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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.
April 2, 2008
08-14
___________________________________
PRODUCT
Dreyer's Brand Slow Churned Light Caramel Delight in 1.75 quart cartons, Recall # F-261-8
CODE
"BEST IF PURCHASED BY 09/11/08" and codes starting with 049-32.
RECALLING FIRM/MANUFACTURER
Dreyer's Salt Lake Operations Center Manufacturing Plant, Salt Lake City, UT, by letter on January 22, 2008. Firm initiated recall is ongoing.
REASON
Product actually contains Dreyer’s brand Slow Churned Light Butter Pecan Ice Cream, and the label on the body of the carton does not list pecans as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
137 cartons distributed
DISTRIBUTION
CO, ID, OR and WY
___________________________________
PRODUCT
Sesame Seed Natural, 25 Lb Bag MHO Item #309 Product of Uganda. Recall # F-262-8
CODE
Lot Number: 332007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mountain High Organics, Inc., New Milford, CT, by e-mail on November 1, 2007.
Manufacturer: Shares! (U) Ltd., Mukono, Uganda. Firm initiated recall is complete.
REASON
FDA’s analysis found the product to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
340/25 bags
DISTRIBUTION
NH
___________________________________
PRODUCT
Trader Joe's Pinjur, 12 oz jars, UPC 00529068, Recall # F-249-8
CODE
Best By 10/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Trader Joes Company, Monrovia, CA, by e-mail and press release on December 7, 2007.
Manufacturer: Konex-Tiva Ltd., Sofia, Bulgaria. Firm initiated recall is ongoing.
REASON
The product contains small glass pieces.
VOLUME OF PRODUCT IN COMMERCE
13,014 cases/24 jars per case/12 oz jars
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a)Tim Hortons Ready-to-Bake SMILE Chocolate Chip Cookie Dough Size: 13.64 kg (30
lbs); Case Count: 175 Codes: Best before date: 10/JUL/08. UPC 10059608005532,
Recall # F-251-8;
b) Tim Hortons Ready-to-Bake Chocolate Chip Muffin Batter Size: 12.3 KG (27 LB);
96 x 4.5 oz/case. Recall # F-252-8
c) Tim Hortons Ready-to-Bake Blueberry Muffin Batter Size: 12.3 KG (27 LB); 9
6 x 4.5 oz/case. Recall # F-253-8;
d) Tim Hortons Ready-to-Bake Low Fat Blueberry Muffin Batter Size: 12.3 KG (27 LB);
96 x 4.5 oz/case. Recall # F-254-8;
e) Tim Hortons Ready-to-Bake Low Fat Cranberry Muffin Batter Size: 12.3 KG (27 LB);
96 x 4.5 oz/case. Recall # F-255-8;
f) Tim Hortons Ready-to-Bake Fruit Explosion Muffin Batter Size: 12.3 KG (27 LB);
96 x 4.5 oz/case. Recall # F-256-8
CODE
a) Best before date: 10/JUL/08;
b) Best before date: 10/JUL/08 & 11/JUL/08;
c) Best before date: 11/JUL/08 and 12/JUL/08;
d) Best before date: 13/APR/08;
e) Best before date 13/APR/08 and 14 APR/08;
f) Best before date: 14/APR/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sygma Boston, Westborough, MA, by e-mail on February 6, 2008.
Manufacturer: Oakrun Farm Bakery Limited, Ancaster, Canada. Firm initiated recall is complete.
REASON
Bakery products may contain broken sifter screen materials.
VOLUME OF PRODUCT IN COMMERCE
3911 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
SWAD Green Chili Chutney. The product is sold in 7.5 oz bottles. The product is shipped in cases containing 12 bottles. Recall # F-259-8
CODE
Expiration dates 3/6/2008 through 9/30/2009
RECALLING FIRM/MANUFACTURER
Palace Foods Inc., Reading, PA, by letter on March 5, 2008. Firm initiated recall is ongoing.
REASON
Product contains undeclared colors - FD&C Yellow #5 and Blue #1.
VOLUME OF PRODUCT IN COMMERCE
36,408 bottles
DISTRIBUTION
GA, IL, NY, and TX.
___________________________________
PRODUCT
Holw el Sham Jelly Strawberry. Box does not contain any size/weight information. Recall # F-250-8
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Middle East Treasures Imports, Edison, NJ, by telephone in August 2007 and by letter dated August 20, 2007.
Manufacturer: Holw El Sham Co., October City, Egypt. Firm initiated recall is ongoing.
REASON
New York State Department of Agriculture and Markets’ testing revealed the presence of Carmoisine (E122), a non-permitted color additive in the product.
VOLUME OF PRODUCT IN COMMERCE
58 cases of 12 boxes each
DISTRIBUTION
NY and NJ
___________________________________
PRODUCT
a) Manischewitz Tam Tam Crackers; Whole Grain, Lightly Salted; Net Wt. 8 oz. (224
grams). UPC 72700-00037. Recall F-257-8;
b) Manischewitz Tam Tam Crackers' Whole Grain, Garden Herb Nt. wt. 8 oz., (224g).
UPC 72700-00038. Recall F-258-8
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
R.A.B. Food Group LLC, Secaucus, NJ, by letter on March 3, 2008. Firm initiated recall is ongoing.
REASON
Certain production runs have undergone oxidative rancidity of the vegetable oil within the formulation.
VOLUME OF PRODUCT IN COMMERCE
18,000 cases
DISTRIBUTION
Nationwide, Canada and Mexico
___________________________________
PRODUCT
Stuckey's® Pecan Log Roll, 12 oz cellophane packages, 24 packages/case, UPC 0-91976-90012-5. Recall # F-260-8
CODE
Lots 70827 and 71017.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stuckey's Corporation, Silver Spring, MD, by telephone and e-mail on February 25 and 26, 2008.
Manufacturer: Standard Candy Company, Eastman, GA. Firm initiated recall is ongoing.
REASON
Nutritional facts panel of product may not list Trans Fat information on the Nutrition Facts panel label.
VOLUME OF PRODUCT IN COMMERCE
14,232 packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Perphenazine Tablets, USP, 2 mg, Rx only, 100 tablets, NDC 0603-5090-21, ANDA 40-226. Recall # D-189-2008
b) Perphenazine Tablets, USP, 4 mg, Rx only, 100 tablets, NDC 0603-5091-21, ANDA 40-226. Recall # D-190-2008
CODE
a) Lot No. T002G07A
b) Lot No. T048F07A
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC, Huntsville, AL, by letter on February 28, 2008. Firm initiated recall is ongoing.
REASON
Tablet separation; cracking and splitting of tablets
VOLUME OF PRODUCT IN COMMERCE
28,398 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Actavis brand Fentanyl Transdermal System, CII, 25 mcg/hr., Rx, NDC 67767-120-18.
