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U.S. Department of Health and Human Services

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Enforcement Report for February 21, 2007

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

 

February 21, 2007
07-08

 

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

___________________________________
PRODUCT
Sam's Choice™, Nature Trail Mix, Net Wt 28oz (1 lb 12oz) 794g, Recall # F-126-7
CODE
Best By: APR-23-2007; MFG: OCT-23-2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ann, Jessup, MD, by press release on December 29, 2006.
Manufacturer: Ann House of Nuts, Inc., Robersonville, NC. Firm initiated recall is ongoing.
REASON
The product contains glass fragments.
VOLUME OF PRODUCT IN COMMERCE
21,720 packages
DISTRIBUTION
AL, KY, MN, NC, NY, TX, VA

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

___________________________________
PRODUCT
Smithfield Cream Cheese, 10/3 lb. (48 oz.) packages per case; Product #6046-04; UPC #70551 10048, Recall # F-115-7
CODE
All lots, Case SKU #726PLFSM
RECALLING FIRM/MANUFACTURER
Recalling Firm: Best Brands Corp., Minnetonka, MN, by telephone on November 6, 2006.
Manufacturer: Fleur De Lait, New Holland, PA. Firm initiated recall is complete.
REASON
The product was stored at non-refrigerated temperatures for an extended period of time.
VOLUME OF PRODUCT IN COMMERCE
7 cases (10/3 lb. blocks per case)
DISTRIBUTION
TX and OK

___________________________________
PRODUCT
a) Finishing Touches and Sweet Williams brands Gourmet Royal Icing and Sweet
NET WT. 12 OZ. (340 grams) packaged in plastic bags. 24 packages/case white
color ingredient statement: sugar, gelatin, starch, water, Recall # F-120-7;
b) Finishing Touches and Sweet Williams brands Gourmet Royal Icing and Sweet
NET WT. 12 OZ. (340 grams) packaged in plastic bags. 24 packages/case red
color ingredient statement: sugar, gelatin, starch, water, red 40 & yellow 6, Recall # F-121-7;
c) Finishing Touches and Sweet Williams brands Gourmet Royal Icing and Sweet
NET WT. 12 OZ. (340 grams) packaged in plastic bags. 24 packages/case green
color ingredient statement: sugar, gelatin, starch, water, blue 1 & yellow 5, Recall # F-122-7
CODE
a) Case code: ZTBICER, ZTBICEG, ZTBICEW, QDCIER, QDCIEG, QDCIEW
Sweet Williams package lot codes: 47112, 47118 and 47110;
b) Case code: ZTBICER, ZTBICEG, ZTBICEW, QDCIER, QDCIEG, QDCIEW;
c) Case code: ZTBICER, ZTBICEG, ZTBICEW, QDCIER, QDCIEG, QDCIEW
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elegant Gourmet, Inc., Woodinville, WA, by telephone on December 14, 2006.
Manufacturer: Sunny Foods International Ltd., DongGuan City, China. Firm initiated recall is complete.
REASON
Product contains mold.
VOLUME OF PRODUCT IN COMMERCE
4,972 cases/24/12 oz bags
DISTRIBUTION
AL, TX, MN, IL, FL, and WA

___________________________________
PRODUCT
Orchard Gold California Style Citrus Punch. The product is sold in 8 oz. bottles in an 8 count pack and 4 packs per case, Recall # F-123-7
CODE
Expiration dates: Jan/3/07 and Jan/4/07
RECALLING FIRM/MANUFACTURER
American Beverage Corp., Verona, PA, by telephone on November 28, 2006. Firm initiated recall is complete.
REASON
Product contains mold/yeast.
VOLUME OF PRODUCT IN COMMERCE
29,568 cases
DISTRIBUTION
PA, OH, NY, and NC

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

___________________________________
PRODUCT
Alesse-28 Tablets Clinical Packs, levonorgestral 0.10mg and ethinyl estradiol 0.02mg, 28 tablet blister packs, 50 count box, NDC 0008-2576-03, Recall # D-443-2007
CODE
Lots # A66651 (Exp 12/06) and A66652 (Exp. 1/07)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Ayerst Laboratories, Philadelphia, PA, by letters dated October 22, 2006.
Manufacturer: Wyeth Pharmaceuticals Company, Guayama, PR. Firm initiated recall is ongoing.
REASON
Impurity (18 month stability)
VOLUME OF PRODUCT IN COMMERCE
9,032 (50 blister packs)
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
GlipiZIDE 5mg Tablets USP, 100 count Unit Dose packages and 100 count bottles, NDC 0182-1994-89 and NDC 0172-3649-60, Recall # D-444-2007
CODE
Lot # 138020A Exp. Date 02/2007 Lot #138020U, Exp. Date 02/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami, FL, by letter on December 11, 2006.
Manufacturer: Ivax Pharmaceuticals, Inc., Cidra, PR. Firm initiated recall is ongoing.
REASON
Exceeds Impurity Specification
VOLUME OF PRODUCT IN COMMERCE
13,848 bottles and 6,024 UD
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

___________________________________
PRODUCT
Control Rx 5000 ppm Fluoride Prescription Dentrifice, Berry Flavor, 2 oz. (56 g). RX, Omnii, NDC 48878-3101-6, Recall # D-434-2007
CODE
Lot Numbers: 60407E03/08 60410E03/08
RECALLING FIRM/MANUFACTURER
Sheffield Laboratories, Div. of Faria Limited LLC, New London, CT, by letter dated January 10, 2007. Firm initiated recall is ongoing.
REASON
Superpotent (fluoride)
VOLUME OF PRODUCT IN COMMERCE
25,776 tubes
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I

