JANUARY 2002
PRODUCT Platelets, Pheresis
CODE Units 8226976 (A and B), 8224542 (A and B),8102834,
8087373.
RECALLING FIRM/MANUFACTURER South Florida Blood Banks,
Inc., West Palm Beach, FL
REASON Platelets, with low pH determinations, were
distributed.
VOLUME OF PRODUCT IN COMMERECE 6 units.
DISTRIBUTION FL.
PRODUCT a)Red Blood Cells; b)Recovered Plasma
CODE a)Units, 1452650, 1550923; b)Units, 1452650,
1550923.
RECALLING FIRM/MANUFACTURER South Texas Blood &
Tissue Center, San Antonio, TX
REASON Blood products, collected from a donor taking the
drug Tegison, were distributed.
VOLUME OF PRODUCT IN COMMERECE 4 units.
DISTRIBUTION TX and CA.
PRODUCT Human Tissue for Transplant: Various Musculoskeletal
Tissues including: Cancellous, Demineralized ground cortical, Femoral
shafts,
Patellar ligaments, Femoral heads, Humeral heads, Fibulas, Fascia lata, Ground
cortical(non-demineralized), Iliac crest wedges, Ilium strips, vertigrafts,
Patellar wedges, Pericardium, Cardiovascular tissues, Pulmonary patch grafts;
processed and frozen.
CODE Identification Numbers, 98-1517-001, 99-1630-001,
99-1630-002, 98 0385B-119, 98-0385B-120, 98-0385B-121, 98-0385B-122, 98-0476-
001,
98-0476B-025, 98-0476B-026, 98-0476B-027, 98-0476B-028, 98-1517-030,
98-1517-031, 98-1517-033, 99-0237-050, 99-0237-051, 99-0237-054, 99-0237-055,
99-0237-056, 99-0237-057, 99-0237-005, 98-1517-002, 98-0385-002, 98-1517-045,
98-1517-035, 98-1517-036, 98-1517-037, 99-0522-009, 99-0522-010, 99-0522-011,
99-0522-012, 99-0522-013, 99-0522-014, 99-1630-017, 98-0385-014, 98-0476-026,
99-0237-048, 98-0206-012, 98-0206-013, 98-0206-014, 98-0206-015, 98-0206-016,
98-0476-011, 98-0476-012, 98-0476-013, 98-0476-014, 98-0385-016, 98-0385-017,
98-0476-028, 98-0206-030, 98-0206-031, 98-0206-032, 98-0206-033, 98-0206-034,
99-1630-003, 98-0206-002, 98-1517-013, 98-1517-014, 98-1517-015, 98-1517-016,
98-1517-017,
98-0476-002,
98-0476-004, 98-0476-015, 98-0476-016, 98-1517-011, 98-1517-025, 99-1630-016,
98-0206-001, 99-0237-047, 98-0476-022, 98-0476-023, 98-0476-024, 98-0476-025,
98-1517-010, 98-0385B-123, 98-0385B-124, 98-0385B-125, 98-0385B-126,
98-1517-034, 99-0237-004, 99-0522-004, 98-1517-026, 98-0476-027, 98-1517B-112,
98-1517B-114, 98-1517B-115, 98-1517B-116, 98-1517B-117, 98-1517B-118,
98-1517B-119, 98-1517B-113, 98-1517-005, 98-0206-005, 98-0476-029, 98-0476-010,
98-1517-027, 98-0206-004, 99-0522-002, 98-0385-018, 98-0385-019, 98-0385-020,
98-0385-021,
99-1630-018,
98-0476-018, 98-0476-019, 98-0476-020, 98-0476-021, 98-1517-040, 98-1517-043,
98-1517-044, 99-0237-041, 99-0237-037, 98-0385B-146, 98-0385B-147,98-0385B-148,
98-0385B-149, 98-0385B-150, 98-0385B-151, 99-0237-038, 99-0237-053,
98-1517-029, 99-0237-001, 99-0237-002, 99-0237-003, 99-0237-045, 99-0237-046,
99-0237-052, 98-0385B-158, 98-0385B-159, 98-0385B-160, 98-0385B-161,
98-0385B-162, 98-0385B-008
98-0385B-009,
98-0385B-010, 98-0385B-011, 98-0385B-047, 98-0385B-048, 98-0385B-049,
98-1517-003, 98-1517-032, 98-0476B-190, 98-0476B-191, 98-0476B-192,
98-0476B-193, 98-0476B-194, 98-0476-007, 98-0476-008, 98-1517-039, 99-0237-010,
99-0237-011, 99-0522-005, 99-0522-006, 99-0522-007, 99-0522-008, 98-1517B-168,
98-1517B-169, 98-0385B-135, 98-0385B-136, 98-0385B-137, 98-0385B-138,
98-0385B-139, 98-0385B-140, 98-0385B-141, 98-0385B-142, 98-0385B-143,
