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U.S. Department of Health and Human Services

Safety

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Enforcement Report for November 1, 2006

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.

November 1, 2006
06-44

 

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS I

______________________________
PRODUCT
a) Shrimp Patties, Ingredients: shrimp, bread, celery, bell pepper, onion, salt,
cayenne, parsley, shallots, Italian bread crumbs, plain bread crumbs,
eggs, cracker meal, garlic, sodium bisulfate. Fry in deep oil until golden brown,
Recall # F-035-7;
b) Stuffed Shrimp, Ingredients: shrimp, bread, celery, bell pepper, onion, salt,
cayenne, parsley, shallots, Italian bread crumbs, plain bread crumbs, cracker meal,
garlic, sodium bisulfate. Fry in deep oil until golden brown, Recall # F-036-7;
c) Seafood Steaks, Ingredients: shrimp, crabmeat, catfish, bread, celery, bell pepper,
onion, salt, cayenne, parsley, shallots, Italian bread crumbs, plain bread crumbs,
eggs, cracker meal, garlic, sodium bisulfate. Fry in deep oil until golden brown,
Recall # F-037-7;
d) Breaded Crab Fingers, Ingredients: crab claws, cracker meal, milk, salt.
Fry until golden brown, Recall # F-038-7;
e) Breaded Shrimp, Ingredients: shrimp, cracker meal, salt, milk, sodium bisulfate.
Fry in deep oil until golden brown, Recall # F-039-7;
f) Breaded Pieces, Ingredients: shrimp, cracker meal, milk, salt, sodium bisulfate.
Fry in oil until golden brown Recall # F-040-7
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Eschete's Seafood, Inc., Houma LA, by telephone, posted a sign on its retail store and by press release on July 27, 2006. Firm initiated recall is complete.
REASON
a), b), and c) products contain undeclared milk;
d), e), and f) products contain undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
Approximately 300 units.
DISTRIBUTION
LA

______________________________
PRODUCT
Sandwich: turkey sandwich in plastic, Tuscan Sun TURKEY, 5.9oz, Recall # F-041-7
CODE
35E (production code) 35 is the week of the year and E is the specific day (A=Monday, B=Tuesday, C=Wednesday, etc). The product is held frozen until distribution from the warehouse to the retail account. At that time a 3 week expiration date is placed on the product.
RECALLING FIRM/MANUFACTURER
Jumbo Foods, Inc., Mukilteo, WA, by telephone beginning on October 3, 2006, and by press release on October 4, 2006. Firm initiated recall is complete.
REASON
Product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
1,360 sandwiches
DISTRIBUTION
WA, OR, and CA

______________________________
PRODUCT
a) 365 Everyday Value All Natural Soy Cream Chocolate,
a dairy-free frozen dessert packaged in 1/2 gallon containers,
Recall # F-042-7;
b) 365 Everyday Value All Natural Soy Cream Vanilla,
a dairy-free frozen dessert packaged in 1/2 gallon containers,
Recall # F-043-7
CODE
a) Sell by dates as follows: 4/27/07, 3/29/07, 6/07/07, 4/19/07,
4/29/07, and 7/05/07;
b) Sell by dates as follows: 3/29/07, 4/19/07, 5/01/07, 6/07/07,
and 7/05/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Whole Foods Market, Austin, TX, by e-mail, telephone and press release on August 11, 2006.
Manufacturer: Foster Farms Dairy, Modesto, CA. Firm initiated recall is complete.
REASON
Dairy-free frozen dessert contains undeclared milk proteins.
VOLUME OF PRODUCT IN COMMERCE
25,326 cases (3 units per case)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
Lidocaine HCI Injection, USP, 1%, 10 mg/ml, 30 mL single dose vial, NDC 0409-4279-02, Recall # D-390-7
CODE
Lots: 39-467-DK, exp. 3/1/08; 41-243-DK, exp. 5/1/08
RECALLING FIRM/MANUFACTURER
Hospira, Inc., Rocky Mount, NC, by letters on October 6, 2006. Firm initiated recall is ongoing.
REASON
Product may contain particulates.
VOLUME OF PRODUCT IN COMMERCE
292,600/30 mL vials
DISTRIBUTION
Nationwide

