JULY 2007

WEEK ENDING JULY 21 

PRODUCT
a) CryoGraft: Sermitendinosus/Gracilis Tendon,
b) Patellar Tendon, 
c) Achilles Tendon, 
d) Meniscus, 
e) Femoral Condyle, 
CODE
a) 8663820;
b) 8644533, 8644544, 8618305, 8619818, 8699898, 8699907, 8870430, 8882386, 8882397, 8720165, 8720176, 8719898, 8719934, 8722363 8718558, 8718564, 8805131, 8805140;
c) 8665384, 8654338, 8654591, 8655444, 8671298, 8725253, 8722435, 8718358;
d) 8654493, 8654505, 8882236;
e) 8655719, 8655729, 8870444, 8722331, 8722345
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA
REASON The recipient of an associated donor tissue tested positive for Clostridium septicum infection.
VOLUME OF PRODUCT IN COMMERCE 35 tissue allografts
DISTRIBUTION AR, AZ, CA, CO, FL, ID, IL, KY, MA, MO, NJ, NM, OH, TN, and TX

PRODUCT Red Blood Cells Leukocytes Reduced, 
CODE Unit 231542945
RECALLING FIRM/MANUFACTURER Blood Systems Inc, Scottsdale, AZ,
REASON Blood product, which was collected from a donor who had engaged in a high risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MT

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Units: 7758018, 7758019, 7758658, 7758722
RECALLING FIRM/MANUFACTURER West Tennessee Regional Blood Center Inc, Jackson, TN
REASON Blood products, which were leukoreduced using expired filters, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION MI and TN

WEEK ENDING JULY 28

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit: 9336043 (Parts 1& 2)
RECALLING FIRM/MANUFACTURER New York Blood Center, New York, NY.
REASON Platelets, inappropriately prepared by splitting the product into two storage bags instead of one, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NY

PRODUCT Red Blood Cells
CODE Unit: 5840351
RECALLING FIRM/MANUFACTURER New York Blood Center, New York, NY
REASON Blood product, tested for viral markers using an unsuitable testing sample was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NY

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit: 231542242
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ
REASON Blood product, which was labeled as irradiated but did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WA

PRODUCT Human Cornea Tissue
CODE Units: 070085100, 070085200
RECALLING FIRM/MANUFACTURER East Tennessee Lions Eye Bank, Knoxville, TN
REASON Human corneal tissues, that tested negative for hepatitis prior to distribution, but were subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different facility, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TN

PRODUCT Source Plasma
CODE Units:  06LFLA5908, 06LFLA6130, and 06LFLA3652
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, Lakeland, FL
REASON Failure to quarantine unit due to medical history; Donor received tattoo.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION CA and NY

PRODUCT Platelets Pheresis Leukocytes Reduced
CODE Unit: 9975205 (split product)
RECALLING FIRM/MANUFACTURER Florida’s Blood Centers, Inc., Orlando, FL
REASON Platelets, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit (2 parts)
DISTRIBUTION FL

PRODUCT Source Plasma
CODE Units: 364006630, 364006317, 364014145, 364005616, 364004960, 364005092, 364010305, 364000724, 364010371, 364012995, 364009468, 364007302, 364006455, 364004249, 364010025, 364010439, 364007156, 364007492, 364011025, 364005950, 364014831, 364014036, 364006783, 364004844, 364012068, 364005459, 364004934, 364009897, 364004305, 364003154, 364012409, 364006573, 364004463, 364009378, 364005540, I72057150, I72060302, 364011280, 364011524, 364013523, 364010303, 364015274, 364011292, 364014898, 364005114, 364000416, 364006078, 364015348, 364007058, 364007094, 364004532, 364005211, 364011410, 364004366, 364004630, 364005484, 364007941, 364011903, 364015345, 364006124, 364006747, 364011427, 364011294, 364006443, 364015287, 364011601, 364006409, 364007379, 364005571, 364014023, 364015261, 364011542, 364007033, 364012332, 364015060, 364012540, 364012953, 364006304, 364015292, 364009842, 364006104, 364011467
RECALLING FIRM/MANUFACTURER International BioResources, Llc, Ft. Worth, TX
REASON Blood products, collected from donors who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE 82 units
DISTRIBUTION NC

PRODUCT
a) Platelets Pooled, 
b) Platelets,
c) Platelets Pooled Irradiated, 
CODE
a) GR40896 (Pool # P25941), GR40943 (Pool # P25937), GR40962 (Pool # P25921), GR40963 (Pool # P25918) GR40978 (Pool # P25942), GR40985 (Pool # P25929) GR41001 (Pool # P25942), KC12056 (Pool # P25960);
b) LE54212;
c) FJ90012 (Pool # P25990)
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON Platelets, which were not prepared within the required time frame following collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 19 units
DISTRIBUTION WI