___________________________________
PRODUCT
Human Tissue for Transplantation, Recall # B-0549-07,
a) Achilles Tendon, Product #LATM;
b) Cancellous Bone, Chips 4-10 mm (15 cc), Product #LCIPM;
c) Iliac Crest Wedge (11-13 mm), Product #LIWMM;
d) Cervical Pre-shaped Allograft (7x11x13 mm), Product #NCAS7;
e) Semitendinosus Tendon, Product #LSTM;
f) Patella Tendon, Whole, Product #LPTWM;
g) Patella Tendon, Hemi, Product #LPTHM;
h) Cancellous Bone, Chips 4-100 mm (30 cc), Product #LCISM;
i) Femoral Head, Product #LFTNM;
j) Costal Cartilage (Rib), Product #LCAM;
k) Gracilis Tendon , Product #LGTM;
l) Unicortical Cloward Dowels, 14 mm, Product #LDIMM;
m) Tibialis Tendon, Product #LTTM;
n) Patella Tendon, Fresh Frozen, Product #LPTHFFM;
o) Iliac Crest Wedge (<10mm), Product #LIWSM,
p) Femoral Shaft, Split Block (1/pk), Product #LFSHM;
q) Fascia Lata, <120 mm, Product #LFLSM;
r) Cortical Cancellous Strips (<15 mm, 5/pk), Product #LMSM;
s) Cancellous Bone, Chips (4-10 mm, 60 cc), Product #LCILM;
t) Cancellous Bone, Chips (1-4mm, 30 cc), Product #LCCSM;
u) Lordotic Allograft Segments (8x12x22 mm), Product #LAS1222;
v) Cervical Pre-shaped Allograft (6x11x13mm), Product #NCAS6;
w) Iliac Crest Wedge (14-17 mm), Product #LIWLM;
x) Cortical Bone, Chips (1-4 mm, 30 cc), Product #LCQSM;
y) Iliac Crest Wedge (18+ mm), Product #LIWXLM;
z) Cervical Allograft Segments (6x11x13mm), Product #CAS61113;
aa) Cervical Allograft Segments (5x11x13mm), Product #CAS51113;
bb) Cervical Allografts, 3000 series:
a) BS30-3005 (5mm);
b) BS30-3006 (6mm);
c) BS30-3007 (7mm);
d) BS30-3008 (8mm);
e) BS30-3009 (9mm);
f) BS30-3010 (10mm),
cc) Corticocancellous Allografts, 4000 series:
a) BS30-4005 (5mm);
b) BS30-4006 (6mm);
c) BS30-4007 (7mm);
d) BS30-4008 (8mm);
e) BS30-4009 (9mm);
f) BS30-4010 (10mm);
dd) Peroneus Longus, Product #LPLTM;
ee) Cancellous Cubes (croutons), 30 cc, Product #LCUMM;
ff) Ilium Bicortical Block, Product #LBBM,
gg) Cancellous Chips, 104mm (15 cc), Product #LCCPM,
CODE
a) Tissue ID#2004-010-006, 2004-013-005, 2004-013-006, 2004-014-006, 2004-015-003,
2004-015-004, 2004-016-003, 2004-017-003, 2004-017-004, 2004-021-005, 2004-021-006,
2004-023-005, 2004-023-006, 2004-024-005, 2004-024-006, 2004-026-003, 2004-026-004,
2004-031-001, 2004-031-002, 2004-032-005, 2004-032-006, 2004-034-003, 2004-035-005,
2004-035-006, 2004-036-003, 2004-036-004, 2004-037-002, 2004-039-005, 2004-040-004,
2004-041-005, 2004-041-006, 2004-043-001, 2004-043-002, 2004-046-003, 2004-047-001,
2004-047-002, 2004-067-002, 2004-070-003, 2004-079-003, 2004-079-004, 2004-080-003,
2004-080-004, 2004-084-003, 2004-087-005, 2004-088-003, 2004-088-004, 2005-001-006,
2005-002-067, 2005-003-023, 2005-003-024, 2005-005-001, 2005-005-002, 2005-007-050,
2005-009-011, 2005-028-002, 2005-031-001, 2005-031-002, 2005-032-006, 2005-297-002,
2005-353-004;
b) Tissue ID #2004-017-014, 2004-017-016, 2004-017-019, 2004-017-020, 2004-017-022,
2004-017-025, 2004-017-028, 2004-017-031, 2004-017-032, 2004-017-033, 2004-017-034,
2004-032-028, 2004-079-015, 2004-085-035, 2004-087-029, 2005-009-026, 2005-009-027,
2005-032-035, 2005-032-036, 2005-032-037, 2005-032-038, 2005-032-039;
c) Tissue ID#2004-036-021, 2004-068-018, 2004-078-039, 2005-002-084, 2005-002-085,
2005-004-109, 2005-031-038, 2005-031-039;
d) Tissue ID #2004-015-015, 2004-015-018, 2004-015-019, 2004-015-020, 2004-015-021,
2004-015-022, 2004-015-024, 2004-015-025;
e) Tissue ID #2004-013-007, 2004-013-008, 2004-015-009, 2004-016-004, 2004-017-005,
2004-017-006, 2004-018-001, 2004-018-002, 2004-021-007, 2004-021-008, 2005-030-024,
2005-031-010, 2005-035-008, 2005-353-007;
f) Tissue ID #2004-015-001, 2004-015-002, 2004-017-002, 2004-022-001, 2004-026-002,
2004-030-001, 2004-030-002, 2004-034-002, 2004-036-002, 2004-037-001, 2004-037-017,
2004-038-001, 2004-046-001, 2004-046-002, 2004-048-002, 2004-069-002, 2004-078-002,
2004-079-001, 2004-079-002, 2004-080-002, 2004-081-003, 2004-084-002, 2005-002-065,
2005-002-064, 2005-003-027, 2005-030-020, 2005-353-001, 2005-031-004;
g) Tissue ID #2004-084-001, 2004-086-001, 2004-086-002, 2004-086-004, 2004-087-004,
2005-001-001, 2005-001-004, 2005-003-025, 2005-004-008, 2005-004-009, 2005-007-048,
2005-008-002, 2005-028-006, 2005-029-042, 2005-029-044, 2005-029-045, 2005-085-003;
h) Tissue ID #2004-008-002, 2004-008-003, 2004-008-015, 2004-010-008, 2004-010-019,
2004-013-022, 2004-013-023, 2004-013-024, 2004-014-013, 2004-014-015, 2004-014-016,
2004-014-017, 2004-014-018, 2004-014-020, 2004-014-021, 2004-014-022, 2004-014-023,
2004-015-027, 2004-015-028, 2004-015-029, 2004-016-014, 2004-016-015, 2004-016-016,
2004-016-018, 2004-016-020, 2004-016-022, 2004-016-023, 2004-016-024, 2004-016-027,
2004-016-028, 2004-016-029, 2004-018-012, 2004-018-013, 2004-018-014, 2004-018-015,
2004-018-016, 2004-018-017, 2004-018-018, 2004-018-019, 2004-018-020, 2004-018-021,
2004-018-022, 2004-018-023, 2004-021-019, 2004-021-020, 2004-022-006, 2004-022-007,
2004-022-010, 2004-022-013, 2004-022-014, 2004-022-015, 2004-023-018, 2004-023-019,
2004-023-021, 2004-023-023, 2004-023-025, 2004-023-027, 2004-023-028, 2004-023-029,
2004-023-032, 2004-024-009, 2004-024-010, 2004-024-011, 2004-024-012, 2004-024-013,
2004-024-014, 2004-024-015, 2004-024-016, 2004-024-017, 2004-024-018, 2004-024-019,
2004-025-001, 2004-025-002, 2004-025-003, 2004-025-004, 2004-025-005, 2004-025-006,
2004-026-007, 2004-026-008, 2004-026-009, 2004-026-010, 2004-026-011, 2004-026-012,
2004-026-013, 2004-026-014, 2004-026-015, 2004-026-016, 2004-026-017, 2004-026-018,
2004-026-019, 2004-026-020, 2004-026-021, 2004-026-022, 2004-030-005, 2004-030-006,
2004-030-007, 2004-030-008, 2004-030-009, 2004-030-010, 2004-030-011, 2004-030-012,
2004-030-013, 2004-030-014, 2004-030-015, 2004-031-005, 2004-031-007, 2004-031-008,
2004-031-009, 2004-031-010, 2004-031-011, 2004-031-012, 2004-031-013, 2004-031-014,
2004-031-015, 2004-031-016, 2004-031-017, 2004-032-007, 2004-032-008, 2004-032-009,
2004-032-010, 2004-032-011, 2004-032-012, 2004-032-013, 2004-032-014, 2004-032-015,
2004-032-016, 2004-032-017, 2004-032-020, 2004-032-021, 2004-032-022, 2004-032-023,
2004-032-024, 2004-032-026, 2004-034-011, 2004-034-012, 2004-034-013, 2004-034-014,
2004-035-026, 2004-035-027, 2004-035-028, 2004-035-029, 2004-035-030, 2004-035-031,
2004-035-032, 2004-035-033, 2004-035-034, 2004-035-035, 2004-035-036, 2004-035-037,
2004-035-038, 2004-035-039, 2004-035-040, 2004-035-041, 2004-035-042, 2004-035-043,
2004-035-044, 2004-035-045, 2004-035-046, 2004-035-047, 2004-035-048, 2004-035-049,
2004-035-050, 2004-035-051, 2004-035-052, 2004-035-053, 2004-035-054, 2004-036-009,
2004-036-016, 2004-037-008, 2004-037-009, 2004-037-012, 2004-038-012, 2004-038-013,
2004-038-014, 2004-038-015, 2004-039-016, 2004-039-017, 2004-039-019, 2004-039-020,
2004-039-021, 2004-039-022, 2004-039-023, 2004-039-024, 2004-039-025, 2004-039-026,
2004-039-027, 2004-039-028, 2004-039-029, 2004-039-030, 2004-039-031, 2004-039-032,
2004-039-033, 2004-039-034, 2004-039-035, 2004-039-036, 2004-040-014, 2004-040-015,
2004-040-016, 2004-040-017, 2004-040-018, 2004-040-019, 2004-040-020, 2004-041-015,
2004-041-024, 2004-042-008, 2004-042-009, 2004-042-010, 2004-042-011, 2004-042-012,
2004-042-013, 2004-042-014, 2004-042-015, 2004-042-016, 2004-042-017, 2004-042-018,
2004-042-019, 2004-042-020, 2004-042-021, 2004-042-022, 2004-042-023, 2004-043-005,
2004-043-006, 2004-043-007, 2004-043-008, 2004-043-009, 2004-043-010, 2004-043-011,
2004-043-012, 2004-043-013, 2004-043-014, 2004-043-015, 2004-043-016, 2004-043-017,
2004-043-018, 2004-043-019, 2004-043-020, 2004-046-006, 2004-046-007, 2004-046-008,
2004-046-009, 2004-046-010, 2004-046-011, 2004-046-012, 2004-046-013, 2004-047-059,
2004-047-060, 2004-047-061, 2004-047-062, 2004-047-063, 2004-047-064, 2004-047-065,
2004-047-066, 2004-047-067, 2004-047-068, 2004-047-070, 2004-047-071, 2004-047-072,
2004-047-074, 2004-047-076, 2004-048-012, 2004-054-002, 2004-054-003, 2004-054-004,
2004-054-005, 2004-054-006, 2004-054-007, 2004-054-008, 2004-055-003, 2004-055-005,
2004-055-007, 2004-055-011, 2004-055-012, 2004-056-002, 2004-056-003, 2004-056-004,
2004-056-005, 2004-056-007, 2004-057-008, 2004-057-009, 2004-057-010, 2004-057-011,
2004-057-015, 2004-057-016, 2004-057-018, 2004-057-019, 2004-057-020, 2004-057-021,
2004-057-022, 2004-057-023, 2004-057-024, 2004-057-025, 2004-057-026, 2004-057-027,
2004-058-006, 2004-058-007, 2004-058-008, 2004-058-009, 2004-059-009, 2004-059-010,
2004-059-011, 2004-059-012, 2004-059-013, 2004-059-014, 2004-059-015, 2004-059-016,
2004-059-017, 2004-059-018, 2004-059-019, 2004-059-020, 2004-059-023, 2004-065-007,
2004-065-008, 2004-065-009, 2004-065-011, 2004-065-013, 2004-065-014, 2004-065-015,
2004-065-017, 2004-065-018, 2004-065-023, 2004-065-025, 2004-065-027, 2004-065-028,
2004-066-012, 2004-066-013, 2004-066-014, 2004-066-015, 2004-066-016, 2004-066-018,
2004-066-021, 2004-066-023, 2004-066-024, 2004-066-026, 2004-066-027, 2004-066-028,
2004-066-029, 2004-066-032, 2004-066-033, 2004-066-034, 2004-066-035, 2004-067-003,
2004-067-004, 2004-067-005, 2004-067-006, 2004-067-007, 2004-067-008, 2004-067-012,
