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U.S. Department of Health and Human Services

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Enforcement Report for March 17, 2004

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.


March 17, 2004
04-11

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

______________________________
PRODUCT
Hale's Blue Boy Brand Cream Soda Flavored Syrup, 24 oz.
Recall # F-139-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
H.C. Foods, Co., Ltd., Commerce, CA, by letter on May 2, 2003. New York State initiated recall is complete.
REASON
Product contains undeclared colors tartrazine (certifiable as FD&C Yellow No. 5) and brilliant blue FCF (certifiable as FD&C Blue No. 1).
VOLUME OF PRODUCT IN COMMERCE
123 cases.
DISTRIBUTION
CA, NV, UT, MN, TX, NY, and KS.

_______________________________
PRODUCT
a) Home Trends West Palm 16 piece Dinnerware Set, packed 2
per carton/case. Recall # F-141-4;
b) Home Trends West Palm Open Stock Mug, 16 oz, packed 6
per Carton/case. Recall # F-142-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Gibson Overseas Inc., Commerce, CA, by Recall notice beginning January 9, 2004. Firm initiated recall is ongoing.
REASON
Mugs contain excessive levels of internal leachable lead.
VOLUME OF PRODUCT IN COMMERCE
a) 17,052;
b) 27,662.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

______________________________
PRODUCT
Kroger brand Premium Orange Juice, Pasteurized, 100 %
Juice, not from concentrate, packed in 3-quart and 1-pint
plastic containers; and Turkey Hill brand Premium Orange
Juice, Pasteurized, 100% Juice, not from concentrate,
Packed in 1-pint, 1-qt, and 1/2 gal plastic containers.
Recall # F-138-4.
CODE
Sell By Date: Kroger brand product - FEB 6,
Sell By Dates: Turkey Hill brand product - FEB 6 and FEB 10.
RECALLING FIRM/MANUFACTURER
Kroger Co., Cincinnati, OH, by fax, email, and telephone on January 9, 2004. Firm initiated recall is complete.
REASON
Orange juice contains metal particles.
VOLUME OF PRODUCT IN COMMERCE
5,335 gallons (19,623 units).
DISTRIBUTION
AL, GA, SC, TN, VA, PA, and WV.

_______________________________
PRODUCT
Dulce de Leche con Guayaba (Milk Paste filled with Guava)
candy in plastic wrappers; distributed in 1 oz.
(UPC 4484237703) and 6 oz. (UPC 4484247702) packages.
Recall # F-146-4.
CODE
The UPC code is used to identify the product. 4484247702 6 oz, 4484247703 1 oz.
RECALLING FIRM/MANUFACTURER
Sabrosita Candy, Trujillo Alto, PR, by representatives visit and letter beginning February 9, 2004. FDA initiated recall is ongoing.
REASON
Product contains color Red #40 Lake which is not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
76 boxes.
DISTRIBUTION
FL.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Clobetasol Propionate Cream, USP, 0.05%, 30 gram tubes, Rx
only. Recall # D-117-4.
CODE
Lot Numbers/Expiration Dates: Lot 19877 (8/2004) and Lot 19987 (11/2004).
RECALLING FIRM/MANUFACTURER
Teva Pharmaceuticals USA, North Wales, PA, by letter dated January 22, 2004. FDA initiated recall is ongoing.
REASON
Impurities/Degradation products: Presence of Benzophenone and Irgacure 184 from the varnish coating on the tubes.
VOLUME OF PRODUCT IN COMMERCE
55,280 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Platelets. Recall # B-0865-4.
CODE
Units: J43948, J43970, J43983, J43987, J70486, M11785, M11790, M11865, M41050, M41053, M41059, M41060, M73651, M73652, M73653, R90405, R90424, R90457, R90460, S28993, S29003, S29009, S29012, S29015, S29017, S29023, S29024, S29025, S29026, S29032, S29034, S29035, S29039, S29057, S29063, S29087, S29101, S73352, S73366, S73367, S73369, S73371, S73385.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw Valley Blood Program, Saginaw, MI, by fax on June 20, 2003. Firm initiated recall is complete.
REASON
Platelets, with an unacceptably low count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
43 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0876-4.
CODE
Unit number 0844856.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letter on June 11, 2002. 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
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0877-4.
CODE
Unit number 1199038.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letter on June 6, 2002. 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
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0879-4.
CODE
Unit number 1214220.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letter on May 21, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0880-4;
b) Fresh Frozen Plasma. Recall # B-0881-4.
CODE
a) and b) Unit number 0785530.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone and letter on June 17, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0882-4;
b) Cryoprecipitated AHF. Recall # B-0883-4.
CODE
a) and b) Unit number 1203061.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone and letter on August 14, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
Recall # B-0884-4;
b) Platelets Pheresis, Irradiated. Recall # B-0885-4.
CODE
a) Unit numbers 1213219 and 1214060;
b) Unit numbers 1214117, 1213309, and 1212692.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone and letter on May 6, 2002. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0886-4.
CODE
Unit number 71W25003-3.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL, by letter on June 9, 2003. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.