______________________________
PRODUCT
1) PREDNISONE 1mg TABLET, 250 count bags
(NDC 61392-642-25) & 30 count boxes (NDC 61392-642-30),
Rx only, Recall # D-201-7;
2) PREDNISONE 2.5mg TABLET, 250 count bags
(NDC 61392-765-25) & 30 count boxes (NDC 61392-765-30),
Rx only, Recall # D-202-7;
3) PREDNISONE 20mg TABLET, 250 count bags
(NDC 61392-418-25) & 30 count boxes (NDC 61392-418-30),
Rx only, Recall # D-203-7;
4) PREDNISONE 5mg TABLET, 250 count bags
(NDC 61392-408-25) & 30 count boxes (NDC 61392-408-30),
Rx only, Recall # D-204-7;
5) PRIMIDONE 250mg TABLET, 250 count bags
(NDC 61392-024-25) & 30 count boxes (NDC 61392-024-30),
Rx only, Recall # D-205-7;
6) PRIMIDONE 50mg TABLET, 250 count bags
(NDC 61392-585-25) & 30 count boxes (NDC 61392-585-30),
Rx only, Recall # D-206-7;
7) PROCHLORPERAZINE 10mg TABLET, 250 count bags
(NDC 61392-988-25) & 30 count boxes (NDC 61392-988-30),
Rx only, Recall # D-207-7;
8) PROCHLORPERAZINE 5mg TABLET, 250 count bags
(NDC 61392-467-25) & 30 count boxes (NDC 61392-467-30),
Rx only, Recall # D-208-7;
9) PROMETHAZINE 25mg TABLET, 250 count bags
(NDC 61392-745-25) & 30 count boxes (NDC 61392-745-30),
Rx only, Recall # D-209-7;
10) PROPAFENONE 150mg TABLET, 250 count bags
(NDC 61392-770-25) & 30 count boxes (NDC 61392-770-30),
Rx only, Recall # D-210-7;
11) PROPRANOLOL 10mg TABLET, 250 count bags
(NDC 61392-420-25) & 30 count boxes (NDC 61392-420-30),
Rx only, Recall # D-211-7;
12) PROPRANOLOL 20mg TABLET, 250 count bags
(NDC 61392-423-25), 30 count boxes (NDC 61392-423-30) &
60 count boxes (NDC 61392-423-60), Rx only, Recall # D-212-7;
13) PROPRANOLOL 40mg TABLET, 250 count bags
(NDC 61392-430-25), 30 count boxes (NDC 61392-430-30) &
60 count boxes (NDC 61392-430-60), Rx only, Recall # D-213-7;
14) PROPRANOLOL 80mg TABLET, 250 count bags
(NDC 61392-433-25) & 30 count boxes (NDC 61392-433-30),
Rx only, Recall # D-214-7;
15) PROPYLTHIOURACIL 50mg TABLET, 250 count bags
(NDC 61392-468-25), 30 count boxes (NDC 61392-468-30),
60 count boxes (NDC 61392-468-60), & 90 count boxes
(NDC 61392-468-90), Rx only, Recall # D-215-7;
16) PSEUDOPHEDRINE 30mg TABLET (c), 250 count bags
(NDC 61392-007-25), 30 count boxes (NDC 61392-007-30), 60 count
boxes (NDC 61392-007-60) & 90 count boxes (NDC 61392-007-90),
Recall # D-216-7;
17) PSEUDOEPHEDRINE 60mg TABLET (c), 250 count bags
(NDC 61392-505-25), 30 count boxes (NDC 61392-505-30),
60 count boxes (NDC 61392-505-60), & 90 count boxes
(NDC 61392-505-90), Recall # D-217-7;
18) PYRIDOSTIGMINE 60 TABLET, 250 count bags (NDC 61392-795-25) &
30 count boxes (NDC 61392-795-30), Rx only, Recall # D-218-7;
19) QUINAPRIL 10mg TABLET, 250 count bags (NDC 61392-454-25)
& 30 count boxes (NDC 61392-454-30), Rx only, Recall # D-219-7;
20) QUINAPRIL 20mg TABLET, 250 count bags (NDC 61392-474-25) &
30 count boxes (NDC 61392-474-30), Rx only, Recall # D-220-7;
21) QUINAPRIL 40mg TABLET, 250 count bags (NDC 61392-475-25) &
30 count boxes (NDC 61392-475-30), Rx only, Recall # D-221-7;
22) QUINIDINE SULFATE 200mg TABLET, 30 count boxes
(NDC 61392-953-30), Rx only, Recall # D-222-7;
23) QUININE SULFATE 260mg TABLET, 250 count bags
(NDC 61392-809-25), 30 count boxes (NDC 61392-809-30) &
60 count boxes (NDC 61392-809-60), Rx only, Recall # D-223-7;
24) QUININE SULFATE 325mg CAPSULE, 250 count bags (NDC 61392-989-25)
& 30 count boxes (NDC 61392-989-30), Rx only, Recall # D-224-7;
25) RANITIDINE 150mg CAPSULE, 250 count bags (NDC 61392-086-25),
30 count boxes (NDC 61392-086-30) & 60 count boxes (NDC 61392-086-60),
Rx only, Recall # D-225-7;
26) RANITIDINE 150mg TABLET, 250 count bags (NDC 61392-836-25),
30 count boxes (NDC 61392-836-30) & 60 count boxes
(NDC 61392-836-60), Rx only, Recall # D-226-7;
27) RANITIDINE 300mg CAPSULE, 250 count bags (NDC 61392-648-25) &
30 count boxes (NDC 61392-648-30), Rx only, Recall # D-227-7;
28) RANITIDINE 300mg TABLET, 250 count bags (NDC 61392-837-25) &
30 count box (NDC 61392-837-30), Rx only, Recall # D-228-7;
29) RAZADYNE (galantamine HBr) 12mg TABLET, 250 count bags
(NDC 61392-559-25) & 30 count boxes (NDC 61392-559-30), Rx only,
Recall # D-229-7;
30) RAZADYNE (galantamine HBr) 4mg TABLET, 250 count bags
(NDC 61392-555-25) & 30 count boxes (NDC 61392-555-30), Rx only,
Recall # D-230-7;
31) REQUIP (ropinirole HCl) 0.25mg TABLET, 250 count bags
(NDC 61392-323-25) & 30 count boxes (NDC 61392-323-30), Rx only,
Recall # D-231-7;
32) REQUIP (ropinirole HCl) 1mg TABLET, 250 count bags
(NDC 61392-324-25) & 30 count boxes (NDC 61392-324-30),
Rx only, Recall # D-232-7;
33) RIFAMPIN 300mg CAPSULE, 250 count bags (NDC 61392-787-25) &
30 count boxes (NDC 61392-787-30), Rx only, Recall # D-233-7;
34) SALSALATE 500mg TABLET, 250 count bags (NDC 61392-788-25) &
30 count boxes (NDC 61392-788-30), Rx only, Recall # D-234-7;
35) SALSALATE 750mg TABLET, 250 count bags (NDC 61392-814-25) &
30 count boxes (NDC 61392-814-30), Rx only, Recall # D-235-7;
36) SELEGILINE HYDROCHLORIDE 5mg CAPSULE, 250 count bags
(NDC 61392-469-25) & 30 count boxes (NDC 61392-469-30), Rx only,
Recall # D-236-7;
37) SENNA GEN 8.6mg TABLET, 250 count bags (NDC 61392-008-25),
30 count boxes (NDC 61392-008-30), & 60 count boxes (NDC 61392-008-60),
Recall # D-237-7;
38) SENNA-S 50mg TABLET, 30 count boxes (NDC 61392-703-30) &
60 count boxes (NDC 61392-703-60), Recall # D-238-7;
39) SKELAXIN 800mg TABLET, 250 count bags (NDC 61392-421-25) &
30 count boxes (NDC 61392-421-30), Rx only, Recall # D-239-7;
40) SODIUM BICARBONATE 10GR TABLET, 250 count bags
(NDC 61392-643-25), 30 count boxes (NDC 61392-643-30) &
60 count boxes (NDC 61392-643-60), Recall # D-240-7;
41) SODIUM CHLORIDE 1gm TABLET, 250 count bags (NDC 61392-508-25) &
30 count boxes (NDC 61392-508-30), Recall # D-241-7;
42) SOTALOL HCl 80mg TABLET, 250 count bags (NDC 61392-999-25),
30 count boxes (NDC 61392-999-30), & 60 count boxes
(NDC 61392-999-60), Rx only, Recall # D-242-7;
43) SPIRONOLACTONE 100mg TABLET, 250 count bags (NDC 61392-501-25) &
30 count boxes (NDC 61392-501-30), Rx only, Recall # D-243-7;
44) SPIRONOLACTONE 25mg TABLET, 250 count bags (NDC 61392-083-25)
& 30 count boxes (NDC 61392-083-30), Rx only, Recall # D-244-7;
45) SPIRONOLACTONE 50mg TABLET, 250 count bags (NDC 61392-563-25)
& 30 count boxes (NDC 61392-563-30), Rx only, Recall # D-245-7;
46) SPIRONOLACTONE and Hydrochlorothiazide 25mg/25mg TABLET,
250 count bags (NDC 61392-076-25) & 30 count boxes (NDC 61392-076-30),
Rx only, Recall # D-246-7;
47) STARLIX 120mg TABLET, 250 count bags (NDC 61392-326-25) &
30 count boxes (NDC 61392-326-30), Rx only, Recall # D-247-7;
48) SUCRALFATE 1gm TABLET, 250 count bags (NDC 61392-817-25),
30 count boxes (NDC 61392-817-30) & 60 count boxes (NDC 61392-817-60),
Rx only, Recall # D-248-7;
49) SULFAMETHOXAZOLE/TRIMETHOPRIM 800mg/160mg, 250 count bags
(NDC 61392-947-25) & 30 count boxes (NDC 61392-947-30), Rx only,
Recall # D-249-7;
50) SULINDAC 150mg TABLET, 250 count bags (NDC 61392-954-25)
& 30 count boxes (NDC 61392-954-30), Rx only, Recall # D-250-7;
51) TEGRETOL XR 400mg TABLET, 250 count bags (NDC 61392-329-25),
Rx only, Recall # D-251-7;
52) TERAZOSIN 10mg CAPSULE, 250 count bags (NDC 61392-946-25) &
30 count boxes (NDC 61392-946-30), Rx only, Recall # D-252-7;
53) TERAZOSIN 1mg CAPSULE, 250 count bags (NDC 61392-943-25) &
30 count boxes (NDC 61392-943-30), Rx only, Recall # D-253-7;
54) TERAZOSIN 2mg CAPSULE, 30 count boxes (NDC 61392-944-30) &
60 count boxes (NDC 61392-944-60), Rx only, Recall # D-254-7;
55) TERAZOSIN 5mg CAPSULE, 250 count bags (NDC 61392-945-25) &
30 count boxes (NDC 61392-945-30), Rx only, Recall # D-255-7;
56) TETRACYCLINE 250mg CAPSULE, 250 count bags (NDC 61392-789-25)
& 30 count boxes (NDC 61392-789-30), Rx only, Recall # D-256-7;
57) TETRACYCLINE 500mg CAPSULE, 250 count bags (NDC 61392-771-25)
& 30 count boxes (NDC 61392-771-30), Rx only, Recall # D-257-7;
58) THEOPHYLLINE ER 100mg TABLET, 250 count bags (NDC 61392-152-25) &
30 count boxes (NDC 61392-152-30), Rx only, Recall # D-258-7;
59) THEOPHYLLINE ER 200mg TABLET, 250 count bags (NDC 61392-016-25) &
30 count boxes (NDC 61392-016-30), Rx only, Recall # D-259-7;
60) THEOPHYLLINE ER 300mg TABLET, 250 count bags (NDC 61392-017-25) &
30 count boxes (NDC 61392-017-30), Rx only, Recall # D-260-7;
61) THIORIDAZINE HCL100mg TABLET, 250 count bags (NDC 61392-144-25 &
30 count boxes (NDC 61392-144-30), Recall # D-261-7;
62) THIORIDAZINE 25mg TABLET, 250 count bags (NDC 61392-463-25) &
30 count boxes (NDC 61392-463-30), Rx only, Recall # D-262-7;
63) THIORIDAZINE 50mg TABLET, 250 count bags (NDC 61392-819-25) &
30 count boxes (NDC 61392-819-30), Rx only, Recall # D-263-7;
64) THIOTHIXENE 10mg CAPSULE, 250 count bags (NDC 61392-800-25),
30 count boxes (NDC 61392-800-30) & 60 count boxes (NDC 61392-800-60),
Rx only, Recall # D-264-7;
65) THIOTHIXENE 5mg CAPSULE, 250 count bags (NDC 61392-175-25),
30 count boxes (NDC 61392-175-30) & 60 count boxes
(NDC 61392-175-60), Rx only, Recall # D-265-7;
66) TIZANIDINE 2mg TABLET, 250 count bags (NDC 61392-564-25) &
30 count boxes (NDC 61392-564-30), Rx only, Recall # D-266-7;
67) TOPROL-XL (metoprolol succinate ER) 50mg TABLET, 250 count bags
(NDC 61392-410-25) & 30 count boxes (NDC 61392-410-30), Rx only,
Recall # D-267-7;
68) TORSEMIDE 10mg TABLET, 250 count bags (NDC 61392-780-25)
& 30 count boxes (NDC 61392-780-30), Rx only, Recall # D-268-7;
69) TORSEMIDE 20mg TABLET, 250 count bags (NDC 61392-411-25)
& 30 count boxes (NDC 61392-411-30), Rx only, Recall # D-269-7;
70) TRAMADOL HYDROCHLORIDE 50mg TABLET, 250 count bags
(NDC 61392-444-25), 30 count boxes (NDC 61392-444-30), & 60 count
boxes (NDC 61392-444-60), Rx only, Recall # D-270-7;
71) TRAMADOL/APAP 37.5/325mg TABLET, 250 count bags (NDC 61392-497-25)
& 30 count boxes (NDC 61392-497-30), Rx only, Recall # D-271-7;
72) TRAZODONE HYDROCHLORIDE 100mg TABLET, 250 count bags
(NDC 61392-490-25), 30 count boxes (NDC 61392-490-30) & 60 count
boxes (NDC 61392-490-60), Rx only, Recall # D-272-7;
73) TRAZODONE 150mg TABLET, 250 count bags (NDC 61392-179-25)
& 30 count boxes (NDC 61392-179-30), Rx only, Recall # D-273-7;
74) TRAZODONE 50mg TABLET, 250 count bags (NDC 61392-487-25)
& 30 count boxes (NDC 61392-487-30), Rx only, Recall # D-274-7;
75) TRIAMTERENE/HYDROCHLOROTHIAZIDE 37.5/25mg CAPSULE,
250 count bags (NDC 61392-718-25), 30 count boxes (NDC 61392-718-30)
& 60 count boxes (NDC 61392-718-60), Rx only, Recall # D-275-7;
76) TRIAMTERENE/HYDROCHLOROTHIAZODE 37.5/25mg TABLET,
250 count bags (NDC 61392-829-25) & 30 count boxes (NDC 61392-829-30),
Rx only, Recall # D-276-7;
77) TRIFLUOPERAZINE 2mg TABLET, 250 count bags (NDC 61392-822-25)
& 30 count boxes (NDC 61392-822-30), Rx only, Recall # D-277-7;
78) TRIHEXYPHENIDYL 2mg TABLET, 250 count bags (NDC 61392-634-25)
& 30 count boxes (NDC 61392-634-30), Rx only, Recall # D-278-7;
79) TRIHEXYPHENIDYL 5mg TABLET, 250 count bags (NDC #61392095625)
& 30 count boxes (NDC #61392095630), Rx only, Recall # D-279-7;
80) TRILEPTAL 150mg TABLET, 250 count bags (NDC 61392-554-25)
& 30 count boxes (NDC 61392-554-30), Rx only, Recall # D-280-7;
81) TRIMETHOPRIM 100mg TABLET, 250 count bags (NDC 61392-793-25)
& 30 count boxes (NDC 61392-793-30), Rx only, D-281-7;
82) URSODIOL 300mg CAPSULE, 250 count bags (NDC 61392-790-25)
& 30 count boxes (NDC 61392-790-30), Rx only, Recall # D-282-7;
83) VALPROIC ACID 250mg CAPSULE, 250 count bags (NDC 61392-823-25)
& 30 count boxes (NDC 61392-823-30), Rx only, Recall # D-283-7;
84) VERAPAMIL 120mg TABLET, 250 count bags (NDC 61392-496-25)
& 30 count boxes (NDC 61392-496-30), Rx only, Recall # D-284-7;
85) VERAPAMIL 40mg TABLET, 250 count bags (NDC 61392-492-25)
& 30 count boxes (NDC 61392-492-30), Rx only, Recall # D-285-7;
86) VERAPAMIL 80mg TABLET, 250 count bags (NDC 61392-493-25)
& 30 count boxes (NDC 61392-493-30), Rx only, Recall # D-286-7;
87) VERAPAMIL ER 180mg TABLET, 250 count bags (NDC 61392-345-25)
& 30 count boxes (NDC 61392-345-30), Rx only, Recall # D-287-7;
88) VERAPAMIL SR 120mg TABLET, 250 count bags (NDC 61392-791-25)
& 30 count boxes (NDC 61392-791-30), Rx only, Recall # D-288-7;
89) WARFARIN 10mg TABLET, 250 count bags (NDC 61392-909-25)
& 30 count boxes (NDC 61392-909-30), Rx only, Recall # 289-7;
90) WARFARIN 1mg TABLET, 250 count bags (NDC 61392-903-25)
& 30 count boxes (NDC 61392-903-30), Rx only, RECALL # D-290-7;
91) WARFARIN 1mg TABLET, 250 count bags (NDC 61392-903-25)
& 30 count boxes (NDC 61392-903-30), Rx only, Recall # D-291-7;
92) WARFARIN 2.5mg TABLET, 250 count bags (NDC 61392-905-25)
& 30 count boxes (NDC 61392-905-30), Rx only, Recall # D-292-7;
93) WARFARIN 2mg TABLET, 250 count bags (NDC 61392-904-25)
& 30 count boxes (NDC 61392-904-30), Rx only, Recall # D-293-7;
94) WARFARIN 3mg TABLET, 250 count bags (NDC 61392-920-25)
& 30 count boxes (NDC 61392-920-30), Rx only, Recall # D-294-7;
95) WARFARIN 4mg TABLET, 250 count bags (NDC 61392-906-25)
& 30 count boxes (NDC 61392-906-30), Rx only, Recall # D-295-7;
96) WARFARIN 5mg TABLET, 250 count boxes (NDC 61392-907-25)
& 30 count boxes (NDC 61392-907-30), Rx only, Recall # D-296-7;
97) WARFARIN 6mg TABLET, 250 count bags (NDC 61392-911-25)
& 30 count boxes (NDC 61392-911-30), Rx only, Recall # D-297-7;
98) WARFARIN 7.5mg TABLET, 250 count bags
(NDC 61392-908-25) & 30 count boxes (NDC 61392-908-30),
Rx only, Recall # D-298-7;
99) ZINC SULFATE 220mg CAPSULE, 250 count bags
(NDC 61392-824-25) & 30 count boxes (NDC 61392-824-30),
Rx only, Recall # D-299-7;
100) ZONISAMIDE 100mg CAPSULE, 250 count bags
(NDC 61392-551-25) & 30 count boxes (NDC 61392-551-30),
Rx only, Recall # D-300-7;
101) ZYRTEC 10mg TABLET, 250 count bags (NDC 61392-550-25)
& 30 count boxes (NDC 61392-550-30), Rx only, Recall # D-301-7
CODE
1) K41718R25, K42174R25, K42803R25, K43349R25, K41718R30,
K42174R30, K42803R30, K43349R30;
2) K41227R25, K41719R25, K42175R25, K42799R25, K43505R25,
K41227R30, K41719R30, K42175R30, K42799R30, K43505R30;
3) K37054A25, K37054B25, K37397B25, K37769A25, K39086A25,
K36771A30, K37397A30, K37769B30, K39086B30, K39464A30,
K39464B30, K41117A30;
4) K37168A25, K37168B30, K42487A30, K40984A30;
5) K36717C25, K37875B25, K39082A25, K40296B25, K40296C25,
K40837A25, K36717A30, K36717B30, K37875A30, K37875C30,
K38696A30, K38696B30, K39169A30, K40114A30, K40296A30,
K40296D30, K40837B30;
6) K36629R25, K36959R25, K37323R25, K37662R25, K38091A25,
K40099A25, K40099B25, K40804A25, K36629R30, K36959R30,
K37323R30, K37662R30, K38091A30, K38092A30, K40416A30,
K40416B30, K40804B30;
7) K41641R25, K41919R25, K42294R25, K42835R25, K41641R30,
K41919R30, K42294R30, K42835R30, K38819A30, K38819B30,
K39475A30;
8) K41742R25, K41915R25, K42756R25, K43003R25, K38504B25,
K41742R30, K41915R30, K42756R30, K43003R30, K38504A30,
K38504C30, K38504D30, K39365A30, K39365B30, K39365C30;
9) K42308R25, K40854R30, K42308R30, K43181R30;
10) K42245R25, K42924R25, K42245R30, K42924R30;
11) K38595A25, K39545A25, K40889B25, K42583A25, K38595B30,
K38595C30, K39239A30, K39239B30, K39545B30, K40414A30,
K40889A30, K41474A30;
12) K35975B25, K36233A25, K36390B25, K38183B25, K38465A25,
K38465B25, K42909A25, K43071A25, K36233B30, K36390A30,
K38183A30, K38465C30, K38747A30, K39546A30, K39288A30,
K39288B30, K35975A60;
13) K36116C25, K36116E25, K38270B25, K41531A25, K42582A25,
K36116B30, K36116D30, K37405A30, K37405B30, K37405C30,
K37405D30, K38270A30, K38270C30, K41531B30, K41608A30,
K39402A30, K39402B30, K36116A60;
14) K37582a25, K42942A25, K43193A25, K38969A25, K39951B25,
K40520A25, K41576A30, K38503A30, K38969B30, K38969C30,
K39951A30, K40520B30;
15) K36317R25, K36632A25, K36943A25, K36943C25, K42712A25,
K38505A25, K39710B25, K36317R30, K36632A30, K36943B30,
K36943D30, K37580A30, K37580B30, K37580C30, K38505B30,
K39710A30, K39710C30, K36317R60, K36317R90;
16) K34517A25, K35250B25, K35899A25, K38056A25, K38056D25,
K40914B25, K35250A30, K35899C30, K41952A30, K37749A30,
K37749B30, K38056C30, K38695A30, K38695B30, K39631A30,
K39768A30, K40431A30, K40914A30, K34517B60, K35899A60,
K34517B90;
17) K35875R25, K36169A25, K41611A25, K36691A25, K36691C25,
K38705B25, K35875R30, K36169A30, K41611B30, K36691B30,
K37408A30, K37408B30, K38705A30, K35875R60, K36169A60,
K35875R90, K36169A90;
18) K40069R25, K40655R25, K41100A25, K40069R30,
K40655R30, K41100A30;
19) K43409R25, K43409R30;
20) K43241R25, K43241R30;
21) K43144R25, K43453R25, K43144R30, K43453R30;
22) K37466A30, K43316A30;
23) K36299F25, K37756B25, K41657A25, K38371A25, K40181A25,
K36299C30, K36299D30, K36299E30, K36299G30, K37756A30,
K37756C30, K41657B30, K38371B30, K38371C30, K42684A30,
K39004A30, K39170A30, K39530A30, K40181B30, K40544A30,
K41041A30, K36299A60;
24) K41046A25, K41619A30, K39500A30, K39500B30;
25) K39382R25, K39549R25, K39813R25, k40268r25, K35853C25,
K36068B25, K36294C25, K36355A25, K36355B25, K36430B25,
K36430X25, K41469A25, K39813R30, K40268R30, K35853B30,
K36068A30, K36068C30, K36294B30, K36430A30, K36430C30,
K36430D30, K41411R30, K35853A60, K35853D60, K36294A60,
K36355C60, K36355D60;
26) K36160R25, K36536R25, K36899R25, K37194A25, K37969B25,
K38456A25, K42486A25, K40270C25, K41131A25, K36160R30,
K36536R30, K36899R30, K37194A30, K37969A30, K37970A30,
K38253A30, K39011A30, K41956A30, K42486B30, K42643A30,
K40270A30, K40270B30, K36160R60, K36536R60, K36899R60,
K37194A60;
27) K41680R25, K42385R25, K43376R25, K41680R30, K42386R30,
K42385R30, K43376R30;
28) K41228R25, K42011R25, K42411R25, K42950R25, K43355R25,
K41228R30, K41888R30, K42011R30, K43229R30, K43355R30;
29) K41643R25, K41976R25, K42300R25, K42937R25, K41643R30,
K41976R30, K42300R30, K42301R30, K42322R30, K42937R30;
30) K41642R25, K42249R25, K42952R25, K41642R30, K42019R30,
K42249R30, K42952R30;
31) K42113R25, K42290R25, K42954R25, K43411R25, K42113R30,
K42290R30, K42291R30, K42954R30, K43411R30;
32) K42111R25, K42274R25, K42275R25, K42877R25, K43468R25,
K42111R30, K42274R30, K42275R30, K42877R30, K43468R30;
33) K40902R25, K41473R25, K42040R25, K42302R25, K43116R25,
K40902R30, K41473R30, K42040R30, K42302R30, K43116R30;
34) K41478R25, K42039R25, K42777R25, K42957R25, K41002R25,
K41478R30, K42039R30, K42777R30, K42957R30, K41002R30;
35) K38139B25, K38443B25, K38139A30, K38139C30, K38443A30,
K38899A30, K38899B30, K40759A30;
36) K40662R25, K41097R25, K41864R25, K42217R25, K40662R30,
K41097R30, K41864R30, K42217R30;
37) K35229A25, K39824A25, K40010A30, K41059A60, K35639A60;
38) K36678R30, K36678R60;
39) K42535R25, K42876R25, K43472R25, K42535R30, K42876R30,
K43472R30;
40) K35520R25, K35763R25, K36088R25, K36445R25, K36746R25,
K37180R25, K35520R30, K35763R30, K36088R30, K36445R30,
K36746R30, K37180R30, K35520R60, K35763R60, K36088R60;
41) K43081R25, K43081R30;
42) K35346C25, K35346D25, K35346H25, K35708A25, K36945A25,
K37089A25, K38377B25, K41598A25, K41136A25, K35346A30,
K35346F30, K35346G30, K35708B30, K36945B30, K38102A30,
K38377A30, K38377C30, K39174A30, K40365A30, K41598B30,
K41136B30, K35346B60, K35346E60;
43) K36502A25, K37065A25, K41610B25, K41713A25, K38351B25,
K38351E25, K40493B25, K40890B25, K36502A30, K37065A30,
K37065B30, K41610A30, K38351A30, K38351C30, K38351D30,
K39724A30, K40493A30, K40567A30;
44) K35644A25, K35644B25, K40321A30;
45) K41604A25, K39192R25, K39653A25, K40782A25, K41604B30,
K42146B30, K39192R30, K39654R30, K39653A30, K40782B30,
K41030A30;
46) K40996R25, K41925R25, K42576R25, K42822R25, K41357R25,
K40996R30, K41925R30, K42576R30, K42822R30, K41357R30;
47) K42722R25, K43059R25, K42722R30, K43059R30;
48) K36807B25, K36111A25, K36354D25, K37415A25, K37415B25,
K41597A25, K38759B25, K38759C25, K40680B25, K40788A25,
K40788C25, K36807A30, K36111C30, K36354B30, K36354C30,
K36354E30, K37415C30, K37415D30, K41597B30, K37819A30,
K37819B30, K38433A30, K38433B30, K38677A30, K38677B30,
K38759A30, K38759D30, K39806A30, K40680A30, K40788B30,
K35900A60, K36111B60;
49) K35348B25, K41660A25, K36724C25, K42272A25, K42806A25,
K37414B25, K37414C25, K37734B25, K38506A25, K38673B25,
K38673C25, K38673D25, K39168A25, k38942a25, K39681B25,
K40269A25, K40269B25, K40877B25, K40992B25, K41109A25,
K35348A30, K35704A30, K35704B30, K35704C30, K36353A30,
K41660B30, K36724A30, K36724B30, K36724D30, K37414A30,
K37734A30, K38673A30, K39534A30, K39681A30, K40877A30,
K40992A30;
50) K38043B25, K38935A25, K36696A30, K36696B30, K36696C30,
K37687A30, K37687B30, K38043A30, K38552A30, K38552B30,
K39860A30, K40530A30, K40709A30, K41052A30;
51) K43219R25;
52) K37079A25, K38098A25, K38905A25, K38905C25, K41360B25,
K36295A30, K37079B30, K37467A30, K38098B30, K38381A30,
K38905B30, K39474A30, K41360A30;
53) K38335A25, K41539A25, K39391A25, K39979B25, K38335B30,
K38856A30, K41539B30, K42468B30, K39391B30, K39979A30,
K39979C30, K39979D30;
54) K35902B30, K37468A30, K38263A30, K40375A30, K40375B30,
K39008A30, K39008B30, K43070A30, K40182A30, K40879A30,
K40879B30, K35902A60;
55) K37478A25, K38551B25, K38551C25, K37478B30, K41605A30,
K41606B30, K38551A30, K39369A30;
56) K42554A25, K39333R25, K39656A25, K42554B30, K39333R30,
K39656A30;
57) K42471A25, K37640R25, K38236R25, K39165R25, K39532B25,
K41573A30, K37640R30, K38236R30, K39165R30, K39531A30;
58) K36351C25, K37391A25, K37391B25, K41068B25, K36351A30,
K36351B30, K38375A30, K38375B30, K38792A30, K39291A30,
K40467A30, K41068A30, K41068C30;
59) K36218A25, K36218B25, K36218D25, K37877A25, K41543A25,
K39980A25, K36218C30, K37877B30, K38184A30, K39980B30,
K39981A30, K43063A30, K40878A30, K41069A30;
60) K36267A25, K36267B25, K36801A25, K37876B25, K38594B25,
K38823A25, K38823B25, K42135A25, K42558A25, K36801B30,
K36802A30, K37876A30, K38594A30, K42047A30, K42076A30,
K39241A30, K43282A30, K40787A30;
61) K42221R25, K43043R25, K43358R25, K42221R30, K43043R30,
K43358R30;
62) K40661R25, K41309R25, K42080R25, K42298R25, K42919R25,
K43408R25, K40661R30, K41309R30, K42080R30, K42298R30,
K42919R30, K43408R30;
63) K42408R25, K42795R25, K43354R25, K42408R30, K42795R30,
K43354R30;
64) K34146A25, K35361B25, K36670D25, K42152A25, K39005A25,
K41114A25, K41114C25, K34146A30, K35361A30, K36670A30,
K36670B30, K36670C30, K38159A30, K38159B30, K39005B30,
K39978A30, K39978B30, K40925A30, K34146A60;
65) K34144A25, K42480A25, K37476A25, K38280A25, K39006A25,
K41361A25, K34144A30, K37476B30, K43435A30, K38280B30,
K39006B30, K34144A60;
66) K42398R25, K42976R25, K42398R30, K42976R30;
67) K42620R25, K40855R30;
68) K42021R25, K42236R25, K42815R25, K43402R25, K42021R30,
K42236R30, K42815R30, K43402R30;
69) K41267R25, K41895R25, K42338R25, K42549R25, K43084R25,
K41267R30, K41895R30, K41893R30, K41894R30, K42338R30,
K42549R30, K43084R30;
70) K41093R25, K41358R25, K41750R25, K43058R25, K43343R25,
K40813R30, K41093R30, K41750R30, K41856R30, K42067R30,
K43058R30, K43343R30, K40813R60, K43058R60, K43343R60;
71) K43044R25, K43044R30;
72) K40374A25, K40374C25, K37053A30, K37082A30, K38072A30,
K39436A30, K40159A30, K40374B30, K35756A60;
73) K37296A25, K37296B25, K38126B25, K39829A25, K40805A25,
K38126A, K38126C30, K38494A30, K38494B30, K38771A30,
K38771B30, K39246A30, K39385A30, K40486A30, K40805B30;
74) K37106A25, K37106B30, K39504A30;
75) K35605A25, K35605C25, K35605D25, K42472A25, K39577A25,
K34194D30, K35605B30, K35605E30, K37454A30, K43438A30,
K38093A30, K38794A30, K39686A30, K34194A60, K34194B60,
K34194C60;
76) K36761C25, K37074A25, K39529A25, K41083A25, K41083B25,
K41363A25, K36761A30, K36761B30, K37074B30, K41033A30,
K41083C30, K41363B30;
77) K39619A25, K39619B25, K40899B25, K38046A30, K38046B30,
K39404A30, K40899A30, K40899C30, K40899D30;
78) K38083B25, K38352A25, K40526A25, K37059A30, K37762A30,
K38083A30, K38352B30, K38904A30, K39465A30, K40784A30;
79) K42150A25, K40156A25, K40156B25, K37481A30, K37481B30,
K37481C30, K37481D30, K41135A30, K39461A30, K40156C30;
80) K41512R25, K41918R25, K42201R25, K43079R25, K41512R30,
K41918R30, K42201R30, K43079R30;
81) K41557R25, K42036R25, K42303R25, K43236R25, K41557R30,
K42036R25, K42037R30, K42303R30, K43236R30;
82) K41410R25, K42020R25, K42573R25, K42814R25, K43403R25,
K41410R30, K42020R30, K42573R30, K42814R30, K43403R30;
83) K37099A25, K37099C25, K37757B25, K37757C25, K41601A25,
K41601X25, K41716A25, K42571A25, K39501A25, K39501B25,
K39929A25, K40858A25, K37099B30, K37757A30, K37757D30,
K41601B30, K39929B30, K39929C30, K40858B30;
84) K38451A25, K38704B25, K38451A30, K41661A30, K38704A30,
K38704C30, K40297A30;
85) K41553R25, K42034R25, K42310R25, K43137A25, K39838R25,
K40649R25, K41553R30, K42034R30, K42310R30, K43137R30,
K39838R30, K40649R30;
86) K37469R25, K38450A25, K41138B25, K37469R30, K38450A30,
K38799A30, K38799B30, K41138B30, K41138C30;
87) K41899R25, K42216R25, K42891R25, K43359R25, K41899R30,
K42216R30, K42891R30, K43359R30;
88) K42038R25, K42813R25, K42639R25, K42038R30, K42813R30,
K42639R30;
89) K35010A25, K35703A25, K36422A25, K36422C25, K36766B25,
K41617A25, K41618B25, K38436B25, K39473A25, K34499A30,
K35010B30, K35703B30, K36422B30, K36422D30, K36766A30,
K36766C30, K38034A30, K38034B30, K38436A30, K38436C30,
K38936A30, K38936B30, K40318A30;
90) K38829B25, K38829C25, K37450A30, K38829A30, K40929A30,
K41134A30;
91) K38829B25, K38829C25, K37450A30, K38829A30, K40929A30,
K41134A30;
92) K36364C25, K37069B25, K36364A30, K36364B30, K36814A30,
K36814B30, K37069A30, K37069C30, K38580A30, K39393A30;
93) K35380A25, K36767A30, K36767B30, K36767C30;
94) K37448B25, K41027A25, K37078A30, K37448A30,
K42269A30, K39701A30, K40354A30;
95) K34510A25, K35368A25, K37075A30, K42179A30;
96) K37076A25, K38606A25, K42547A30;
97) K42168A25, K42180A25, K37449B25, K40468A25, K40880A25,
K37077A30, K42180B30, K37449A30, K40468B30, K40880B30,
K41113A30;
98) K39625B25, K41616A30, K39625A30;
99) K36762A25, K36762B30, K41538A30, K42081A30;
100) K41725R25, K42197R25, K43244R25, K41725R30,
K42197R30, K43244R30;
101) K42014R25, K42311R25, K42445R25, K42878R25,
42014R30, K42013R30, K42311R30, K42445R30, K42878R30
RECALLING FIRM/MANUFACTURER
Heartland Repack Services, LLC, Toledo, OH, by letter dated July 28, 2006. Firm initiated recall is ongoing.
REASON
Mispacked; possibility of a product package mix-up.
VOLUME OF PRODUCT IN COMMERCE
411,677 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
Esmolol Hydrochloride Injection, 100 mg/10mL (10 mg/mL), 10 mL single dose vial, Rx only, NDC 63323-652-10, Recall # D-391-7
CODE
Lot: 402505, exp. 06/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abraxis Pharmaceutical Products, Rosemont, IL, by letter on September 22, 2006.
Manufacturer: Abraxis Pharmaceutical Products, Grand Island, NY. Firm initiated recall is ongoing.
REASON
Failed total impurity specification.
VOLUME OF PRODUCT IN COMMERCE
17,425 vials
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0020-7;
b) Platelets, Recall # B-0021-7
CODE
a) and b) Unit: 53FW36330
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone on March 16, 2005 and by letter dated March 18, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Diltiazem, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD and D.C.