2004-067-014, 2004-067-015, 2004-068-007, 2004-068-012, 2004-069-007, 2004-069-008,
2004-069-009, 2004-069-010, 2004-069-011, 2004-069-012, 2004-069-013, 2004-069-014,
2004-069-015, 2004-069-016, 2004-070-004, 2004-070-005, 2004-070-006, 2004-070-007,
2004-070-008, 2004-070-009, 2004-070-010, 2004-070-011, 2004-076-007, 2004-076-008,
2004-076-009, 2004-076-010, 2004-076-011, 2004-076-012, 2004-076-013, 2004-076-014,
2004-076-015, 2004-076-016, 2004-076-017, 2004-076-018, 2004-076-019, 2004-076-020,
2004-078-011, 2004-078-012, 2004-078-013, 2004-078-014, 2004-078-015, 2004-078-016,
2004-078-017, 2004-078-018, 2004-078-019, 2004-078-020, 2004-078-021, 2004-078-022,
2004-078-023, 2004-078-024, 2004-078-025, 2004-078-026, 2004-078-027, 2004-078-028,
2004-078-029, 2004-078-030, 2004-078-031, 2004-078-032, 2004-079-005, 2004-079-006,
2004-079-007, 2004-079-008, 2004-079-009, 2004-079-010, 2004-079-011, 2004-079-012,
2004-079-013, 2004-079-014, 2004-080-019, 2004-080-020, 2004-080-021, 2004-080-022,
2004-080-023, 2004-080-024, 2004-080-025, 2004-080-026, 2004-080-027, 2004-080-028,
2004-081-004, 2004-081-005, 2004-081-006, 2004-081-007, 2004-081-008, 2004-081-009,
2004-081-010, 2004-081-011, 2004-081-012, 2004-082-005, 2004-082-006, 2004-082-007,
2004-082-008, 2004-082-009, 2004-082-010, 2004-082-011, 2004-082-012, 2004-083-005,
2004-083-006, 2004-083-008, 2004-083-009, 2004-084-005, 2004-084-006, 2004-084-007,
2004-084-009, 2004-084-010, 2004-084-011, 2004-084-012, 2004-085-027, 2004-085-028,
2004-085-031, 2004-086-009, 2004-086-010, 2004-086-011, 2004-086-012, 2004-086-013,
2004-086-014, 2004-086-015, 2004-086-016, 2004-086-017, 2004-086-018, 2004-086-019,
2004-086-020, 2004-086-021, 2004-086-022, 2004-086-023, 2004-086-024, 2004-086-025,
2004-086-026, 2004-086-027, 2004-086-028, 2004-086-029, 2004-086-030, 2004-087-009,
2004-087-010, 2004-087-011, 2004-087-012, 2004-087-013, 2004-087-014, 2004-087-015,
2004-087-016, 2004-087-017, 2004-087-018, 2004-087-019, 2004-087-020, 2004-087-021,
2004-087-022, 2004-087-023, 2004-087-024, 2004-087-025, 2004-087-026, 2004-087-027,
2004-087-028, 2005-002-079, 2005-002-082, 2005-009-022, 2005-009-023, 2005-009-024,
2005-028-016, 2004-039-018;
i) Tissue ID #2004-008-019, 2004-008-020, 2004-010-026, 2004-010-027, 2004-013-035,
2004-013-036, 2004-014-031, 2004-014-032, 2004-015-034, 2004-015-035, 2004-021-017,
2004-021-018, 2004-022-004, 2004-023-008, 2004-031-003, 2004-031-004, 2004-032-034,
2004-036-008, 2004-040-005, 2004-040-006, 2004-041-007, 2004-041-008, 2004-043-003,
2004-043-004, 2004-047-004, 2004-055-001, 2004-078-010, 2004-085-015, 2004-085-016,
2004-086-007, 2005-001-018, 2005-002-074, 2005-007-061, 2004-065-005;
j) Tissue ID #2004-037-004 and 2004-037-005;
k) Tissue ID #2004-013-019, 2004-013-010, 2004-015-008, 2004-018-003, 2004-021-009,
2004-021-010, 2004-035-010, 2005-031-007
l) Tissue ID #2004-021-037, 2004-021-038, 2004-021-039, 2004-021-040, 2004-021-041,
2004-021-042, 2004-021-044, 2004-021-045, 2004-021-046, 2004-021-047, 2004-021-048,
2004-021-049, 2004-021-050, 2004-021-051, 2004-022-016, 2004-022-017, 2004-022-018,
2004-022-019, 2004-022-020, 2004-032-030, 2004-032-032, 2004-032-033, 2004-035-055,
2004-035-056, 2004-035-057, 2004-035-058, 2004-035-059, 2004-035-060, 2004-035-061,
2004-035-062, 2004-035-063, 2004-035-064, 2004-035-065, 2004-035-066, 2004-035-067,
2004-039-037, 2004-039-038, 2004-039-039, 2004-039-040, 2004-039-041, 2004-039-042,
2004-039-043, 2004-039-044, 2004-039-045, 2004-039-046, 2004-039-047;
m) Tissue ID #2004-013-013, 2004-013-014, 2004-013-015, 2004-013-016, 2004-014-007,
2004-014-008, 2004-015-010, 2004-015-011, 2004-015-012, 2004-016-008, 2004-016-009,
2004-016-010, 2004-016-011, 2004-017-007, 2004-017-008, 2004-017-009, 2004-017-010,
2004-018-007, 2004-018-008, 2004-018-009, 2004-018-010, 2004-021-013, 2004-021-014,
2004-021-015, 2004-035-011, 2004-035-012, 2004-035-014, 2004-036-006, 2004-047-003,
2004-078-005, 2004-078-006, 2004-078-007, 2004-078-008, 2004-080-011, 2004-088-007,
2005-001-013, 2005-001-014, 2005-001-015, 2005-002-071, 2005-002-072, 2005-002-073,
2005-003-028, 2005-003-029, 2005-003-030, 2005-004-019, 2005-004-020, 2004-005-012,
2005-005-013, 2005-006-010, 2005-007-057, 2005-007-058, 2005-007-059, 2005-007-060,
2005-008-007, 2005-008-008, 2005-009-017, 2005-028-013, 2005-028-014, 2005-030-030,
2005-030-031, 2005-297-007, 2005-297-008, 2005-297-009, 2005-297-010, 2005-353-008,
2005-353-009, 2005-353-010, 2005-353-011;
n) Tissue ID #2004-010-001, 2004-010-002, 2004-010-003, 2004-013-001, 2004-014-003,
2004-014-004, 2004-021-001, 2004-021-002, 2004-021-003, 2004-021-004, 2004-024-001,
2004-034-001, 2004-035-001, 2004-035-002, 2004-035-003, 2004-035-004, 2004-039-004,
2004-040-001, 2004-040-002, 2004-041-002, 2004-041-003, 2004-042-002, 2004-042-003,
2004-042-004, 2004-065-001, 2004-065-004, 2004-065-002, 2004-065-003;
o) Tissue ID #2005-004-108, 2004-085-043, 2004-085-044, 2004-085-045;
p) Tissue ID #2004-085-052, 2004-085-053, 2004-085-054, 2004-085-055, and 2004-087-037;
q) Tissue ID #2005-006-012, 2005-028-007, 2005-028-008;
r) Tissue ID #2004-014-025, 2004-014-028, 2004-031-048, 2004-034-015, 2004-034-016,
2004-048-014, 2004-059-029, 2004-065-029, 2004-066-043, 2004-068-017, 2005-008-081;
s) Tissue ID#2005-031-032, 2005-004-107;
t) Tissue ID #2004-042-084, 2004-042-085, 2005-007-067, 2005-007-068, 2004-088-009;
u) Tissue ID #2004-047-018, 2004-047-019;
v) Tissue ID #2004-034-020, 2004-034-021, 2004-034-022, 2004-034-023, 2004-034-024,
2004-034-025, 2004-034-026, 2004-034-027, 2004-034-028, 2004-034-030, 2004-034-033;
w) Tissue ID# 2004-021-057, 2004-021-058, 2004-021-059, 2004-021-062, 2004-022-026,
2004-030-018, 2004-031-020, 2004-031-024, 2004-034-017, 2004-035-074, 2004-035-075,
2004-035-076, 2004-035-077, 2004-036-022, 2004-036-024, 2004-036-025, 2004-039-049,
2004-039-050, 2004-039-051, 2004-039-052, 2004-047-083, 2004-048-015, 2004-057-034,
2004-058-020, 2004-066-048, 2004-068-019, 2004-068-021, 2004-068-023, 2004-078-042,
2004-078-043, 2004-078-044, 2004-078-045, 2004-086-035, 2004-086-037;
x) Tissue ID#2004-017-035, 2004-017-036, 2004-026-032, 2004-026-033, 2004-030-017,
2004-056-008, 2004-056-009, 2004-038-19, 2004-038-19, 2004-038-20;
y) Tissue ID#2004-021-060, 2004-021-061, 2004-022-024, 2004-023-036, 2004-023-037,
2004-031-021, 2004-031-022, 2004-034-018, 2004-039-053, 2004-043-021, 2004-043-022,
2004-080-016, 2004-080-017;
z) Tissue ID#2004-042-057;
aa) Tissue ID#2004-042-033;
bb) Cervical Allografts, 3000 series:
a) Tissue ID # 2004-021-063, 2004-021-066, 2005-004-111, 2005-007-073, 2005-008-083,
2005-008-084, 2005-008-085, 2005-008-086, 2005-008-087, 2005-008-088, 2005-008-090,
2005-008-091, 2005-029-067, 2005-029-068, 2005-029-070, 2005-029-071, 2005-029-072,
2005-029-073, 2005-029-074, 2005-029-075, 2005-029-076, 2005-029-077, 2005-029-078,
2005-029-079, 2005-029-080, 2005-029-081, 2005-029-082;
b) Tissue ID # 2004-021-067, 2004-021-068, 2004-021-071, 2005-004-113, 2005-007-076,
2005-008-092, 2005-008-093, 2005-008-094, 2005-008-095, 2005-008-096, 2005-008-097,
2005-008-098, 2005-029-083, 2005-029-084, 2005-029-085, 2005-029-088, 2005-029-090,
2005-029-091, 2005-029-092, 2005-029-093, 2005-029-094, 2005-029-095;
c) Tissue ID # 2004-021-074, 2005-004-116, 2005-008-102, 2005-008-103, 2005-008-106,
2005-008-107, 2005-008-108, 2005-008-109, 2005-008-110, 2005-008-111, 2005-029-096,
2005-029-097, 2005-029-098, 2005-029-100, 2005-029-101;
d) Tissue ID # 2004-013-065, 2004-013-067, 2004-021-075, 2005-004-120, 2005-004-121,
2005-008-112, 2005-008-113, 2005-008-114, 2005-008-116, 2005-008-117, 2005-029-102,
2005-029-103, 2005-031-090, 2005-031-091, 2005-031-092, 2005-031-093, 2005-031-094;
e) Tissue ID # 2004-013-068, 2004-013-070, 2004-013-071, 2004-013-074, 2004-013-075,
2004-013-078, 2004-013-079, 2004-013-083, 2004-013-085, 2004-013-086, 2004-021-076,
2004-021-077, 2004-021-078, 2004-021-079, 2004-021-081, 2004-021-082, 2004-021-083,
2005-004-122, 2005-004-123, 2005-004-124, 2005-004-127, 2005-004-128, 2005-004-129,
2005-004-130, 2005-004-131, 2005-004-132, 2005-004-135, 2005-004-137, 2005-004-139,
2005-004-140, 2005-004-141, 2005-004-142, 2005-004-143, 2005-008-119, 2005-008-120,
2005-029-106, 2005-029-109, 2005-029-110, 2005-029-112, 2005-029-113, 2005-029-114,
2005-031-095, 2005-031-096, 2005-031-097, 2005-031-100, 2005-031-102, 2005-031-104,
2005-031-105, 2005-031-106, 2005-031-107, 2005-031-108;
f) Tissue ID # 2004-013-088, 2004-013-090, 2004-013-092, 2004-013-093, 2004-013-094,
2005-008-121, 2005-008-122, 2005-008-123, 2005-008-124, 2005-029-115, 2005-029-116,
2005-029-117, 2005-029-118, 2005-029-119, 2005-029-120, 2005-029-121, 2005-031-110,
2005-031-111, 2005-031-114, 2005-031-115, 2005-031-119, 2005-031-120, 2005-031-121,
2005-031-122, 2005-031-124, 2005-031-126, 2005-031-128, 2005-031-129, 2005-031-130,
2005-031-131, 2005-031-132;
cc) Corticocancellous Allografts, 4000 series:
a) Tissue ID # 2004-014-033, 2004-042-087, 2004-042-088, 2004-042-089, 2004-042-090,
2004-083-013, 2004-083-014, 2004-083-015, 2004-087-039, 2004-087-040, 2004-087-041,