98-0385B-144, 98-0385B-145, 98-1517B-124, 98-1517B-125, 98-1517B-126,
98-1517B-127, 98-1517B-128, 98-1517B-129, 98-1517B-131, 98-1517B-132,
98-1517B-133, 98-1517B-134, 98-1517B-135, 98-1517B-136, 98-1517B-137, 98-1517B-123,
98-1517B-130, 98-0385B-173, 98-0385B-174, 98-0385B-175, 98-0385B-176,
98-0385B-177, 98-0385B-178, 98-0385B-179, 98-0385B-180, 98-0385B-181,
98-0385B-182, 98-0385-008, 98-0476B-147, 99-0237-006, 99-0237-007, 98-1517-018,
99-0522-001,98-0476-005, 98-0476B-023, 98-0476B-024, 98-1517B-098,
98-1517B-099, 98-1517B-100, 98-1517B-101, 98-1517B-102, 98-1517B-103,
98-1517B-104, 98-1517B-105, 98-1517B-107, 98-1517B-106, 98-0385B-065,
98-0385B-066, 98-0385B-067, 98-0385B-068, 98-0385B-069, 98-0385B-070, 98-0385B-071,
98-0385B-072, 98-0385B-073, 98-0385B-074, 98-0476B-113, 98-0476B-162,
98-0476B-163, 98-0476B-164, 98-0476B-165, 98-0476B-166, 98-0476B-167,
98-0476B-057, 98-0476B-058, 98-1517B-149, 98-1517B-150, 98-1517B-151,
98-1517B-152, 98-1517B-153, 98-1517B-154, 98-1517B-155, 98-1517B-156,
98-1517B-158, 98-1517B-157, 98-0385-001, 98-0206-006, 98-1517B-003,
98-1517B-004, 98-0385B-087, 98-0385B-088, 99-0237-016, 99-0237-017,
98-0476B-060, 98-0476B-061, 98-0476B-062, 98-0476B-063, 98-0476B-064,
98-0476B-065, 98-0476B-066, 98-0476B-067, 98-0476B-156, 98-0476B-157,
98-0476B-158, 98-0476B-159, 98-0476B-160, 98-0476B-161, 98-1517B-050,
98-1517B-051, 98-1517B-052, 98-1517B-053, 98-1517B-054, 98-1517B-055,
98-1517B-056, 98-1517B-057, 98-1517B-058, 98-1517B-059, 98-1517B-060,
98-1517B-061, 98-1517B-062, 98-1517B-063, 98-1517B-064, 98-1517-024,
98-0385B-205, 98-0385B-206, 98-0385B-207, 98-0385B-208, 98-0385B-209,
98-0476-003, 98-0476B-035, 98-0476B-036, 98-0476B-037, 98-0385-023,
98-1517-004, 98-0476B-214, 98-0476B-215, 98-0476B-216, 98-0476B-217,
98-0476B-218, 98-1517B-138, 98-1517B-159, 98-1517B-160, 98-1517B-161,
98-1517B-162,
98-1517B-163,
98-1517B-164, 98-0385B-163, 98-0385B-164, 98-0385B-165, 98-0385B-166,
98-0385B-167, 98-0385B-168, 98-0385B-169, 98-0385B-170, 98-0385B-171,
98-0385B-172, 98-0385B-130, 98-0385B-131, 98-0385B-132, 98-0385B-133,
98-0385B-134, 98-0476B-030, 98-0476B-031, 98-0476B-033, 98-0476B-034,
98-1517B-023, 98-1517B-024, 98-1517B-165, 98-1517B-166, 98-0385B-056,
98-0385B-057, 98-0385B-058, 98-0385B-059, 98-0385B-060, 98-0385B-061,
98-0476B-136, 98-0476B-137, 98-0476B-138, 98-0385B-041, 98-0385B-042,
98-0385B-043, 98-0385B-044, 98-0385B-045, 98-0385B-046, 98-0385B-127,
98-0385B-128, 98-0385B-129, 98-0206-010, 98-0206-011, 98-1517B-005, 98-1517B-006,
98-1517B-007, 98-1517B-008, 98-1517B-009, 98-1517B-010, 98-1517B-086,
98-1517B-087, 98-1517B-088, 98-1517B-089, 98-1517B-090, 98-1517B-091,
98-1517B-092, 98-0476B-246, 98-0476B-247, 98-0476B-248, 98-0476B-249,
98-0476B-250, 98-0476B-180, 98-0476B-181, 98-0476B-182, 98-0476B-183,
98-0476B-184,
98-0476B-185,
98-0476B-186, 98-0476B-187, 98-0476B-188, 98-0476B-189, 98-0385-022,
98-0476B-148, 98-0476B-098, 98-0476B-099, 98-0476B-100, 98-0476B-101,
98-0476B-102, 98-0476B-103, 98-0476B-104, 98-0476B-105, 98-0476B-106,
98-0476B-107, 98-0476B-108, 98-0476B-109, 98-0206-017,
98-1517B-109,
98-1517B-110, 98-1517B-111, 98-0385B-017, 98-0385B-018, 98-0385B-019,
98-0385B-020, 98-0385B-021, 98-0385B-022, 98-0385B-023, 98-0385B-024,
98-0385B-025, 98-0385B-026, 98-0385B-027, 98-0385B-028, 99-0237-042,