______________________________
PRODUCT
a) Platelets, Recall # B-0026-7;
b) Platelets, Irradiated, Recall # B-0027-7
CODE
a) Units: 53FF72565, 53FF72571, 53G75857, 53G75861, 53G75866, 53GC60848, 53GC60850, 53GC60852, 53GE91007, 53GR66304, 53GR66315, 53GR66346, 53GE90546, 53GE90549, 53GE90559, 53GE90575, 53GE90541, 53GE90583, 53GE90587, 53GE90594, 53GE90595, 53GE90597, 53GE91003, 53GE91004, 53GC60843, 53GE90562, 53GE90563, 53GE90570, 53GE90581, 53GE90584, 53G75846, 53G75854, 53G75864, 53GR66303, 53GR66309, 53GR66323, 53FF72558, 53FF72566, 53FF72569, 53FF72570, 53FF72572, 53FF72576, 53FF72577, 53GC60842, 53GC60845, 53GE90542, 53GE90543, 53GE90544, 53GE90547, 53GE90556, 53GE90557, 53GE90560, 53GE90566, 53GE90571, 53GE90572, 53GE90574, 53GE90576, 53GE90580, 53GE90590, 53GE90591, 53GE90596, 53GE90599, 53GE91009, 53GE91010, 53FF72561, 53FF72562, 53FF72563, 53FF72567, 53FF72573, 53FF72574, 53G75865, 53G75871, 53GC60847, 53GC60849, 53GE90565, 53GE90568, 53GE90577, 53GE90578, 53GE90579, 53GE90585, 53GE90586, 53GE90588, 53GE90592, 53GE90593, 53GE91002, 53GE91011, 53GR66301, 53GR66316, 53GR66336, 53GR66344, 53G75859, 53GR66313, 53GR66335, 53GR66342, 53M10639, 53M10656, 53G75855, 53G75878, 53G75879, 53GR66332, 53GR66340, 53M10633, 53G75863, 53G75842, 53G75847, 53G75850, 53G75851, 53G75860, 53G75867, 53G75870, 53G75873, 53G75882, 53GR66302, 53GR66318, 53GR66337, 53GR66338, 53M10626, 53M10630, 53M10634, 53M10635, 53M10640, 53M10641, 53M10655, 53GR66334, 53G75856, 53G75868, 53GR66310, 53GR66319, 53GR66320, 53GR66321, 53GR66322, 53GR66325, 53GR66328, 53M10628, 53M10629, 53M10637, 53M10642, 53M10657;

b) Units: 53GE90554, 53GE90558, 53GR66308, 53GR66311, 53GR66330, 53GV62772, 53GV62776, 53GV62792, 53GV62795, 53GV62796, 53GV62803, 53GV62805, 53GV62809, 53GV62818, 53GV62819, 53GV62820, 53GV62823, 53M10627, 53M10632, 53M10636, 53M10648, 53G75849, 53GE90550, 53GE90551, 53GR66326
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Region, Baltimore, MD, by facsimile on January 8, 2005 and February 8, 2005. Firm initiated recall is complete.
REASON
Blood products, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
163 units
DISTRIBUTION
MD, PA, and D.C.

______________________________
PRODUCT
Plasma, Frozen, Recall # B-0030-7
CODE
Unit: 53J99062
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone on July 21, 2005 and by letter dated July 22, 2005. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with Klebsiella, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
D.C.