_______________________________
PRODUCT
Source Plasma. Recall # B-0887-4.
CODE
Units HP101972, 06884864, 06883003, HP100241, 05106806, 05069811, 05068012, 05062959, 04760511, 04752707, 04750888, 04743965, 04740940, 04726067, 04723806, 04720034, 04717584, 04558880, HP96856, HP96286, 04554196, 04529064, 04526414, 04257233, 04253716, 04099215, 04096856, 04093145, 04092308, 04029779, 04027577, 04022503, 04020165, 04011606, 93382991, 93277303, 93274579, 93089166, 93086882, 93082693, 93710404, 93705615, 93702874, 93599504, 93596749, 92800007, 92798069, 92794504, 92679887, 92677043, 92672819, 92554078, 92418714, 92415706, 92309944, 92307537, 92298200, 92292253, 92249523, 92243231, 91327055, 91321114, 91299475, 91293787, 91197689, 91194626, 91137401, 91133175, 91065186, 91063472, 91053695, 91052254, 91027818, 91021540, 90989667, 90750465, 90098079, 90093944, 90089923, 90085611, 90189272, 90185823, 79190305, 79187497, 79181457.
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc., of Chicago, Chicago, IL, by facsimile on November 14, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from an unreliable donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
85 units.
DISTRIBUTION
CA, and Ireland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-0888-4;
b) Recovered Plasma. Recall # B-0889-4.
CODE
a) and b) Unit number 1896710.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services Inc., Jackson, MS, by fax dated February 11, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who disclosed a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MS, and Switzerland.

______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-0892-4;
b) Fresh Frozen Plasma. Recall # B-0893-4.
CODE
a) and b) Unit 5077822.
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Eastern Maine Medical Center, Bangor, ME, by letter dated December 8, 2003. Firm initiated recall is complete.
REASON
Blood Products, collected from a donor who had received MMR vaccine prior to donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
ME.