98-0385-024, 98-0385-025, 98-0385-026, 98-0385-027,
98-0385-028,
98-0385-029, 98-1517B-172, 98-1517B-173, 98-1517B-175, 98-1517B-174,
98-0476B-154, 98-0476B-155, 98-1517B-070, 98-1517B-071, 98-1517B-072,
98-1517B-073, 98-1517B-074, 98-1517B-075, 98-1517B-076, 98-1517B-077,
98-1517B-078, 98-1517B-079, 98-1517B-080, 98-1517B-081, 98-1517B-082,
98-1517B-083, 98-1517B-084, 98-1517B-085, 98-0385B-075, 98-0385B-076,
98-0385B-077, 98-0385B-078, 98-0385B-079, 98-0385B-080, 98-0385B-081,
98-0385B-082, 98-0385B-083, 98-0385B-084, 98-0385B-085, 98-0385B-086,
98-1517-038, 98-0385B-050, 98-0385B-051, 98-0385B-052, 98-0385B-053,
98-0385B-054, 98-0385B-055, 98-0476B-149, 98-0476B-150, 98-1517B-028,
98-1517B-029, 98-1517B-030, 98-1517B-031, 98-1517B-032, 98-1517B-033,
98-1517B-034, 98-1517B-035, 98-1517B-036, 98-1517B-037, 98-1517B-038,
98-1517B-039, 98-1517B-040, 98-1517B-041, 98-1517B-042, 98-1517B-043,
98-1517B-044, 98-1517B-045, 98-1517B-046, 98-1517B-047, 98-0476B-029,
98-0476B-084, 98-0476B-085,
98-0476B-086,
98-0476B-087, 98-0476B-088, 98-0476B-090, 98-0476B-091, 98-0385B-195,
98-0385B-196, 98-0385B-197, 98-0385B-198, 98-0385B-199, 98-0385B-200,
98-0385B-201, 98-0385B-202, 98-0385B-203, 98-0385B-204, 98-1517-041,
98-1517-042, 99-0522-003, 98-0385B-109, 98-0385B-110, 98-0385B-111,
98-0385B-112, 98-0385B-113, 98-0385B-114, 98-0385B-115, 98-0385B-116,
98-0385B-117, 98-0385B-118, 99-0237-043, 99-0237-044, 99-0237-049,
98-1517B-011, 98-1517B-012, 98-1517B-013, 98-1517B-014, 98-1517B-015, 98-1517B-016,
98-1517B-017, 98-1517B-018, 98-0476B-225, 98-0476B-226, 98-0476B-227,
98-0476B-228, 98-0476B-229, 98-0476B-230, 98-0476B-231, 98-0476B-232,
98-0476B-233, 98-0476B-234, 98-0476B-235, 98-0476B-236, 98-0476B-237,
98-0476B-238, 98-0476B-240, 98-0476B-241, 98-0476B-242, 98-0476B-243,
98-0476B-244, 98-0476B-245, 98-0476B-015, 98-0476B-016, 98-0476B-017,
98-0476B-018, 98-0476B-019, 98-0476B-020, 98-0476-017, 98-0385-007,
98-0476B-195, 98-0476B-196, 98-0476B-197, 98-0476B-198, 98-0476B-199,
98-0476B-200, 98-0476B-201, 98-0476B-202, 98-0385B-183, 98-0385B-184,
98-0385B-185, 98-0385B-186, 98-0385B-187, 98-0385B-188, 98-0385B-189,
98-0385B-190, 98-0385B-191, 98-0385B-192, 98-0385B-193, 98-0385B-194,
98-0476B-040,
98-0476B-041,
98-0476B-042, 98-0476B-043, 98-0476B-044, 98-0476B-045, 98-0476B-046,
98-0476B-047, 98-0476B-048, 98-0476B-049, 98-0476B-050, 98-0476B-051,
98-0476B-052, 98-0476B-053, 98-0476B-054, 98-0476B-126, 98-0476B-127,
98-0476B-128, 98-0476B-129, 98-0476B-130, 98-0476B-131, 98-0476B-132,
98-0476B-133, 98-0476B-134, 98-0476B-135, 98-1517B-048, 98-1517B-049,
98-1517B-139, 98-1517B-141, 98-1517B-142, 98-1517B-143, 98-1517B-144,
98-1517B-145, 98-1517B-146, 98-1517B-148, 98-1517B-140, 98-1517B-147,
98-0476B-092, 98-0476B-093, 98-0476B-094, 98-0476B-095, 98-0476B-096,
98-0476B-097, 98-0476B-203, 98-0476B-204, 98-0476B-205, 98-0476B-206,
98-0476B-207, 98-0385-009, 98-0385-010, 98-1517-006, 98-0476B-114,
98-0476B-115, 98-0476B-116, 98-0476B-117, 98-0476B-068, 98-0476B-069, 98-0476B-070,
98-0476B-071, 98-0476B-072, 98-0476B-073, 98-0476B-074, 98-0476B-075,
98-0476B-076, 98-0476B-077, 98-0476B-078, 98-0476B-080, 98-0476B-081,
98-0476B-082,
98-0476B-083,
98-0476B-013, 98-0476B-014, 98-0476B-118, 98-0476B-119, 98-0476B-120, 98-0476B-121,