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0031-7;
b) Fresh Frozen Plasma, Recall $ B-0032-7
CODE
a) Units: 13GE37321, 13GE37341, 13GW51393 and 13GW51403;
b) Units: 13GE37321, 13GE37331, 13GE37341 and 13GW51403
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on December 6, 2005, and by letter dated December 21, 2005. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
MI and CA

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0042-7;
b) Red Blood Cells, Rejuvenated, Washed, Recall # B-0043-7;
c) Red Blood Cells, Deglycerolized, Recall # B-0044-7;
d) Platelets, Recall # B-0045-7;
e) Platelets, Irradiated, Recall # B-0046-7;
f) Cryoprecipitated, AHF, Recall # B-0047-7;
g) Cryoprecipitated AHF, Pooled, Recall # B-0048-7:
h) Fresh Frozen Plasma, Recall # B-0049-7
CODE
a) Units: 18GF42971, 18GF42973, 18GF42974, 18GF42975, 18GF42977, 18GF42979,
18GF42987, 18GG56741, 18GG56754, 18GG56760, 18GG56762, 18GG56767,
18GF42926, 18GF42929, 18GF42930, 18GF42935, 18GF42938, 18GF42945,
18GF42948, 18GF42950, 18GF42951, 18GF42953, 18GG56672, 18GG56676,
18GG56704, 18GG56713, 18GF42880, 18GF42884, 18GF42904, 18GF42906,
18GF42845, 18GF42849, 18GF42867, 18GF42794, 18GF42796, 18GF42821,
18GF42767, 18GF42771, 18GF42776, 18GF42779, 18GF42782, 18GF42788,
18GF42789, 18GG56528, 18GG56534, 18GG56535, 18GG56552, 18GG56555,
18GG56559, 18GG56564, 18GG56410, 18GG56422, 18GG56437, 18GG56440,
18GG56450, 18GF42682, 18GF42684, 18GF42689, 18GK28136, 18GK28137,
18GK28140, 18GK28141, 18GK28148, 18GK28154, 18GK28106, 18GK28108,
18GK28111, 18GK28116, 18GK28126, 18GK28045, 18GK28047, 18GK28048,
18GK28050, 18GK28064, 18GK28067, 18GK28071, 18GK28084, 18GK28086,
18GK28088, 18GK28089, 18GK28091, 18GK27962, 18GK27971, 18GK27972,
18GK27973, 18GK27975, 18GK27929, 18GK27941, 18GK27943, 18GK27948,
18GK56232, 18GG56233, 18GG56234, 18GG56238, 18GG56250, 18GG56253,
18GG56264, 18GG56265, 18GF42481, 18GF42492, 18GK27744, 18GK27750,
18GK27752, 18GK27753, 18GK27764, 18GK27711, 18GK27714, 18GK27715,
18GK27717, 18GK27718, 18GK27721, 18GK27723, 18GK27727, 18GK27728,
18GK27730, 18GG56014, 18GG56015, 18GG56022, 18GK27507, 18GK27513,
18GK27485, 18GK27486, 18GK27492, 18GK27474, 18GK27481, 18GK27484,
18GK27470, 18GH89842, 18GH89837, 18GH89839, 18GH89830, 18GH89833,
18GG55868, 18GG55852, 18GG55853, 18GG55862, 18GG55832, 18GG55848,
18GG55827, 18GG55829, 18GH89540, 18GH89535, 18GH89536, 18GH89529,
18GH89531, 18GH89532, 18GH89520, 18GH89522, 18GH89512, 18GH89515,
18GH89517, 18GH89510, , 18GK27236, 18GK27238, 18GK27240, 18GK27219,
18GK27221, 18GK27214, 18GK27133, 18GK27135, 18GK27104, 18GK27099,
18GK27100, 18GF41961, 18GF41956, 18GF41958, 18GF41960, 18GF41949,
18GF41950, 18GF41954, 18GF41946, 18GF41948, 18GF41929, 18GF41931,
18GG55334, 18GG55336, 18GG55348, 18GG55323, 18GG55331, 18GG55281,
18GG55283, 18GG55285, 18GG55292, 18GG55306, 18GK26710, 18GK26714,
18GK26719, 18GK26720, 18GK26731, 18GK26733, 18GK26739, 18GK26742,
18GK26743, 18GG55172, 18GG55189, 18GG55084, 18GG55090, 18GG55091,
18GG55099, 18GG55100, 18GG55103, 18GG55112, 18GG55114, 18GH88692,
18GH88695, 18GH88697, 18GH88707, 18GH88711, 18GH88713, 18GH88725,
18GH88727, 18GH88728, 18GH88730, 18GH88731, 18GH88733, 18GF41436,
18GF41449, 18GF41451, 18GH88653, 18GH88668, 18GH88673, 18GH88612,
18GH88619, 18GK26231, 18GK26233, 18GK26235, 18GK26239, 18GK26247,
18GK26249, 18GK26207, 18GF41245, 18GF41248, 18GF41260, 18GF41261,
18GF41269, 18GF41271, 18GF41193, 18GF41196, 18GF41207, 18GF41178,
18GF41180, 18GH88080, 18GH88100, 18GH88127, 18GH88133, 18GH88136,
18GK25984, 18GK25986, 18GK25987, 18GK25991, 18GK26004, 18GK26010,
18GH88005, 18GH87989, 18GH87986, 18GH87980, 18GG54273, 18GG54271,
18GG54248, 18GG54244, 18GH87840, 18GH87843, 18GH87848, 18GH87860,
18GH87865, 18GH87868, 18GH87870, 18GH87892, 18GF40937, 18GF40935,
18GF40933, 18GF40930 and 18GF40928;
b) Unit: 18GG56264;
c) Unit: 18GG54248;
d) Units: 18GG56410, 18GK27962, 18GH88080, 18GH88100 and 18GH88102;
e) Unit: 18GG56437;
f) Units: 18GK28111, 18GH89512, 18GH89515, 18GH87980, 18GH87860, and
18GH87865;
g) Unit: 18GK28050;
h) Units: 18GK28064, 18GG56232, 18GG56234, 18GG56236, 18GG56240,
18GG56015, 18GG56018, 18GG55323, 18GH88127, 18GH88001, 18GG54271,
18GG54270, 18GG54268 and 18GH87870
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by letter on April 2, 2003, by facsimile on March 28, 2003 and by telephone on March 19/20, 2003. Firm initiated recall is ongoing.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
301 units
DISTRIBUTION
AL, CA, CT, GA, IN, NV, OK, PA, SC, VA, OH, MD, MI, and MA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0082-7
CODE
Unit: 53GR70769
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on July 1, 2005 and by letter dated July 12, 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
MD

______________________________
PRODUCT
Recovered Plasma, Recall # B-0084-7
CODE
Unit: GR38567
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by letter on May 16, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for variant Creutzfeldt - Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

______________________________
PRODUCT
Source Plasma, Recall # B-0085-7
CODE
Units: 03LWID9056 03LWIE0563 03LWIE1438 03LWIE1703 03LWIE2881 03LWIE7822 03LWIF5263 03LWIF5709 03LWIF6162 03LWIF6703 03LWIF7544 03LWIF8839 03LWIG0019 04LWIA0693 04LWIA1413 04LWIA6459 04LWIA7250 04LWIB7909 04LWIC0795 04LWIC2962 04LWIC3881 04LWIC4249 04LWIC5138 04LWIC7988 04LWIC8464 04LWIC9002 04LWIC9487 03LWIS2936 03LWIS3052 03LWIS3082 03LWIS3114 03LWIS3204 03LWIS3554 03LWIS4083 03LWIS4116 03LWIS4147 03LWIS4185 03LWIS4239 03LWIS4334 04LWIS0036 04LWIS0127 04LWIS0262 04LWIS0545 04LWIS0600 04LWIS0616 04LWIS0850 04LWIS1717 04LWIS1784 04LWIS1810 04LWIS1874 04LWIS2074 04LWIS2110 04LWIS2149 04LWIS2179
RECALLING FIRM/MANUFACTURER
BioLife Plasma Service L.P., Onalaska, WI, by facsimile on July 29, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt - Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
54 units
DISTRIBUTION
Austria

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0089-7
CODE
Unit: 31137-2614
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on April 16, 2004.
Manufacturer: Blood Systems, Inc., dba United Blood Services, Tupelo, MS. 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
MS

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0091-7;
b) Fresh Frozen Plasma, Recall # B-0092-7
CODE
a) and b) Unit: 31136-6731
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on February 27, 2004 or by letter dated March 30, 2004.
Manufacturer: Blood Systems, Inc., dba United Blood Services, Tupelo, MS. 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
2 units
DISTRIBUTION
MS and UK

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0093-7;
b) Fresh Frozen Plasma, Recall # B-0094-7;
c) Platelets Pheresis, Leukocytes Reduced, Recall # B-0095-7
CODE
a) Units: 16375-9054, 16454-4031;
b) Unit: 16454-4031;
c) Units: 16375-9757 (Splits 1, 2, and 3)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on October 20, 2003 or letter dated December 1, 2003.
Manufacturer: Blood Systems, Inc., dba United Blood Services, Meridian, MS. 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
6 units
DISTRIBUTION
AL and MS

______________________________
PRODUCT
Platelets Pheresis, Recall # B-0096-7
CODE
Units: W020004200121, W020005200003 (Split A), W020005200003 (Split B), W020005200144, 4802037, W020004200013, W020004200036, W020004200125, W020004200132, W020004200161, W020004200164, W020004200182, W020004200192, W020005200052, W020005200072, W020005200094 (Split A), W020005200094 (Split B), W020005200124, W020005200171, W020004200011, W020004200029, W020004200033, W020004200055, W020004200056, W020004200263, W020004200265, W020004200270 (Split A), W020004200270 (Split B), W020004200272, W020005200144 (Split B), W020005200145 (Split B), W020005200157 (Split B), W020005200159, W020005200171 (Split B), W020005200176, W020005200177, W020005200178, W020005200174 (Split A), W020005200174 (Split B), W020004200031, W020004200129, W020004200130, W020004200133, W020004200053
RECALLING FIRM/MANUFACTURER
Department of the Navy, National Naval Medical Center, Bethesda, MD, by letter dated August 1, 2005. Firm initiated recall is complete.
REASON
Blood products, manufactured in a manner that may compromise the sterility of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
44 units
DISTRIBUTION
MD and D.C.

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0100-7
CODE
Unit: 032KE77458
RECALLING FIRM/MANUFACTURER
American National Red Cross, Badger-Hawkeye Region, Madison, WI, by telephone on February 7, 2003. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a unit of whole blood more than eight hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0101-7
CODE
Unit: 032GP23395 (Part 1)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Badger-Hawkeye Region, Madison, WI, by telephone on December 12, 2002. Firm initiated recall is complete.
REASON
Platelets, inappropriately prepared by splitting the product into two storage bags instead of one, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

______________________________
PRODUCT
Human Corneas for Transplantation, Recall # B-0118-7
CODE
CIO50081OS and CIO50081OD
RECALLING FIRM/MANUFACTURER
Michigan Eye Bank, Ann Arbor, MI, by letter dated June 28, 2006. Firm initiated recall is complete.
REASON
Human corneas, recovered from a donor who had not been properly evaluated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissue allografts
DISTRIBUTION
NJ and OH

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0125-7;
b) Recovered Plasma, Recall # B-0126-7
CODE
a) and b) Units: 032GE56561, 032GE58023
RECALLING FIRM/MANUFACTURER
American National Red Cross, Badger-Hawkeye Region, Madison, WI, by letter or facsimile on June 17, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, ME, and MA

______________________________
PRODUCT
Acellular Dermal Matrix Grafts
AlloDerm, Repliform and GraftJacket, Recall # B-0128-7
CODE
Lot # B14672 - (003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 015, 017, 019, 021, 022, 023, 024, 025, 027, 029, 030, 031, 032, 034, 039, 040, 041, 042, 044, 045, 046, 048, 049, 050, 051, 052, 053, 054, 055, 056, 057, 058, 059, 060, 061, 063, 064, 065, 066, 067, 068, 069, 070, 071, 072, 074, 077, 078, 080, 083, 085, 088, 090, 092, 093, 094, 095, 096, 097, 098, 099, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119)
RECALLING FIRM/MANUFACTURER
LifeCell Corporation, Somerville, NJ, by telephone on July 21, 2006, and by follow-up
letter dated July 26, 2006. Firm initiated recall is ongoing.
REASON
Human tissues, collected from a donor who had not been properly evaluated for hemo-dilution, were distributed.
VOLUME OF PRODUCT IN COMMERCE
91 tissue allografts
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Human Cornea, Recall # B-0129-7
CODE
NE2006-1-1-72, L-01
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tissue Banks International, Baltimore, MD, by telephone on January 25,
2006, and by follow-up letter dated April 13, 2006.
Manufacturer: New England Eye & Tissue Transplant Bank, Boston, MA. Firm initiated
recall is complete.
REASON
Human Cornea, recovered from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
MA

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0130-7
CODE
Unit: 7220939
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on August 19, 2004. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0131-7
CODE
Unit 4728726 (split)
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on August 3, 2006 and by letter dated August 11, 2006. Firm initiated recall is complete.
REASON
Blood products, which were labeled with the incorrect platelet yield, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0133-7
CODE
Unit: 231518233
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Billings, MT, by telephone on July 8, 2004. 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
MT

______________________________
PRODUCT
Platelets, Recall # B-0134-7
CODE
Unit: H25683
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated July 13, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had taken aspirin prior to the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0137-7
CODE
Unit: 164605491
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Meridian, MS, by telephone on January 6, 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
AL

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0138-7
CODE
Unit: 200393452
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lafayette, LA, by letter dated November 9, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0139-7;
b) Platelets Leukocytes Reduced, Recall # B-0140-7
CODE
a) and b) Unit: 22FZ20878
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Philadelphia, PA, by telephone, letter, or facsimile on May 16, 17, 19, and 25, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0144-7
CODE
Unit: 42FG17318
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by telephone on February 9, 2006, and by letter dated February 13, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0145-7
CODE
Units: 1673943, 1612186, and 1182017
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, UC Medical Center, Cincinnati, OH, by letter dated January 19, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OH

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0146-7
CODE
Unit: 42FQ26498
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by telephone on March 23, 2006, and by letter dated March 28, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

______________________________
PRODUCT
Platelets, Recall # B-0147-7
CODE
Unit: 5578508
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on July 20, 2006. Firm initiated recall is complete.
REASON
Platelets, with an unacceptable pH, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0148-7
CODE
Unit: 71X37821-1
RECALLING FIRM/MANUFACTURER
Life Source Community Blood Centers, Lecanto, FL, by facsimile transmission dated October 5, 2005. Firm initiated recall is complete.
REASON
Platelets, with a low pH, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

______________________________
PRODUCT
a) Platelets, Recall # B-0150-7;
b) Fresh Frozen Plasma, Recall # B-0151-7;
c) Plasma, Recall # B-0152-7;
d) Plasma Frozen, Recall # B-0153-7;
e) Cryoprecipitated AHF, Recall # B-0154-7;
f) Cryoprecipitated AHF Pooled, Recall # B-0155-7
CODE
a) Units 17FZ15071, 17FZ17844, 17KH79866, 17KK64067, and 17KP76411;
b) Units: 17FM09895, 17FR15623, 17FZ15071, 17KM41521, 17KQ58071,
17KX84529, and 17KH79866;
c) Unit: 17KE03007;
d) Units: 17KL98251 and 17KR90333;
e) Unit: 17KE03007;
f) Units: 17FZ620395, 17FV10750, 17FV10753, and 17FV10777
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Paul, MN, by letter dated April 10, 2003. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from whole blood units in which an associated blood component contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
CA, MI, MN, OH, TN, and WI