_______________________________
PRODUCT
a) Cryoprecipitated AHF. Recall # B-0894-4;
b) Cryoprecipitated AHF, Pooled. Recall # B-0895-4;
c) Fresh Frozen Plasma. Recall # B-0896-4;
d) Fresh Frozen Plasma, Irradiated. Recall # B-0897-4;
e) Plasma, Cryo-Reduced. Recall # B-0898-4;
f) Platelets. Recall # B-0899-4;
g) Platelets, Irradiated. Recall # B-0900-4.
CODE
a) Unit Numbers: 016LQ19689, 016LE71866, 016LT21861,
016LG37166, 016GW04038, 016KC22003, 016LV77250,
016LV77256, 016LZ17921, 016LH47406, 016LS88841,
016GW04936, 016LR45882, 016GP02503, 016LY00412,
016LV70508, 016LX41165, 016LG35099, 016KG03182,
016GQ02090, 016KC19290, 016LS86138, 016LZ17481,
016LE83551, 016LL58227, 016GW06185, 016GW08516,
016GW08514, 016LX34241, 016GJ08983, 016KC19100,
016LM59904;
Unit Numbers: 016LR37048 (pool #5707), 016LY94390 (pool
#6643), 016LX38258 pool #7380), 016KC22027 (pool #9737),
016LE69637 (pool #6459), 016LG27655 (pool #6821),
016LV68157 (pool #7294), 016LX38256 (pool #7393),
016LC16386 (pool #7539), 016LV70370 (pool #7746),
016LG36896 (pool #8243), 016GW04056 (pool #8248),
016LX48197 (pool #8911), 016LS73532 (pool #6228),
016LV69465 (pool #7569), 016LY95032 (pool #6781),
016LZ13718 (pool #5451), 016LE63110 (pool #5409),
016LY84891 (pool #5483), 016LV58222 (pool #5666),
016LS69489 (pool #5704), 016LY87037 (pool #5754),
016LL49474 (pool #5814), 016LS73630 (pool #6257),
016LE68922 (pool #6334), 016LX34099 (pool #6599),
016LY94226 (pool #6656), 016LY94589 (pool #6724),
016LG29701 (pool #7055), 016LT20324 (pool #7094),
016GM07807 (pool #7119), 016LZ15873 (pool #7376),
016LH49826 (pool #7709), 016LG37653 (pool #8391),
016LV77495 (pool #8897), 016LS68671 (pool #5549),
016LS69328 (pool #5690), 016LE64154 (pool #5653),
016LG24802 (pool #5987), 016LL51004 (pool #6846),
016LR45895 (pool #8191), 016LV59025 (pool #5764),
016GW04313 (pool #8263), 016LY83722 (pool #5315),
016LV56821 (pool #5292), 016LS67083 (pool #5387),
016LS68014 (pool #5504), 016LV58223 (pool #5618),
016LS70036 (pool #5757), 016LX30637 (pool #5797),
016LH43977 (pool #6235), 016LX33150 (pool #6316),
016LY92501 (pool #6484), 016LS74467 (pool #6323),
016LS74424 (pool #6322), 016LE69623 (pool #6472),
016LS75581 (pool #6548), 016LS75840 (pool #6537),
016LS75908 (pool #6533), 016LX34187 (pool #6635),
016LY94229 (pool #6603), 016LG27712 (pool #6671),
016LG27922 (pool #6774), 016LG28623 (pool #6980),
016LV67156 (pool #7089), 016LM53265 (pool #7593),
016LL54765 (pool #7999), 016LV73519 (pool #8236),
016LE81927 (pool #8319), 016KC14141 (pool #5791),
016LT18715 (pool #5792);
c) Unit Numbers: 016LL53863, 016LG22957, 016GW03073,
016LV68495, 016LM50302, 016LW33727, 016LW42490,
016LC13673, 016LS85828, 016LQ20358, 016LZ16993,
016LS84433, 016LE70074, 016LN26138, 016LW41672,
016LW42924, 016LQ19851, 016KC16962, 016LE75970,
016LR53489, 016LE66020, 016LH59705, 016LM47701,
016LW42869, 016GM05069, 016LT19359, 016LY93717,
016LE70693, 016LS76739, 016LV72470, 016LR45510,
016LV73390, 016LY83709, 016LR37008, 016LM49792,
016LR40523, 016LH26022, 016LV62763, 016LT20555,
016LH53821, 016LW51829, 016LN38046, 016LW31534,
016LS67515, 016LW41535, 016LW41610, 016LE63367,
016GM02066, 016LM47550, 016LW42594, 016LV58731,
016LE64792, 016LG24657, 016LY89773, 016LY89746,
016LY93452, 016LW46059, 016LG29384, 016LR42686,
016GS00537, 016LW50374, 016LM56036, 016LE80566,
016LV73408, 016LR46484, 016LR46599, 016LX45395,
016GJ09706, 016LS87315, 016KC13363, 016LW42362,
016LW42757, 016LS71844, 016LN27697, 016LY92942,
016LH46442, 016LH46725, 016LH47735, 016LY00196,
016LE82545, 016LG44149, 016LV62039, 016LL49161,
016LV64905, 016LM54254, 016LV57035, 016GW12424;
d) Unit number 016lN33525;
e) Unit Numbers: 016LV77495, 016LC16386, 016LS69489,
016LY86374, 016LR37048, 016GP02503, 016KG03182,
016LG29701, 016LG27922, 016LG27655, 016GW08516,
016GW08514, 016LS70036, 016LV59025, 016LG37166,
016KC19100, 016LQ19689, 016GP01995, 016GW04038,
016GM07807, 016LS74467, 016LS74424, 016LH47406,
016LV70370, 016LH49826, 016LL54765, 016KC22003,
016LE69623, 016LG36896, 016GW04056, 016LS75581,
016LE69637, 016LE74523, 016LM59904, 016LE63110,
016LS69328, 016LZ17921, 016LS88841, 016GW04313,
016LV56821, 016LS67083, 016LY87037, 016LX30637,
016LY92501, 016LL51004, 016LV67156, 016LT20324,
016LV68157, 016LX38256, 016LV70508, 016LG35099,
016LV73519, 016LT21861, 016LE81927;
f) Unit Numbers: 016LQ20365, 016LH49271, 016LE66148,
016LC05940, 016LH39581, 016LE94152, 016LG22957,
016LV57035, 016LY87732, 016LG24657, 016LV62763,
016LV68495, 016LE64327, 016LV58731, 016LQ19876,
016LV73607, 016LW42869, 016LV59775, 016LW46742,
016LW50374, 016GQ01658, 016LS85353, 016LW51829,
016LS26454, 016LN23131, 016LM47196, 016LS68152,
016LR36415, 016LT18484, 016LM47701, 016LW42490,
016LW42594, 016LV58790, 016LH41857, 016LW42757,
016LS71844, 016LY91258, 016LY92942, 016LS76220,
016LR40191, 016LR40761, 016KC16962, 016LT20555,
016LR42686, 016LX40460, 016LE78850, 016LR46484,
016LE95156, 016LH26022, 016LW41535, 016LW41610,
016LE63400, 016LX29786, 016LS68636, 016LM47339,
016LE64446, 016LE65820, 016LM50302, 016LS76029,
016LS76739, 016GP01622, 016GS00537, 016LW49177,
016LL55188, 016LS84445, 016LZ16993, 016LE80566,
016LV73390, 016KC22003, 016LY84448, 016LX29927,
016LS72076, 016LR45510, 016LH59705, 016LH53821,
016LY88664, 016LS73083, 016LS81750, 016LE82545,
016LG37607, 016LG37627, 016LG44149, 016LS26461,
016LY84594, 016LW41672, 016LV57019, 016GW01134,
016LT20775, 016LE70693, 016GW12424;
g) Unit Numbers: 016LH47735, 016LE77008, 016LH52010,
016GW02345, 016LL63897, 016GW01162.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by letter on April 11, 15, 16, 17, 18, 22, 23, 25, or 29, 2003. Firm initiated recall is complete.
REASON
Blood Products, corresponding to units of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 32 units;
b) 71 units;
c) 87 units;
d) 1 units;
e) 54 units;
f) 90 units;
g) 6 units.
DISTRIBUTION
Nationwide and PR.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0902-4.
CODE
Unit numbers 6014624 and 6014626.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by telephone on December 18, 2001. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but were not tested to determine the white blood cell count as required in the firm's standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MS.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0904-4.
CODE
Unit number 1807364.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by facsimile beginning on October 30, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to the application of a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
Platelets. Recall # B-0906-4.
CODE
Unit number 2030795.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, LY, by letter on January 30, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to recent ingestion of aspirin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0909-4.
CODE
Unit number 224731.
RECALLING FIRM/MANUFACTURER
Aultman Hospital Association Blood Bank, Canton, OH, by telephone and facsimile on December 17, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for the antibody to hepatitis C virus (anti-HCV), but was collected from an ineligible donor based on a previous positive test for anti-HCV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0910-4.
CODE
Unit number 8422677.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on October 8, 2003. Firm initiated recall is complete.
REASON
An associated product was found to be contaminated with Staphylococcus aureus.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