98-0476B-122, 98-0476B-123, 98-0476B-124, 98-0476B-125, 98-0476B-056,
98-0385B-089, 98-0385B-090, 98-0385B-091, 98-0385B-092, 98-0385B-093,
98-0385B-094, 98-0385B-095, 98-0385B-096, 98-0385B-097, 98-0385B-098,
98-0385B-099, 98-0385B-100, 98-0385B-101, 98-0385B-102, 98-0385B-103,
98-0385B-104, 98-0385B-105, 98-0385B-106, 98-0385B-107, 98-0385B-108,
98-1517B-176, 98-1517B-177, 98-0385B-012, 98-0385B-013, 98-0385B-014,
98-0385B-015, 98-0385B-016, 98-0385B-029, 98-0385B-030, 98-0385B-031,
98-0385B-032, 98-0385B-033, 98-0385B-034, 98-0385-015, 98-0385B-062,
98-0476B-112, 98-0385-003, 98-0385-004, 98-0385B-152, 98-0385B-153,
98-0385B-154, 98-0385B-155, 98-0385B-156, 98-0385B-157, 98-0385B-035,
98-0385B-036, 98-0385B-037, 98-0385B-038, 98-0385B-039, 98-0385B-040,
98-0476B-059, 98-0385-005, 98-0385-006, 98-0476B-038, 98-0476B-039,
98-1517B-120,
98-1517B-121,
98-1517B-122, 99-1630-004, 99-1630-005, 98-0476B-219, 98-0476B-220,
98-0476B-221, 98-0476B-222, 98-0476B-223, 98-0476B-224, 98-0476B-168,
98-0476B-169, 98-0476B-170, 98-0476B-171, 98-1517B-108, 98-0476B-172,
98-0476B-173, 98-0476B-174, 98-0476B-175, 98-0476B-176, 98-0476B-177,
98-0476B-178, 98-0476B-179, 98-0476B-151, 98-0476B-152, 98-0476B-153,
98-0476B-208, 98-0476B-209, 98-0476B-210, 98-0476B-211, 98-0476B-212,
98-0476B-213, 98-0476B-021, 98-0476B-022, 98-0476B-139, 98-0476B-140,
98-0476B-141, 98-0476B-142, 98-0476B-143, 98-0476B-144, 98-0476B-145,
98-0476B-146, 98-1517B-019, 98-1517B-020, 98-1517B-021, 98-1517B-022,
99-0237-019, 99-0237-018, 98-1517B-167, 98-1517B-025, 98-1517B-026,
98-1517B-027, 99-0237-032, 99-0237-034, 99-0237-035, 99-0237-036, 98-1517B-065,
98-1517B-067, 98-1517B-068, 98-1517B-069, 98-1517B-066, 98-0476-006,
98-1517B-170, 98-1517B-171, 99-0237-012, 99-0237-013, 99-0237-028, 99-0237-029,
99-0237-021, 99-0237-022, 99-0237-020, 99-0237-009.
RECALLING FIRM/MANUFACTURER LifeNet,Virginia Beach, VA
REASON Various tissues for transplant which were collected
from donors who had not been properly evaluated.
VOLUME OF PRODUCT IN COMMERECE 778 allografts.
DISTRIBUTION Nationwide and Canada.
PRODUCT a)Red Blood Cells; b)Red Blood Cells; c)Recovered
Plasma
CODE a)Unit 42FQ88410, 42FQ87167; b)Unit 42FQ92260;
c)Unit 42FQ87167, 42FQ92260, 42FQ88410.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Cleveland, OH
REASON Blood products, collected from a donor with a
history of having tested positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERECE 6 units.
DISTRIBUTION OH.
PRODUCT a) Red Blood Cells, Leukoreduced; b)Recovered Plasma
CODE a)and b)Unit KW22861
RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San
Diego, CA
REASON Blood products, collected from a donor with a
history of jaundice and of having tested positive for hepatitis, were
distributed.
VOLUME OF PRODUCT IN COMMERECE 2 units.
DISTRIBUTION CA.
PRODUCT a) Red Blood Cells; b) Platelets Unit
CODE a) and b) Unit C42999.
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank,
Aurora, IL
REASON Blood products, collected from a donor who reported
travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERECE 2 units.
DISTRIBUTION IL.
PRODUCT a)Red Blood Cells; b)Red Blood Cells, Leukocytes
Removed; c)Recovered Plasma
CODE a)Units 29KC28175, 29GS24459; b)Unit 29GX31111;
c)Units 29KC28175, 29GS24459, 29GX31111.