2004-087-042, 2005-001-019, 2005-001-020, 2005-002-002, 2005-004-021, 2005-004-022,
2005-004-023, 2005-004-024, 2005-004-025, 2005-004-026, 2005-004-027, 2005-004-028,
2005-004-029, 2005-006-021, 2005-006-022, 2005-007-001, 2005-007-002, 2005-008-019,
2005-008-020, 2005-008-021, 2005-008-022, 2005-008-023, 2005-028-026, 2005-028-027,
2005-029-001, 2005-029-002, 2005-031-054, 2005-031-055, 2005-031-056, 2005-031-057,
2005-032-009, 2005-032-010, 2005-032-011, 2005-032-012, 2005-032-013, 2005-032-014,
2005-032-015;
b) Tissue ID # 2004-014-034, 2004-014-035, 2004-014-036, 2004-014-037, 2004-024-023,
2004-024-024, 2004-024-025, 2004-024-026, 2004-024-027, 2004-040-035, 2004-042-091,
2004-042-092, 2004-042-093, 2004-042-094, 2004-046-004, 2004-083-016, 2004-085-056,
2004-087-043, 2004-087-044, 2004-087-045, 2004-087-046, 2005-001-021, 2005-001-022,
2005-001-023, 2005-001-024, 2005-002-003, 2005-002-004, 2005-002-005, 2005-002-006,
2005-002-007, 2005-002-008, 2005-004-030, 2005-004-031, 2005-004-032, 2005-004-033,
2005-004-034, 2005-004-035, 2005-004-036, 2005-004-037, 2005-004-038, 2005-004-039,
2005-004-040, 2005-004-041, 2005-004-042, 2005-004-043, 2005-005-019, 2005-006-023,
2005-007-003, 2005-007-004, 2005-007-005, 2005-007-006, 2005-007-007, 2005-008-024,
2005-008-025, 2005-008-026, 2005-008-027, 2005-008-028, 2005-008-029, 2005-008-030,
2005-008-031, 2005-008-032, 2005-008-033, 2005-008-034, 2005-009-001, 2005-009-002,
2005-009-003, 2005-009-019, 2005-009-020, 2005-009-021, 2005-028-028, 2005-028-029,
2005-028-030, 2005-028-031, 2005-029-003, 2005-029-004, 2005-029-005, 2005-030-001,
2005-030-002, 2005-031-058, 2005-031-059, 2005-031-060, 2005-031-061, 2005-031-062,
2005-031-063, 2005-031-064, 2005-031-065, 2005-031-066, 2005-031-067, 2005-032-016,
2005-032-018, 2005-032-019, 2005-032-020, 2005-032-021, 2005-032-022, 2005-032-023,
2005-032-024, 2005-032-025, 2005-032-026, 2005-032-027, 2005-297-013, 2005-297-014,
2005-353-012;
c) Tissue ID # 2004-013-038, 2004-013-039, 2004-013-040, 2004-013-041, 2004-013-042,
2004-013-043, 2004-013-044, 2004-013-045, 2004-013-046, 2004-013-047, 2004-013-048,
2004-014-038, 2004-014-039, 2004-014-040, 2004-014-041, 2004-014-042, 2004-014-043,
2004-014-044, 2004-014-045, 2004-014-046, 2004-014-047, 2004-014-048, 2004-014-049,
2004-024-028, 2004-024-029, 2004-024-030, 2004-024-031, 2004-040-036, 2004-042-095,
2004-046-004-002, 2004-083-017, 2004-083-018, 2004-083-019, 2004-083-020, 2004-083-021,
2004-085-057, 2004-085-058, 2004-087-047, 2004-087-048, 2005-001-025, 2005-001-026,
2005-001-027, 2005-002-009, 2005-002-010, 2005-002-011, 2005-002-012, 2005-002-013,
2005-002-014, 2005-002-015, 2005-002-016, 2005-002-017, 2005-002-018, 2005-002-019,
2005-002-020, 2005-002-021, 2005-002-022, 2005-002-023, 2005-002-024, 2005-003-003,
2005-003-004, 2005-004-044, 2005-004-045, 2005-004-046, 2005-004-047, 2005-004-048,
2005-004-049, 2005-004-050, 2005-004-051, 2005-004-052, 2005-004-053, 2005-004-054,
2005-004-055, 2005-004-056, 2005-004-057, 2005-004-058, 2005-004-059, 2005-004-060,
2005-005-020, 2005-005-021, 2005-005-022, 2005-005-023, 2005-006-024, 2005-006-026,
2005-007-008, 2005-007-009, 2005-007-010, 2005-007-011, 2005-007-012, 2005-007-013,
2005-007-014, 2005-007-015, 2005-007-016, 2005-007-017, 2005-007-018, 2005-007-019,
2005-007-020, 2005-007-021, 2005-007-022, 2005-007-023, 2005-007-024, 2005-007-025,
2005-008-035, 2005-008-036, 2005-008-037, 2005-008-038, 2005-008-039, 2005-008-040,
2005-008-041, 2005-008-042, 2005-008-043, 2005-008-044, 2005-008-045, 2005-008-046,
2005-009-004, 2005-009-005, 2005-009-006, 2005-009-007, 2005-009-018, 2005-028-032,
2005-028-033, 2005-028-034, 2005-028-035, 2005-028-036, 2005-028-037, 2005-028-038,
2005-028-040, 2005-029-006, 2005-029-007, 2005-029-008, 2005-029-009, 2005-029-010,
2005-029-011, 2005-029-012, 2005-029-014, 2005-029-015, 2005-029-016, 2005-029-017,
2005-029-018, 2005-030-003, 2005-030-004, 2005-030-005, 2005-030-006, 2005-030-007,
2005-030-008, 2005-030-009, 2005-031-068, 2005-031-069, 2005-031-070, 2005-031-071,
2005-031-072, 2005-032-029, 2005-032-030, 2005-032-031, 2005-032-032, 2005-032-033,
2005-297-015, 2005-297-019;
d) Tissue ID # 2004-013-049, 2004-013-050, 2004-013-051, 2004-013-052, 2004-013-053,
2004-013-054, 2004-013-055, 2004-013-056, 2004-013-057, 2004-013-058, 2004-013-059,
2004-014-050, 2004-014-051, 2004-014-052, 2004-014-053, 2004-014-054, 2004-014-055,
2004-014-056, 2004-014-057, 2004-014-058, 2004-014-059, 2004-024-032, 2004-024-033,
2004-024-034, 2004-024-035, 2004-040-037, 2004-040-038, 2004-042-096, 2004-042-097,
2004-042-098, 2004-042-099, 2004-046-004-003, 2004-046-005-001, 2004-085-059, 2004-087-049,
2004-087-050, 2005-001-028, 2005-001-029, 2005-001-031, 2005-002-025, 2005-002-026,
2005-002-027, 2005-002-028, 2005-002-029, 2005-002-030, 2005-002-031, 2005-002-032,
2005-002-033, 2005-002-034, 2005-002-035, 2005-002-036, 2005-002-037, 2005-002-038,
2005-002-039, 2005-002-040, 2005-002-041, 2005-002-042, 2005-002-043, 2005-002-044,
2005-002-045, 2005-002-046, 2005-002-047, 2005-002-048, 2005-002-049, 2005-002-050,
2005-003-005, 2005-003-006, 2005-003-009, 2005-003-010, 2005-003-011, 2005-003-012,
2005-004-061, 2005-004-062, 2005-004-063, 2005-004-064, 2005-004-065, 2005-004-066,
2005-004-067, 2005-004-068, 2005-004-069, 2005-004-070, 2005-004-071, 2005-004-072,
2005-004-073, 2005-004-074, 2005-004-075, 2005-004-076, 2005-004-077, 2005-004-078,
2005-005-024, 2005-005-025, 2005-005-026, 2005-005-027, 2005-005-028, 2005-005-029,
2005-007-026, 2005-007-027, 2005-007-028, 2005-007-029, 2005-007-030, 2005-007-031,
2005-007-032, 2005-007-033, 2005-007-034, 2005-007-035, 2005-007-036, 2005-007-037,
2005-007-038, 2005-007-039, 2005-007-040, 2005-007-042, 2005-008-047, 2005-008-048,
2005-008-049, 2005-008-050, 2005-008-051, 2005-008-052, 2005-009-008, 2005-009-009,
2005-028-042, 2005-028-044, 2005-028-045, 2005-028-046, 2005-028-047, 2005-029-019,
2005-029-020, 2005-029-021, 2005-029-022, 2005-029-023, 2005-029-024, 2005-029-025,
2005-029-026, 2005-029-027, 2005-029-028, 2005-029-029, 2005-030-010, 2005-030-011,
2005-030-012, 2005-030-013, 2005-030-014, 2005-030-015, 2005-030-016, 2005-031-073,
2005-031-074, 2005-031-075, 2005-031-076, 2005-031-077, 2005-032-034, 2005-297-020,
2005-297-022, 2005-297-023, 2005-297-024, 2005-353-013, 2005-353-014, 2005-353-016;
e) Tissue ID # 2004-013-060, 2004-013-061, 2004-013-062, 2004-013-063, 2004-013-064,
2004-014-060, 2004-014-061, 2004-014-062, 2004-014-063, 2004-014-064, 2004-024-036,
2004-024-037, 2004-024-038, 2004-024-039, 2004-040-039, 2004-042-100, 2004-042-101,
2004-042-102, 2004-042-103, 2004-046-005-002, 2004-046-005-003, 2004-083-022, 2004-085-061,
2005-002-051, 2005-002-052, 2005-002-053, 2005-002-054, 2005-002-055, 2005-002-056,
2005-002-057, 2005-002-058, 2005-002-059, 2005-002-060, 2005-002-061, 2005-002-062,
2005-003-020, 2005-003-022, 2005-004-079, 2005-004-080, 2005-004-081, 2005-004-082,
2005-004-083, 2005-004-084, 2005-004-085, 2005-004-086, 2005-004-087, 2005-004-088,
2005-004-089, 2005-005-030, 2005-005-031, 2005-005-032, 2005-005-033, 2005-005-034,
2005-005-035, 2005-005-036, 2005-005-037, 2005-005-038, 2005-005-039, 2005-005-042,
2005-006-033, 2005-006-034, 2005-006-035, 2005-006-036, 2005-006-037, 2005-007-043,
2005-007-044, 2005-008-053, 2005-008-054, 2005-008-055, 2005-008-056, 2005-008-057,
2005-008-058, 2005-008-059, 2005-008-060, 2005-008-061, 2005-008-062, 2005-008-063,
2005-028-048, 2005-029-031, 2005-029-032, 2005-029-033, 2005-029-034, 2005-029-035,
2005-029-036, 2005-029-037, 2005-029-038, 2005-029-039, 2005-029-040, 2005-029-041,
2005-030-017, 2005-030-018, 2005-031-078, 2005-031-079, 2005-031-080, 2005-031-081,
2005-031-082, 2005-297-025, 2005-297-026, 2005-353-017, 2005-353-018;
f) Tissue ID # 2004-014-065, 2004-014-066, 2004-024-041, 2004-040-043, 2004-040-044,
2004-040-045, 2004-040-046, 2004-040-047, 2004-040-048, 2004-040-049, 2004-042-104,
2004-042-105, 2004-042-106, 2004-087-051, 2005-001-039, 2005-001-040, 2005-001-041,
2005-001-042, 2005-001-043, 2005-001-044, 2005-001-045, 2005-002-063, 2005-004-090,
2005-004-091, 2005-004-092, 2005-004-093, 2005-004-094, 2005-004-095, 2005-004-096,
2005-004-097, 2005-004-098, 2005-004-099, 2005-004-100, 2005-005-043, 2005-008-064,
2005-008-065, 2005-008-066, 2005-008-067, 2005-008-068, 2005-008-069, 2005-008-070,
2005-008-071, 2005-008-072, 2005-008-073, 2005-028-053, 2005-031-083, 2005-031-084,
2005-031-085, 2005-031-086, 2005-031-087, 2005-031-088, 2005-297-029, 2005-297-033,
2005-297-034, 2005-297-035, 2005-297-036, 2005-353-020;
g) Tissue ID#2004-013-011;
h) Tissue ID#2004-048-005, 2004-048-008, 2004-088-010, 2004-088-012, 2004-088-013,
2004-088-014;
i) Tissue ID #2004-035-073;
j) Tissue ID #2005-297-045 and 2005-353-024
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lost Mountain Tissue Bank, Kennesaw, GA, by voluntary withdrawal notification dated July 10, 2006 and a written notification dated September 5, 2006.
Manufacturer: Donor Referral Services, 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
1,742 allografts
DISTRIBUTION
Nationwide, Turkey and Korea

