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From: TSS ()
Subject: MAD COW BLOOD AND TISSUE RECALLS FOR HUMANS COMPLIMENTS FDA ET AL END OF ENFORCEMENT REPORT FOR DECEMBER 27, 2006
Date: December 28, 2006 at 10:30 am PST
MAD COW BLOOD AND TISSUE RECALLS FOR HUMANS COMPLIMENTS FDA ET AL END OF ENFORCEMENT REPORT FOR DECEMBER 27, 2006 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. ______________________________
PRODUCT
Human Cadaveric Unprocessed Tissue, Recall # B-0420-7
CODE
A0501, A0502, A0503, A0504, A0505, A0506, A0507, B0501, B0502, B0503,
B0504, B0505, C0501, C0502, C0503, C0507, C0508, D0402, D0502, D0503,
D0504, D0505, D0509, E0401, E0402, E0403, E0404, E0405, E0406, E0407,
E0410, E0411, E0412, E0413, E0502, E0503, E0504, E0506, E0507, E0508,
E0509, E0510, E0511, F0401, F0402, F0405, F0407, F0408, F0410, F0411,
F0502, F0503, G0402, G0403, G0404, G0405, G0406, G0407, G0409, G0502,
G0503, H0401, I0401, I0402, I0403, J0401, J0402, J0403, J0404, J0405, J0406,
J0407, J0408, J0409, J0501, J0503, K0401, K0402, K0403, K0404, K0405,
K0501, K0502, K0503, K0504, K0505, L0401, L0403, L0404, L0405, L0406,
L0407, L0408, L0409, L0410, L0411, L0412, L0501
RECALLING FIRM/MANUFACTURER
Recalling Firm: Donor Referral Services, Raleigh, NC, by facsimile transmission dated June 30, 2006.
Alternate address: Hope of North Carolina, Raleigh, NC. Firm initiated recall is ongoing.
REASON
Human Tissues, recovered from donors without adequate donor eligibility determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
99 units
DISTRIBUTION
FL and TX ______________________________
PRODUCT
Human Tissue for Transplantation, Recall # B-0421-7:
a) Achilles Tendon (various sizes), Fresh Frozen, Irradiated;
b) Cancellous Chips, Crushed 1-4mm/15 & 30cc, Freeze Dried, Irradiated;
c) Cancellous Chips 4-10mm/15cc, 30cc & 60cc, Freeze Dried, Irradiated;
d) Cancellous, Cortical Chips 1-4mm/30cc, Freeze Dried, Irradiated;
e) Cancellous Cubes 5-5mm/30cc, Freeze Dried, Irradiated;
f) Cloward Dowel (various sizes), Freeze Dried, Irradiated;
g) Cortical Plate 2x20cm, Freeze Dried, Irradiated;
h) Cortical Button 12x9mm, Freeze Dried, Irradiated;
i) Fascia Lata (various sizes), Freeze Dried, Irradiated;
j) Femoral Head w/Neck (various sizes), Fresh Frozen, Irradiated;
k) Femoral Ring 30mm, Fresh Frozen, Irradiated;
l) Femur Segment 6.0cm, Fresh Frozen, Irradiated;
m) Femur Shaft, Split 23cm, Fresh Frozen, Irradiated;
n) Fibula Ring 0.7cm, Freeze Dried, Irradiated;
o) Fibula Segment (various sizes), Freeze Dried, Irradiated;
p) Gracilis 0.7x28cm, Fresh Frozen, Irradiated;
q) Ilium Tricortical Block (various sizes), Freeze Dried, Irradiated;
r) Patella Tendon, Bisected (various sizes), Fresh Frozen, Irradiated;
s) Patella Tricortical 8x26mm, Freeze Dried, Irradiated;
t) Semitendonosus (various sizes), Fresh Frozen, Irradiated;
u) Tibialis Tendon Anterior (various sizes), Fresh Frozen, Irradiated;
v) Tibialis Tendon Posterior (various sizes), Fresh Frozen, Irradiated;
w) Tibial Shaft, Split (various sizes)
CODE
a) 05-0131-071, 05-0131-072, 05-0138-008, 06-0007-009, 06-0007-010,
06-0019-003;
b) 05-0129-001, 05-0129-002, 05-0129-004, 05-0129-005, 05-0129-007,
05-0129-008, 05-0131-040, 05-0131-041, 05-0131-042, 05-0131-043,