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0156-7;
b) Platelets, Recall # B-0157-7;
CODE
a), and b) Unit: 163603956
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Meridian, MS, by letter dated December 23, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL, MS, and VA

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0171-7;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0172-7;
c) Platelets, Recall # B-0173-7;
d) Recovered Plasma, Recall # B-0174-7
CODE
a) Unit: 163430243;
b) Units: 163562690, 163703728, and 163728297;
c) Units: 163562690 and 163703728;
d) Unit: 163728297
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Meridian, MS, by letter dated August 19, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had lived in an area that was at high risk for group O HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
MS, AL, VA, and Switzerland

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0003-7
CODE
Unit: 53GQ26187
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Regions, Baltimore, MD, by facsimile on June 28, 2005. Firm initiated recall is complete.
REASON
Blood product, which may have been exposed to unacceptable temperatures during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0023-7;
b) Recovered Plasma, Recall # B-0024-7
CODE
a) and b) Unit: 53LL66797
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Regions, Baltimore,
MD, by telephone on January 13, 2005, and by letter dated February 11, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of Idiopathic Thrombocytopenic Purpura (ITP), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD and CA

______________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0034-7
CODE
Unit: 53FE18607 -- part A
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Regions, Baltimore,
MD, by telephone on November 9, 2005, and by letter dated November 10, 2005. Firm
initiated recall is complete.
REASON
Red Cells, possibly contaminated with Corynebacterium, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

______________________________
PRODUCT
Red Blood Cells, (for further manufacture-non-injectable), Recall # B-0050-7
CODE
Unit: 18GK27222
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on March 20, 2003, and by letter on April 2, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NB

______________________________
PRODUCT
Recovered Plasma, Recall # B-0076-7
CODE
Unit: 4715955
RECALLING FIRM/MANUFACTURER
Mary Greeley Medical Center, Ames, IA, by facsimile on June 24, 2005. Firm initiated recall is complete.
REASON
Blood product, which tested negative for viral markers, but was collected from a donor who previously tested repeatedly reactive for HIV-p24 antigen, Western Blot indeterminate, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

______________________________
PRODUCT
Platelets (Apheresis), Leukocytes Reduced, Irradiated, Recall # B-0079-7
CODE
Unit: 0025467
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by telephone on September 4, 2003. Firm
initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0081-7
CODE
Units: 246303266 (2 units), 246303278 (2 units), 246303264
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Rapid City, SD, by telephone on July 16, 2003. Firm initiated recall is complete.
REASON
Blood products, which were out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
SD

______________________________
PRODUCT
Source Plasma, Recall # B-0083-7
CODE
Units: I61041070, I61041209, I61041283, I61041334, I61041382, I61041412, I61041429, I61041512, I61041868, I61041879, I61042250, I61042252, I61042318, I61042580, I61042658, I61042659, I61042807, I61042810, I61042851, I61042852, I61042909, I61043107, I61043109, I61043158, I61043187, I61043226, I61043238, I61043294, I61043312, I61043315, I61043366, I61043600, I61043607, I61043614, I61043639, I61043697, I61043713, I61043815, I61043867, I61043899, I61043929, I61043946, I61043991, I61044319, I61044364, I61044367, I61044484, I61044507, I61044510, I61044559, I61044668, I61044695
RECALLING FIRM/MANUFACTURER
International BioResources, Eugene, OR, by facsimile on June 25, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
52 units
DISTRIBUTION
NC

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0088-7
CODE
Units: 16454-5598 (split unit), 16374-3305 (split unit), 16374-3328 (split unit)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on November 21, 2003.
Manufacturer: Blood Systems, Inc., dba United Blood Services, Meridian, MS. Firm initiated recall is complete.
REASON
Blood products, collected from donors with unacceptable hematocrit determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
MS

______________________________
PRODUCT
Recovered Plasma, Recall # B-0090-7
CODE
Unit: 31137-2614
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on May 25, 2004.
Manufacturer: Blood Systems, Inc., dba United Blood Services, Tupelo, MS. 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
Switzerland

______________________________
PRODUCT
a) Platelets Leukocytes Reduced, Recall # B-0122-7;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-0123-7;
c) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0124-7
CODE
a) Units 13GP21299 and 13GT14736;
b) Units 18KT03007, 18KT03019, 18KT03020, 18KT02996, 18KT02997,
18P66786, 18P66773, 18P66791, 18P66795, 32FP20252, 32GP37819,
32GP37820, 32KM54254 and 32KM54247;
c) Units 50KP03645, 50P45273 and 50KP03653
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Lansing, MI, by telephone on November 17, 2005 and by letter dated November 22, 2005. Firm initiated recall is complete.
REASON
Blood products, which may have been stored at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
MI

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0132-7
CODE
Unit: 164567957
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Meridian, MS, by telephone on April 10, 2004. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS

______________________________
PRODUCT
Red Blood Cells Irradiated, Recall # B-0135-7
CODE
Unit: 71Q268115
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham, AL, by facsimile on September 8, 2005. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0136-7
CODE
Unit: 71X276034 (split)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham, AL, by facsimile on August 16, 2005. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AL

______________________________
PRODUCT
a) Red Blood Cell, Recall # B-0141-7;
b) Platelets, Recall # B-0142-7;
c) Fresh Frozen Plasma, Recall # B-0143-7
CODE
a), b), and c) Unit: 0210611
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone and letter on June 27, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
LA and CA

______________________________
PRODUCT
Red Blood Cells, Recall # B-0149-7
CODE
Units 17FZ06057, 17FZ15071, 17KX42496, 17KG76458, 17KK64067, 17KR50804, and 17KF68595
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Paul, MN, by letter dated April 10, 2003. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from whole blood units in which an associated blood component contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA, MI, MN, OH, TN, and WI

______________________________
PRODUCT
Recovered Plasma, Recall # B-0158-7
CODE
Unit: 163603956
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Meridian, MS, by letter dated December 23, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL, MS, and VA

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle (3cc-27x1-1/4 A) Product # 888153744, Recall # Z-0051-2007
CODE
Lot numbers: 611406 and 611407
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kendall a Division of Tyco Healthcare Group LP, Argyle, NY, by letter on September 12, 2006.
Manufacturer: Kendall, Deland, FL. Firm initiated recall is ongoing.
REASON
Incorrect needle. There is an incorrect needle configuration on the syringe. The correct needle has a 27 gage A-bevel, the needle on the syringe has no bevel, typically used for dental irrigation.
VOLUME OF PRODUCT IN COMMERCE
130,000 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition transceivers, the patient worn data acquisition transceivers, the transceiver access points with antenna, the network infrastructure, A computer platform running the ApexPro Telemetry Application and a computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application)., Recall # Z-0054-2007
CODE
Software versions v3.8 and earlier
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Wauwatosa, WI, by letter on June 23, 2006.
Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.
REASON
System Warning Alarm failure: When a patient being monitored is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing yellow border around the patient panel at the CIC does not occur.
VOLUME OF PRODUCT IN COMMERCE
379 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Depuy PFC Oval Dome Patella, Part Number 960100, 3-Peg. 32 mm, sterile, REF 96-0100, Recall # Z-0057-2007
CODE
Lot: 2203528
RECALLING FIRM/MANUFACTURER
Recalling Firm: Depuy Orthopaedics, Inc., Warsaw, IN, by telephone on September 14, 2006.
Manufacturer: Depuy-Cork Div. Of Depuy Orthopaedics, Ringaskiddy County Cork, Ireland. Firm initiated recall is complete.
REASON
Mislabeled units containing a size 32 mm. Patella were labeled as a 38 mm patella.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Convertors Tiburon Cardiovascular Split Drape II, Sterile, for single use only;
Made in Mexico. The cardiovascular drapes were packaged under the
following configurations: a) Catalog #9158 - 1 CV split drape
b) Catalog #9158CE - 8 x 1 CV split drape, Recall # Z-0058-2007;
b) Convertors Cardiovascular Split Pack II, the pack contains 1 Tiburon
Cardiovascular Split Drape II and 3 Astound Surgical Gowns; Sterile,
for single use only; Made in Mexico; Catalog #29158, Recall # Z-0059-2007;
c) Presource Custom Sterile Packs containing the Cardiovascular Split Drape II;
the custom sterile packs were packaged with the bulk, non-sterile drapes and
then the complete custom pack was sterilized; identified by the following catalog
numbers: a) SVC13AMEMK - Sterile Open Heart Adult Pack;
b) SCV31OHMPJ -- Sterile Open Heart w Drapes Pack;
c) SVC42OPVCG - Sterile Open Heart Adult Pack;
d) SCV32CPMUO - Sterile CAB 146060 Pack;
e) SCV34OHTMJ - Sterile Basin Pack;
f) SCV31LVLUM - Sterile Liver Transplant Pack;
g) SCV19CVHHF -- Sterile Cardiovascular Pack;
h) SCV11ADLLD - Sterile Open Heart/Adult;
i) SCV92CBHRB - Sterile CABG Pack;
j) SCV92CASIA - Sterile Cardiovascular Pack;
k) SBA32GSMUL - Sterile General Surgery Pack;
l) SCV30OHKWA - Sterile Open Heart Pack;
m) SBA31LVLUM - Sterile Liver Transplant Pack;
n) SBA35LTBLQ - Sterile Lung Transplant Pack;
o) SCV44CVDEB - Sterile CV Pack;
p) SCV22OHMES - Open Heart Pack;
q) SCV23AOSFH - Open Heart Part 3;
r) SCV43OHHRF - Open Heart;
s) SCV24CAGME - CABG Drape Pack;
t) SAN12CCKGB - Cardiac Pack;
u) SBA13BRBSE - Breast Reduction;
v) SCV11CBNYP - CABG G 3;
w) SCV11CESLB - C.V. Drape Pack;
x) SCV11CGCPR - CABG;
y) SCV11CGXXB - CABG Pack;
z) SCV11CJICL - Cardiac Major;
aa) SCV11CTMUK - C T Set Up;
bb) SCV11DPMYG - S Drape Pack;
cc) SCV11HEMMI - Open Heart A B;
dd) SCV11MRCPE - Major Cardiac;
ee) SCV11OCNYN - OH CABG;
ff) SCV11OHLD2 - Open Heart A&B Pack;
gg) SCV11OHNMC - Open Heart;
hh) SCV11OPLKC - O P CABG;
ii) SCV11VASLB - C V Valve Drape;
jj) SCV11VLNYM - G 3 Valve;
kk) SCV12OHYHY - Graft and Linen;
ll) SCV13AABSV - Aortic Aneurysm;
mm) SCV13AMEMJ - Open Heart Pack B;
nn) SCV13BBEMC - Cardio-Thoracic Aux;
oo) SCV13CB767 - CABG;
pp) SCV13OHCAI - Open Heart Pack;
qq) SCV13OOBIG - Open Heart Drape;
rr) SCV14O1BGO - Open Heart Pack A;
ss) SCV22OHPGA - Open Heart Pack;
tt) SCV22OOMSE - Open Heart Preferred;
uu) SCV24OH20A - Open Heart Drape Pack;
vv) SCV43DREJI - Open Heart Drape Pack;
ww) SCV69OH17E - Open Heart;
xx) SCV59HVSGJ - Heart Valve Pack;
yy) SCV59OHNVM - Open Heart Pack;
zz) SCV53HTDMG - Open Heart;
aaa) SCV56CH11A - Open Heart Pack;
bbb) SCV59MJTCW - Open Heart Pack;
ccc) SCV52OH97F - Open Heart Pack;
ddd) SCV41OHHIE - Open Heart Pack;
eee) SCV52HTSJE - Open Heart Pack;
fff) SCV59OHMHV - Basic Heart Pack; Recall # Z-0060-2007;
d) Cardiovascular Split Sheet II, Bulk Non-Sterile; 130 units per box;
Made in Mexico; catalog #9158N, Recall # Z-0061-2007;
e) Cardinal Health Sterile Presource PBDS Modules, have Presource
Custom Sterile Packs containing the Cardiovascular Split Drape II or
a Sterile Convertors Tiburon Cardiovascular Split Drape II bundled in
the module; identified by the following catalog numbers: PBDS modules
containing catalog 9158:
PC40OHRJR - Basic Open Heart Kit, RWJ;
PC40OHRJT - Basic Open Heart Kit, RWJ; PBDS modules containing
custom sterile packs:
a) PWOCBSBSE - Breast Reduction Kit, pack SBA13BRBSE;
b) PC40CGSLK - CABG Kit, pack SCV11CESLB;
c) PCOCCGNYO - CABG Kit, pack SCV11OCNYN;
d) PCOCOHNME - Open Heart Kit, pack SCV11OHNMC;
e) PC40VPSLD - Valve Kit, pack SCV11VASLB;
f) PC78OHUVZ - Open Heart Kit, pack SCV56CH11A;
g) PC82OH16C - Open Heart Kit, pack SCV59MJTCW;
h) PC82OH17O - Open Heart Kit, pack SCV69OH17E;
i) PCVROHDMI - Open Heart Kit, pack SCV53HTDMG;
j) PC15CGFCL - CABG Kit, pack SCV32CPMUO;
k) PCOCOHLLD - Open Heart Kit - Adult, pack SCV11ADLLD;
l) PG15OTFCI - General Surgery Kit, pack SBA32GSMUL;
m) PGCGLRLUP - Liver Transplant Kit 747340, pack SBA31LVLUM;
n) PC13OHEMR - Open Heart Adult Pack Kit, pack SCV13AMEMJ;
o) PC60CJICX - Cardiac Major Kit, pack SCV11CJICL;
p) PCOCOHMMK - Open Heart AB Kit, pack SCV11HEMMI;
q) PCV2CG34A - G 3 CABG Kit, pack SCV11CBNYP;
r) PCV2CP10J - CABG Kit, pack SCV11CGCPR;
s) PCV2VRNHW - G 3 Valve Kit, pack SCV11VLNYM;
t) PVOCAA76F - AAA Kit, pack SCV13AABSV
u) UCV42OPVC3 - Open Heart Kit, pack SCV42OPVCG;
v) PC92CBHRB - CABG 2 of 2 Kit, pack SCV92CBHRB;
w) PC44CGDEB - CV Kit, pack SCV44CVDEB;
x) PC22OHMHW - Open Heart Kit, pack SCV22OHMES;
y) PC23OPSFH - Open Heart Kit, pack SCV23AOSFH;
z) PC43OHHRG - Open Heart Kit, pack SCV43OHHRF;
aa) PV24CAGME - CABG Kit, pack SCV24CAGME,
Recall # Z-0062-2007
CODE
a) Lot numbers 06FRD326, 06FRD341, 06GRD006, 06GRD013, 06HRD110;
Lot numbers 06FAD344, 06FAD370, 06FAD405, 06HAD109;
b) Lot number: 06FAD300, 06FDA304, 06FAD378, 06FAD386, 06HAD299,
06HAD462, 06HAD485;
c) Cat #SVC13AMEMK, order #777594; cat #SCV31OHMPJ, order #773933;
cat #SVC42OPVCG, order #774231; cat #SCV32CPMUO, order #774845;
cat #SCV34OHTMJ, order #775103; cat #SCV31LVLUM, order #775646;
cat #SCV19CVHHF, order #776102; cat #SCV11ADLLD, order #776475;
cat #SCV92CBHRB, order #776785; cat #SCV92CASIA, order #776792;
cat #SBA32GSMUL, order #777047; cat #SCV30OHKWA, order #777171;
cat #SBA31LVLUM, order #777288; cat #SBA35LTBLQ, order #777599;
cat #SCV44CVDEB, order #780376; cat #SCV22OHMES, order #731809;
cat #SCV23AOSFH, order #737659; cat #SCV43OHHRF, order #739410;
cat #SCV24CAGME, order #740765; cat #SAN12CCKGB, order #732285;
cat #SBA13BRBSE, order #731714; cat #SCV11CBNYP, order #732629;
cat #SCV11CESLB, order #734779; cat #SCV11CGCPR, order #732923;
cat #SCV11CGXXB, order #735832; cat #SCV11CJICL, order #735189;
cat #SCV11CTMUK, order #734463; cat #SCV11DPMYG, order #732152;
cat #SCV11HEMMI, order #733639; cat #SCV11MRCPE, order #733157;
cat #SCV11OCNYN, order #732625; cat #SCV11OHLD2, order #732191;
cat #SCV11OHNMC, order #732446; cat #SCV11OPLKC, order #735134;
cat #SCV11VASLB, order #737823; cat #SCV11VLNYM, order #732656;
cat #SCV12OHYHY, order #735934, 734739, 732575; cat #SCV13AABSV,
order #732913; cat #SCV13AMEMJ, order #732970; cat #SCV13BBEMC,
order #732070; cat #SCV13CB767, order #732869; cat #SCV13OHCAI,
order #733777, 731664; cat #SCV13OOBIG, order #734407;
cat #SCV14O1BGO, order #738338; cat #SCV22OHPGA, order #735643;
cat #SCV22OOMSE, order #738400; cat #SCV24OH20A, order #735637;
cat #SCV43DREJI, order #741763; cat #SCV69OH17E, order #975704;
cat #SCV59HVSGJ, order #975779; cat #SCV59OHNVM, order #976192;
cat #SCV53HTDMG, order #976853; cat #SCV56CH11A, order #977429;
cat #SCV59MJTCW, order #977839, 978730; cat #SCV52OH97F, order #978285;
cat #SCV41OHHIE, order #978409; cat #SCV52HTSJE, order #978410;
cat #SCV59OHMHV, order #978523;
d) Lot numbers 17362D; 17361D; 17461D; 17761D; 17762D; 17861D;
17961D; 18061D; 18861D; 19362D; 19461D; 19462D; 19561D; 19862D;
19961D; 21262D; 22861D; 22862D; 22961D; 23361D; 23562D; 23761D;
e) Catalog #PC40OHRJR, order #10054217, 10055120, 10057934;
cat #PC40OHRJT, order #10065291; cat #PWOCBSBSE, order #10060748;
cat #PC40CGSLK, order #10061804, 10066623; cat #PCOCCGNYO, order #10065587;
cat #PCOCOHNME, order #10065687; cat #PC40VPSLD, order #10043999;
cat #PC78OHUVZ, order #10060807, 10069028; cat #PC82OH16C, order #10068824;
cat #PC82OH17O, order #10052174, 10054524, 10065426, 10065686;
cat #PCVROHDMI, order #10057971; cat # PC15CGFCL, order #10064101;
cat #PCOCOHLLD, order #10065095; cat #PG15OTFCI, order #10067619;
cat #PGCGLRLUP, order #10062174, 10068393; cat #PC13OHEMR,
order #10063121, 10070917; cat #PC60CJICX, order #10067310;
cat #PCOCOHMMK, order #10055151, 10066811; cat #PCV2CG34A,
order #10047446; cat #PCV2CP10J, order #10062941; cat #PCV2VRNHW,
order #10047450; cat #PVOCAA76F, order #10066307; cat #UCV42OPVC3,
order #774231; cat #PC92CBHRB, order #776785; cat #PC44CGDEB,
order #780376; cat #PC22OHMHW, order #731809; cat #PC23OPSFH,
order #737659; cat #PC43OHHRG, order #739410; cat #PV24CAGME, order #740765
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, McGaw Park, IL, by letters dated September 27, 2006.
Manufacturer: Cirpro De Delicias, Parque Industrial Las Virgenes, Panamericana, Apartado Postal, Mexico. Firm initiated recall is ongoing.
REASON
The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.
VOLUME OF PRODUCT IN COMMERCE
3,780 drapes
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Locator-Wand Cover that is sold in a shelf carton (unit packaging)
separate to the sterile tray containing and identified as PORT-A-CATH
P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow
Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4672-24. Contents:
Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane
Catheter 5.8Fr with CATH-FINDER Sensor Wire, Locator-Wand cover,
Luer Cap, 20G PORT-A-CATH needle, 18G Blunt needle, Vein Pick,
Point-Lok Sharps Safety Device, Product Information. EtO Sterilized.
Single Use, Recall # Z-0064-2007;
b) Locator-Wand Cover that is sold in a shelf carton (unit packaging)
separate to the sterile tray containing and identified as PORT-A-CATH
P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow
Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4673-24. Contents:
Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane
Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover,
Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt needle,
20G GRIPPER PLUS non-Coring Safety needle, 18G Extra Thin Wall
Introducer Needle, 6 Fr introducer, 2 'J' Guidewires, 2 Syringes,
Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle,
3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized.
Single Use, Recall # Z-0065-2007;
c) Locator-Wand Cover that is sold in a shelf carton (unit packaging)
separate to the sterile tray containing and identified as PORT-A-CATH II
Fluoro-Free, Low Profile Venous Access System, PolyFlow Polyurethane
Catheter, 1.9mm O.D. tray. REF 21-4683-24. Contents: Portal with
ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane Catheter
with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer
Cap, 20G PORT-A-CATH needle, 18G Blunt needle, 20G GRIPPER PLUS
non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr
introducer, 2 'J' Guidewires, Syringes, Vein Pick, Tunneling Tool, 20G
90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices,
Product Information. EtO Sterilized. Single Use, Recall # Z-0066-2007;
d) Locator-Wand Cover that is sold in a shelf carton (unit packaging)
separate to the sterile tray containing and identified as PORT-A-CATH
P.A.S. PORT Elite Fluoro-Free, Venous Access System, PolyFlow
Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4690-24. Contents:
Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane
Catheter 5.8Fr with CATH-FINDER Sensor Wire, Locator-Wand cover,
Luer Cap, 20G PORT-A-CATH needle, 18G Blunt needle, Vein Pick,
Point-Lok Sharps Safety Device, Product Information. EtO Sterilized.
Single Use, Recall # Z-0067-2007
CODE
a) Lot number: M42230;
b) Lot number: M41249;
c) Lot number: M42880;
d) Lot number: M41399
RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul, MN, by telephone, facsimile and letter on September 27, 2006. Firm initiated recall is ongoing.
REASON
Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was originally recalled because Locator Wand covers, which are supplied on the outside of PORT-A-CATH and P.A.S. PORT sterile trays, may have an insufficient seal and product sterility could be compromised.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
CA, FL, MA, MD, OH, OK, and TX