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Irradiated, Recall # B-0117-07
CODE
Unit: 2466272 (Part B)
RECALLING FIRM/MANUFACTURER
Walter Reed Army Medical Center, Washington, D.C., by telephone on August 20, 2004. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as irradiated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
D.C.

___________________________________
PRODUCT
Platelets Pheresis, Recall # B-0432-07
CODE
Unit: 9152638 (parts 1, 2 and 3)
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on May 19, 2002. Firm initiated recall is complete.
REASON
Blood products, labeled “Leukocyte Reduced” but which failed to meet the criteria for a leukoreduced unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL

___________________________________
PRODUCT
Red Blood Cells, Recall # B-0709-07
CODE
Unit: 6224764
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., New York, NY, by telephone and letter dated August 9, 2004.
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B- 0710-07
CODE
Unit: 2801296
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on September 23, 2006 and by letter dated October 2, 2006. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Propionibacterium acnes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0753-07
CODE
Unit: 004GK81754
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by facsimile and by letters on November 14, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA

___________________________________
PRODUCT
Human Tissue for Transplantation: Corneas, Recall # B-0754-07
CODE
Tissue numbers: 060028100(OD) and 060028200
RECALLING FIRM/MANUFACTURER
Oklahoma Lions Eye Bank, Oklahoma City, OK, by telephone on July 19, 2006 and by letter on July 31, 2006. Firm initiated recall is complete.
REASON
Human Corneas, inadequately tested for infectious diseases in that the blood sample used for testing may have been hemodiluted, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
OK and CA

___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0755-07
CODE
Units: 5783246 (Bag 1&2)
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., New York, NY, by telephone on October 6, 2003. Firm initiated recall is complete.
REASON
Blood products, labeled as leukoreduced, but which did not meet the requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0798-07
CODE
Unit: 042KF17815
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northern Ohio Region, Cleveland, by letter and telephone on November 11, 2005. Firm initiated recall is complete.
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
OH

___________________________________
PRODUCT
Red Blood Cells, Recall # B-0799-07
CODE
Unit: LN07129
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Sterling, VA, by letter on November 30, 2005. Firm initiated recall is complete.
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
VA

___________________________________
PRODUCT
Red Blood Cells, Recall # B-0800-07
CODE
Unit: KT50039
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Sterling, VA, by letter on February 2, 2006. Firm initiated recall is complete.
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
VA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0654-07
CODE
Units: 22LE17208 (Parts 1, 2, and 3), 22LE15587 (Parts 1, 2, and 3)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on August 9, 2006 or by facsimile on August 14, 2006, and by follow-up letter dated August 17, 2006. Firm initiated recall is complete.
REASON
Blood products, which were labeled leukoreduced but were not tested to determine the white blood cell count as required by the firm's standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
PA

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0727-07
CODE
Unit: 5443689
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on August 4, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

___________________________________
PRODUCT
Recovered Plasma, Recall # B-0732-07
CODE
Unit: 5552730
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., New York, NY, by telephone and letter dated August 11, 2005. Firm initiated recall is complete.
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
CA

___________________________________
PRODUCT
Platelets, Recall # B-0735-07
CODE
Units: 3696887, 3696889, 3696890, 3696891, 3696894
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., New York, NY, by letter dated October 12, 2004 and telephone on October 13, 2004. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood that may have been shipped at the incorrect temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NY

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0736-07
CODE
Units: C67218, C67234, C69631, C63912, C66091, C66093, C67230, C63907, C66085, C66393, C66400, C65181, C65180, C63905, C65178
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by letter dated October 5, 2006. Firm initiated recall is complete.
REASON
Blood products, which were out of controlled storage for more than 30 minutes during leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
PA