RECALLING FIRM/MANUFACTURER American Red Cross,
Mid-Atlantic Regional Blood Services, Norfolk, VA
REASON Blood products, which tested negative for anti-HCV,
but were collected from a donor who provided post donation information
regarding
previously testing repeatedly reactive for Hepatitis C, were distributed.
VOLUME OF PRODUCT IN COMMERECE 6 units.
DISTRIBUTION VA and NC
PRODUCT Platelets, Pheresis, Leukocytes Removed
CODE Unit C38373 (part B).
RECALLING FIRM/MANUFACTURER Stanford Medical School
Blood Center, Palo Alto, CA
REASON Blood product, not quarantined after receiving
information concerning post donation illness related to a sore throat, was
distributed.
VOLUME OF PRODUCT IN COMMERECE 1 unit
DISTRIBUTION CA.
WEEK ENDING JANUARY 19
PRODUCT Platelets
CODE Units 90204, 90207, 90208, 90209, 90212.
RECALLING FIRM/MANUFACTURER Lane Memorial Blood Bank,
Eugene, OR
REASON Platelets, prepared with short rest times, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION OR
PRODUCT Red Blood Cells, Irradiated
CODE Unit GL30657
RECALLING FIRM/MANUFACTURER Blood Bank of San Bernardino
and Riverside Counties, San Bernardino, CA
REASON Blood product, collected from a donor who reported
travel to anarea designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT a) Red Blood Cells; b) Red Blood Cells,
Leukoreduced; c) Platelets; d) Fresh Frozen Plasma
CODE a), c) and d) Unit 0475883; b), c) and d) Unit
0452175
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center,
Cincinnati, OH
REASON Blood products, collected from a donor with a
history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION OH, KY and FL.
PRODUCT a) Whole Blood; b) Red Blood Cells; c) Recovered
Plasma
CODE a) 0674137; b) and c) 0464795.
RECALLING FIRM/MANUFACTURER Recalling Firm: Central Kentucky Blood Center, Lexington, KY
REASON Blood products, collected from a donor with a
history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION KY and PA
PRODUCT Counterfeit Neupogen (Filgrastim), labeled as
containing 300 mcg/1.0 ml, packaged 10/1.0 ml. single use vials per carton;
quantity distributed unknown.
CODE Lot Number P000890, Expiration Date 12/02, Lot
Number P000992, Expiration Date 06/03, Lot Number P000948, Expiration Date 0503
RECALLING FIRM/MANUFACTURER First Choice Pharmaceutical
Wholesalers, Inc., Davie, FL
REASON Counterfeit Neupogen was distributed.
VOLUME OF PRODUCT IN COMMERCE Quantity distributed unknown
DISTRIBUTION CT, FL, MD, MS, NY, NJ and CA.
PRODUCT Source Plasma
CODE Unit G-06924-035.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic
Corporation, City of Industry, CA
REASON Blood product, collected from a donor at increased
risk for nvCJD due to having lived in the United Kingdom, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Spain.
PRODUCT Platelets
CODE Unit L18480.
RECALLING FIRM/MANUFACTURER Central Illinois Community
Blood Bank, Springfield, IL
REASON Platelets, which were prepared from a Whole Blood
unit collected from a donor who had taken aspirin within thirty six hours of
donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT a)Red Blood Cells; b)Platelets; c)Cryoprecipitated
AHF; d)Recovered Plasma
CODE a) and d) Units FX11976, FX12047, FX12460, FX12482;
b) Unit FX11976; c) Unit FX12047.
RECALLING FIRM/MANUFACTURER Central Illinois Community
Blood Bank, Springfield, IL
REASON Blood products, collected from donor's who had not
been properly screened, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION Illinois and Switzerland.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit 011GN28095.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services,St. Louis, MO
REASON Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MO.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit 011GG05960.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services,St. Louis, MO
REASON Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MO.
PRODUCT a) Red Blood Cells, Irradiated; b) Platelets,
Pheresis, Irradiated
CODE a) Units 6232418, 3598452; b) Units 4203391, 2621939.
RECALLING FIRM/MANUFACTURER LifeSource Blood Services,
Glenview, IL
REASON Blood products, for which documentation of
irradiation was incomplete, were distributed
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION IL.
PRODUCT Source Plasma
CODE Units 00YARB2710, 00YARB3056, 00YARB2539,
00YARB1483, 00YARB2338, 00YARB2567.
RECALLING FIRM/MANUFACTURER Community Bio-Resources,
Inc., Fayetteville, AR
REASON Blood products, collected from a donor who had not
completed the CJD/nvCJD increased risk questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION Austria.
PRODUCT Platelets, Pheresis
CODE Unit 1425342.
RECALLING FIRM/MANUFACTURER New York Blood Center, New
York, NY
REASON Blood product, which had an unacceptable platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma; d) Recovered Plasma
CODE a), b) and c) Unit 011M59982; a) and d) Unit
011M45914.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, St. Louis, MO
REASON Blood products, were collected from a donor who
provided post donation information regarding having tested positive for
hepatitis, and engaging in high risk behavior.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION MO and AL.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Recovered
Plasma
CODE a) and b) Unit 011LX74127
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, St. Louis, MO
REASON Donor, who had been deferred at another donor
center, was allowed to donate.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MO.
