October 29, 2003
03-44
_______________________________
PRODUCT
Winners Circle, SunBurst and CFW Vending Breakfast Bonus, a product containing cooked ham, egg and cheese on a bun wrapped in clear flexible plastic, Net wt. 4.75 oz. Recall # F-016-4.
CODE
Finished product "Sell By" date: 3/7/03, 3/11/03, 3/14/03, 3/18/03, 3/21/03 and 4/8/03.
RECALLING FIRM/MANUFACTURER
Sunburst Foods Inc, Goldsboro, NC, by on-site visit on March 24, 2003, and by telephone and follow-up letter on April 2, 2003. Firm initiated recall is complete.
REASON
Product contained undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
2,455 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Dried Fruit Candy-Sweet Potato. Ying Feng Foodstuffs brand, net wt. 6 oz. Product of China. Product is packaged in clear plastic bags. The label declared the product as a dried preserved fruit candy yet sweet potato is listed in the ingredient statement. Barcode # 6911749 383313. Recall # F-021-4.
CODE
Expiration: 24 Months.
RECALLING FIRM/MANUFACTURER
Eastwell Trading Corp, Brooklyn, NY, by press release and letters dated July 29, 2003. New York State initiated recall is complete.
REASON
Product contained undeclared sulfites (750 ppm) based on New York State Department of Agriculture and Markets sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
12 cases (100-6 oz. packages per case).
DISTRIBUTION
NY and MA.
_______________________________
PRODUCT
a) Strawberry flavored chocolate with cream filling
labeled: "Solen Fresh Cilek aromali krema dolgulu
kokolin." Made in Turkey. Recall # F-022-4;
b) Cherry flavored chocolate with cream filling
labeled: "Solen Fresh Cilek aromali krema dolgulu
kokolin." Made in Turkey. Recall # F-023-4.
CODE
a) Strawberry 7700;
b) Cherry 7710.
RECALLING FIRM/MANUFACTURER
United Corporation, San Juan, PR, by letter dated February 12, 2003. FDA initiated recall is complete.
REASON
Product contains unapproved color additive Ponceau 4R E 124.
VOLUME OF PRODUCT IN COMMERCE
333 cartons/12 each.
DISTRIBUTION
Puerto Rico.
_______________________________
PRODUCT
a) Winners Circle, SunBurst and CFW Vending Egg & Cheese
Biscuit, a product containing egg and cheese on a
biscuit wrapped in clear flexible plastic, manufactured
under 3 brand names. Recall # F-017-4;
b) CFW Vending Sausage Egg Biscuit, a product containing
sausage and egg on a biscuit wrapped in clear flexible
plastic 4.0 oz. Recall # F-018-4;
c) CFW Vending Sausage/Egg/Cheese, a product containing
sausage, egg and cheese on a bun wrapped in clear
flexible plastic, Net wt. 6.5oz. Recall # F-019-4;
d) CFW Vending Chili Cheese Dogs, a product containing
a meat product with cheese on a bun wrapped in clear
flexible plastic, Net wt. 8.5 oz. Recall # F-020-4.
CODE
Finished product "Sell By" date: 3/7/03, 3/11/03, 3/14/03, 3/18/03, 3/21/03 and 4/8/03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sunburst Foods Inc, Goldsboro, NC, by on-site visit on March 24, 2003, and by telephone and follow- up letter on April 2, 2003. Firm initiated recall is complete.
REASON
a) Product contained undeclared whey and casein but
buttermilk is listed as an ingredient and product is
identified as containing cheese;
b) Product contained undeclared whey and casein but
buttermilk is listed as an ingredient and product is
identified as containing -egg;
c) Undeclared whey and casein but buttermilk is listed as
an ingredient and product is identified as containing
egg and cheese;
d) Product contained undeclared whey and casein but
product is identified as containing cheese.
VOLUME OF PRODUCT IN COMMERCE
a) 992 units;
b) 56 units;
c) 56 units;
d) 56 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
a) Zyprexa Tablets (Olanzapine), 5 mg, 60 tablet bottles,
Rx only. Recall # D-003-4;
b) Zyprexa Tablets (Olanzapine), 10 mg, 60 tablet bottles,
Rx only. Recall # D-004-4;
c) Zyprexa Tablets (Olanzapine), 15 mg, 60 tablet bottles,
Rx only. Recall # D-005-4;
d) Zyprexa Tablets (Olanzapine), 20 mg, 60 tablet bottles,
Rx only. Recall # D-006-4.