___________________________________
PRODUCT
Source Plasma, Recall # B-0737-07
CODE
Units: 05692439, 05691258, 05690633
RECALLING FIRM/MANUFACTURE
Knoxville Plasma Corporation, Knoxville, TN, by facsimile on August 5, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0738-07
CODE
Units: 05KTNA7130, 05KTNA6913, 05KTNA6617, 05KTNA6511, 05KTNA6306, 05KTNA6027, 05KTNA5698, 05KTNA5586, 05KTNA5379, 05KTNA4814, 05KTNA4704, 05KTNA4508, 05KTNA4397, 05KTNA4224, 05KTNA4102, 05KTNA3941, 05KTNA3852, 05KTNA3726, 05KTNA3608, 05KTNA2864, 05KTNA2782, 05KTNA2604, 05KTNA2064, 05KTNA1966, 05KTNA1782, 05KTNA1688, 05KTNA1446, 05KTNA1259, 05KTNA1119, 05KTNA0522, 05KTNA0402, 05KTNA0183, 05KTNA0071, 04KTNA0991, 04KTNA0791, 04KTNA0672, 04KTNA0466, 04KTNA0342, 04KTNA0175, 04KTNA0064, 19818542, 19816463, 19815428, 19813684, 19812762, 19811130, 19810225, 19808659, 19807836, 19803043, 19802152, 19256238, 19255200, 19253213, 19252223, 19250533, 19009148, 19006772, 19005492, 19003887, 19000817, 18959789, 18957884, 18956917, 18951714, 09977396, 09975354, 09974357, 09972544, 09971707, 10288511, 10287200, 10284452, 10281703, 08898692, 09189096, 09187061, 09184169, 09183049, 06909833, 06908560, 06906573, 06905408, 06903732, 06902414, 06900700, 06877248, 06876227, 06874384, 06873059, 06871895, 06870690, 06849306, 06848132, 06846961, 06845537, 06842109, 05030491, 05029716, 05028306, 05026982, 05025725, 05023288, 05022298, 05021017, 04879121, 04877820, 04876793, 04875864, 04873600, 04873266, 04830511, 04829522, 04828044, 04827801
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corporation, Knoxville, TN, by facsimile on July 22, 2005 and July 26, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
115 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0739-07
CODE
Units: 05KTNA7131, 05KTNA6614, 05KTNA6172, 05KTNA6015, 05KTNA5773, 05KTNA5266, 05KTNA5170, 05KTNA3940, 05KTNA2783, 05KTNA2606, 05KTNA1542, 05KTNA1444, 05KTNA1120, 05KTNA0892, 05KTNA0764, 05KTNA0523, 05KTNA0401, 05KTNA0179, 05KTNA0069, 04KTNA1413, 04KTNA1296, 04KTNA0993, 04KTNA0790, 04KTNA0173, 04KTNA0063, 19816494, 19815435, 19813707, 19812793, 19810256, 19808611, 19807492, 19805641, 19804750, 19803067, 19801964, 19258874, 19258379, 19256269, 19255194, 19253220, 19252230, 19010489, 19009179, 19006802, 19005508, 19003955, 19002729, 19000824, 18958690, 18955569, 18951240, 09980457, 09977655, 09976825, 09974692, 09973398, 09971585, 10290330, 10289181, 10287521, 10286005, 10281567, 08900388, 08898715, 08893420, 08890757, 09189331, 09187139
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corporation, Knoxville, TN, by facsimile on July 22, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
69 Units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0740-07
CODE
Unit: 05KTNA3722
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corporation, Knoxville, TN, by facsimile on July 22, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0741-07
CODE
Units: 06879426, 06876296, 06874445
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corporation, Knoxville, TN, by facsimile on August 5, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0742-07
CODE
Units: 05KTNA0769, 04KTNA1343, 04KTNA1116, 19804767, 19803081, 19802350
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corporation, Knoxville, TN, by facsimile on August 5, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0743-07
CODE
Units: 05026104, 05022359, 05021185, 04877899, 04875192, 04874720, 04872429, 04871125, 04830016, 04827436, 04826415, 04821663, 05697014, 05695591, 05698332
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corporation, Knoxville, TN, by facsimile on August 5, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0744-07
CODE
Units: 09184602, 09183025, 09181328, 06908768, 06906597, 06905538, 06902513, 06900793, 06877675, 06876364, 06873967, 06872380, 06850302, 06849825, 06844936, 05026098, 05022168, 04880486, 04878063, 04877394, 04875994, 04872481, 04871057, 04830139, 04828822, 04827443, 04826736, 04824725, 04823681, 04821311, 05699377, 05697601, 05696635, 05693986, 05693269
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corporation, Knoxville, TN, by facsimile on August 9, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0745-07
CODE
Units: 18951653, 09977273, 09976290, 09971776, 09970762, 10289099, 10287613, 10285480, 10284483, 08899286, 08895424, 08893406, 08892416, 09189713, 09188884, 09182950, 06908706, 06906177, 06905149, 06903305, 06901585, 06900786, 06878191, 06876418, 06875350, 06872359, 06871123, 06849795, 06847371, 06846077
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corporation, Knoxville, TN, by facsimile on August 9, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0746-07
CODE
Units: 05KTNA1572, 05KTNA1491, 05KTNA0953, 05KTNA0237, 04KTNA0888, 04KTNA0171, 19253732, 18960068, 18957372, 18955866, 18954586, 18953220, 09980334, 09979505, 09976764, 09975606, 09973749, 10288559, 10281321, 08899835, 08898685, 08891228, 09189676, 09188778, 09184626, 09183117, 09181281, 06909857
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corporation, Knoxville, TN, by facsimile on August 9, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0747-07
CODE
Units: 04875208, 04826712, 05696666, 05694730, 05694013, 05692774, 05692088, 05690985
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corporation, Knoxville, TN, by facsimile on August 9, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0748-07
CODE
Unit: 04828990
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corporation, Knoxville, TN, by facsimile on August 5, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0749-07
CODE
Units: 05KTNA6169, 05KTNA6013, 05KTNA5893, 05KTNA5697, 05KTNA5585, 05KTNA5376, 05KTNA5265, 05KTNA4815, 05KTNA4507, 05KTNA4395, 05KTNA4222, 05KTNA4100, 05KTNA3609, 05KTNA3519, 05KTNA3311, 05KTNA3137, 05KTNA3092, 05KTNA2863, 05KTNA2781, 05KTNA2438, 05KTNA2330, 05KTNA2062, 05KTNA1973, 05KTNA1783, 05KTNA1686, 05KTNA1526, 05KTNA1443, 05KTNA1257, 05KTNA1121, 05KTNA0760
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corporation, Knoxville, TN, by facsimile on July 22, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0750-07
CODE
Units: 05KTNA0521, 05KTNA0178, 05KTNA0068, 04KTNA1117, 04KTNA0994, 04KTNA0792, 04KTNA0584, 04KTNA0465, 04KTNA0285, 04KTNA0062, 19820514, 19818566, 19816470, 19815404, 19813691, 19812786, 19810232, 19808628, 19807485, 19805610, 19804705, 19803029, 19801926, 19258836, 19257921, 19256214, 19255217, 19253237, 19252254, 19010496, 19009131, 19005485, 19003931, 19002743, 18959802, 18958591, 18956931, 18955859, 18954128, 18953114, 18951561, 18950724, 09978553, 09976740, 09975330, 09973626, 09972490, 09970779, 10289716, 10287255, 10286296, 10284407, 10283516, 10281628, 10280911, 08898777, 08898036, 08895417, 08893956, 08892423, 08891211, 09189706, 09188426, 09187122, 09185999, 09184404, 09183018, 09181359, 06908522, 06906702, 06905453, 06903794, 06902124
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corporation, Knoxville, TN, by facsimile on August 12, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
73 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0751-07
CODE
Units: 05KTNA6615, 05KTNA6509, 05KTNA6342, 05KTNA6171, 05KTNA6016, 05KTNA5928, 05KTNA5700, 05KTNA5588, 05KTNA5377, 05KTNA5268, 05KTNA5090, 05KTNA5008, 05KTNA4816, 05KTNA4705, 05KTNA4517, 05KTNA4398, 05KTNA4225, 05KTNA4101, 05KTNA3942, 05KTNA3853, 05KTNA3724, 05KTNA3611, 05KTNA3432, 05KTNA3312, 05KTNA3139, 05KTNA2517, 05KTNA2333, 05KTNA2224, 05KTNA2066, 05KTNA1963, 05KTNA1785, 05KTNA1621, 05KTNA1529, 05KTNA1261, 05KTNA1123, 05KTNA0893, 05KTNA0761, 05KTAN0526, 05KTNA0400, 05KTNA0074, 04KTNA0992, 04KTNA0788, 04KTNA0675, 04KTNA0467, 04KTNA0399, 04KTNA0172, 04KTNA0065, 19815114, 19813714, 19811178, 19810584, 19808666, 19807522, 19805658, 19804743, 19803074, 19801957, 19257938, 19256986, 19009162, 19005515, 19003894, 19002736, 19000800, 18959772, 18957877, 18956900, 18953145, 18952414, 09980365, 09977334, 09972612, 10287965, 10283530, 10282304, 10280942, 09255248, 19253886, 19252261, 19010502
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corporation, Knoxville, TN, by facsimile on July 20, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
80 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0752-07
CODE
Units: 05KTNA7132, 05KTNA6912, 05KTNA6809, 05KTNA6613, 05KTNA6510, 05KTNA6307, 05KTNA6170, 05KTNA6014, 05KTNA5894, 05KTNA5699, 05KTNA5587, 05KTNA5378, 05KTNA5267, 05KTNA4968, 05KTNA4703, 05KTNA4649, 05KTNA4396, 05KTNA4099, 05KTNA3939, 05KTNA3854, 05KTNA3725, 05KTNA3612, 05KTNA3430, 05KTNA3314, 05KTNA3138, 05KTNA2603, 05KTNA2516, 05KTNA2332, 05KTNA2063, 05KTNA1960, 05KTNA1256, 05KTNA0923, 05KTNA0519, 05KTNA0403, 05KTNA0201, 05KTNA0067, 04KTNA1415, 04KTNA1298, 04KTNA1118, 04KTNA1027, 04KTNA0789, 04KTNA0673, 04KTNA0338, 04KTNA0261, 04KTNA0061, 19820286, 19818559, 19816487, 19815398