______________________________
PRODUCT
Sienet Cosmos V15C, model number 10018969, Recall # Z-0069-2007
CODE
Serial numbers: 1001, 1010, 1011, 1028, and 1029
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter, dated September 20, 2006.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Potential loss of images. Images may not be successfully sent to the RAID system.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA, MD, MO, and PA

______________________________
PRODUCT
a) Syngo Imaging, picture archiving and communications system.
Model number 7502029, Recall # Z-0070-2007;
b) Sienet Sky, picture archiving and communications system.
Model number 8463163, Recall # Z-0071-2007;
c) Sienet Magic View 300, picture archiving and communications system.
Model numbers 10014063 and 10014064, Recall # Z-0072-2007
CODE
All versions
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter, dated September 5, 2006.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.
VOLUME OF PRODUCT IN COMMERCE
1,818 units
DISTRIBUTION
Nationwide

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PRODUCT
Cook Zilver 635 Billary Stent -- Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-4.0-40, Recall # Z-0080-2007
CODE
Lot: 1722922
RECALLING FIRM/MANUFACTURER
Cook, Inc., Bloomington, IN, by telephone on September 21, 2006. Firm initiated recall is ongoing.
REASON
The side of the boxes give incorrect sizes for these stents. The label front is correct. (side label-5x40-front label-8x40).
VOLUME OF PRODUCT IN COMMERCE
5
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set, REF/catalog no. 27-135. Universal Product Number (UPN) M001271350, Recall # Z-0081-2007
CODE
Lot: 8955327, Exp. August 20009
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Spencer, IN, by letter dated September 21, 2006. Firm initiated recall is ongoing.
REASON
Sterility compromised/package integrity: the bottom of the Tyvek pouch may not have been sealed.
VOLUME OF PRODUCT IN COMMERCE
80 units
DISTRIBUTION
Nationwide

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PRODUCT
Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer, Catalog Numbers: 914-418 and 914-426, Recall # Z-0115-2007
CODE
Software Version 2.60
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America, Inc., Westlake, OH, by telephone on July 6, 2006 and by letter dated July 21, 2006.
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is complete.
REASON
Incorrect FI02 (Fraction of Inspired Oxygen) values: programming issue can cause incorrect values to be transmitted to the LIS when: 1)- The FI02 result is edited in the manual sample processing mode- 2)- An existing result is opened and FI02 is then edited and sent….In both cases RADIANCE will transmit the original FI02 value, not the value that was edited.
VOLUME OF PRODUCT IN COMMERCE
506 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

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PRODUCT
Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators, Recall # Z-0002-2007
CODE
Serial numbers: 051089, 051449, 055130, 056463, 059146, 059334, 060912, 060961, 063612, 065790,
RECALLING FIRM/MANUFACTURER
Guidant Corporation, Saint Paul, MN, by visits on June 5, 2006. Firm initiated recall is ongoing.
REASON
Final software load did not occur prior to shipment of select programmers.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Nationwide