CODE
a) Lot Number: 6AA66A;
b) Lot Numbers/Exp. Date: 6AH19A (01/05), 7AA39A (03/05),
and 7EA97A (04/05);
c) Lot Numbers/Exp. Date: 6AH35A (01/05), 6AG70A (11/04);
d) Lot Numbers: 7EC85A and 7AA79A.
RECALLING FIRM
Walsh Heartland, LLC, Paragould, AR, by telephone on August 15, 2003 and August 21, 2003.Firm initiated recall is ongoing.
MANUFACTURER--Unknown
REASON
Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE
547 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Zyprexa Tablets (Olanzapine), 10 mg, 60 tablet bottles,
Rx only. Recall # D-009-4;
b) Zyprexa Tablets (Olanzapine), 15 mg, 60 tablet bottles,
Rx only. Recall # D-010-4.
CODE
a) Lot No./Exp. Date: 6AH19A (Exp. 01/05), 7AA39A (Exp.
03/05), 7EA97A (Exp. 04/05).
b) Lot No./Exp. Date: 6AH35A (Exp. 01/05) and 6AG70A (Exp.
11/04).
RECALLING FIRM
R&L Associates of Walled Lake, LLc, Walled Lake, MI, by fax on August 14, 2003. Firm initiated recall is ongoing.
MANUFACTURER--unknown
REASON
Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Zyprexa Tablets (Olanzapine), 5 mg, 60 tablet bottles,
Rx only. Recall # D-011-4;
b) Zyprexa Tablets (Olanzapine), 10 mg, 60 tablet bottles,
Rx only. Recall # D-012-4.
CODE
a) Lot # 6AA66A;
b) Lot # 6AH19A.
RECALLING FIRM
Houston Rx, Inc., Humble, TX, by letters on August 27, 2003.
Firm initiated recall is ongoing.
MANUFACTURER--unknown
REASON
Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE
45 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Kaletra capsules (Lopinavir/Ritonavir), Each soft gelatin capsule contains: Lopinavir 133.3mg, Ritonavir 33.3mg, 180 capsule bottles, Rx only. Recall # D-013-4.
CODE
Lot No. 852072E25.
RECALLING FIRM
The Harvard Drug Group, Livonia, MI, by letter dated August 19, 2003.
Firm initiated recall is ongoing.
MANUFACTURER--unknown
Counterfeit: bottles labeled as containing Kaletra capsules may contain Kaletra capsules and/or Agenerase capsules or a mix of both, as well as, bottles of Kaletra capsules have been repackaged/relabeled by an unknown source with an extended expiration date/counterfeit lot number.
VOLUME OF PRODUCT IN COMMERCE
71 bottles.
DISTRIBUTION
Nationwide.
***CORRECTION***
On the October 24, 2003 Enforcement Report, Recall # B-0076-4, Red Blood Cells, Leukocytes Reduced, the CODE Unit # was incorrect, it should read Unit # 53GF48288.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1687-3.
CODE
Units 6801119, 6801120, 6801121, 6801123, 6801126, 6801127, 6301129, 6801130, 6801131, 6801132, 6801134, 6801135, 6801136, 6801137, 6801138.
RECALLING FIRM/MANUFACTURER
W.E. & Lela I. Stewart Blood Center, Inc, Tyler, TX, by telephone on October 5, 2001, and December 4, 2001, and by letters dated December 11th and 15th, 2001. Firm initiated recall is complete.
REASON
Blood products, manufactured from Whole Blood units that were collected in the incorrect size collection bag, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1690-3;
b) Recovered Plasma. Recall # B-1691-3.
CODE
a) and b) Units 042Q77979, 042J44316.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by telephone on April 29, 2003, and by letter dated May 2, 2003. 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
4 units.
DISTRIBUTION
OH and CA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1692-3;
b) Fresh Frozen Plasma. Recall # B-1693-3.
CODE
a) and b) Unit 18230-4015.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 22, 2003 and by letter dated June 23, 2003.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is ongoing.
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
2 units.
DISTRIBUTION
TX, and WY.
_______________________________
PRODUCT
Source Plasma. Recall # B-1694-3.
CODE
Unit CD0122147.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Carbondale, LLC, Carbondale, IL , by facsimile transmission dated June 2, 2003. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that compromises the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
a) Red Blood Cells, Irradiated. Recall # B-1695-3;
b) Platelets. Recall # B-1696-3.
CODE
a) and b) Unit (1 unit) 8404938.