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corporation, Knoxville, TN, by facsimile on July 21, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
49 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0772-07
CODE
Units: 109847, 110012, 110160, 110618, 110686, 111002, 111136, 111184, 111185, 111314, 111454, 111461, 111797, 111919, 112038, 112159, 112281, 112462, 112475, 112516, 112540, 113149, 113254, 113419, 113546, 113941, 114048, 114185, 114480, 114579, 115061, 115472, 115473, 115492, 115569, 115582, 115759, 115779, 116125, 116282, 116485, 116638, 116926, 116931, 116975, 117116, 117188, 117217, 117308, 117564, 117574, 117786, 117822, 117900, 117907, 118316, 118405, 118505, 118563, 118692, 118723, 118747, 118897, 119170, 119263, 119319, 119388, 119545, 119550, 119699, 119826, 119937, 119938, 120128, 120147, 120180, 120207, 120273, 120447, 120677, 120689, 120753, 120875, 120889, 120899, 120942, 121232, 121239, 121270, 121360, 121380, 121440, 121501, 121624, 121835, 121894, 122031, 122075, 122092, 122308, 122371, 122460, 122708, 123064, 123144, 123323, 123453, 123567, 123662, 123677, 123757, 124041, 124049, 124171, 124581, 124589, 124604, 124811, 124895, 124911, 124959, 125198, 125288, 125292, 125322, 125436, 125487, 125551, 125603, 125698, 125804, 125993, 126428, 126461, 126660, 126788, 127027, 127080, 127248, 127391, 127411, 127709, 128322, 128347, 128348, 128353, 128577, 128578, 128634, 128705, 128775, 128776, 128811, 129018, 129053, 129192, 129246, 129393, 129804, 129910, 130362, 130857, 130916, 131017, 131022, 131145, 131267, 131295, 132058, 132128, 132378, 132678, 133365, 133590, 133798, 134138, 134461, 134606, 134983, 135104, 135200, 135219, 135571, 135572, 135811, 135974, 136115, 136124, 136589, 136739, 137131, 137307, 137493, 137533, 137535, 137916, 138110, 138299, 138537, 139603, 140215, 140544, 141078, 141080, 141221, 141369, 141620, 141621, 141628, 141670, 141694, 141800, 141850, 142265, 142593, 142662, 142677, 142825, 142865, 142869, 143040, 143062, 143150, 143335, 143381, 143857, 143894, 143901, 143941, 144415, 144417, 144550, 144602, 144687, 144723, 144813, 144826, 144877, 145110, 145383, 145411, 145581, 145588, 146097, 146217, 146283, 146337, 146343, 146426, 146430, 146648, 146699, 146929, 147215, 147263, 147280, 147325, 147389, 147394, 147407, 147752, 147757, 147883, 147945, 148020, 148238, 149043, 150213, 150678, 150680, 150983, 151079, 151742, 151777, 152271, 152622, 152644, 153174, 153364, 153422, 153429, 153473, 153745, 153818, 153940, 154057, 154069, 154309, 154711, 154996, 155172, 155175, 155259, 155326, 155343, 155432, 155442, 155527, 155588, 156310, 156330, 156367, 156593, 156594, 156627, 156913, 157562, 157780, 158678, 158878, 159709, 160023, 160035, 160037, 160102, 160370, 160418, 160441, 161527, 162220, 162294, 162330, 163556, 163596, 163688, 163737, 163930, 163941, 164194, 164331, 164340, 164379, 164396, 164437, 164454, 164466, 164581, 164704, 164786, 164822, 165220, 165257, 165276, 165295, 165302, 165352, 165354, 165373, 165413, 165442, 165512, 165543, 165588, 165932, 166036, 166073, 166076, 166376, 166682, 167225, 167270, 167291, 167313, 167605, 167702, 167987, 168032, 168042, 168071, 168076, 168656, 168716, 169055, 169216, 169626, 169831, 170390, 170399, 170471, 170490, 170496, 170497, 170507, 170522, 170727, 170742, 171177, 171253, 171391, 171643, 172057, 172170, 172331, 172411, 172435, 172452, 172520, 172525, 172673, 173243, 173416, 173565, 173841, 173890, 174337, 175650, 178088, 178147, 178467, 179031, 179049, 179786, 180318, 180770, 181077, 181351, 181505, 182291, 183987, 184153, 184335, 184436, 184443, 185092, 185407, 186067, 186228, 186303, 186570, 186571, 186572, 186978, 187032, 187454, 187620, 188333, 188831, 188834, 188840, 188884, 189019, 189024, 189064, 189360, 189972, 191743, 192086, 193398, 193455, 194260, 194533, 194903, 194985, 195066, 195384, 195547, 195924, 196309, 196616, 196758, 196765, 197061, 197093, 197224, 197415, 197417, 197738, 197740, 198018, 198019, 198367, 198420, 198518, 198747, 198820, 198837, 198913, 199005, 199181, 199228, 199231, 199269, 199354, 199366, 199453, 199668, 199947, 199983, 200126, 200138, 200190, 200192, 200197, 200237, 200267, 200325, 200650, 200651, 200721, 200725, 200755, 200785, 200864, 201070, 201112, 201125, 201139, 201165, 201345, 201373, 201380, 201386, 201414, 201425, 201650, 201676, 201720, 201757, 201840, 202015, 202121, 202254, 202412, 202468, 202526, 202641, 202684, 202685, 202708, 202850, 202853, 202893, 202990, 203321, 203327, 203350, 203374, 203400, 203497, 203554, 203658, 203832, 203855, 203884, 204012, 204028, 204143, 204178, 204187, 204301, 204356, 204463, 204470, 204546, 204644, 204694, 205047, 205069, 205260, 205262, 205287, 205347, 205359, 205544, 205693, 205750, 205754, 205990, 206406, 206417, 206524, 206586, 206694, 206725, 206849, 206863, 207197, 207340, 207464, 207503, 207509, 207659, 207887, 207923, 208156, 208164, 208298, 208415, 208454, 208467, 208551, 208683, 208900, 209119, 209131, 209191, 209407, 209426, 209656, 209770, 209968, 210103, 210178, 210415, 210624, 210631, 210663, 210671, 210790, 210998, 211034, 211461, 211530, 211539, 211705, 211907, 212032, 212037, 212211, 212465, 212802, 212896, 213008, 213016, 213127, 213288, 213338, 213393, 213567, 214038, 214225, 214408, 214485, 214893, 215503, 215540, 215573, 215870, 215939, 216567, 216640, 216734, 216740, 216822, 216833, 216842, 216876, 216926, 216968, 217008, 217116, 217121, 217413, 217479, 217488, 217607, 217703, 217710, 217730, 217781, 217916, 218012, 218310, 218476, 218563, 218619, 218962, 219041, 219120, 219200, 219220, 219226, 219244, 219252, 219747, 220112, 220140, 220195, 220197, 220370, 220452, 220701, 220998, 221319, 221502, 221521, 221566, 221711, 221739, 221829, 221877, 221997, 222436, 222830, 222844, 222895, 223067, 223365, 223422, 223666, 223944, 223978, 224004, 224699, 224977, 225142, 225739, 225915, 225940, 227214, 227372, 227398, 227403, 227585, 227856, 229077, 229543, 230219, 230480, 231153, 231991, 232260, 232594, 232682, 232837, 232933, 232942, 233226, 233302, 233325, 233354, 233451, 233619, 233632, 233646, 233881, 234084, 234155, 234205, 234429, 234586, 234917, 235022, 235214, 235537, 235550, 235558, 235606, 235619, 235801, 235807, 235930, 236005, 236024, 236058, 236135, 236262, 236525, 236531, 236544, 236599, 236635, 236649, 236701, 236744, 236745, 236759, 236817, 236833, 236868, 236928, 237007, 237163, 237164, 237174, 237349, 237471, 237489, 237493, 237547, 237559, 237673, 237839, 237840, 238526, 238532, 238745, 238751, 238866, 238951, 239139, 239144, 239336, 239349, 239446, 239530, 239600, 239658, 239709, 239904, 239970, 240040, 240131, 240146, 240338, 240420, 240524, 240570, 240649, 240810, 240828, 240854, 240937, 241049, 241065, 241079, 241137, 241158, 241257, 241319, 241333, 241419, 241446, 241552, 241593, 241737, 241749, 241810, 241852, 241896, 241924, 242070, 242135, 242166, 242168, 242176, 242224, 242244, 242315, 242322, 242367, 242387, 242399, 242431, 242451, 242521, 242538, 242597, 242633, 242645, 242727, 242744, 242851, 242936, 243010, 243210, 243285, 243419, 243473, 243479, 243486, 243657, 243720, 243746, 243768, 243770, 243807, 243809, 243928, 243979, 244276, 244392, 244420, 244598, 244810, 244911, 245040, 245094, 245132, 245149, 245182, 245206, 245289, 245415, 245838, 245843, 245859, 245930, 245946, 246054, 246085, 246303, 246334, 246386, 246488, 246543, 246544, 246741, 246753, 246763, 246818, 246978, 247029, 247036, 247037, 247422, 247497, 247502, 247509, 247525, 247555, 247621, 247638, 247680, 247695, 247736, 247798, 247799, 247852, 247853, 247864, 247865, 247907, 247911, 247933, 248007, 248013, 248020, 248050, 248194, 248244, 248319, 248500, 248746, 248763, 248828, 248866, 248998, 249009, 249016, 249025, 249045, 249058, 249101, 249192, 249236, 249331, 249403, 249406, 249440, 249483, 249485, 249500, 249504, 249598, 249608, 249664, 249666, 249730, 249748, 249761, 249763, 249800, 249859, 249871, 249933, 249944, 249945, 249955, 249974, 249977, 249998, 250123, 250190, 250211, 250229, 250230, 250326, 250337, 250340, 250397, 250454, 250464, 250584, 250602, 250725, 250769, 250790, 250791, 250887, 250949, 251066, 251093, 251095, 251112, 251124, 251141, 251167, 251190, 251212, 251303, 251361, 251375, 251384, 251408, 251461, 251510, 251566, 251568, 251569, 251598, 251611, 251628, 251734, 251767, 251800, 251821, 251847, 251887, 251896, 251914, 252083, 252183, 252206, 252288, 252294, 252321, 252386, 252390, 252558, 252657, 252691, 252864, 253033, 253046, 253153, 253171, 253233, 253245, 253395, 257030
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Lakeland, FL, by facsimile beginning August 9, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not have complete medical history interviews, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1041 units
DISTRIBUTION
CA, MD, MA, NY, Canada, England, France, Germany and Korea