_______________________________
PRODUCT
Source Plasma. Recall # B-0913-4.
CODE
G-24395-093, G-24878-093, G-25128-093, G-25590-093,
G-25845-093, G-26240-093, G-26459-093, G-33208-093,
G-33426-093, G-33895-093, G-34121-093, G-34577-093,
G-34820-093, N-16745-093, G-82456-093, G-82830-093,
G-84254-093, G-84628-093, G-85120-093, G-85614-093,
G-36085-093, G-86464-093, G-86881-093, G-87290-093,
G-87711-093, G-88131-093, G-88538-093, G-89015-093,
G-89476-093, G-89846-093, G-90260-093, G-90763-093,
G-91208-093, G-93375-093, G-93797-093, G-94167-093,
G-94616-093, G-95002-093, G-95439-093, G-95831-093,
G-96252-093, G-96631-093, G-97015-093, G-97364-093,
G-97689-093, G-98019-093, G-98366-093, G-98711-093,
G-99066-093, G-99411-093, G-99754-093, G-05106-093,
G-05404-093, G-05731-093, G-06103-093, G-06444-093,
G-06805-093, G-07145-093, G-07381-093, G-07678-093,
T-45875-093, T-46055-093, T-46204-093, T-46379-093,
T-46524-093, T-46732-093, T-46886-093, T-47089-093,
T-47249-093, T-47409-093, T-47542-093, T-47750-093,
T-47921-093, T-47994-093, T-48167-093, T-48255-093,
T-48410-093, T-48482-093, T-48627-093, T-48698-093,
T-48829-093, T-48890-093, T-49022-093, T-49083-093,
T-49201-093, T-49248-093, T-49363-093, T-49430-093,
T-49558-093, T-49625-093, T-49754-093, G-19776-093,
G-19973-093, G-20346-093, G-20525-093, G-20898-093,
G-21082-093, G-21472-093, G-21679-093, G-22052-093,
G-22286-093, G-22663-093, G-22881-093, G-23226-093,
G-23422-093, G-23817-093, G-24020-093, G-24406-093,
G-24608-093, G-24954-093, G-25178-093, G-25543-093,
G-25779-093, G-26166-093, G-26383-093, G-26785-093,
G-27007-093, G-27390-093, G-27587-093, G-29078-093,
G-29260-093, G-29648-093, G-29842-093, G-32089-093.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corp, Brownsville, TX, by facsimile dated July 24, and on September 5, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from an unreliable donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
124 units.
DISTRIBUTION
NC, CA, Switzerland, United Kingdom, Italy, and Spain.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0914-4;
b) Fresh Frozen Plasma. Recall # B-0915-4.
CODE
a) and b) Unit # 16LR26866.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by letter dated January 6, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0917-4.
CODE
Unit KC38138.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by letter dated August 22, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was taking the drug Profasi (Human Chorionic Gonadotropin (HCG), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0918-4.
CODE
Unit number 0393311.
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Erie County, Erie, PA, by letter dated September 23, 2003. 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
PA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0866-4.
CODE
Unit number 0683271.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone and by letter dated July 2, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was not properly recorded, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0874-4.
CODE
Units number 1769227, 1771858, 1762330, 1762606, 1763286,
1794103, 1767897, 1762031, 1747922, 1761509, 1776139,
1769554, 1775662, 1774849, 1780595, 1772555, 1776346, 1777664, 1779868, 1784604, 1790776, 1778983, 1778882, 1759617, 1762119, 1778387, 1771699, 1777039, 1777044, 1777628, 1776509, 1761469, 1761497, 1778662, 1758504, 1739624, 1771560, 1759729, 1759240, 1759572, 1759656, 1759672, 1778573, 1779985, 1758449, 1782403, 1772590, 1773510, 1779021, 1773567, 1760988, 1773676, 1769551, 1778398, 1773800, 1773848, 1771748, 1761316, 1766579, 1767999, 1759614, 1730925, 1769549, 1784605, 1779288, 1794106, 1742744, 1776714, 1777582, 1762115, 1772360, 1796934, 1760997, 1776115, 1777302, 1761001, 1776098, 1762345, 1763208, 1778649, 1762768, 1767778, 1767784, 1778724, 1776683, 1778636, 1762112, 1778582, 1762332, 1751091, 1769378, 1786649, 1771545, 1762359, 1762030, 1777274, 1761292, 1761306, 1760860, 1774800, 1778395, 1778394, 1794901, 1763120, 1767888, 1767905, 1749914, 1769556, 1761958, 1771568, 1761366, 1774782, 1776345, 1779299, 1761365, 1761359, 1761345, 1761342, 1776112, 1761325, 1771586, 1771707, 1781607, 1780190, 1781613, 1781611, 1779289, 1778532, 1776069, 1772431, 1776026, 1778703, 1797187, 1778981, 1767791, 1711695, 1775409, 1750120, 1767899, 1759667, 1783138, 1776707, 1772042, 1794900, 1775663, 1761317, 1767886, 1761415, 1797262, 1773973, 1761511, 1760989, 1761501, 1796935, 1761494, 1760870, 1761417, 1771759, 