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma
CODE a) and b) Unit 011N18566.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, St. Louis, MO
REASON Blood products, collected from a donor who had
received blood products while in a country at increased risk for HIV Group O,
and who had also engaged in high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MO.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit 21KL28446.
RECALLING FIRM/MANUFACTURER American Red Cross,
Portland, OR
REASON Blood product, collected from a donor who reported travel
to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OR.
PRODUCT Red Blood Cells, Leukoreduced, Irradiated
CODE Unit 21GE20086.
RECALLING FIRM/MANUFACTURER American Red Cross, Portland,
OR
REASON Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OR.
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma
CODE a) and b) Unit 11FN86287.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, St. Louis, MO
REASON Blood products, collected from a donor who had
engaged in high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MO and NJ.
PRODUCT Human Tissue for Transplant (3 tissues): a)
Descending Thoracic Aorta; b) Pulmonary Hemi-artery; c) Pulmonary Trunk Patch
CODE a) Model No. A020 - Serial No. 6489451; b) Model No.
PH00 - Serial No. 6489478; c) Model No.
P010 - Serial No. 6489486.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA
REASON Tissues for transplant were collected from a donor
who had not been properly evaluated.
VOLUME OF PRODUCT IN COMMERCE 3 tissues.
DISTRIBUTION MN, FL and PA
PRODUCT Source Plasma Units
CODE T-16183-051, T-16000-051, T-16149-051, T-15936-051,
T-16109-051, T-15911-051, T-16072-051, T-15858-051, T-16036-051, T-15831-051,
T-15768-051, T-15740-051, T-15674-051, T-15631-051, T-15567-051, T-15529-051,
T-15477-051, T-15435-051, T-15375-051, T-15302-051, T-15254-051, T-15145-051,
T-15104-051, T-15020-051, T-14987-051,
T-14925-051, T-14872-051
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los Angeles,
CA
Manufacturer: Alpha Therapeutic Corporation, Fontana, CA
REASON Blood products, collected from a donor who
subsequently Provided information involving high-risk behaviors, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 27 units
DISTRIBUTION Spain
PRODUCT Red Blood Cells
CODE Unit 7014073.
RECALLING FIRM/MANUFACTURER Blood Bank of Alaska,
Anchorage, AK
REASON Blood product, collected from a donor with a history
of jaundice, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AK.
PRODUCT Various Human Freeze Dried Bone and/or Frozen Human
Tissue, grafts including:
Cancellous
Chips, 40cc; Cancellous Chips,30cc;
Cancellous
Chips, 60cc; Cancellous Chips, 90cc
Cancellous
Cubes, 40cc; Corticocancellous Chips, 40cc;
Frozen
Achilles Tendon with Bone Block;
Frozen
Bisected Femoral Shaft;
Frozen
Bisected Patella Ligament;
Frozen
Femoral Head; Frozen Humeral Head;
Fascia
Lata Medium (Freeze Dried);
Fascia
Lata, Regular (Freeze Dried);
Fascia
Lata Small (Freeze Dried);
Iliac
Crest Wedge Size 5cm.
CODE Graft Identificaiton Numbers (45 grafts);
98-1302-022, 98-1302-023, 99-0893-004, 99-0893-005, 99-0893-007, 99-0893-009,
98-1302-015, 99-0893-008, 99-0893-008, 98-1302-010, 98-1302-001, 98-1302-004,
98-1302-024, 98-1302-025, 98-1302-026, 98-1302-027, 98-1302-028, 98-1302-029,
98-1302-030,
98-1302-031, 98-1302-032, 98-1302-033, 98-1302-034, 98-1302-035, 99-0893-013,
98-1302-014, 98-1302-007, 98-1302-005, 98-1302-006, 98-1302-008, 98-1302-016,
98-1302-017, 98-1302-009, 99-0893-010, 99-0893-015, 98-1302-002, 99-0893-002,
99-0893-003, 98-1302-011, 98-1302-012, 98-1302-018, 98-1302-019, 98-1302-020,
98-1302-021, 98-1302-036, 98-1302-003.
RECALLING FIRM/MANUFACTURER New England Organ Bank,
Newton, MA
REASON Various tissues for transplant which were collected
from donors who had not been properly evaluated.
VOLUME OF PRODUCT IN COMMERCE 45 grafts
DISTRIBUTION Massachusetts, Main, Rhode Island, Louisiana,
and Minnesota
PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c)
Recovered Plasma
CODE a) and c) Units 21GG61180, 21GK50548, 21GH47812,
21GJ30559, 21GG25081, 21GM14995, 21GK10418; b) Unit 21GK10418.
RECALLING FIRM/MANUFACTURER American Red Cross,
Portland, OR
REASON Blood products, collected from a donor with a
history of having tested positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 15 units.
DISTRIBUTION OR, CA, MI and PA.