RECALLING FIRM/MANUFACTURER
Texoma Regional Blood Center, Sherman, TX , by telephone on March 11, 2002, and by letter dated March 13, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo applied within the previous twelve months, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1702-3;
b) Platelets, Leukocytes Reduced. Recall # B-1703-3.
CODE
a) Unit numbers 16GJ17887 and 16GJ14754;
b) unit number 16GJ14754.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Ohio Region, Columbus, OH, by letter on May 21, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1704-3.
CODE
Unit number 50P36733.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Western Lake Erie Region, Toledo, OH, by telephone on May 27, 2003, and by letter on May 28, 2003. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1706-3;
b) Platelets. Recall # B-1707-3;
c) Fresh Frozen Plasma. Recall # B-1708-3.
CODE
a) Unit numbers FL04548, FL04549, FL04550, FL04551,
FL04552, FL04553, FL04554, FL04556, FL04557, FL04558,
FL04559, FL04560, FL04561, FL04562, FL04563, FL04565,
FL04566, FL04567, FL04568, FL04569, FL04570, FL04572,
FS49928, FS49929, FS49930, FS49932, FS49933, FS49935,
FS49936, FS49937, FS49939, FS49940, FS49942, FS49943,
FS49944, FS49945, FS49948, FS49949, FS49951, FT03896,
FT03899, FT03903, FT03904, FT03906, FT03907, FT03908,
FT03909, FT03910, FT03911, FT03912, FT03913, FT03914,
FT03915, FT03916, FT03917, FT03918, FT03919, FT03920,
FT03921, FT03923, FT03924, FT03925, FT03926, FT03927,
FT03928, FV01059, FV01060, FV01062, FV01063, FV01064,
FV01065, FV01066, FV01067, FV01068, FV01069, FV01070,
FV01071, FV01074, FV01075, FV01076, FV01078, FV01080,
FV01081, FV01082, FV01083, FV01084, FV01085, FV01087,
FV01088, FV01090, FV01092, FV01093, FV01096, FV01099,
FV01100, FV01101, FV01103, GG73880, GG73881, GG73882,
GG73884, GG73885, GG73886, GG73887, GG73889, GG73891,
GG73892, GG73893, GG73894, GG73895, GG73896, GJ73538,
GJ73539, GJ73541, GJ73543, GJ73544, GJ73545, GJ73551,
GJ73552, GJ73554, GJ73555, GJ73556, GJ73560, GJ73562,
GJ73563, GJ73565, GJ73567, GJ73569, GJ73572, GJ73574,
GL09831, GL09832, GL09833, GL09834, GL09835, GL09836,
GL09837, GL09838, GL09839, GL09840, GL09841, GL09843,
GL09844, GL09845, GL09847, GL09849, GL09850, GL09851,
GL09852, GL09853, GL09854, GL09855, GL09857, GL09858,
GL09860, GL09862, GL09864, GL09865, GL09866, GL09867,
GL09868, GL09869, GL09870, GL09871, GL09872, GL09873,
GL09875, GL09876, GL09877, GL09880, GL09881, GL09882,
GP50079, GP50080, GP50082, GP50083, KJ52664, KJ52665,
KJ52666, KJ52667, KJ52668, KJ52670, KJ52671, KJ52672,
KJ52673, KJ52674, KJ52676, KJ52677, KJ52678, KJ52679,
KJ52680, KJ52681, KJ52682, KJ52683, KJ52685, KJ52686,
KJ52688, KJ52689, KJ52690, KJ52691, KJ52692, KJ52693,
KJ52752, KJ52753, KJ52754, KJ52755, KJ52756, KJ52757,
KJ52760, KJ52761, KJ52762, KJ52763, KJ52764, KJ52765,
KJ52767, KJ52768, KJ52769, KJ52770, KJ52771, KJ52772,
KJ52773, KL06919, KL06920, KL06921, KL06922, KL06923,
KL06924, KL06925, KL06927, KL06928, KL06929, KL06930,
KL06931, KL06932, KL06933, KL06934, KL06937, KL06938,
KL06939, KL06940, KL06941, KL06942, KL06943, KL06944,
KL06945, KL06946, KL06947, KL06948, KL06949, KL06950,
KL06951, KL06952, KL06953, KL06954, KL06955, KL06956,
KL06957, KL06958, KL06959, KL06960, KL06961, KL06962,
KL06963, KL06964, KL06965, KL06966, KL06967, KL06968,
KL06969, KL06970, KL06971, KL06980, KL06981, KL06982,
KL06983, KL06984, KL06985, KL06986, KL06987, KL06988,