Each box of 5 pouches contains pouches labeled Abrika Pharmaceuticals Fentanyl Transdermal System CII, NDC 67767-120-08, Recall # D-191-2008;
b) Actavis brand Fentanyl Transdermal System, CII, 50 mcg/hr., Rx. Each box of 5
pouches contains pouches labeled Abrika Pharmaceuticals Fentanyl Transdermal
System CII, NDC 67767-121-08, Recall # D-192-2008;
c) Actavis brand Fentanyl Transdermal System, CII, 75 mcg/hr., Rx, NDC 67767-122-18.
Each box of 5 pouches contains pouches labeled Abrika Pharmaceuticals Fentanyl
Transdermal System CII, NDC 67767-122-08, Recall # D-193-2008;
d) Actavis brand Fentanyl Transdermal System, CII, 100 mcg/hr., Rx, NDC 67767-123-
18. Each box of 5 pouches contains pouches labeled Abrika Pharmaceuticals Fentanyl
Transdermal System CII, NDC 67767-123-08, Recall # D-194-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Actavis Elizabeth LLC, Elizabeth, NJ, by press release on February 17, 2008 and February 29, 2008.
Manufacturer: Corium International, Inc., Grand Rapids, MI. Firm initiated recall is ongoing.
REASON
Defective Delivery System; the patches may leak, resulting in the potential for overdosing.
VOLUME OF PRODUCT IN COMMERCE
590224 boxes of 5 patches each
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Chigarid External Analgesic, Camphor 2.8%, Phenol 1.5% and Menthol 0.1%, 0.5 FL. OZ. bottles, For the temporary relief of itching & pain associated with insect bites, Recall # D-181-2008
CODE
All lots of product are being recalled. UPC code 71053244420
RECALLING FIRM/MANUFACTURER
Recalling Firm: Richard E. Colgin I, Ltd., Dallas, TX, by letter on February 11, 2008.
Manufacturer: Trinkote Industrial Finishes, Inc., Fort Worth, TX. Firm initiated recall is ongoing.
REASON
Defective container; product has the potential to evaporate over time
VOLUME OF PRODUCT IN COMMERCE
84,672 units (1/2-oz. bottles)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Cromolyn Sodium Inhalation Solution USP 20 mg/2 mL Unit Dose Vials, 60 and 120 count boxes, Rx only, Steri-Neb brand of Sterile Unit Dose Vials, Not For Injection Aqueous Solution for Nebulization, Preservative Free, For Oral Inhalation Use Only, Recall # D-182-2008
CODE
60 count boxes; NDC number 0172-6406-49. Lot numbers W19522 exp 01/2010, W19661 exp 02/2010, W19821 exp 03/2010, W19841 exp 03/2010, W20101 exp 05/2010, and W20161 exp 05/2010 120 count boxes; NDC number 0172-6406-59. Lot numbers W19111 exp 11/2009 and W19811 exp 02/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami, FL, by letter dated March 12, 2008.
Manufacturer: IVAX Pharmaceuticals UK Limited, Cheshire WA7 3FA. UK. Firm initiated recall is ongoing.
REASON
Failed pH Specification
VOLUME OF PRODUCT IN COMMERCE
30,088 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Hydrochlorothiazide Tablets USP 25mg, 10 count bags, Rx only, Recall # D-183-2008
CODE
NDA# 55154-5841-0; Batch# M083850; Lot #CDV89AB
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, Zanesville, OH, by letter on February 19, 2008.
Manufacturer: IVAX Ireland Pharmaceuticals, Waterford, Ireland. Firm initiated recall is ongoing.
REASON
Incorrect Expiration Date; bag label bears an incorrect expiration date of 12/09. The unit dose blister inside the bag label bears the correct expiration date of 12/08
VOLUME OF PRODUCT IN COMMERCE
1680 bags of 10/25 mg tablets
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Children's Chewable Aspirin, 81 mg each, Pain Reliever/Fever Reducer, ORANGE FLAVOR, 36 Tablets, NDC 0603-0024-36, Recall # D-186-2008
b) Acetaminophen 325 mg/Phenylephrine HCl 5 mg/Chlorpheniramine Maleate 2 mg tablets, OTC, packed in bulk, net wt. 15.00 kg, Recall # D-187-2008
c) Health A2Z Extra Strength PAIN RELIEF PM, Pain Reliever/Sleep Aid, Acetaminophen 500 mg and Diphenhydramine HCl 25 mg, 24 Caplets per bottle and in bulk, OTC, Recall # D-188-2008
CODE
a) Lot 7J16471 (exp. 10/2010)
b) Bulk Lot 7K27541 (exp. 10/08)
c) Lot 6C02096 (exp. 3/2009) and bulk lot 6C02097 (exp. 3/2009)
RECALLING FIRM/MANUFACTURER
A & Z Pharmaceutical, Inc., Hauppauge, NY, by telephone on March 7, 2008, by letter on March 19, 2008 and by fax on March 20, 2008. FDA initiated recall is ongoing.
REASON
Failure to validate manufacturing process; the products were re-worked without proper validation
VOLUME OF PRODUCT IN COMMERCE
(1) Lot 7J16471: 2088 bottles; (2) Lot 7K27541: 1,164,654 bulk tablets; (3) Lot 6C02096: 29,571bottles; Lot 6C02097: 744,290 bulk tablets
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Rantidine Syrup (Ranitidine Oral Solution, USP); 15 mg/mL (75mg/5mL) One Pint (473 mL). Recall # D-185-2008
CODE
Lot # 115600, Exp. Feb 08; Lot # 115800, Exp. Feb 08; Lot # 116000, Exp. Mar. 08; Lot # 116400, Exp. Mar. 08; Lot # 118000, Exp. Apr. 08; Lot # 118300, Exp. Mar. 08; Lot # 118500, Exp. Apr. 08; Lot # 118700, Exp May 08; Lot # 119400, Exp May 08; Lot # 121700, Exp. Jun 08; Lot # 121900, Exp Jun 08; Lot # 122500, Exp May 08; Lot # 122900, Exp Jul 08; Lot # 124300, Exp Aug 08; Lot # 127000, Exp Sep 08; Lot # 129300, Exp. Oct 08; Lot # 131200, Exp. Nov. 08; Lot # 132600, Exp Oct 08; Lot # 136300, Exp. Dec. 08.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Actavis Elizabeth LLC, Elizabeth, NJ, by letter on February 22, 2007.
Manufacturer: VistaPharm, Inc., Largo, FL. Firm initiated recall is ongoing.
REASON
Failed Related Compound Specification (9 month stability)
VOLUME OF PRODUCT IN COMMERCE
284, 196 bottles (27,204 bottles on hold at distribution center)
DISTRIBUTION
Nationwide and Puerto Rico
****CORRECTION****
Enforcement Report on March 19, 2008, Recall # B-0964/0972-08 is complete.