PRODUCT a) Red Blood Cells; b) Platelets
CODE a) and b) Unit 53GE49324.
RECALLING FIRM/MANUFACTURER American Red Cross,
Baltimore, MD
REASON Blood products, collected from a donor who reported
travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MD and DC.
PRODUCT a) Red Blood Cells; b) Platelets
CODE a) and b) Unit W19112.
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA
REASON Blood products, collected from a donor who had lived
in an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.
PRODUCT Red Blood Cells
CODE Unit 29KY05839.
RECALLING FIRM/MANUFACTURER American Red Cross, Norfolk,
VA
REASON Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit 53H81155.
RECALLING FIRM/MANUFACTURER American Red Cross,
Baltimore, MD
REASON Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MD.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit 53G42454.
RECALLING FIRM/MANUFACTURER American Red Cross,
Baltimore, MD
REASON Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MD.
PRODUCT Red Blood Cells
CODE Unit 53M94621.
RECALLING FIRM/MANUFACTURER American Red Cross, Baltimore,
MD
REASON Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Platelets; c)
Plasma, Frozen
CODE a), b) and c) Unit 53J67564.
RECALLING FIRM/MANUFACTURER American Red Cross,
Baltimore, MD
REASON Blood products, collected from a donor taking the
drug Evista, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MD and DC.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Fresh Frozen
Plasma
CODE a) and b) Unit0738502.
RECALLING FIRM/MANUFACTURER Blood Centers of the
Pacific, San Francisco, CA
REASON Blood products, collected from a donor who took the
drug Accutane, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT a) Red Blood Cells; b) Red Blood Cells,
Leukoreduced; c) Frozen Plasma
CODE a) Units 29GL58513, 29GP55604; b) Unit 29GL58012; c)
Unit 29GL58513;
RECALLING FIRM/MANUFACTURER American Red Cross, Norfolk,
VA
REASON Blood products, collected from a donor taking the
drug Arava, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION VA and NC.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit 35GG97881.
RECALLING FIRM/MANUFACTURER American Red Cross, Roanoke,
VA
REASON Blood products, prepared from an overweight whole
blood unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WV.
PRODUCT Recovered Plasma
CODE Unit 29GL58012, 29GP55604
RECALLING FIRM/MANUFACTURER American Red Cross, Norfolk,
VA
REASON Blood products, collected from a donor taking the
drug Arava, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA
WEEK ENDING JANUARY 26
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukoreduced
; c) Platelets
CODE a) Units 29FV44321, 29FN32612, 29FG76227, 29FC56149,
29FK28659, 29KH20881; b) Unit 29FJ06387; c) Unit 29KH20881.
RECALLING FIRM/MANUFACTURER American Red Cross, Norfolk,
VA
REASON Blood products, collected from a donor who had lived
in an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION VA, NC and CT.
PRODUCT Source Plasma
CODE Units T-16479-097, T-16660-097.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha
Therapeutic Corporation, Los Angeles
Manufacturer:
Alpha Therapeutic Corporation, San Diego, CA.
REASON Blood products, collected from a donor who
previously tested reactive for HBsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Spain.
PRODUCT Plasmapheresis
CODE Unit T01736.
RECALLING FIRM/MANUFACTURER Michigan Community Blood
Center,Grand Rapids, MI
REASON Blood product, collected from a donor taking the
drug Lipitor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT a) Red Blood Cells, Leukoreduced; b)
Cryoprecipitated AHF; c) Recovered Plasma
CODE a), b) and c) Unit G61121
RECALLING FIRM/MANUFACTURER Michigan Community Blood
Center, Grand Rapids, MI
REASON Blood products, collected from a donor who lived in
an HIV group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MI and Switzerland.
PRODUCT Platelets, Pheresis, Leukoreduced
CODE Unit 6042191.
RECALLING FIRM/MANUFACTURER Central Indiana Regional
Blood Center, Inc., Indianapolis, IN
REASON Blood product, which was labeled with an incorrect
platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.
PRODUCT Fresh Frozen Plasma
CODE Unit T91528.
RECALLING FIRM/MANUFACTURER Michigan Community Blood
Center, Grand Rapids, MI
REASON Blood product, that tested negative for antibody to
hepatitis B core antigen (anti-HBc), but was collected from a donor that tested
repeatedly reactive for anti-HBc on more than one occasion, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT Red Blood Cells
CODE Unit number G32644.
RECALLING FIRM/MANUFACTURER Michigan Community Blood
Center, Grand Rapids, MI
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 MI.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Platelets
CODE a) and b) Unit number 01GC48337.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, West
Henrietta, NY
Manufacturer:
American Red Cross Blood Services, Syracuse, NY
REASON Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NY and PA.
