.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA.
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
VA.
PRODUCT
Platelets.
CODE
Unit K30461.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA.
REASON
Blood product, which was manufactured from a whole blood unit in which clots
were noted in the associated red blood cells unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
PRODUCT
Platelets.
CODE
Unit V07224.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA.
REASON
Blood product, which was manufactured from a whole blood unit in which clots
were noted in the associated red blood cells unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE
a) and b) Unit KT22280.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Annandale, 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
2 units.
DISTRIBUTION
MD and NJ.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Fresh Frozen Plasma.
c) Recovered Plasma.
CODE
a) Units 153971933, 153978224, and 150211210;
b) Unit 153971933;
c) Units 153978224 and 150211210.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX.
REASON
Blood products, which were collected from a donor who had tested positive for
hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
TX and Switzerland.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit 150250065.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX.
REASON
Blood products, which were collected from a donor who was taking the medication
Enbrel, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and MS.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit 150260048.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX.
REASON
Platelets, with a positive bacterial culture, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit numbers 15022-1959 and 15022-2089.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX.
REASON
Blood products, that initially tested negative for West Nile Virus (WNV), were
subsequently re-tested and found reactive for WNV.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number V08821.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA.
REASON
Blood product, collected from an ineligible donor due to use of the medication
Vioxx, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
PRODUCT
Human tissue for transplantation of the following types:
Ground human bone, AlloPac.
CODE
Part Code 10216050, lot numbers 045236-101 and 045236-106.
RECALLING FIRM/MANUFACTURER AlloSource, Inc., Centennial, CO.
REASON
Human tissue for transplantation was incorrectly tested for human immunodeficiency
virus (HIV) in that the blood sample used for testing was hemodiluted.
VOLUME OF PRODUCT IN COMMERCE
2 lots.
DISTRIBUTION
MN and FL.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 5480671.
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc., Eastern Maine Medical Center, Bangor, ME.
REASON
Blood product, collected from a donor that did not have a hematocrit or hemoglobin
test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
ME.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 9030343.
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc., Scarborough, ME.
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
ME.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit 12811-3944.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Albuquerque, NM.
REASON
Blood products, collected from a donor with a history of von Willebrand's disease,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NM.
PRODUCT
Red Blood Cells.
CODE
Unit 2050371.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY.
REASON
Red Blood Cells, that may have contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
PRODUCT
Red Blood Cells, Autologous.
CODE
Units 7502161, 7502163, 7502168.
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR.
REASON
Blood products, not tested for HCV, HIV and HBV NAT, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OR.
PRODUCT
Source Plasma.
CODE
Unit numbers CS0202560, CS0202955, CS0203442, CS0203770, CS0204006, CS0204618,
and CS0204952.
RECALLING FIRM/MANUFACTURER
Westgate Biologicals, LLC, College Station, TX.
REASON
Blood products, collected from an ineligible donor due to recent surgery, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
NC.
PRODUCT
Source Plasma.
CODE
Unit 181424.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Austin, TX.
REASON
Source Plasma, collected from a donor whose health history screening was inadequately
documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
PRODUCT
Source Plasma.
CODE
Unit number: 04HVAA2598
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P, Harrisonburg, VA.
REASON
Blood product, collected from a donor whose medical history was not determined
at the time of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Source Plasma.
CODE
Unit DSMMVC.
RECALLING FIRM/MANUFACTURER
International Bio-Resources, L.L.C., Tuscaloosa, AL.
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
IL.
PRODUCT
Source Plasma.
CODE
Unit DSMVTD.
RECALLING FIRM/MANUFACTURER
International Bio-Resources, L.L.C., Tuscaloosa, AL.
REASON
Blood product, which was collected from a donor in which a satisfactory arm
inspection was not performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
PRODUCT
Platelets Pheresis, Irradiated Washed.
CODE
Unit number 40P01173.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of America Region, Peoria, IL.
REASON
Blood product that was possibly out of controlled storage for more than 30 minutes
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
PRODUCT
Recovered Plasma.
CODE
Unit number K36758.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA.
REASON
Blood product, that was not properly quarantined after the donor of the product
reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit 224310746.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV.
REASON
Blood product, which was stored at unacceptable storage temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NV.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit 224304431.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV.
REASON
Blood product, which was stored at unacceptable storage temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NV.
PRODUCT
Red Blood Cells Washed.
CODE
Unit 224340812.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV.
REASON
Blood product, which was stored at unacceptable storage temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NV.