___________________________________
PRODUCT
Platelets Leukocytes Reduced, Recall # B-0775-08
CODE
Lot: 0898605
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center Inc., Jackson, TN, by telephone on January 19, 2007. Firm initiated recall is complete.
REASON
Blood product, for which there was incomplete documentation of the irradiation process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Source Plasma, Recall # B-0780-08
CODE
Lot #’s: 04EWIA4081, 04EWIA5031, 04EWIB0977, 04EWIC3433, 04EWIC8797, 04EWIE0078, 04EWIE0618, 04EWIE1384, 04EWIB1527, 04EWIC8373
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by fax on September 22, 2005.
Manufacturer: BioLife Plasma Services, LP, Eau Claire, WI. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis but were collected from a donor who disclosed a previous positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
CA and Vienna, Austria
___________________________________
PRODUCT
Source Plasma, Recall # B-0850-08
CODE
Lot #’s: 04SWIF8138, 04SWIF9259
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by fax on March 15, 2005.
Manufacturer: BioLife Plasma Services, LP, Sheboygan, WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who engaged in multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma, Recall # B-0794-08
CODE
Lot #: 3870001174
RECALLING FIRM/MANUFACTURER
International BioResources LLC, Springfield, IL, by facsimile on September 26, 2007. Firm initiated recall is complete.
REASON
Blood product, which was not properly quarantined after receiving post donation information concerning a history of incarceration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Vienna, Austria
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0944-08
CODE
Lot #: 72C215027
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Brooksville, FL, by facsimile on June 14, 2007. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0945-08
CODE
Lot #: 72C244662
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on August 13, 2007. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0996-08;
b) Platelets, Recall # B-0997-08;
c) Fresh Frozen Plasma, Recall # B-0998-08;
d) Red Blood Cells Leukocytes Reduced, Recall # B-0999-08;
e) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1000-08;
CODE
a) Lot #’s: 4179859, 4179857, 4179873, 4179872, 4179870, 4179854, 4179869,
4179868, 4179867, 4179866, 4179860, 3545301, 3100147, 3099786, 4150515,
4150520, 4150524, 4150528, 4150531, 4150532, 4150535, 4150538, 4150542,
4150547, 4150521, 4150509, 3086262, 3086261, 3086260, 3086263;
b) Lot #’s: 4179857, 4179873, 4179860, 3545301, 3099786, 4150515, 4150520,
4150524, 4150531, 4150535, 4150547, 4150521, 4150509;
c) Lot #’s: 1275435, 3545301, 3100147, 3099786;
d) Lot #’s: 4179871, 4179848, 8532307, 4150543, 4150544, 4150546;
e) Lot #: 1275435
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letters dated February 23, 2006 and March 17, 2006. Firm initiated recall is complete.
REASON
Blood products, collected using expired arm scrub supplies, were distributed.
VOLUME OF PRODUCT IN COMMERCE
54 blood components
DISTRIBUTION
OH, IN, NY
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-1004-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1005-08;
c) Platelets Leukocytes Reduced, Recall # B-1006-08;
d) AS-1 Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1007-08;
e) Red Blood Cells, Recall # B-1008-08;
f) Whole Blood CPD, Recall # B-1009-08;
g) Whole Blood CPDA-1, Recall # B-1010-08;
h) Cryoprecipitated AHF, Recall # B-1011-08;
i) Platelets Pooled Leukocytes Reduced, Recall # B-1012-08;
j) Plasma Frozen within 24 hours after phlebotomy, Recall # B-1013-08;
k) Plasma Cryoprecipitate Reduced, Recall # B-1014-08
CODE
a) Lot #’s: 22GE00283, 22LW93606, 22FC47659, 22FC47665, 22FS54856,
22GG14987, 22GS32434, 22KN78220, 22GS32241, 22GS32424, 22LP25387,
22LW93026, 22KK88507, 22KK88513, 22GG14986, 22FS54842, 22GL42310,
22GS32432, 22LW92884, 22GL42313, 22GE00281, 22GE00926, 22GS32641,
22FS54850, 22GE00956, 22GL42316, 22FQ48053, 22FQ48070, 22FQ48084,
22FQ48311, 22FS54857, 22FX40629, 22GL42315, 22GL42317, 22KX88782,
22LP25558, 22LZ15445, 22GG12789, 22GS32648, 22GS32649, 22GS32653,
22FC47680, 22FQ48088, 22FS54846, 22KV94704, 22FC47674, 22GL44036,
22GE00290, 22GS32426, 22LW93042, 22LW92883, 22FQ48063, 22FS54863,
22GE00939, 22GE00274, 22LW93049, 22GG14982, 22FC47697, 22GG14986,
2LW93054, 22FX40646, 22GL44034, 22KN78225, 22KT91690, 22KT91692,
22KX88779, 22LP25381, 22LP25385, 22LW93056, 22GS32428, 22GS32430,
22FS54852, 22FX40630, 22GS32420, 22GS32423, 22KN78213, 22KT91684,
22LP25390, 22FS54845, 22LW93039, 22LW93604, 22GG15355, 22LW93047,
2GE00280, 22GE00929, 22GE00277, 22GE00943, 22FC47669, 22GG14984,
22GG15369, 22GS32417 22LP25388, 22LP25394, 22LP25395, 22LP25519,
22LW93030, 22LP25380, 22LP25391, 22LW93033, 22LW93034, 22GL42311,
22GL42311, 22GL42311, 22GL42311, 22GS32663, 22GS32663, 22GS32663,
22GS32663;
b) Lot #’s: 22FQ47133, 22KN77820, 22GG12789, 22GS32236, 22LW93939,
22LW93948, 22KK88513, 22LZ15174, 22GS32671, 22FC47809, 22FS53589,
22FS53595, 22FC47614, 22KH18119, 22FC47609, 22GS32241, 22LZ15445,
22FC47836, 22GS32257, 22FC47838, 22GS32245, 22GS32295, 22FC47602,
22KT91461, 22GS32262, 22LW93595, 22LZ15375, 22LZ15377, 22GS32255,
22KT91473, 22LW93673, 22LZ15017, 22LZ15019, 22LZ15378, 22FC47803,
22KK88519, 22LW93671, 22KF71878, 22KX88752, 22KX88753, 22KX88756,
22KX88758, 22KX88759, 22GQ20897, 22KL40950, 22GS32290, 22GQ20900,
22KH18121, 22KT91465, 22LW93940, 22LZ15355, 22LZ15356, 22GQ20895,
22GS32240, 22KL40958, 22GS32222, 22KK88512, 22LW93362, 22LW93364,
22GS32258, 22LW93942, 22FC47845, 22GG14970, 22KF71862, 22KK88505,
22LZ15180, 22FQ48015, 22FC47600, 22LZ15021, 22LZ15380, 22GS32275,