PRODUCT Platelets
CODE Unit numbers 3386361, 3386355, and 3386354.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood
Center, Houston, TX
REASON Blood products, labeled with the incorrect
expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX and AK.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Recovered
Plasma
CODE a) and b) Unit 1716065
RECALLING FIRM/MANUFACTURER South Texas Blood &
Tissue Center, San Antonio, TX
REASON Blood products, collected from a donor taking
Methadone for pain, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) and b) Unit 23140-1242
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer: United Blood Services, Billings, MT
REASON Blood products, collected from a donor with a
history of Non-Hodgkins Lymphoma, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MT and Switzerland.
PRODUCT a) Red Blood Cells; b) Platelets
CODE a) Unit 6471202, 6471204; b) Unit 6471204.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Beaumont, TX
REASON Blood products, collected from donors who reported
travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.
PRODUCT Red Blood Cells
CODE Unit 25152-5343.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Hot Springs, AR
REASON Blood product, prepared from an overweight unit of
Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AK.
PRODUCT Platelets
CODE Units 1260419, 1261620, 1261621, 1261672, 2737836,
2737838, 2737839, 2737841, 2738572, 2739664, 2739666, 2739668, 2739671,
2739712, 1260605, 1260607, 1260635, 2738046, 2739353, 2739407, 1261358,
1261437, 2739316, 2739350, 1261936, 2740079, 2740080, 2740081, 1261893,
1261933, 1261941, 1261942, 1260474, 1260478, 1260479, 1260480, 1260420,
1260424, 1260469, 1260470, 1260487, 1260489, 1260493, 1260500, 1260669,
1261031, 1261036, 1261216, 1261221, 1261222, 1261316, 1261326, 1261395,
1261435, 1261560, 1261796, 2737873, 2737874, 2737881, 2737882, 2737884,
2737886, 2737888, 2737890, 2738148, 2738648, 2738651, 2739411, 2739466,
2739545, 2739571, 2739829, 2739868, 2739877, 2740124, 2740180, 1260486,
1260513, 1261115, 1261122, 1261314, 1261318, 1261478, 1261484, 1261489, 1261505,
1261511, 1261512, 1261529, 1261531, 1261546, 1261714, 1261715, 1261717,
1261719, 1261722, 1261746, 1261747, 1261750, 1261751, 1261758, 1261774,
1260767, 1261780, 1261785, 1261787, 1261788, 1261789, 1261808, 1261850,
1261860, 1261865, 1261898, 2737908, 2737913, 2737953, 2737957, 2738375,
2738407,
2738569,
2738798, 2738963, 2738964, 2739467, 2739472, 2739544, 2739546, 2739549,
2739550, 2739554, 2739557, 2739565, 2739580, 2739797, 2739798, 2739799,
2739800, 2739823, 2739825, 2739827, 2739864, 2739869, 2739871, 2739872,
2739873, 2739876, 2739881, 2739885, 2739891, 2739959, 2740044, 2740046,
2740050, 1260563, 1260584, 1260588, 1260632, 1260679, 1261673, 1261708,
1261891, 1261932, 1261938, 1261949, 1261987, 1261989, 1261990, 1261991,
1261992, 1262010, 1262013, 1262048, 1262051, 1262054, 1262056, 1262089,
2737978, 2737982, 2737983, 1260632, 2737984, 2737989, 2737990, 2738082,
2738085, 2738136, 2738140, 2738150, 2739265, 2739267, 2739310, 2739311,
2739314, 2740047, 2740076, 2740078, 2740126, 2740127, 2740133, 27400135,
2740136, 2740137, 2740159, 2740156, 2740157, 2740164, 2740217, 2740249
RECALLING FIRM/MANUFACTURER Houchin Community Blood
Bank, Bakersfield, CA
REASON Platelets, with decreased platelet counts, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 208 units.
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE Unit numbers 14047091 and 1408715.
RECALLING FIRM/MANUFACTURER Nabi, Denton, TX
REASON Blood products, that tested negative for the
hepatitis C virus(HCV), but were collected from a donor that subsequently
tested HCV positive, were not properly quarantined and were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells
CODE Unit 04N295546.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Center, Gainesville, FL
REASON Blood product, collected from a donor with a history
of Non-Hodgkins Lymphoma, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) and b) Unit M30488
RECALLING FIRM/MANUFACTURER Northern California
Community Blood Bank, Eureka, CA
REASON Blood products, collected from a donor who had body
piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Platelets, Pheresis
CODE Unit 6500454.
RECALLING FIRM/MANUFACTURER Northern California
Community Blood Bank, Eureka, CA
REASON Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Red Blood Cells
CODE Unit 4505958.
RECALLING FIRM/MANUFACTURER Northern California
Community Blood Bank, Eureka, Ca
REASON Blood product, collected from a donor who tested CMV
antibody positive, was labeled as CMV antibody negative.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c)
Recovered Plasma
CODE a) Units 0641174, 0636072; b) Unit 0636072; c) Unit
0641174.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Centers of the Pacific, Irwin Center, San Francisco, CA
Manufacturer: Blood Centers of the Pacific,
Peninsula/South Bay Center, Burlingame, CA.
REASON Blood products, collected from a donor with a
history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION CA.
PRODUCT a) Red Blood Cells; b) Platelets
CODE a) and b) Unit 4507258