1761308, 1761313, 1784297, 1748030, 1762315, 1769192, 1769377, 1762118, 1769672, 1771192, 1793893, 1776092, 1777289, 1776689, 1775338, 1776717, 1775481, 1780478, 1779345, 1776950, 1762290, 1778638, 1762342, 1775484, 1761310, 1776711, 1776708, 1778648, 1777729, 1760696, 1779303, 1778657, 1778388, 1783351, 1777299, 1778695, 1777303, 1777042, 1776511, 1763392, 1769685, 1775944, 1778552, 1777172, 1775190, 1779310, 1763211, 1744337, 1758605, 1769188, 1776705, 1761282, 1769189, 1776519, 1780121, 1777787, 1759665, 1761491, 1776031, 1760410, 1734425, 1778641, 1760336, 1762334, 1762335, 4002619, 1783139, 1758002, 1777330, 1754947, 1777300, 1778728, 4002681, 1777296, 1772573, 1777295, 1762392, 1773136, 1760693, 1796653, 1777291, 1777301, 1769226, 1758517, 1769458, 1769496, 1778396, 1745987, 1778551, 1769553, 1778571, 1760695, 1760698, 1771442, 1785583, 1760049, 1778389, 1769785, 1770243, 1778580, 1769190, 1770822, 1772808, 1769558, 1775687, 1776760, 1775381, 1761253, 1777288, 1775472, 1772601, 1779083, 1775488, 1775492, 1777270, 1760198, 1775471, 1761311, 1776027, 1776030, 1776510, 1761343, 1794102, 1766667, 1761318, 1750128, 1763100, 1774662, 1774482, 1774484, 1760498, 1774608, 1774629, 1778700, 1774738, 1775084, 1750129, 1760300, 1776165, 1762533, 1760092, 1762299, 1760631, 1762271, 1762270, 1752547, 1758446, 1760303, 1754216, 1750883, 6007488, 1763122, 1762396, 1763099, 1760694, 1760411, 1762318, 1763068, 1757020, 1762395, 1756348, 1762699, 1762340, 6010159, 1762339, 4002201, 1763101, 1760136, 1760697, 1777073, 6010620, 1761495, 1777104, 1761493, 4003162, 1761492, 1761002, 4002788, 1777103, 1761409, 4002196, 1760197, 1761499, 1767917, 1759712, 1760334, 1761344, 6010392, 1759751, 1759754, 1763196, 1777035, 1761319, 1761021, 1759758, 1762113, 1762111, 1760091, 1762110, 6011090, 1762107, 1762079, 1762032, 4002448, 1759507, 1761000, 1759510, 1760856, 1760142, 1760979, 1759172, 1761510, 1777269, 1761508, 1760992, 1761504, 1760994, 1760995, 1760857, 1778659, 1778581, 1778584, 1778585, 1778634, 1778650, 1778651, 1778729, 1778658, 1777759, 1778660, 1778661, 1791221, 1778691, 1778693, 1778706, 1763201, 1778656, 1777367, 1776698, 1771569, 1776715, 1776719, 1777271, 1777292, 1777293, 1791722, 1777307, 1793813, 1777519, 1777605, 1793988, 1793987, 1777666, 1777696, 1778739, 1777297, 1779654, 1783348, 1783349, 1783989, 1783990, 1785742, 1785919, 1778725, 1779308, 1790091, 1779665, 1787424, 1780597, 1779987, 1779988, 1780191, 1780210, 1786648, 1790775, 1778741, 1791220, 1778921, 1791204, 1791203, 1779124, 1779139, 1783137, 1783995, 1783133, 1780598, 1781429, 1781432, 1781435, 1781585, 1782402, 1776686, 1779293, 1769379, 1768713, 1768878, 1768879, 1768994, 1746544, 1769248, 1769591, 1769254, 1768177, 1769380, 1769382, 1769383, 1769504, 1769552, 1769555, 1776712, 1769249, 1767780, 1763207, 1763209, 1763297, 1766572, 1766574, 1766577, 1766578, 1768711, 1766580, 1768709, 1767789, 1767885, 1767887, 1767901, 1767948, 1767950, 1769593, 1750121, 1775668, 1776682, 1774151, 1769557, 1774607, 1775012, 1775123, 1796394, 1775547, 6010160, 1794690, 1776385, 1776454, 1776523, 1776559, 1776677, 1776679, 1775485, 1772222, 1771588, 1771694, 1774213, 1771567, 1796395, 1771587, 1772088, 1771714, 1770692, 1770274, 1772432, 1772587, 1772711, 1773179, 1771441, 1776032, 1777495, 1769251, 1760637, 1776071, 1756615.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by letter dated August 7, 2000. Firm initiated recall is complete.
REASON
Blood products, not placed in the freezer within required timeframes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
528 units.
DISTRIBUTION
MS, IL, NJ, AR, CA, VA, TX, and TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0878-4.
CODE
Unit number 0682280.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letter on May 20, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0901-4.
CODE
Unit numbers 1835817, 1835811, 1835808, 1835815, 1834528, and 1835858.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by telephone on March 26, 2001. Firm initiated recall is complete.
REASON
Blood products, found to be out of specification for red blood cell recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
MS.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0903-4.
CODE
Unit number 6020172 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by facsimile on April 18, 2003. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but failed quality control testing due to an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MS.