22GS32663, 22LW93355, 22LZ15181, 22LZ15612, 22FC47665, 22FQ48084,
22GL42310, 22GL42315, 22GS32417, 22GS32432, 22KL40965, 22KT91696,
22KX88779, 22LC40546, 22FS54847, 22FS54852, 22FS54856, 22FS54858,
22GS32434, 22LW93056, 22FX40629, 22GE00280, 22GE00927, 22GE00929,
22GG14987, 22GL44034, 22GL44036, 22KN78220, 22GG14982, 22GS32653,
22LW93049, 22FC47697, 22FQ48053, 22GL42317, 22LP25381, 22LP25395,
22LP25399, 22LW93047, 22GE00926, 22KC98113, 22KC98118, 22KK88515,
22LW93042, 22FQ48063, 22GE00283, 22FQ48311, 22FC47710, 22KT93259,
22LW9303, 22GE00281, 22GS32426, 22KT91702, 22LP25558, 22LW93660,
22FC47669, 22FS54845, 22GG14984, 22GG15355, 22LP25388, 22LW93033,
22KL40961, 22KL40963, 22KL40969, 22FS54857, 22LP25380, 22FC47685,
22GS32424, 22KC98109, 22GL42313, 22GS32420, 22KC98111, 22KC98121,
22FX40635, 22LW93054, 22FQ48070, 22FS54846, 22FS54854, 22KX88782,
22LW93656, 22FC47674, 22FS54863, 22LW93604, 22LW93026, 22GE00956,
22GS32637, 22GS32648, 22GS32649, 22FC47716, 22FS54850, 22LW92884,
22LP25390, 22FQ48057, 22FX40646, 22KT91684, 22FS54851, 22GL42316,
22FQ48088, 22GS32641, 22LC40549, 22LP25394, 22LP25519, 22LW93606,
22KT91692, 22GE00290, 22LP25387, 22FC47659, 22FS54842, 22FX40630,
22GE00274, 22GE00277, 22GS32428, 22KN78213, 22GE00939, 22GS32423,
22KT91690, 22LW93030, 22LW93039, 22LW92883, 22GE00943, 22GL42305,
22LW93658;
c) Lot #’s: 22FQ48053, 22LP25399, 22GE00274, 22GG15369, 22FX40646,
22KN78225, 22FQ48311, 22GE00277, 22GG15447, 22GS32432, 22KN78220,
22KT91684, 22LP25380, 22LP25381, 22LP25385, 22LP25390, 22LP25394,
22LW93604, 22GL42316, 22KC98109, 22GH44105, 22FQ48070, 22FQ48088,
22FS54845, 22GS32417, 22KT91690, 22LW92884, 22LW93047, 22GL42315,
22FS54856, 22FS54863, 22GE00927, 22KC98121, 22KC98113, 22FX40630,
22FQ48063, 22FQ48084, 22FS54852, 22FX40629, 22GE00929, 22GE00943,
22GL44034, 22GS32648, 22GS32653, 22KC98111, 22LW93026, 22LW93030,
22LW93049, 22FS54846, 22GE00280, 22GS32426, 22LW93042, 22LW93054,
22GS32434, 22LW92883, 22LW93056, 22GG15355, 22GL44036, 22KN78213,
22FS54850, 22GE00956, 22GL42316, 22KC98109, 22KT93259, 22LP25388,
22GS32641, 22KT91692, 22GS32430, 22GE00283, 22GE00290, 22LP25558,
22KT93232, 22FS54842, 22FS54858, 22KC98118, 22LW93033, 22GS32423,
22GG14987, 22LW93034, 22GL42310;
d) Lot #’s: 22LZ15371, 22LZ15455, 22GS32247, 22FC47680, 22GS32430,
22GL42311, 22LP25391;
e) Lot #’s: 22LZ15441, 22LZ15443, 22LZ15444, 22GG14965, 22LW93933,
22LW93954, 22KH18129;
f) Lot #’s: 22GG14969, 22KX88750, 22LW93937, 22LZ15360;
g) Lot #’s: 22LL34477, 22LL34479, 22LL25381, 22LL34481, 22LL28330, 22LL34486;
h) Lot #’s: 22GS32275, 22LZ15355, 22GS32671, 22KT91461, 22FC47836,
22FC47838, 22FQ48015, 22GS32222, 22GS32236, 22GS32262, 22KT91465,
22LZ15612, 22GQ20900, 22LW93362, 22LZ15371, 22GS32290, 22KT91463,
22LZ15380, 22LZ15377, 22LZ15375, 22LW93670, 22LZ15356, 22KF71878,
22KL40963, 22KL40965, 22LW93671, 22LZ15180, 22KK88519, 22KK88512,
22KK88515, 22LZ15174, 22FC47845, 22GS32245, 22GS32247, 22GS32255,
22GS32257, 22GS32258, 22GS32295, 22KL40969, 22KT91473, 22LZ15181,
22LZ15455, 22LZ15378, 22LW93673;
i) Pool numbers: 891, 901, 1240, 1247, 747, 886, 1197, 1050, 1288, 739, 791, 962;
j) Lot #’s: 22KC98113, 22KC98111, 22LW93656, 22KL40950, 22KF71861;
k) Lot #: 22LW93670
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by fax on July 17, 2007 and follow-up letter on August 17, 2007. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
560 components
DISTRIBUTION
PA, NJ, NY, VA, MD, and PR
___________________________________
PRODUCT
Platelets Leukocytes Reduced, Recall # B-1026-08
CODE
Lot #: 71X598268
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Lecanto, FL, by facsimile on April 6, 2007. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1027-08
CODE
Lot #: 5210627
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., Long Island City, NY, by facsimile on April 26, 2006.
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1029-08
CODE
Lot #’: 1543472 Part 1 and 2
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on January 3, 2008 and follow up letter on January 9, 2008. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1033-08
CODE
Lot #: 71X576713
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on December 26, 2006. Firm initiated recall is complete.
REASON
Blood product, labeled “Leukocyte Reduced” but which failed to meet the criteria for a leukoreduced unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Source Plasma, Recall # B-1034-08
CODE
Lot #’s: TA2074378, TA2074623, TA2080224, TA2080431, TA2083653, TA2083938, TA2090794
RECALLING FIRM/MANUFACTURER
DCI Biologicals Texarkana, LLC, Texarkana, AR, by facsimile on July 7, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information regarding a history of receiving a tattoo and being incarcerated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
NC and UK
___________________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-1038-08;
b) Plasma Cryoprecipitate Reduced, Recall # B-1039-08;
c) Red Blood Cells Leukocytes Reduced, Recall # B-1040-08;
d) Platelets, Recall # B-1041-08
CODE
a), b), c), and d) Lot #: 2545816
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on March 11, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX, WI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1067-08
CODE
Lot #: 1678319 (3 units)
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on May 7, 2007 and by letter dated May 7, 2007. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
Cornea, Recall # B-1071-08
CODE
Tissue #: 2008013038
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartland Lions Eye Bank, Kansas City, MO, by telephone on January 16, 2008 and follow-up letter dated January 22, 2008.