KL06989, KL06990, KL06991, KL06993, KL06994, KL07043,
KL07044, KL07045, KL07046, KL07048, KL07049, KL07050,
KL07051, KL07052, KL07054, KL07055, KL07056, KL07057,
KL07058, KL07060, KL07061, KL07062, KL07063, KL07064,
KL07065, KL07066, KL07085, KL07090, KM06215, KM06216,
KM06217, KM06218, KM06219, KM06220, KM06222, KM06223,
KM06224, KM06225, KM06226, KM06227, KM06228, KM06229,
KM06230, KM06231, KM06232, KM06233, KM06234, KM06235,
KM06236, KM06237, KM06239, KM06241, KM06242, KM06243,
KM06244, KM06245, KM06246, KM06247, KM06251, KM06252,
KM06254, KM06255, KM06256, KM06257, KM06258, KM06260,
KM06261, KM06262, KS66762, KS66763, KS66764, KS66765,
KS66766, KS66767, KS66768, KS66770, and KS66771;
b) Unit numbers FL04548, FL04549, FL04550, FL04551,
FL04553, FL04554, FL04558, FL04560, FL04561, FL04562,
FL04563, FL04565, FL04566, FL04568, FL04569, FL04572,
FS49928, FS49929, FS49930, FS49932, FS49933, FS49934,
FS49935, FS49936, FS49937, FS49939, FS49940, FS49942,
FS49943, FS49944, FS49945, FS49947, FS49948, FS49949,
FS49950, FS49951, FT03896, FT03903, FT03904, FT03906,
FT03907, FT03908, FT03909, FT03910, FT03911, FT03912,
FT03913, FT03914, FT03915, FT03916, FT03917, FT03918,
FT03919, FT03920, FT03921, FT03923, FT03924, FT03925,
FT03926, FT03927, FT03928, FV01059, FV01062, FV01064,
FV01065, FV01067, FV01068, FV01069, FV01070, FV01071,
FV01072, FV01073, FV01074, FV01075, FV01078, FV01079,
FV01080, FV01082, FV01084, FV01085, FV01088, FV01090,
FV01091, FV01093, FV01095, FV01096, FV01098, FV01099,
FV01101, FV01102, FV01103, FV01104, GG73889, GG73890,
GG73891, GG73892, GG73893, GG73894, GG73895, GG73896,
GJ73538, GJ73541, GJ73542, GJ73543, GJ73545, GJ73549,
GJ73551, GJ73552, GJ73554, GJ73556, GJ73557, GJ73562,
GJ73563, GJ73565, GJ73567, GJ73568, GJ73569, GJ73571,
GJ73572, GJ73574, GJ73575, GL09831, GL09832, GL09833,
GL09834, GL09835, GL09836, GL09837, GL09838, GL09839,
GL09840, GL09841, GL09843, GL09844, GL09845, GL09847,
GL09849, GL09850, GL09851, GL09852, GL09853, GL09854,
GL09855, GL09857, GL09858, GL09860, GL09864, GL09865,
GL09866, GL09867, GL09868, GL09869, GL09870, GL09873,
GL09877, GL09880, GL09881, GP50079, GP50080, GP50082,
GP50083, KJ52665, KJ52666, KJ52667, KJ52668, KJ52670,
KJ52671, KJ52672, KJ52673, KJ52674, KJ52676, KJ52677,
KJ52678, KJ52679, KJ52680, KJ52681, KJ52682, KJ52684,
KJ52685, KJ52686, KJ52687, KJ52688, KJ52689, KJ52690,
KJ52691, KJ52692, KJ52693, KJ52752, KJ52753, KJ52754,
KJ52755, KJ52756, KJ52758, KJ52759, KJ52760, KJ52761,
KJ52763, KJ52764, KJ52765, KJ52767, KJ52769, KJ52770,
KJ52771, KJ52772, KJ52773, KL06920, KL06921, KL06922,
KL06923, KL06924, KL06925, KL06927, KL06929, KL06930,
KL06931, KL06932, KL06933, KL06934, KL06937, KL06938,
KL06939, KL06940, KL06941, KL06943, KL06944, KL06945,
KL06946, KL06947, KL06948, KL06949, KL06950, KL06951,
KL06952, KL06954, KL06955, KL06956, KL06958, KL06959,
KL06960, KL06962, KL06963, KL06964, KL06965, KL06966,
KL06967, KL06968, KL06969, KL06970, KL06971, KL06980,
KL06981, KL06982, KL06983, KL06984, KL06985, KL06986,
KL06988, KL06989, KL06990, KL06991, KL06993, KL07043,
KL07046, KL07048, KL07049, KL07050, KL07051, KL07052,
KL07053, KL07054, KL07055, KL07056, KL07057, KL07058,
KL07059, KL07060, KL07061, KL07062, KL07063, KL07064,
KL07065, KM06215, KM06216, KM06217, KM06218, KM06219,
KM06220, KM06221, KM06222, KM06223, KM06224, KM06225,
KM06226, KM06228, KM06229, KM06230, KM06231, KM06232,
KM06233, KM06234, KM06235, KM06236, KM06237, KM06239,