_______________________________
PRODUCT
Red Blood Cells, Washed. Recall # B-0905-4.
CODE
Unit number 20LC51429.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Lewis and Clark Region, Boise, ID, by telephone on February 9, 2002, and by letter on March 19, 2003. Firm initiated recall is complete.
REASON
Blood product, that was found to be out of specification for red blood cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
ID.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0907-4;
b) Red Blood Cells, Leukocytes Reduced Irradiated.
Recall # B-0908-4.
CODE
a) Unit number FC32925;
b) Unit number FC32928.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by letters on December 15 and 22, 2003.
Manufacturer: Heartland Blood Centers, Tinley Park, IL. Firm initiated recall is complete.
REASON
Blood products, that were not leukoreduced within the appropriate time period after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WI, and IN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated. Recall #
B-0912-4.
CODE
Unit # FC70332.
RECALLING FIRM/MANUFACTURER
Heartland Blood Centers, Aurora, IL, by telephone on December 23, 2003. Firm initiated recall is complete.
REASON
The irradiated Red Blood Cells were labeled with an extended expiration date.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0916-4.
CODE
Units # 18233-0183, 18233-0185, 18233-0189, 18233-0200.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on October 16, 2003. Firm initiated recall is complete.
REASON
Blood products, collected on trip scales that were incorrectly calibrated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
WY.