Manufacturer: Heartland Lions Eye Bank, Springfield, MO. Firm initiated recall is complete.
REASON
Ineligible cornea was mislabeled and distributed.
VOLUME OF PRODUCT IN COMMERCE
1 cornea
DISTRIBUTION
KS
__________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0887-08
CODE
Unit: 766187
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc, Orlando, FL, by telephone on September 26, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0894-08;
b) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated, Recall # B-0895-08
CODE
a) Lot #: GJ123791;
b) Lot #: GJ123792
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on February 13, 2007 and by letter dated February 22, 2007. Firm initiated recall is complete.
REASON
Blood products, which was out of controlled storage for an undocumented length of time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT
a) Cryopreserved Allograft Skin, Non-Meshed and Cryopreserved Allograft Skin,
Meshed, Recall # B-0928-08;
b) AlloDerm GBR, 2x4 cm, .46-.86 (mm); 2x2 cm, .46-.86 (mm); 1x4 cm, .46-.86 (mm),
Recall # B-0929-08;
c) AlloDerm Graftable, 2x4 cm, 6-12 (1/1000 in.); AlloDerm Graftable (Non Meshed),
14-20 (1/1000 in.); AlloDerm Graftable (Meshed 1:1), 14-20 (1/1000 in.); AlloDerm
Graftable (Meshed 1:1), 9-13 (1/1000 in.), Recall # B-0930-08;
d) AlloDerm, Oral Plastic Surgery, 1x4 cm, .89-1.65 (mm); 2x4 cm, .89-1.65 (mm);
1x2 cm, .89-1.65 (mm); 1x1 cm, .89-1.65 (mm), Recall # B-0931-08;
e) AlloDerm Implantable, 3x7 cm, .79-1.27 (mm); 2x4 cm, .33-.76 (mm); 3x7 cm,
.53-.76 (mm); 4x7 cm, .53-.76 (mm); 2x4 cm, .79-1.78 (mm); 4x7 cm, .53-.76 (mm);
3x7 cm, 1.14-1.78 (mm); 4x7 cm., .79-1.02(mm), Recall # B-0932-08;
f) AlloDerm Implantable (Abdominal Wall Repair), 4x12 cm, .79-2.03 (mm); 4x16 cm,
.79-2.03 (mm); 6x16 cm, .79- 2.03 (mm), Recall # B-0933-08;
g) GRAFTJACKET, 5x10 cm, .89-1.40 (mm); 5x5 cm, .89-1.52 (mm); 4x7 cm,
.89 - 1.40 (mm), Recall # B-0934-08;
h) Repliform, 5x10 cm, .9-1.6 (mm), 35-65 (1/1000 in.); 6x12 cm, .9-1.6 (mm), 35-65
(1/1000 in.); 2x7 cm, .9-1.6 (mm), 35-65 (1/1000 in.); 3x7 cm, .9-1.6 (mm), 35-65
(1/1000 in.); 4x7 cm, .9-1.6 (mm), 35-65 (1/1000 in.), Recall # B-0935-08;
i) GRAFTJACKET, Maximum Force, 4x7 cm, 1.27-1.78 (mm); Maximum Force, 5x5
cm, 1.40 - 1.91 (mm); Maxforce Extreme, 4x7 cm, 1.80-2.29 (mm), Recall # B-0936-
08;
j) GRAFTJACKET, Ulcer Repair, 4x4 cm, .38-1.02 (mm) and 4x8 cm, .38-1.02 (mm),
Recall # B-0937-08
CODE
a) Lot # 20788C; sublots 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011;
Expiration: 04/26/09; Lot # 21607C; sublots: 001, 002, 003, 004. Expiration 6/29/09. Lot # 21745C; sublots: 001, 002, 003, 004, 005, 006, 007, 008, 009. Expiration: 7/8/09. Lot # 26039C, sublots: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014. Expiration: 03/06/10. Lot # 27278C: sublots: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011,. Expiration: 04/22/10. Lot # 29398C: sublots: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011. Expiration: 07/10/10. Lot 33219C; sublots: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014. Expiration: 11/09/10. Lot # 44269C; sublots: 001, 002, 003, 004, 005, 006, 007,. Expiration: 09/05/11. Lot # 45291C; sublots: 001, 002, 003, 004, 005, 006. Expiration: 10/03/11. Lot # 46811C; sublots: 001, 002, 003, 004,. Expiration: 11/06/11. Lot # 47609C; sublots: 001, 002, 003, 004, 005, 006, 007, 008. Expiration: 11/28/11. Lot number: 21186C, sublots: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012; Expiration: 5/24/09. Lot 22357C: sublots: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013. Expiration: 8/18/09. Lot 48179C; sublots: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017,. Expiration: 12/13/11;
b) Lot # B13646; sublots: 002. 004, 005, 011, 012, 020, 022. Expiration: 02/17/08; Lot:
B20823: Sublots: 024, 026. Expiration: 05/29/09. Lot # B14441; sublot: 009;
Expiration: 04/16/08: Lot B20823: sublots: 005, 006, 007, 008, 009, 010, 012, 013,
014, 015, 016, 017, 018, 019, 022, 023. Expiration: 05/29/09. Lot: B20823;
sublot: 002. Expiration: 05/29/09;
c) Lot # B13646; sublot: 009, Expiration: 02/17/08. Lot # B16057; sublot: 034.
Expiration: 7/30/08; Lot B161718; sublot 004, 007. Expiration: 9/4/08.