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PRODUCT
AC-powered Adjustable Hospital Bed. (ICCG Bed) Affected Model numbers: IH820-3MDLX, IHSC900DLX, IH820-3MDLX-QS, IH820-3MPDLX-QS, SC900-80WDLX-QSP, SC900-80PDLX-QSP, IH820-3MDLX-AE-333PS, SC90080GDLX-AE-366PA, SC90080GDLX-AE-333PS, IH820-3MDLX-AE-366PS, IH820-3MDLX-AE-333PA, IH820-3MDLX-AE-366PA and SC90080GDLX-AE-366PS, Recall # Z-0063-2007
CODE
Serial Numbers: 06CF035033 06DF003462 06DF007408 06DF018274 06DF027564 06DF029581 06DF042349 06EF006839 06CF035034 06DF003483 06DF007409 06DF018275 06DF027565 06DF029582 06DF042350 06EF006840 06CF035035 06DF003484 06DF007410 06DF018276 06DF027566 06DF029583 06DF042351 06EF006841 06CF035036 06DF007274 06DF007411 06DF018277 06DF027567 06DF029584 06DF042352 06EF006842 06CF035037 06DF007275 06DF007412 06DF018278 06DF027568 06DF029585 06DF042353 06EF006843 06CF035038 06DF007276 06DF007413 06DF018279 06DF027569 06DF029586 06DF042354 06EF006844 06CF035039 06DF007277 06DF007414 06DF018280 06DF027570 06DF032354 06DF042355 06EF006845 06CF035040 06DF007278 06DF007415 06DF018281 06DF027571 06DF032355 06DF042356 06EF006846 06CF035041 06DF007279 06DF007416 06DF018282 06DF027572 06DF032356 06DF042357 06EF006847 06CF035042 06DF007280 06DF007417 06DF018283 06DF027573 06DF032357 06DF042358 06EF006848 06CF035043 06DF007281 06DF007418 06DF018284 06DF027574 06DF032358 06DF042359 06EF006849 06CF035044 06DF007282 06DF007419 06DF018285 06DF027575 06DF032359 06DF042360 06EF006850 06CF035045 06DF007283 06DF007420 06DF018286 06DF027576 06DF032360 06DF042361 06EF006851 06CF035046 06DF007284 06DF007421 06DF018287 06DF027577 06DF032361 06DF042362 06EF006852 06CF035047 06DF007285 06DF007422 06DF018288 06DF027578 06DF032362 06DF042363 06EF006853 06CF035048 06DF007286 06DF007423 06DF018289 06DF027579 06DF032363 06DF042364 06EF006854 06CF035049 06DF007287 06DF007424 06DF018290 06DF027580 06DF032364 06DF042365 06EF006855 06CF035050 06DF007288 06DF007425 06DF018291 06DF027581 06DF032365 06DF042366 06EF006856 06CF035051 06DF007289 06DF018186 06DF018292 06DF027582 06DF032366 06DF042367 06EF006857 06CF035052 06DF007290 06DF018187 06DF018293 06DF027583 06DF032367 06DF042368 06EF006858 06CF035053 06DF007291 06DF018188 06DF018294 06DF027584 06DF032368 06DF042369 06EF006859 06CF035054 06DF007292 06DF018189 06DF018295 06DF027585 06DF032369 06DF042370 06EF006860 06CF035055 06DF007293 06DF018190 06DF018296 06DF027586 06DF032370 06DF042371 06EF006861 06CF035056 06DF007294 06DF018191 06DF018297 06DF027618 06DF032371 06DF042372 06EF006862 06CF035057 06DF007295 06DF018192 06DF018298 06DF027619 06DF032372 06DF042373 06EF006863 06CF035058 06DF007296 06DF018193 06DF027474 06DF027620 06DF032373 06DF042374 06EF006864 06CF035059 06DF007297 06DF018194 06DF027475 06DF027621 06DF032374 06DF042375 06EF006865 06CF035060 06DF007298 06DF018201 06DF027476 06DF027622 06DF032375 06DF042376 06EF006866 06CF035061 06DF007299 06DF018202 06DF027477 06DF027623 06DF032376 06DF042377 06EF006867 06CF035062 06DF007300 06DF018203 06DF027478 06DF027624 06DF032377 06DF042378 06EF006868 06CF035063 06DF007301 06DF018204 06DF027479 06DF027625 06DF032378 06DF042379 06EF006869 06CF035064 06DF007302 06DF018205 06DF027480 06DF027626 06DF032379 06DF042380 06EF006870 06CF035065 06DF007303 06DF018206 06DF027481 06DF027627 06DF032380 06DF042381 06EF006871 06CF035066 06DF007304 06DF018207 06DF027482 06DF027628 06DF032381 06DF042382 06EF006872 06CF035067 06DF007342 06DF018208 06DF027483 06DF027629 06DF032382 06DF042383 06EF006873 06CF035068 06DF007343 06DF018209 06DF027484 06DF027630 06DF032385 06DF042384 06EF006874 06CF035069 06DF007344 06DF018210 06DF027485 06DF027631 06DF032388 06DF042385 06EF006875 06CF035070 06DF007345 06DF018211 06DF027486 06DF027632 06DF032389 06DF042386 06EF006876 06CF035071 06DF007346 06DF018212 06DF027502 06DF027633 06DF032390 06DF042387 06EF006877 06CF035072 06DF007347 06DF018213 06DF027503 06DF027634 06DF038967 06DF042388 06EF006878 06CF035073 06DF007348 06DF018214 06DF027504 06DF027635 06DF038968 06DF042389 06EF006879 06CF035074 06DF007349 06DF018215 06DF027505 06DF027636 06DF038969 06DF042390 06EF006880 06CF035075 06DF007350 06DF018216 06DF027506 06DF027637 06DF038970 06DF042391 06EF006881 06CF035076 06DF007351 06DF018217 06DF027507 06DF027638 06DF038971 06DF042392 06EF006882 06CF035077 06DF007352 06DF018218 06DF027508 06DF027639 06DF038972 06DF042393 06EF006883 06CF035078 06DF007353 06DF018219 06DF027509 06DF027640 06DF038973 06DF042394 06EF006884 06CF035079 06DF007354 06DF018220 06DF027510 06DF027641 06DF038974 06DF042395 06EF006885 06CF035080 06DF007355 06DF018221 06DF027511 06DF027642 06DF038975 06DF042396 06EF006886 06CF035081 06DF007356 06DF018222 06DF027512 06DF027643 06DF038976 06DF042397 06EF006887 06CF035082 06DF007357 06DF018223 06DF027513 06DF027644 06DF038977 06DF042398 06EF006888 06CF035083 06DF007358 06DF018224 06DF027514 06DF027645 06DF038978 06DF042399 06EF006889 06CF035084 06DF007359 06DF018225 06DF027515 06DF027646 06DF038979 06DF042400 06EF006890 06CF035085 06DF007360 06DF018226 06DF027516 06DF027647 06DF038980 06DF042401 06EF006891 06CF035086 06DF007361 06DF018227 06DF027517 06DF027648 06DF038981 06DF042402 06EF006892 06CF035087 06DF007362 06DF018228 06DF027518 06DF027649 06DF038982 06DF042403 06EF006893 06CF035088 06DF007363 06DF018229 06DF027519 06DF027650 06DF038983 06DF042404 06EF006894 06CF035089 06DF007364 06DF018230 06DF027520 06DF027651 06DF038984 06DF042405 06EF006895 06CF035090 06DF007365 06DF018231 06DF027521 06DF027652 06DF038985 06DF042406 06EF006896 06CF035091 06DF007366 06DF018232 06DF027522 06DF027653 06DF038986 06DF042407 06EF006897 06CF035092 06DF007367 06DF018233 06DF027523 06DF027654 06DF038987 06DF042408 06EF006898 06CF035093 06DF007368 06DF018234 06DF027524 06DF027655 06DF038988 06DF042409 06EF006899 06CF035094 06DF007369 06DF018235 06DF027525 06DF027656 06DF038989 06DF042410 06EF006900 06CF035095 06DF007370 06DF018236 06DF027526 06DF027657 06DF038990 06DF042411 06EF006901 06CF035096 06DF007371 06DF018237 06DF027527 06DF027658 06DF038991 06EF006785 06EF006902 06CF035097 06DF007372 06DF018238 06DF027528 06DF027659 06DF038992 06EF006786 06EF006903 06CF035098 06DF007373 06DF018239 06DF027529 06DF027660 06DF038993 06EF006787 06EF006904 06CF035099 06DF007374 06DF018240 06DF027530 06DF027661 06DF038994 06EF006788 06EF006905 06CF035100 06DF007375 06DF018241 06DF027531 06DF027662 06DF038995 06EF006789 06EF006906 06CF035101 06DF007376 06DF018242 06DF027532 06DF027663 06DF038996 06EF006800 06EF006907 06CF035102 06DF007377 06DF018243 06DF027533 06DF027664 06DF038997 06EF006801 06EF006908 06CF035103 06DF007378 06DF018244 06DF027534 06DF027665 06DF038998 06EF006802 06EF006909 06CF046827 06DF007379 06DF018245 06DF027535 06DF027666 06DF038999 06EF006803 06EF006910 06CF046828 06DF007380 06DF018246 06DF027536 06DF027667 06DF039000 06EF006804 06EF006911 06CF046829 06DF007381 06DF018247 06DF027537 06DF027668 06DF039001 06EF006805 06EF006912 06CF046830 06DF007382 06DF018248 06DF027538 06DF027669 06DF039002 06EF006806 06EF006913 06CF046831 06DF007383 06DF018249 06DF027539 06DF027670 06DF039003 06EF006807 06EF006914 06CF046832 06DF007384 06DF018250 06DF027540 06DF027671 06DF039004 06EF006808 06EF006915 06CF046833 06DF007385 06DF018251 06DF027541 06DF027672 06DF039005 06EF006809 06EF006916 06CF046834 06DF007386 06DF018252 06DF027542 06DF027673 06DF039006 06EF006810 06EF006917 06CF046835 06DF007387 06DF018253 06DF027543 06DF027674 06DF039007 06EF006811 06EF006918 06CF046836 06DF007388 06DF018254 06DF027544 06DF027675 06DF039008 06EF006812 06EF006919 06CF046837 06DF007389 06DF018255 06DF027545 06DF027676 06DF039009 06EF006813 06EF006920 06CF046838 06DF007390 06DF018256 06DF027546 06DF027677 06DF039010 06EF006814 06EF006921 06CF046839 06DF007391 06DF018257 06DF027547 06DF027678 06DF039011 06EF006815 06EF006922 06CF046840 06DF007392 06DF018258 06DF027548 06DF027679 06DF039012 06EF006816 06EF006923 06CF046841 06DF007393 06DF018259 06DF027549 06DF027680 06DF039013 06EF006817 06EF006924 06CF046842 06DF007394 06DF018260 06DF027550 06DF029567 06DF039014 06EF006818 06EF006925 06CF046843 06DF007395 06DF018261 06DF027551 06DF029568 06DF039015 06EF006819 06EF006926 06CF046844 06DF007396 06DF018262 06DF027552 06DF029569 06DF039016 06EF006820 06EF006927 06CF046845 06DF007397 06DF018263 06DF027553 06DF029570 06DF039017 06EF006821 06EF006928 06CF046846 06DF007398 06DF018264 06DF027554 06DF029571 06DF039018 06EF006822 06EF006929 06CF046847 06DF007399 06DF018265 06DF027555 06DF029572 06DF039019 06EF006823 06EF006930 06CF046848 06DF007400 06DF018266 06DF027556 06DF029573 06DF039020 06EF006824 06EF006931 06CF046849 06DF007401 06DF018267 06DF027557 06DF029574 06DF039021 06EF006832 06EF006932 06CF046850 06DF007402 06DF018268 06DF027558 06DF029575 06DF039022 06EF006833 06EF006933 06CF046851 06DF007403 06DF018269 06DF027559 06DF029576 06DF039023 06EF006834 06EF006934 06CF046852 06DF007404 06DF018270 06DF027560 06DF029577 06DF039024 06EF006835 06EF006935 06CF046853 06DF007405 06DF018271 06DF027561 06DF029578 06DF042346 06EF006836 06EF006936 06CF046854 06DF007406 06DF018272 06DF027562 06DF029579 06DF042347 06EF006837 06EF006937 06DF003461 06DF007407 06DF018273 06DF027563 06DF029580 06DF042348 06EF006838 06EF006938 06EF006939 06EF010455 06EF014740 06EF016729 06EF024142 06EF030019 06EF041599 06FF009829 06EF006940 06EF010456 06EF014741 06EF016730 06EF024143 06EF030020 06EF041600 06FF009830 06EF006941 06EF010457 06EF014742 06EF016731 06EF024144 06EF030021 06EF041601 06FF009831 06EF006942 06EF010458 06EF014743 06EF016732 06EF024145 06EF030022 06EF041602 06FF009832 06EF006943 06EF010459 06EF014744 06EF016733 06EF024146 06EF030023 06EF041603 06FF009833 06EF006944 06EF010460 06EF014746 06EF016734 06EF024147 06EF030024 06EF041605 06FF009834 06EF006945 06EF010461 06EF014747 06EF016735 06EF024148 06EF030025 06EF041606 06FF012780 06EF006946 06EF010462 06EF015792 06EF016736 06EF024149 06EF030026 06EF041607 06FF012781 06EF006947 06EF010463 06EF015793 06EF016737 06EF024150 06EF030027 06EF041608 06FF012782 06EF006948 06EF010464 06EF015794 06EF016738 06EF024151 06EF030028 06EF041609 06FF012783 06EF006949 06EF010465 06EF015795 06EF016739 06EF024152 06EF030029 06EF041610 06FF012784 06EF006950 06EF010466 06EF015796 06EF016740 06EF024153 06EF030030 06EF041611 06FF012785 06EF006951 06EF010467 06EF015797 06EF016741 06EF024154 06EF030031 06EF041612 06FF012786 06EF006952 06EF010468 06EF015798 06EF016742 06EF024155 06EF030032 06EF041613 06FF012787 06EF006953 06EF010469 06EF015799 06EF016743 06EF024156 06EF030033 06EF041614 06FF012788 06EF006954 06EF010470 06EF015800 06EF016744 06EF024157 06EF030034 06EF041615 06FF012789 06EF006955 06EF010501 06EF015801 06EF016745 06EF024158 06EF030035 06EF041616 06FF012790 06EF006956 06EF010502 06EF015802 06EF016746 06EF024159 06EF030036 06EF041617 06FF012791 06EF006957 06EF010503 06EF015803 06EF016748 06EF024160 06EF030037 06EF041618 06FF015278 06EF006958 06EF010504 06EF015804 06EF016749 06EF024161 06EF030038 06EF041619 06FF015279 06EF006959 06EF010505 06EF015805 06EF016750 06EF024162 06EF030039 06EF041620 06FF015280 06EF006960 06EF010507 06EF015806 06EF016751 06EF024163 06EF030040 06EF041621 06FF015281 06EF006961 06EF010508 06EF015807 06EF022487 06EF024164 06EF030041 06EF041632 06FF015282 06EF006962 06EF010509 06EF015808 06EF022488 06EF024165 06EF030042 06EF041633 06FF015283 06EF006963 06EF010510 06EF015809 06EF022489 06EF024166 06EF030043 06EF041634 06FF015284 06EF006964 06EF010511 06EF015810 06EF022490 06EF024167 06EF030044 06EF041635 06FF015285 06EF006965 06EF010512 06EF015811 06EF022491 06EF024168 06EF030045 06EF041636 06FF015286 06EF006966 06EF010513 06EF015812 06EF022492 06EF024169 06EF030046 06EF041637 06FF015287 06EF006967 06EF010514 06EF015813 06EF022493 06EF024170 06EF034192 06EF041638 06FF017482 06EF006968 06EF010515 06EF015814 06EF022494 06EF024171 06EF034193 06EF041639 06FF017483 06EF006969 06EF010516 06EF015815 06EF022495 06EF024172 06EF034194 06EF041640 06FF017484 06EF006970 06EF010518 06EF015816 06EF022496 06EF024173 06EF034195 06EF041641 06FF017485 06EF006971 06EF010519 06EF015817 06EF023973 06EF024174 06EF034196 06EF041642 06FF017486 06EF006972 06EF010520 06EF015818 06EF023974 06EF024175 06EF034197 06EF041643 06FF017487 06EF006973 06EF010521 06EF015819 06EF023975 06EF024746 06EF034198 06FF006314 06FF017488 06EF006974 06EF010522 06EF015820 06EF023976 06EF024747 06EF034199 06FF006315 06FF017489 06EF006975 06EF010523 06EF015821 06EF023977 06EF024748 06EF034200 06FF006316 06FF017490 06EF006976 06EF010524 06EF015822 06EF023978 06EF024749 06EF034201 06FF006317 06FF018153 06EF006977 06EF010525 06EF015823 06EF023979 06EF024750 06EF035665 06FF006318 06FF018154 06EF006978 06EF010526 06EF015824 06EF023980 06EF024751 06EF035666 06FF006319 06FF018155 06EF006979 06EF010528 06EF015825 06EF023981 06EF024752 06EF035667 06FF006322 06FF018156 06EF006980 06EF010529 06EF015826 06EF023982 06EF024753 06EF035668 06FF006323 06FF018157 06EF006981 06EF010530 06EF015827 06EF023983 06EF024754 06EF035669 06FF006324 06FF018158 06EF006982 06EF010531 06EF015828 06EF023984 06EF024755 06EF035671 06FF007328 06FF018159 06EF006983 06EF010532 06EF015829 06EF023985 06EF024756 06EF035672 06FF007329 06FF018160 06EF006984 06EF010533 06EF015830 06EF023986 06EF024757 06EF035673 06FF007330 06FF018161 06EF006985 06EF010534 06EF015831 06EF023987 06EF024758 06EF035674 06FF007331 06FF018162 06EF006986 06EF010535 06EF015832 06EF023988 06EF024759 06EF038008 06FF007332 06FF018163 06EF006987 06EF010536 06EF015833 06EF023989 06EF024760 06EF038009 06FF007333 06FF018164 06EF006988 06EF010537 06EF015834 06EF023990 06EF024761 06EF038010 06FF007334 06FF018165 06EF006989 06EF010538 06EF015835 06EF023991 06EF024762 06EF038011 06FF007335 06FF018166 06EF006990 06EF010539 06EF015836 06EF023992 06EF024763 06EF038012 06FF007336 06FF018167 06EF006991 06EF010540 06EF015837 06EF023993 06EF024764 06EF038043 06FF007337 06FF018168 06EF006992 06EF010541 06EF015838 06EF023994 06EF024765 06EF038044 06FF007338 06FF018169 06EF006993 06EF010542 06EF015839 06EF023995 06EF024766 06EF038045 06FF007339 06FF018170 06EF006994 06EF010543 06EF015840 06EF023996 06EF024767 06EF038046 06FF007340 06FF018171 06EF006995 06EF010544 06EF015841 06EF023997 06EF024768 06EF038047 06FF007341 06FF018172 06EF006996 06EF014690 06EF015842 06EF023998 06EF024769 06EF038048 06FF007342 06FF018173 06EF006997 06EF014691 06EF015843 06EF023999 06EF024770 06EF038049 06FF007343 06FF018174 06EF006998 06EF014692 06EF015844 06EF024000 06EF027907 06EF038050 06FF007344 06FF018175 06EF006999 06EF014693 06EF015845 06EF024001 06EF027908 06EF038051 06FF007345 06FF018176 06EF007000 06EF014694 06EF015846 06EF024002 06EF027909 06EF038052 06FF007346 06FF018177 06EF007001 06EF014695 06EF015847 06EF024003 06EF027910 06EF038053 06FF007347 06FF018178 06EF007002 06EF014696 06EF015848 06EF024004 06EF027911 06EF038054 06FF007348 06FF018179 06EF007003 06EF014697 06EF015849 06EF024005 06EF027912 06EF038055 06FF007349 06FF018180 06EF007004 06EF014698 06EF015850 06EF024006 06EF027913 06EF038056 06FF007350 06FF018181 06EF007005 06EF014705 06EF015851 06EF024007 06EF027914 06EF038057 06FF007351 06FF018182 06EF007006 06EF014706 06EF016696 06EF024008 06EF027915 06EF038058 06FF007352 06FF018183 06EF007007 06EF014707 06EF016697 06EF024009 06EF027916 06EF038059 06FF007353 06FF018184 06EF007008 06EF014708 06EF016698 06EF024010 06EF029988 06EF038063 06FF007354 06FF018185 06EF007009 06EF014709 06EF016699 06EF024011 06EF029989 06EF039050 06FF007355 06FF018186 06EF007010 06EF014710 06EF016700 06EF024012 06EF029990 06EF039051 06FF007356 06FF018187 06EF007011 06EF014711 06EF016701 06EF024013 06EF029991 06EF039052 06FF007357 06FF018188 06EF007012 06EF014712 06EF016702 06EF024014 06EF029992 06EF039053 06FF007358 06FF018189 06EF007013 06EF014713 06EF016703 06EF024015 06EF029993 06EF039054 06FF007359 06FF018190 06EF007014 06EF014714 06EF016704 06EF024016 06EF029994 06EF039055 06FF007360 06FF018191 06EF007015 06EF014715 06EF016705 06EF024017 06EF029995 06EF039056 06FF007361 06FF018192 06EF007016 06EF014716 06EF016706 06EF024018 06EF029996 06EF039057 06FF007362 06FF018193 06EF007017 06EF014717 06EF016707 06EF024019 06EF029997 06EF039058 06FF007363 06FF018194 06EF007018 06EF014718 06EF016708 06EF024020 06EF029998 06EF039059 06FF007364 06FF018195 06EF009212 06EF014719 06EF016709 06EF024021 06EF029999 06EF039060 06FF007365 06FF018196 06EF009213 06EF014720 06EF016710 06EF024022 06EF030000 06EF039061 06FF007366 06FF018197 06EF009214 06EF014721 06EF016711 06EF024023 06EF030001 06EF039062 06FF007367 06FF018198 06EF009215 06EF014722 06EF016712 06EF024024 06EF030002 06EF039935 06FF007368 06FF018199 06EF009216 06EF014723 06EF016713 06EF024025 06EF030003 06EF041579 06FF007369 06FF018200 06EF009217 06EF014724 06EF016714 06EF024026 06EF030004 06EF041580 06FF007370 06FF018201 06EF009218 06EF014725 06EF016715 06EF024027 06EF030005 06EF041581 06FF007371 06FF018202 06EF009219 06EF014726 06EF016716 06EF024028 06EF030006 06EF041582 06FF007372 06FF018203 06EF009220 06EF014727 06EF016717 06EF024029 06EF030007 06EF041583 06FF007373 06FF018204 06EF009221 06EF014728 06EF016718 06EF024030 06EF030008 06EF041584 06FF007374 06FF018205 06EF009222 06EF014729 06EF016719 06EF024031 06EF030009 06EF041585 06FF007375 06FF018206 06EF009223 06EF014730 06EF016720 06EF024032 06EF030010 06EF041586 06FF007376 06FF018207 06EF009224 06EF014731 06EF016721 06EF024033 06EF030011 06EF041588 06FF007377 06FF018208 06EF009225 06EF014732 06EF016722 06EF024034 06EF030012 06EF041591 06FF007378 06FF018209 06EF009226 06EF014734 06EF016723 06EF024035 06EF030013 06EF041593 06FF007379 06FF018210 06EF009227 06EF014735 06EF016724 06EF024036 06EF030014 06EF041594 06FF007380 06FF018211 06EF010442 06EF014736 06EF016725 06EF024037 06EF030015 06EF041595 06FF007381 06FF018212 06EF010443 06EF014737 06EF016726 06EF024139 06EF030016 06EF041596 06FF009816 06FF018213 06EF010444 06EF014738 06EF016727 06EF024140 06EF030017 06EF041597 06FF009817 06FF018214 06EF010445 06EF014739 06EF016728 06EF024141 06EF030018 06EF041598 06FF009818 06FF018216 06FF018217 06FF033953 06FF038551 06FF047441 06GF016272 06FF018218 06FF033954 06FF038552 06FF048159 06GF016273 06FF018219 06FF033955 06FF038553 06FF048160 06GF016274 06FF018220 06FF033956 06FF038554 06FF048161 06GF016275 06FF018221 06FF033957 06FF038555 06FF048162 06GF016276 06FF018222 06FF033958 06FF038559 06FF048163 06GF016277 06FF018223 06FF033959 06FF038560 06GF000401 06GF016278 06FF018224 06FF037043 06FF038561 06GF000402 06GF016279 06FF018225 06FF037044 06FF038562 06GF000403 06GF016281 06FF018226 06FF037045 06FF038563 06GF000404 06GF016287 06FF018227 06FF037046 06FF038564 06GF000405 06GF016288 06FF018228 06FF037047 06FF038565 06GF000406 06GF016289 06FF018229 06FF037048 06FF038570 06GF000407 06GF016290 06FF018230 06FF037049 06FF038571 06GF000408 06GF016291 06FF018231 06FF037050 06FF038572 06GF000409 06GF016292 06FF018232 06FF037051 06FF038573 06GF000410 06GF016293 06FF018233 06FF037052 06FF038574 06GF000411 06GF016294 06FF018234 06FF037053 06FF038575 06GF000412 06GF022752 06FF018235 06FF037054 06FF038576 06GF000413 06GF022753 06FF018236 06FF038470 06FF038577 06GF000414 06GF022754 06FF018237 06FF038471 06FF038578 06GF000415 06GF022755 06FF018238 06FF038472 06FF038579 06GF000416 06GF022756 06FF018239 06FF038473 06FF038580 06GF000417 06GF022757 06FF018240 06FF038474 06FF038581 06GF000418 06GF022770 06FF018241 06FF038475 06FF038582 06GF000419 06GF022771 06FF018242 06FF038476 06FF038583 06GF000420 06GF022772 06FF023914 06FF038477 06FF038584 06GF008944 06GF022773 06FF023915 06FF038478 06FF038585 06GF010962 06GF022774 06FF023916 06FF038479 06FF038586 06GF010963 06GF022775 06FF023917 06FF038480 06FF038587 06GF010964 06GF022776 06FF023918 06FF038481 06FF038588 06GF010966 06GF022777 06FF023919 06FF038482 06FF038589 06GF010967 06GF022778 06FF023920 06FF038483 06FF038590 06GF010968 06GF022779 06FF023921 06FF038484 06FF038591 06GF010969 06GF022780 06FF023922 06FF038485 06FF038592 06GF010970 06GF02278106FF023923 06FF038486 06FF038593 06GF010971 06GF022782 06FF023924 06FF038487 06FF038594 06GF010972 06GF022783 06FF023925 06FF038488 06FF038595 06GF010974 06GF022784 06FF023926 06FF038489 06FF038596 06GF010975 06GF022785 06FF023927 06FF038490 06FF038597 06GF010976 06GF022786 06FF023928 06FF038491 06FF038598 06GF010977 06GF022787 06FF023929 06FF038492 06FF038599 06GF010978 06GF027976 06FF029435 06FF038493 06FF038600 06GF012758 06GF027977 06FF029436 06FF038494 06FF038601 06GF012759 06GF027978 06FF029437 06FF038495 06FF038602 06GF012760 06GF027979 06FF029438 06FF038496 06FF038603 06GF012761 06GF027980 06FF029439 06FF038497 06FF038604 06GF012762 06GF027981 06FF029440 06FF038498 06FF038605 06GF012763 06GF027982 06FF029441 06FF038499 06FF038606 06GF012764 06GF027983 06FF029442 06FF038500 06FF038607 06GF012765 06GF027984 06FF029443 06FF038501 06FF038608 06GF012766 06GF027985 06FF029444 06FF038502 06FF038609 06GF012767 06GF027986 06FF029445 06FF038503 06FF041453 06GF012768 06GF027987 06FF029446 06FF038504 06FF041455 06GF012769 06GF027988 06FF029447 06FF038505 06FF041457 06GF012770 06GF027989 06FF029448 06FF038506 06FF041458 06GF012771 06GF027990 06FF029449 06FF038507 06FF041459 06GF012772 06GF027991 06FF029450 06FF038508 06FF041460 06GF012773 06GF027992 06FF029451 06FF038509 06FF041461 06GF012774 06GF027993 06FF029452 06FF038510 06FF041462 06GF012775 06GF027994 06FF029453 06FF038511 06FF041463 06GF012776 06GF027997 06FF029454 06FF038512 06FF041464 06GF012777 06GF027998 06FF029455 06FF038513 06FF041465 06GF012778 06GF028002 06FF029456 06FF038514 06FF041466 06GF012779 06GF028003 06FF030551 06FF038515 06FF041467 06GF012780 06GF028004 06FF030552 06FF038516 06FF041468 06GF012781 06FF030553 06FF038517 06FF041469 06GF012782 06FF030554 06FF038518 06FF041470 06GF012783 06FF030555 06FF038519 06FF041471 06GF012784 06FF030556 06FF038520 06FF042745 06GF012785 06FF030557 06FF038521 06FF042746 06GF012786 06FF030558 06FF038522 06FF042747 06GF012787 06FF030559 06FF038523 06FF042748 06GF016241 06FF030560 06FF038524 06FF042749 06GF016242 06FF030561 06FF038525 06FF042750 06GF016243 06FF030962 06FF038526 06FF042751 06GF016244 06FF030963 06FF038527 06FF042752 06GF016245 06FF030964 06FF038528 06FF042753 06GF016246 06FF030965 06FF038529 06FF042754 06GF016247 06FF030966 06FF038530 06FF042755 06GF016248 06FF030967 06FF038531 06FF042756 06GF016250 06FF030968 06FF038532 06FF043261 06GF016251 06FF030969 06FF038533 06FF043262 06GF016252 06FF030970 06FF038534 06FF043263 06GF016253 06FF030971 06FF038535 06FF043264 06GF016254 06FF030972 06FF038536 06FF045037 06GF016255 06FF030973 06FF038537 06FF045038 06GF016258 06FF030974 06FF038538 06FF045039 06GF016259 06FF033940 06FF038539 06FF045040 06GF016260 06FF033941 06FF038540 06FF045041 06GF016261 06FF033943 06FF038541 06FF045042 06GF016262 06FF033944 06FF038542 06FF045043 06GF016263 06FF033945 06FF038543 06FF045044 06GF016264 06FF033946 06FF038544 06FF045045 06GF016265 06FF033947 06FF038545 06FF045046 06GF016266 06FF033948 06FF038546 06FF045047 06GF016267 06FF033949 06FF038547 06FF045048 06GF016268 06FF033950 06FF038548 06FF045049 06GF016269 06FF033951 06FF038549 06FF045050 06GF016270 06FF033952 06FF038550 06FF045051 06GF016271
RECALLING FIRM/MANUFACTURER
Invacare Corporation, Sanford, FL, by e-mail on September 27, 2006. Firm initiated recall is ongoing.
REASON
The incorrect caution label that describes washing instructions was applied to beds distributed in the US, i.e. the specified label is P/N 1116654 (English translation); the label that was used is P/N 1119165 (French translation).
VOLUME OF PRODUCT IN COMMERCE
2,065 beds
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
Apligraf (Graftskin), Recall # Z-0068-2007
CODE
Lot: GS0609.05.01.2A Unit Numbers: 7, 8, 14, 15, 16, 18, 19, 25, 26, 29, 32, 34, 36, 40, 44, 46, 49, 52, 53, 54, 56, 58, 59, 60, 61, 63, 66, 68, 69, 70, 82 , 88, 91, 93, 94, 119, 120, 122, 126, 129, 130, 139, 142, 143, 144, 145 LOT:GS0609.05.02.1A Unit Numbers: 197, 198
RECALLING FIRM/MANUFACTURER
Organogenesis, Inc., Canton, MA, by fax and telephone on October 2, 2006. Firm initiated recall is ongoing.
REASON
Product pH out of specification.
VOLUME OF PRODUCT IN COMMERCE
17,232 cases (103,392 x 6 fl. oz. bottles)
DISTRIBUTION
Nationwide and Panama