_______________________________
PRODUCT
Source Plasma. Recall # B-0919-4.
CODE
Unit number 53DDSDPD.
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Melrose Park, IL, by facsimile on November 12, 2003. Firm initiated recall is complete.
REASON
Blood product, which did not have the arm inspection documented on the donation record, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers.
6260-3-014 T3 MOD REV DIST STM 14MMX225MM;
6260-3-015 T3 MOD REV DIST STM 15MMX225MM;
6260-3-016 T3 MOD REV DIST STM 16MMX225MM;
6260-3-017 T3 MOD REV DIST STM 17MMX225MM;
6260-3-018 T3 MOD REV DIST STM 18MMX225MM;
6260-3-019 T3 MOD REV DIST STM 19MMX225MM;
6260-3-020 T3 MOD REV DIST STM 20MMX225MM;
6260-3-022 T3 MOD REV DIST STM 22MMX225MM;
6230-3-024 T3 MOD REV DIST STM 24MMX225MM;
6260-3-114 T3 MOD REV DIST STM 14MMX265MM;
6260-3-115 T3 MOD REV DIST STM 15MMX265MM;
6260-3-116 T3 MOD REV DIST STM 16MMX265MM;
6260-3-117 T3 MOD REV DIST STM 17MMX265MM;
6260-3-118 T3 MOD REV DIST STM 18MMX265MM;
6260-3-119 T3 MOD REV DIST STM 19MMX265MM;
6260-3-120 T3 MOD REV DIST STM 20MMX265MM;
6260-3-122 T3 MOD REV DIST STM 22MMX265MM;
6260-3-124 T3 MOD REV DIST STM 24MMX265MM;
6260-3-214 KINKED T3 DIST STM 14MMX265MM;
6260-3-215 KINKED T3 DIST STM 15MMX265MM;
6260-3-216 KINKED T3 DIST STM 16MMX265MM;
6260-3-217 KINKED T3 DIST STM 17MMX265MM;
6260-3-218 KINKED T3 DIST STM 18MMX265MM;
6260-3-219 KINKED T3 DIST STM 19MMX265MM;
6260-3-220 KINKED T3 DIST STM 20MMX265MM;
6260-3-222 KINKED T3 DIST STM 22MMX265MM;
6260-3-224 KINKED T3 DIST STM 24MMX265MM;
6260-3-314 KINKED T3 DIST STM 14MMX305MM;
6260-3-315 KINKED T3 DIST STM 15MMX305MM;
6260-3-316 KINKED T3 DIST STM 16MMX305MM;
6260-3-317 KINKED T3 DIST STM 17MMX305MM;
6260-3-318 KINKED T3 DIST STM 18MMX305MM;
6260-3-319 KINKED T3 DIST STM 19MMX305MM;
6260-3-320 KINKED T3 DIST STM 20MMX305MM;
6260-3-322 KINKED T3 DIST STM 22MMX305MM;
6260-3-324 KINKED T3 DIST STM 24MMX305MM;
LR3ST RESTORATION REV HIP SYS SURGICAL TECHNIQUE;
6262-7-000-0 RESTORATION REV HIP SYS TEMPLATE SET FOR STRAIGHT STEMS ONLY;
LTEM71 1-9 RESTORATION REV HIP SYS 265MM BOWED STEM TEMPLATES;
LTEM72 1-9 RESTORATION REV HIP SYS 305MM BOWED STEM TEMPLATES. Recall # Z-0571-04.
CODE
All Lots.
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Mahwah, NJ, by letters and accountability forms on December 30, 2003. Firm initiated recall is ongoing.
REASON
Restoration T3 Revision Hip System distal stem has demonstrated fractures.
VOLUME OF PRODUCT IN COMMERCE
8,986.
DISTRIBUTION
Latin America, Canada, and Asia Pacific.