Lot # B16057; sublot: 034. Expiration: 7/30/08 Lot B16057; sublot: 501. Expiration:
7/30/08 Lot B17809; sublots: 601, 603, 606, 607, 609, 610, 612, 613, 614, 616, 617,
620, 622, 623, Expiration 11/7/08. Lot B17809, sublots: 602, 604, 605, 608, 611, 615,
618, 619,. Expiration: 11/07/08.; Lot B20286; sublots: 601, 602, 604; Expiration:
04/23/09;
d) Lot # B14441; sublots: 001, 003, 005. ExpirationL 04/16/08. Lot # B16057; sublots:
029, 030, 031, 032. Expiration: 7/30/08 Lot B16718; sublot 001. Expiration: 09/04/08 Lot # B14441; sublot: 017. Expiration 04/16/08. Lot B16718; sublot: 002. Expiration: 09/04/08; Lot B16718; sublot: 006. Expiration: 9/04/08 Lot: B18489, sublots: 004, 005. Expiration: 01/03/09. Lot 18767; sublots: 003, 004. Expiration: 01/21/09. Lot B19197; sublots: 004, 005, 006, Expiration 02/13/09. Lot B19213, sublots: 001, 003, 006. Expiration 02/14/09. Lot B19322; sublot: 033, 037, 038. Expiration# 02/21/09: Lot B19350; sublots: 003, 004, 005, 007, 008; Expiration: 02/22/09 Lot B19928; sublots: 031, 032, 034, 035; Expiration: 03/29/09; Lot B20054: sublots: 033,, 034, 037, 038; Expiration: 04/08/09; Lot B20109; sublots: 003,004, 005; Expiration: 04/11/09; Lot B20510: sublots:001,005, 006; Expiration: 05/08/09. Lot # B14441; sublot: 017. Expiration 4/16/08. Lot B16718; sublot:002. Expiration: 9/4/08. Lot B16718; sublot: 006. Expiration 9/4/08. Lot B16057: sublots:001, 002, 003, 004, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 023, 024, 025, 026, 027, 028. Expiration: 7/30/08. Lot B16991: sublots: 001, 002, 003, 005, 006, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 021, 022, 023,. Expiration: 09/18/08 Lot B19322; sublot: 001, 002, 003, 004, 005, 007, 008, 009, 010, 011, 013, 016, 020, 023, 024, 025, 026, 028, 029, 030, 031,. Expiration: 02/21/09 Lot: B19928; sublots: 001, 002, 003, 004, 005, 006, 007, 008, 009, 011, 012, 013, 016, 017, 018, 019, 020, 021, 022, 023, 024, 025, 026, 027, 028, 029, 030; Expiration: 03/29/09. Lot B20054; sublots: 001, 003, 004, 005, 007, 011, 012, 013, 014, 016, 017, 018, 019, 020, 021, 026, 027, 028, 030, 031,. Expiration: 04/08/09;
e) Lot B14441; sublot: 019. Expiration 04/16/08. Lot B16057; sublot: 043. Expiration:
07/30/08 Lot B16718; sublot 003. Expiration 09/04/08. Lot B16718; sublot: 012. Expiration: 09/04/08 Lot B16718. sublot: 014. Expiration: 09/04/08. Lot 16991, sublot: 029. Lot B16991; sublot 027. Expiration: 9/18/08; Lot B192193, sublot: 007; Expiration: 02/14/09: Lot B20605: sublot: 006; Expiration: 05/14/09. Lot B16991. sublot: 029. Expiration: 09/18/08. Lot B19213; sublot: 012; Expiration: 02/14/09. Lot B19350; sublot: 014; Expiration: 02/22/09;
f) Lot B14441; sublot: 022. 023. Expiration: 04/16/08. Lot B16991; sublot: 031, 033.
Expiration: 09/18/08; Lot B19092; sublot 009., 010. Expiration: 02/07/09; Lot B19197; sublot: 007. Expiration: 2/13/09; Lot B19322; sublot: 044; Expiration: 02/21/09; Lot B19350; sublot: 018; Expiration: 02/22/09; Lot B19928; sublot: 046; Expiration: 03/29/09. Lot B18489; sublots: 021, 023, 024. Expiration: 01/03/09. Lot B18767, sublot 016, 017. Expiration: 01/21/09; Lot B19092; sublot 011; Expiration: 02/07/09; Lot B19197; sublot: 011; Expiration: 02/13/09; Lot B19350: sublot: 022, 023; Expiration: 02/22/09 Lot B20054; sublot: 047; Expiration: 04/08/09; Lot B20510; sublots: 015, 016, 020, 021; ExpirationL 05/08/09; Lot B20605: sublots: 013, 014; Expiration: 05/14/09. Lot B18489; sublots: 043, 044. Expiration: 1/03/09; Lot B19197' sublot 020; Expiration: 03/13/09; Lot B19213; sublot: 020. Expiration: 02/14/09; Lot B19322: sublot: 054; Expiration: 02/21/09; Lot B19350; sublot: 033; Expiration: 02/22/09; Lot B20054; sublots: 066, 068, 069, 070; Expiration: 04/08/09;
g) Lot # B14441; sublot: 032. Expiration 04/16/08; Lot B16057; sublots: 053, 055.
Expiration: 07/30/08: Lot B19213; sublot: 018; Expiration: 02/14/09 Lot: B16057; sublot: 050. Expiration: 07/30/08; Lot B19322; sublot: 047; Expiration: 02/21/09: Lot B18489; sublots: 026, 033. Expiration: 01/03/09: Lot B19350; sublot: 027; Expiration: 02/22/09; Lot B20054: sublot: 050. 051; 052; Expiration: 04/08/09; Lot B19350; sublot: 029; Expiration: 02/22/09; Lot B20054; sublots 043, 054, 055; Expiration: 04/08/09: Lot: B21696; sublot: 021; Expiration: 07/25/09. Lot B16057; sublot: 050. Expiration 7/30/08; Lot B19322; sublot: 047; Expiration 02/21/09: Lot B18489; sublots: 026, 033. Expiration: 01/03/09: Lot B19350; sublot:027; Expiration: 02/22/09; Lot B20054: sublot: 050, 051, 052; Expiration 4/8/09. Lot B19322: sublot: 041. Expiration: 02/21/09: Lot B19350; sublot: 012; Expiration: 02/22/09;
h) Lot # B16057; sublot: 052. Expiration: 07/30/08; Lot B19322; sublots: 048, 049, 050,
051, 052. Expiration: 2/21/09. Lot B16057; sublots: 056, 058. Expiration: 07/30/08; Lot B19322; sublot: 053. Expiration: 02/21/09; Lot B18489; sublot 035. Expiration: 01/03/09 Lot B19350: sublots: 031 032; Expiration: 02/22/09; Lot B20054: sublots: 062,063; Expiration: 04/08/09. Lot B21719; sublot: 029; Expiration: 07/26/09. Lot B189489, sublot: 010. Expiration: 01/03/09; Lot B19213; sublots: 008, 009; Expiration: 02/14/09. Lot B18489; sublots: 013, 014. Expiration: 1/03/09. Lot B18489; sublot: 015. Expiration 1/03/09; Lot B19322; sublot: 042. Expiration: 02/21/09; Lot B19350; sublot: 010, 17; Expiration: 02/22/09; Lot B20054; sublots: 041, 042; Expiration 04/08/09;
i) Lot B18489; sublot: 016, Expiration: 01/03/09. Lot B18767; sublot 010. Expiration:
01/21/09. Lot B19092; sublot: 008. Expiration: 02/07/09; Lot B19350; sublot: 013; Expiration: 2/22/09. Lot B19928; sublots: 044, 045; Expiration: 3/29/09. Lot B20109; sublots: 009, 010; Expiration 4/11/09. Lot B18489; sublots: 025, 027, 028, 029, 031, 032. Expiration: 01/03/09. Lot B18767; sublot: 019. Expiration: 01/21/09; Lot B19092; sublots: 013. 014. Expiration: 02/07/09. Lot B19213; sublot 017.. Expiration 02/14/09; Lot: B20054; sublot 049; Expiration: 04/08/09. Lot B19350; sublot: 011; Expiration: 02/22/09;
j) Lot: B20604; sublots: 007, 008, 009, 010, 011, 012, 013, 014, 015, 020, 024, 025, 027.