______________________________
PRODUCT
HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Cat. Number 4126, Recall # Z-0073-2007
CODE
Lot numbers: 22026/01, 14036/01, 12066/02 and 12066/03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sebia, Inc., Norcross, GA, by fax letter and telephone on or about August 29, 2006.
Manufacturer: Sebia, Evry, France. Firm initiated recall is ongoing.
REASON
The material used in packaging leaches into the product resulting in the presence of an additional artifact band above the HbA fraction.
VOLUME OF PRODUCT IN COMMERCE
228 kits
DISTRIBUTION
Nationwide and PR

______________________________
PRODUCT
CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) packaged for use with Cryosurgical console, Recall # Z-0079-2007
CODE
Lot: 50515, 50602, 50609
RECALLING FIRM/MANUFACTURER
Recalling Firm: ATS Medical, Inc., Minneapolis, MN, by fax on April 7, 2006 and by letter on May 5, 2006.
Manufacturer: CryoCath Technologies, Inc., Kirkland, Canada. Firm initiated recall is complete.
REASON
Incorrect Expiration Date: Three lots of the FrostByte (TM) clamp packaged with SurgiFrost 7 cm cryosurgical probes have incorrect expiration dates. These lots are labeled with a two (2) year expiration date while the correct date is one (1) year.
VOLUME OF PRODUCT IN COMMERCE
71 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS III

______________________________
PRODUCT
Fort Dodge Aureomycin Chlortetracycline Soluble Powder Concentrate Antibiotic, For Veterinary Use in Drinking Water, 64 g/lb. chlortetracycline hydrochloride, each packet contains 25.6 g chlortetracycline HCl, packaged in 6.4-oz. pouches, 62 pouches per pail, NADA 65-440, Recall # V-001-2007
CODE
Lot: #051770, Exp. 11/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fort Dodge Laboratories, Inc., Fort Dodge, IA, by letters dated September 7, 2006.
Manufacturer: Virbac Bridgeton, Bridgeton, MO. Firm initiated recall is ongoing.
REASON
Out of specification (low) at the 6-month stability time interval.
VOLUME OF PRODUCT IN COMMERCE
234 pails
DISTRIBUTION
MO, VA, IA, TN, IN, Panama, and Venezuela


END OF ENFORCEMENT REPORT FOR November 1, 2006

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