_______________________________
PRODUCT
EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm diameters), sterile, stored in 2% benzyl alcohol. Recall # Z-0588-04.
CODE
Lot#, Catalog #, Description:
030911-NR, ENR-20210, 2CM X 10CM;
030911-NR, ENR-20404, 4CM X 4CM;
030911-NR, ENR-20506, 5CM X 6CM;
030808-NR, ENR-20610, 6CM X 10CM;
030811-NR, ENR-20610, 6CM X 10CM;
030911-NR, ENR-21012, 10CM X 12CM;
030924-NR, ENR-21012, 10CM X 12CM;
031027-NR, ENR-21212, 12CM Diameter.
RECALLING FIRM/MANUFACTURER
Shelhigh, Inc., Union, NJ, by letter on December 19, 2003. Firm initiated recall is ongoing.
REASON
The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile.
VOLUME OF PRODUCT IN COMMERCE
1,002.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Recall # Z-0589-04.
CODE
Affected products include: Model 100540 Fleximount SGL Ceiling, Serial No.'s less than SC995486;
Model 100740 SGL Ceiling CS II, Serial No's less than SCCS990745;
Model 100580 SGL Trolley, Serial No.'s less than TRS962633; Model 100780 SGL Trolley OP II, Serial No.'s less than STOP97417;
Model 102540 SGL Ceiling OP II, Serial No.'s less than SCOP003354.
RECALLING FIRM/MANUFACTURER
Burton Medical Products Corp., Chatsworth, CA, by letter on January 30, 2004. Firm initiated recall is ongoing.
REASON
Pivot joint on these ceiling mount lights may fail and lights may fall onto patients.
VOLUME OF PRODUCT IN COMMERCE
17,000 estimated.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Cronus Endovascular Guidewire, Length 210 cm (full
coat), Diameter 0.014 inch, Part Number 001-001096-1.
Recall # Z-0590-04;
b) Cronus Endovascular Guidewire, Length 210 cm (partial
coat), Diameter 0.014 inch, Part Number 001-001096-3.
Recall # Z-0591-04;
c) Cronus Endovascular Guidewire, Length 300 cm (partial
coat), Diameter 0.014 inch, Part Number 001-001096-4.
Recall # Z-0592-04.
d) Floppy Cronus Endovascular Guidewire, Length 180 cm
(partial coat), Diameter 0.014 inch, Part Number
001-001232-3. Recall # Z-0593-04;
e) Floppy Cronus Endovascular Guidewire, Length 300 cm
(partial coat), Diameter 0.014 inch, Part Number 001-
Recall # Z-0594-04;
f) Cronus-1 Endovascular Guidewire, Length 210 cm (full
coat), Diameter 0.014 inch, Part Number 001-001263-1.
Recall # Z-0595-04.
CODE
a) Lots 0206-4004, 0207-4005, 0301-4015, 0301-4016, and
0304-4020;
b) Lots 0307-4029, 0307-4039, 0307-4042, 0307-4043, and
0307-4044;
c) Lots 0212-4014, 0307-4041, and 0308-4053;
d) Lots 0305-4024, 0305-4025, 0305-4026, 0306-4027, 0307-
4028, 0307-4030, 0307-4031, and 0307-4050;
e) Lots 0211-4012, 0307-4037, 0308-4057, and 0308-4058;
f) Lot 0212-2027.
RECALLING FIRM/MANUFACTURER
Stereotaxis, Inc., Saint Louis, MO, by letter dated January 27, 2004. Firm initiated recall is complete.
REASON
The magnet at the end of the guidewire could break off.
VOLUME OF PRODUCT IN COMMERCE
291 guidewires.
DISTRIBUTION
IA, MA, MO, OK, TX, Germany and The Netherlands.

_______________________________
PRODUCT
MediSense Precision QID Blood Glucose Test Strips. The
product is sold in box of 50 and 100. The NDC number for
the 50 count box is 57599-7400-4. The NDC number for the
100 count box is 57599-7401-5. Recall # Z-0596-04.
CODE
Lot number 89873 exp 4/30/04, Lot number 90524 exp. 11/30/04, Lot number 90848 exp. 1/31/05, Lot number 90891 exp. 1/31/05, and Lot number 91326 exp. 3/31/05.
RECALLING FIRM/MANUFACTURER
AmeriSource Bergen, Chesterbrook, PA, by letter on January 28, 2004. Firm initiated recall is ongoing.
REASON
Potential counterfeit product/box.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide, PR, and the Bahamas.

END OF ENFORCEMENT REPORT FOR MARCH 17, 2004

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