KM06240, KM06241, KM06242, KM06243, KM06244, KM06245,
KM06246, KM06247, KM06248, KM06251, KM06252, KM06254,
KM06255, KM06256, KM06257, KM06258, KM06259, KM06260,
KM06261, KM06262, KS66762, KS66763, KS66764, KS66765,
KS66766, KS66768, KS66770, and KS66771
c) Unit numbers FL04558, FL04561, FL04562, FT03896,
FT03914, FT03919, FT03921, FT03924, FV01073, GL09850,
GL09851, GL09852, GL09856, GL09860, GL09863, KJ52665,
KJ52666, KJ52667, KJ52668, KJ52671, KJ52672, KJ52673,
KJ52674, KJ52676, KJ52679, KJ52680, KJ52681, KJ52682,
KJ52683, KJ52684, KJ52685, KJ52686, KJ52687, KJ52758,
KJ52760, KL06919, KL06920, KL06922, KL06925, KL06927,
KL06929, KL06930, KL06932, KL06934, KL06937, KL06938,
KL06939, KL06940, KL06944, KL06945, KL06946, KL06947,
KL06950, KL06951, KL06952, KL06954, KL06955, KL06956,
KL06959, KL06963, KL06964, KL06969, KL06970, KL06980,
KL06984, KL07048, KL07049, KL07050, KL07054, KL07056,
KL07057, KL07058, KL07062, KL07063, KL07064, KL07065,
KM06216, KM06217, KM06218, KM06219, KM06221, KM06222,
KM06223, KM06224, KM06225, KM06226, KM06230, KM06231,
KM06232, KM06235, KM06236, KM06239, KM06240, KM06241,
KM06244, KM06245, KM06246, KM06247, KM06248, KM06251,
KM06254, KM06256, KM06257, KM06260, KM06261, and
KM06262.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by letter beginning June 18, 2002. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood that were collected in the incorrect size collection bag, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 357 units;
b) 332 units;
c) 106 units.
DISTRIBUTION
PA, and OH.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1763-3;
b) Fresh Frozen Plasma. Recall # B-1764-3;
c) Recovered Plasma. Recall # B-1765-3.
CODE
a) Unit numbers LC09637, LC08204, LC06028, LC03305,
LC02438, LC01729, FS55247, FS52998, FS49013, FS45522,
and FS42202;
b) Unit numbers LC06028, LC02438, and FS45522;
c) Unit numbers LC09637, LC08204, LC03305, LC01729,
FS55247, FS52998, FS49013, and FS42202.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Annandale, VA, by letter and facsimile on February 25, 2001. 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
a) 11 units;
b) 3 units;
c) 8 units.
DISTRIBUTION
VA, D.C., and NJ.
_______________________________
PRODUCT
Product: Source Plasma. Recall # B-1821-3.
CODE
Unit 00EWIC7005.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P. (Formerly Community Bio-Services), Eau Claire, WI, by fax dated July 25, 2002. Firm initiated recall is complete.
REASON
Blood Product, collected from a donor whose health history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1838-3;
b) Recovered Plasma. Recall # B-1839-3.
CODE
a) and b) Unit 41FW34387.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by letter dated December 17, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL.
_______________________________
PRODUCT
Sedecal Portable X-Ray System. Model Number SP-HF-4.0. Recall # Z-0001-04.
CODE
Not supplied.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sedecal USA, Inc, Arlington Heights, IL, by manufacturer representative
visit on or after October 10, 2003.
Manufacturer: Sedecal SA, Madrid, Spain. Firm initiated recall is ongoing.
REASON
A minimum source-skin-distance of less than 30 cm and not identifying the tube
manufacturer on the tube housing label resulted in your SP-HF-4.0 Portable Systems
not complying with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VT.