05-0131-044, 05-0131-045, 05-0131-046, 05-0131-047, 05-0131-048,
05-0131-049, 05-0138-023, 05-0138-024, 05-0138-025, 05-0138-026,
05-0139-014, 05-0139-016, 05-0139-017, 05-0139-018, 06-0007-015,
06-0007-016, 06-0007-017, 06-0007-018, 06-0019-017, 06-0019-018,
06-0019-020;
c) 05-0129-009, 05-0129-010, 05-0129-011, 05-0129-012, 05-0129-013,
05-0129-014, 05-129-015, 05-0129-016, 05-0129-017, 05-0131-019,
05-0131-020, 05-0131-021, 05-0131-022, 05-0131-023, 05-0131-024,
05-0131-025, 05-0131-026, 05-0131-027, 05-0131-028, 05-0131-029,
05-0131-030, 05-0131-031, 05-0138-027, 05-0138-029, 05-0138-030,
05-0138-032, 05-0139-019, 05-0139-020, 05-0139-021, 05-0139-022,
05-0139-023, 06-0007-019, 06-0007-020, 06-0007-021, 06-0007-022,
06-0007-023, 06-0007-024, 06-0019-022, 06-0019-023, 06-0019-024,
06-0019-025, 06-0019-026, 06-0019-027;
d) 05-0139-059, 05-0139-060, 05-0139-061, 05-0139-062, 05-0139-063,
05-0139-064, 05-0139-065, 05-0139-066, 05-0139-067, 05-0139-068;
e) 05-0131-014, 05-0131-015, 05-0131-016, 05-0131-017, 05-0131-018,
06-0007-025;
f) 05-0131-050, 05-0131-051, 05-0131-052, 05-0131-053, 05-0131-055,
05-0131-056, 05-0131-057, 06-0007-030;
g) 05-0138-011, 05-0138-012, 05-0138-013, 05-0139-001, 05-0139-002,
06-0007-035, 06-0007-037, 06-0019-016;
h) 05-0139-008;
i) 06-0007-013, 06-0007-014;
j) 05-0138-022, 05-0139-030, 05-0139-031, 06-0007-032, 06-0007-033;
k) 06-0019-009, 06-0019-010, 06-0019-011, 06-0019-012, 06-0019-013,
06-0019-014, 6-0019-015;
l) 05-0131-066, 05-0131-067, 05-0131-069, 05-0131-070;
m) 05-0129-025;
n) 05-0131-037, 06-0007-027, 06-0007-028;
o) 05-0131-036, 05-0138-018, 05-0138-020, 05-0138-021;
p) 06-0007-008;
q) 05-0131-032, 05-0131-033, 05-0131-034, 05-0131-075;
r) 05-0129-032, 05-0129-033, 05-0129-034, 05-0131-073, 05-0131-074,
06-0007-011, 06-0007-012;
s) 06-0007-031;
t) 05-0138-003, 06-0007-006;
u) 06-0007-001, 06-0007-002;
v) 06-0007-003, 06-0007-004;
w) 05-0139-003, 05-0139-005, 05-0139-006
RECALLING FIRM/MANUFACTURER
Alamo Tissue Services, Ltd., San Antonio, TX, by letters on June 28, 2006. Firm initiated recall is ongoing.
REASON
Human Tissues, recovered from donors without adequate donor eligibility determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
161 units
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
Feed 454A - Kalmbach 18% Turkey & Broiler Grower/Finisher Pellet (Medicated), Net Weight 50 LBS., Recall # V-009-2007
CODE
Lot: 004863
RECALLING FIRM/MANUFACTURER
Kalmbach Feeds Inc, Upper Sandusky OH, by telephone on November 29, 2006. Firm initiated recall is ongoing.
REASON
Off label use of Type A medicated article. Product is labeled for calves and used in poultry feed.
VOLUME OF PRODUCT IN COMMERCE
50/50 lb. bags
DISTRIBUTION
PA and MI END OF ENFORCEMENT REPORT FOR DECEMBER 27, 2006 ### http://www.fda.gov/bbs/topics/enforce/2006/ENF00984.html
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&T=0&P=12771
http://www.microbes.info/forums/index.php?showtopic=375
http://lists.iatp.org/listarchive/archive.cfm?id=119823 http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&T=0&P=11421 http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&T=0&P=5165 http://list.uvm.edu/cgi-bin/wa?A2=ind0610b&L=safety&D=1&P=2658 http://vcjdblood.blogspot.com/
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