Expiration: 05/14/09; Lot: B20823; sublots: 028, 041, 053, 065, 069, 070, 071. Expiration: 05/29/09. Lot: B20604: sublots: 032, 033, 034, 036, 037, 038, 039, 041, 047, 050, 051, 052, 053, 054, 055, 056, 057, 058, 059, 060. Expiration: 05/14/09.
RECALLING FIRM/MANUFACTURER
LifeCell Corporation, Somerville, NJ, by letters, fax and telephone on October 17, 2007 and by letters on October 22, 2007. Firm initiated recall is complete.
REASON
Human tissues from donors, tested using diagnostic test kits rather than FDA licensed or cleared screening tests for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc total), were distributed.
VOLUME OF PRODUCT IN COMMERCE
493 Product Lots
DISTRIBUTION
Nationwide, Canada and Korea
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated, Recall # B-0976-08
CODE
Lot #: 3824801 (split unit)
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on January 3, 2007 and by letter dated January 17, 2007. Firm initiated recall is complete.
REASON
Blood products, which were out of controlled storage for an undocumented length of time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0990-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0991-08
CODE
a) and b) Lot #: 71R694243
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc. – Birmingham Region, Birmingham, AL, by facsimile on March 16, 2006. Firm initiated recall is complete.
REASON
Blood products, which were untested for the human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the Nucleic Acid Test (NAT), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1028-08
CODE
Lot #’s: GX41487, KM15911 and KM15725
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN by telephone on October 5, 2007 and follow-up letter on October 31, 2007. Firm initiated recall is complete.
REASON
Blood products, which were exposed to unacceptable temperatures during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1035-08
CODE
Lot #: 2307581
RECALLING FIRM/MANUFACTURER
Florida Blood Centers, Inc., Orlando, FL, by telephone on June 20, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
****CORRECTION****
Enforcement Report for March 26, 2008, 08-13, Recall # Z-1367-2008, Gambro,
CODE: All numbers beginning with 6 deleted. Code numbers should now be 003409-400, 003409-410, 003410-500, 003410-510, 003410-710, 003411-500, 003412-500, 003414-500, 003414-510, 003415-510, 003422-500, 003422-515, 003422-520, 003429-500
VOLUME OF PRODUCT IN COMMERCE: 41,000,000 units.
___________________________________
PRODUCT
Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with battery backup. Part Numbers: 3202487-073, 3202487-079, 3202488-036, Recall # Z-1050-2008
Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with battery backup. Part Numbers: 3202487-073, 3202487-079, 3202488-036,
CODE
Serial Numbers (domestic units): 36133753, 36133760, 36139018, 36139023, 36139030, 36137448, 36138998, 36141356, 36141357, 36141358, 36141360, 36141361, 36141362, 36141363, 36141365, 36141366, 36141367, 36141370, 36141373, 36141378, 36141380, 36141381, 36141382, 36141383, 36141384, 36141393, 36141394, 36141395, 36141396, 36141399, 36141400, 36142717, 36142718, 36142730, 36142731, 36141386, 36141398, 36133739, 36133740, 36133742, 36133743, 36133744, 36133745, 36133746, 36133747, 36133748, 36133749, 36133750, 36133751, 36133752, 36133754, 36133755, 36133756, 36133757, 36133758, 36133759, 36137218, 36137219, 36137220, 36137222, 36137224, 36137225, 36137226, 36137227, 36137230, 36137231, 36137352, 36137353, 36137355, 36137356, 36137357, 36137359, 36137360, 36137361, 36137362, 36137363, 36137364, 36137365, 36137366, 36137367, 36137368, 36137369, 36139002, 36139010 Serial Numbers (international units): 36137354, 36137358, 36137370, 36137371, 36137372, 36138999, 36139000, 36139005, 36139006, 36139007, 36139009, 36139011, 36139012, 36139013, 36139014, 36139021, 36139024, 36139025, 36139031
RECALLING FIRM/MANUFACTURER
Physio Control, Inc., Redmond, WA, by telephone and letters. Firm initiated recall is ongoing.
REASON
Inoperable Device - Potential for delay in therapy or prevention of defibrillation therapy due to corrosion of the Printed Circuit Board Assemblies (PCBA).
VOLUME OF PRODUCT IN COMMERCE
103 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Cardiovascular Procedure Kit, P/N: 70932-01, X-coated Pump and Table Pack, -
(the X-coated pump and table pack contains a weighted flexible sucker, Catalog No.:
804113), Recall # Z-1310-2008;
b) Cardiovascular Procedure Kit, P/N 64789-01, Wisconsin Cardiovascular Services
Pump and Table Pack, (the Pump & table pack contains a weighted flexible sucker,
Catalog No. 804113), Recall # Z-1311-2008;
c) Cardiovascular Procedure Kit, P/N 70295-02, St. Louis University Hospital Pump &
Table Pack, (Pump & table pack contains a weighted flexible sucker, Catalog No. 804113), Recall # Z-1312-2008;
d) Cardiovascular Procedure Kit, P/N 70579-04, St. Louis University Hospital Pump &
Table Pack, (the Pump & Table pack contains a weighted flexible sucker, Catalog
No. 804113), Recall # Z-1313-2008
CODE
a) Lot Numbers: GC06, GC27, GD27, GG19, GK07, GL05, GM02, GM30, HA02,
HC05, HD12, HE23, HF29, HH23, HK27, HM22, HP03 and KA14;
b) Lot Numbers: GF08, GF30, GN06, HA15, HE09, HH02, HK27, HM01, HM22,
HN12, HP17 and KA07;
c) Lot Number: HM15;
d) Lot Numbers: GC20, GE24, GF22, GG12, GH17, GL25, GN06, HA22, HD19,
HF07, HG18 and HM08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated January 29, 2008.
Manufacturer: Terumo Cardiovascular Systems Corp., Ashland, MA. Firm initiated recall is ongoing.
REASON
Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining in the patient.
VOLUME OF PRODUCT IN COMMERCE
1121 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, Recall # Z-1352-2008
CODE
Lot Numbers: 180263, 187303, 181472, 183607, 181471, 188135, 185593, 186624, 187398, 190790, and 189158
RECALLING FIRM/MANUFACTURER
Biosite Inc., San Diego, CA, by letters on December 4, 2007 and December 14, 2007. Firm initiated recall is ongoing.