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

___________________________________
PRODUCT
Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty: 1 ea, non-sterile, Recall # Z-0411-2007
CODE
Lot numbers: MH05F006 and MH05J015
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN, by letter on December 8, 2006.
Manufacturer: Marson Medical, Inc., Paramus, NJ. Firm initiated recall is ongoing.
REASON
Due to a manufacturing error, the proximal end may deform causing the protrusions that engage the associated implant to break off of the instrument during use.
VOLUME OF PRODUCT IN COMMERCE
58 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Access® Immunoassay Systems Thyroglobulin Antibody Reagent Kit, in vitro diagnostic, Part Number 33890, Recall # Z-0417-2007
CODE
518729 (expires 10/31/06); 520617 (expires 12/31/06); 612764 (expires 12/31/06); 613481 (expires 3/31/07); 614541 (expires 5/31/07); 616787 (expires 8/31/07)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea CA, by letter on October 27, 2006.
Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
REASON
Low end imprecision affecting both S0 calibrators and patient samples which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay.
VOLUME OF PRODUCT IN COMMERCE
474 units
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

______________________________
PRODUCT
a) 'Thyroxine L,' (Levothyroxine Sodium Tablets, USP) (Veterinary)- 0.1 mg,
0.2 mg, 0.3 mg, 0.3 mg, 0.4 mg, 0.5 mg, 0.6 mg, 0.7 mg and 0.8 mg tablets
UPC Codes: 362250301123 362250302120 362250303127 362250304124
362250305121 362250306128 362250307125 362250308122, Recall # V-013-2007;
b) 'Thyroxine L,' Levothyroxine Sodium Oral Solution, (Veterinary) - 1.0 mg/mL,
Recall # V-014-2007;
c) Thyroxyl (Levothyroxine Sodium Tablets, USP) (Veterinary)- 0.1 mg, 0.2 mg,
0.3 mg, 0.3 mg, 0.4 mg, 0.5 mg, 0.6 mg, 0.7 mg and 0.8 mg tablets,
Recall # V-015-2007
CODE
a) Batch Numbers: 84AB, 85AB, 86AB, 87AB, 88AB, 89Ab, 90AB,
91AB, 92AB, 93AB, 01AC, 82AB, 83AB,80AB, 81AB, 78AB, 79AB,77AB;
b) Batch/Lot # 93AA, 94AA, 95AA, 96AA, 97AA, 98AA, 99AA, 01AB, 02AB,
& 03AB;
c) 31AB, 32AB, 33AB, 34AB, 36AB, 36AB, 37AB, 38AB, 39AB, 40AB, 41AB,
42AB, 43AB, 44AB, 85AB, 72AA, 73AA, 74AA, 75AA, 76AA, 77AA, 78AA,
79AA, 80AA, 81AA, 82AA, 83AA, 84AA, 85AA, 86AA, 87AA, 88AA, 89AA,
90AA, 91AA, 05AB, 06AB, 08AB, 09AB, 10AB, 11AB, 12AB, 13AB, 14AB,
15AB, 16AB, 17AB, 18AB, 19AB, 20AB, 21AB, 22AB, 23AB, 24AB, 25AB,
26AB, 28AB, 29AB, 30AB
RECALLING FIRM/MANUFACTURER
Belcher Pharmaceuticals Inc., Largo, FL, by letter on October 9. 2006. Firm initiated recall is ongoing.
REASON
Processing and cleaning procedures were not validated prior to production. Product had some GMP failures related to the quality system.
VOLUME OF PRODUCT IN COMMERCE
88,210 bottles
DISTRIBUTION
MO

END OF ENFORCEMENT REPORT FOR FEBRUARY 21, 2007

 

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