flatfish
01-03-2007, 11:55 AM
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0456-7
CODE
Unit number 5213589
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile dated March18, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0459-7;
b) Recovered Plasma, Recall # B-0460-7
CODE
a) and b) Unit: 4765590
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile dated April 5, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Oklahoma and Switzerland
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0461-7;
b) Recovered Plasma, Recall # B-0462-7
CODE
a) and b) Unit number 4900925
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile dated March 11, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Oklahoma and Switzerland
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0463-7;
b) Recovered Plasma, Recall # B-0464-7
CODE
a) and b) Unit number 5253844
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile dated July 7, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Oklahoma and Switzerland
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0474-7;
b) Recovered Plasma, Recall # B-0475-7
CODE
a) and b) Unit: 0249958
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone and facsimile beginning July 20, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and LA
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0481-7;
b) Platelets, Recall # B-0482-7;
c) Fresh Frozen Plasma, Recall # B-0483-7
CODE
a), b), and c) Unit 0253260
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone and facsimile beginning July 25, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who may have been at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA and LA
================================================== =========
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
______________________________
PRODUCT
Human Tissue for Transplantation:
a) Achilles Tendon Frozen;
b) Patellar Ligament Hemi, Frozen;
c) Cartilage in Saline Vacuum;
d) Tibialis Anterior Tendon, Frozen
e) Tibialis Tendon Frozen;
f) Tibialis Tendon Posterior Frozen;
Recall # B-0114-7;
a) Fascia Lyo 101-150 sq cm;
b) Pericardium Lyo 26-50 sq cm;
c) ) Semitendonosus / Gracilis Frozen;
d) Patella Ligament Whole Frozen,
Recall # B-0115-7
CODE
a) 03-0178792, 03-0173682, 03-0168103, 03-0168104, 03-0162640, 03-0168841, 03-0181591, 03-0168302, 03-0179205, 03-0181592, 03-0042572, 03-0155372, 03-0182234, 03-0032401, 03-0174931, 03-0155371, 03-0161144, 03-0182782, 03-0182623, 03-0181628, 03-0182051, 03-0032400, 03-0168301, 03-0147962, 03-0173822, 03-0182235, 03-0181627, 03-0128130, 03-0162639, 03-0182783, 03-0182624, 03-0161143, 03-0182052, 03-0151503, 03-0147961, 03-0042571, 03-0179206, 03-0172621, 03-0135831, 03-0174932, 03-0173821, 03-0173681, 03-0172251, 03-0178791, 03-0173841, 03-0173842;
b) 03-0168842, 03-0181593, 03-0135832, 03-0181595, 03-0182781, 03-0178796, 03-0182625, 03-0182626, 03-0168844, 03-0173823, 03-0173825, 03-0179203, 03-0173826, 03-0182011, 03-0182049, 03-0179202, 03-0042574, 03-0139081, 03-0151502, 03-0147967, 03-0168102, 03-0162641, 03-0161142, 03-0128132, 03-0042575, 03-0168101, 03-0172618, 03-0181594, 03-0162643, 03-0168843, 03-0181438, 03-0172252, 03-0181596, 03-0178793, 03-0178794, 03-0032405, 03-0139084, 03-0179204, 03-0182047, 03-0181212, 03-0172620, 03-0182048, 03-0172617, 03-0172619, 03-0042573, 03-0042576, 03-0178795, 03-0139082, 03-0162644, 03-0173824, 03-0181213, 03-0172253, 03-0182050, 03-0151501, 03-0179201, 03-0181436, 03-0181437, 03-0032402, 03-00324404, 03-0162642, 03-0128131, 03-0128133, 03-0147968, 03-0181211;
c) 03-0014874, 03-0014871, 03-0014878, 03-0014875, 03-0014876, 03-0014877;
d) 03-0182053, 03-0182054, 03-0181621, 03-0179207, 03-0179208, 03-0181600, 03-0181599, 03-0168303, 03-0168304, 03-0155375, 03-0173846, 03-0173847, 03-0181622;
e) 03-0042582, 03-0042580, 03-0042581, 03-0178797, 03-0178798, 03-0178799, 03-0147963, 03-0147964, 03-0147965, 03-0147966;
f) 03-0155377, 03-0173845, 03-0182055, 03-0181623, 03-0155376, 03-0181598, 03-0181624, 03-0179209, 03-0181597, 03-0179210;
a) 03-0182237, 03-0182238, 03-0168105;
b) 03-0168845, 03-0173684, 03-168846, 03-0174935, 03-0174936, 03-0173683
c) 03-0147971;
d) 03-0182232, 03-0182233, 03-0155373, 03-0155374, 03-0179281, 03-0111812, 03-0174933, 03-0161141, 03-0173844, 03-0181625, 03-0173843
RECALLING FIRM/MANUFACTURER
DCI Donor Services Tissue Services Division, Nashville, TN, by letters on May 23, 2005. Firm initiated recall is ongoing.
REASON
Human tissue, which was either implicated in a post-transplant bacterial infection, or was processed in the same manner as tissue that was implicated in a post-transplant bacterial infection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
170 tissue allografts
DISTRIBUTION
New Mexico, TN, CA, NV, and AK.