REASON
False Lower Results: Toxin A results in the Triage Micro C. difficile Panel have shown falsely lower visual signals (color strength) in certain lots compared to results observed with previous lots.
VOLUME OF PRODUCT IN COMMERCE
4,549 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Liquid Alkaline Phosphatase Reagent Set, Catalog Nos. A7516-150, A7516-450,
A7516-625, HA916-302 and HA916-492, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Recall # Z-1353-2008;
b) Liquid Alkaline Phosphatase (R2) Reagent Set, Catalog No.: H A416-R2, In vitro
diagnostic; for the quantitative determination of alkaline phosphatase in serum,
Recall # Z-1354-2008;
c) Liquid Alk Phos Reagent, Catalog No. 3-A7516-L, In vitro diagnostic,
Recall # Z-1355-2008;
d) Liquid Alk Phos R1 Reagent, Catalog No. 3-A7516-R1, In vitro diagnostic,
Recall # Z-1356-2008;
e) Liquid Alk Phos R2 Reagent, Catalog No. 3-A7516-R2, In vitro diagnostic,
Recall # Z-1357-2008;
f) Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent, Catalog Nos.
7-A7516-R1-120, 7-A7516-R1-500 and 8-A7516-R1-120, In vitro diagnostic,
50 mL, 120 mL , 2 L and 500 mL containers, , Recall # Z-1358-2008;
g) Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent; Catalog Nos.
7-A7516-R2-125, 7-A7516-R2-90 and 8-A7516-R2-30, In vitro diagnostic, 30 mL,
90 mL , 125 mL, and 400 mL containers, Recall # Z-1359-2008;
h) Liquid Alkaline Phosphatase Reagent Set; Catalog No. A7516-150-SAM, In vitro
diagnostic; for the quantitative determination of alkaline phosphatase in serum,
Recall # Z-1360-2008
CODE
All lots beginning with 727801; exp. 4/09
RECALLING FIRM/MANUFACTURER
Pointe Scientific, Inc., Canton, MI, by letter dated February 7, 2008. Firm initiated recall is ongoing.
REASON
Product may be contaminated with microorganisms.
VOLUME OF PRODUCT IN COMMERCE
262 sets plus 40.2 L bulk
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Biomet Vanguard Width Checker, Part Number: 32-487062, 67.5/75 Sizing Wing;
The device is a preparatory instrument used for femoral knee insertion, Recall #
1361-2008;
b) Biomet Vanguard Knee Instrumentation, Part Number: 32-487062, 67.5/70/75mm
Sizing Wing, Biomet UK Ltd, Made in Britain; The device is a preparatory instrument
used for femoral knee insertion. (Distributed to Puerto Rico), Recall # Z-1362-2008.
CODE
a) Lot #: 212910;
b) Lot #: 1162107
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated February 12, 2008. Firm initiated recall is ongoing.
REASON
The instrument’s sizing line is in the wrong place.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
Nationwide and Canada
__________________________________
PRODUCT
a) Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials
(Normal), Recall # Z-1350-2008;
b) Osmocoll, COP Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials
(3 each High and Low), Recall # Z-1351-2008
CODE
a) Lot Numbers: 6 units packages: 0256118, 0256131, 0256151, 0256195, 0256213,
0256248, 0256306, 0256354, 0257016, 0257113, 0257032, 0257071, 0257150, 100299, 100500, 100677, and 100183: Individual vials Lot Numbers: I-61-22 , expiration 4/08 and I-62-34, expiration 10/08; Only individual vials of SS-025 (Lot I-62-34, expiration 10/08 ) included in Osmocoll SS-039 of 6 unit package Lot Numbers: 0397032 and 100455;
b) Lot Numbers: 100136, 100445, and 100558; Individual vials Lot Numbers: I-65-18,
expiration 9/09 (low control) and I-65-19, expiration 7/09 (high control)
RECALLING FIRM/MANUFACTURER
Wescor, Inc., Logan, UT, by letter on January 11, 2008. Firm initiated recall is complete.
REASON
Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.
VOLUME OF PRODUCT IN COMMERCE
1,025 1 mL glass vials
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm,
Recall # Z-1363-2008;
b) BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA003, 3.0mm,
Recall # Z-1364-2008
CODE
a) Lot Number: 765291;
b) Lot Number: 765295
RECALLING FIRM/MANUFACTURER
Biomet 3i, Inc., Palm Beach Gardens, FL, by telephone and letter dated February 15, 2008. Firm initiated recall is ongoing.
REASON
Mispackaging: The Locator Abutment labeled as LOA002 may contain Catalog/Item # LOA003 product and visa versa.
VOLUME OF PRODUCT IN COMMERCE
197 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
BIOMET 3i Certain MicroMiniplant Straight Healing Abutment, Model/Item Number: ISMHA32, 3.4mm(D) X Omm(P) X 2mm(H), Recall # Z-1365-2008
CODE
Lot Number: 593025-5
RECALLING FIRM/MANUFACTURER
Biomet 3i, Inc., Palm Beach Gardens, FL, by telephone and letter. Firm initiated recall is ongoing.
REASON
The Micro-miniplant Straight Healing Abutments do not fully seat onto the restorative platform of the implant leaving a gap between the abutment and the implant.
VOLUME OF PRODUCT IN COMMERCE
270 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) VetTek Hypertonic Saline Solution 7.2% Sterile-Preservative Free For Animal Use
Only, packaged in 1,000-mL bottles, each 100 mL of sterile aqueous solution
contains sodium chloride 7.2 g, RX, NDC 60270-813-20, Recall # V-032-2008;
b) VetTek C-M-P-K Injection, Calcium-Magnesium-Phoshorus-Potassium-Dextrose
Solution, For Animal Use Only, packaged in 500 mL bottles, each 500 mL of sterile
aqueous solution contains Calcium 10.8 g (as calcium borogluconate, equivalent to
calcium gluconate 23.2%, Potassium 8.0 g (as potassium chloride), Phosphorus 2.5 g
(as sodium hypophosphite.H2O, Magnesium 1.6 g (as magnesium borogluconate),
Dextrose.H2O 75.0 g, NDC 60270-026-17, RX, Recall # V-033-2008
CODE
a) Lot 704114F;
b) Lot #711385F
RECALLING FIRM/MANUFACTURER
IVX Animal Health Inc., Saint Joseph, MO, by letters dated March 4, 2008. Firm initiated recall is ongoing.
REASON
Lack of sterility assurance.
VOLUME OF PRODUCT IN COMMERCE
a) 8,256 bottles;
b) 11,256 bottles
DISTRIBUTION
MO
END OF ENFORCEMENT REPORT FOR APRIL 2, 2008
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