______________________________
CONTINUED
Red Blood Cells, Leukocytes Reduced, Recall # B-0456-7
CODE
Unit number 5213589
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile dated March18, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0459-7;
b) Recovered Plasma, Recall # B-0460-7
CODE
a) and b) Unit: 4765590
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile dated April 5, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Oklahoma and Switzerland
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0461-7;
b) Recovered Plasma, Recall # B-0462-7
CODE
a) and b) Unit number 4900925
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile dated March 11, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Oklahoma and Switzerland
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0463-7;
b) Recovered Plasma, Recall # B-0464-7
CODE
a) and b) Unit number 5253844
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile dated July 7, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Oklahoma and Switzerland
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0474-7;
b) Recovered Plasma, Recall # B-0475-7
CODE
a) and b) Unit: 0249958
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone and facsimile beginning July 20, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and LA
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0481-7;
b) Platelets, Recall # B-0482-7;
c) Fresh Frozen Plasma, Recall # B-0483-7
CODE
a), b), and c) Unit 0253260
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone and facsimile beginning July 25, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who may have been at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA and LA
================================================== =========
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
______________________________
PRODUCT
Human Tissue for Transplantation:
a) Achilles Tendon Frozen;
b) Patellar Ligament Hemi, Frozen;
c) Cartilage in Saline Vacuum;
d) Tibialis Anterior Tendon, Frozen
e) Tibialis Tendon Frozen;
f) Tibialis Tendon Posterior Frozen;
Recall # B-0114-7;
a) Fascia Lyo 101-150 sq cm;
b) Pericardium Lyo 26-50 sq cm;
c) ) Semitendonosus / Gracilis Frozen;
d) Patella Ligament Whole Frozen,
Recall # B-0115-7
CODE
a) 03-0178792, 03-0173682, 03-0168103, 03-0168104, 03-0162640, 03-0168841, 03-0181591, 03-0168302, 03-0179205, 03-0181592, 03-0042572, 03-0155372, 03-0182234, 03-0032401, 03-0174931, 03-0155371, 03-0161144, 03-0182782, 03-0182623, 03-0181628, 03-0182051, 03-0032400, 03-0168301, 03-0147962, 03-0173822, 03-0182235, 03-0181627, 03-0128130, 03-0162639, 03-0182783, 03-0182624, 03-0161143, 03-0182052, 03-0151503, 03-0147961, 03-0042571, 03-0179206, 03-0172621, 03-0135831, 03-0174932, 03-0173821, 03-0173681, 03-0172251, 03-0178791, 03-0173841, 03-0173842;
b) 03-0168842, 03-0181593, 03-0135832, 03-0181595, 03-0182781, 03-0178796, 03-0182625, 03-0182626, 03-0168844, 03-0173823, 03-0173825, 03-0179203, 03-0173826, 03-0182011, 03-0182049, 03-0179202, 03-0042574, 03-0139081, 03-0151502, 03-0147967, 03-0168102, 03-0162641, 03-0161142, 03-0128132, 03-0042575, 03-0168101, 03-0172618, 03-0181594, 03-0162643, 03-0168843, 03-0181438, 03-0172252, 03-0181596, 03-0178793, 03-0178794, 03-0032405, 03-0139084, 03-0179204, 03-0182047, 03-0181212, 03-0172620, 03-0182048, 03-0172617, 03-0172619, 03-0042573, 03-0042576, 03-0178795, 03-0139082, 03-0162644, 03-0173824, 03-0181213, 03-0172253, 03-0182050, 03-0151501, 03-0179201, 03-0181436, 03-0181437, 03-0032402, 03-00324404, 03-0162642, 03-0128131, 03-0128133, 03-0147968, 03-0181211;
c) 03-0014874, 03-0014871, 03-0014878, 03-0014875, 03-0014876, 03-0014877;
d) 03-0182053, 03-0182054, 03-0181621, 03-0179207, 03-0179208, 03-0181600, 03-0181599, 03-0168303, 03-0168304, 03-0155375, 03-0173846, 03-0173847, 03-0181622;
e) 03-0042582, 03-0042580, 03-0042581, 03-0178797, 03-0178798, 03-0178799, 03-0147963, 03-0147964, 03-0147965, 03-0147966;
f) 03-0155377, 03-0173845, 03-0182055, 03-0181623, 03-0155376, 03-0181598, 03-0181624, 03-0179209, 03-0181597, 03-0179210;
a) 03-0182237, 03-0182238, 03-0168105;
b) 03-0168845, 03-0173684, 03-168846, 03-0174935, 03-0174936, 03-0173683
c) 03-0147971;
d) 03-0182232, 03-0182233, 03-0155373, 03-0155374, 03-0179281, 03-0111812, 03-0174933, 03-0161141, 03-0173844, 03-0181625, 03-0173843
RECALLING FIRM/MANUFACTURER
DCI Donor Services Tissue Services Division, Nashville, TN, by letters on May 23, 2005. Firm initiated recall is ongoing.
REASON
Human tissue, which was either implicated in a post-transplant bacterial infection, or was processed in the same manner as tissue that was implicated in a post-transplant bacterial infection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
170 tissue allografts
DISTRIBUTION
New Mexico, TN, CA, NV, and AK.
______________________________
CONTINUED