_______________________________
PRODUCT
Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD, 45 cm distal length, total length 155 cm) with an MP (45 degree) dual marker band tip. Catalog No. 606-2511 FX UPN H7396062511FX3. Recall # Z-0018-04.
CODE
Lot T0601010, expiration date 2004-05.
RECALLING FIRM/MANUFACTURER
Cordis Neurovascular, Inc., Miami Lakes, FL, by e-mail on August 20, 2001 and by letters on October 19, 2001. Firm initiated recall is complete.
REASON
These catheters have J-shape tips instead of the labeled MP (multipurpose) tips and also are packed into the incorrect tip tray.
VOLUME OF PRODUCT IN COMMERCE
54.
DISTRIBUTION
US and Japan.
_______________________________
PRODUCT
Sharpoint 2.75 mm x 3.75 mm Clear Trap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives. Recall # Z-0026-04.
CODE
M190500 exp 11/2007 and M203840 exp 12/2007.
RECALLING FIRM/MANUFACTURER
Surgical Specialties Corp., Reading, PA, by fax on August 21, 2003 and by letter on August 22, 2003. Firm initiated recall is ongoing.
REASON
The text on product handle is incorrect.
VOLUME OF PRODUCT IN COMMERCE
666 units.
DISTRIBUTION
CA. NC, IL, Belgium, Canada, and Australia.
_______________________________
PRODUCT
Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers 3242901 (100 tubes) and 3242897 (6 tubes). Recall # Z-0029-04.
CODE
Lots 0001531727, 001583486 and 0001671243; lot 0001604743.
RECALLING FIRM/MANUFACTURER
Dow Corning Corp, Hemlock, MI, by telephone and by letter dated September 5, 2003. Firm initiated recall is ongoing.
REASON
The product maybe contaminated with iron, chromium and nickel from stainless steel equipment failure during manufacture.
VOLUME OF PRODUCT IN COMMERCE
4,176 tubes.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Coulter AcT 5diff Open Vial Hematology Analyzers, Part
Numbers: 6605580, 6605581, 6605604. Recall # Z-0039-04;
b) Coulter AcT 5diff Cap Pierce Hematology Analyzers, Part
Numbers: 6605641, 6605705. Recall # Z-0040-04.
CODE
a) All instruments are affected;
b) None apply.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter on September 8, 2003. Firm initiated recall is ongoing.
REASON
Samples with high fat content will not count platelets accurately.
VOLUME OF PRODUCT IN COMMERCE
1,221.
DISTRIBUTION
Nationwide and Canada.
_______________________________
PRODUCT
SONOLINE Antares Diagnostic Ultrasound System. Catalog No. 5936518, 7035415, 5936682, 5936682, 5936708, 5936716, 5936724. Recall # Z0041-04.
CODE
Serial numbers: 10106, 10107, 10108, 10253, 10323, 10347, 10352, 10392, 10393, 10394, 10407, 10429, 10430, 10431, 10462, 10465, 10470, 10475, 10492, 10504, 10511, 10535, 10540, 10541, 10542, 10543, 10576, 10585, 10611, 10614, 10626, 10651, 10662, 10712, 10724, 10727, 10745, 10819, 10829, 10837, 10843, 10848, 10849, 10850, 10851, 10852, 10861, 10869, 10873, 10875, 10921, 11008, 11022, 11025, 11049, 11050, 11051, 11053, 11054, 11071, 11102, 11104, 10012, 10027, 10195, 10471, 10483, 10484, 10491, 10583, 10664, 10703, 11033, 11034, 10781, 10432, 10257, 10262, 10274, 10281, 10338, 10383, 10493, 10686, 10836, 10847, 11009, 11030, 11057, 10400, 10401, 10453, 10466, 10737, 10752, 10777, 10778, 10784, 11027, 11028, 11029, 10286, 10602, 10753, 10923, 10018, 10058, 10071, 10116, 10434 , 10668, 10970, 10351, 10697, 10991, 10997, 10277, 10681, 11073, 10130, 10267, 10782, 11002, 11019, 11032, 11072, 10648.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Issaquah, WA, by letter on September 5, 2003. Firm initiated recall is ongoing.
REASON
Product labeling failed to include complete information about ALARA (As Low As Reasonably Achievable) safety instructions.
VOLUME OF PRODUCT IN COMMERCE
136 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System. Part # 252-0300. Recall # Z-0042-04.
CODE
Lot # W007919.
RECALLING FIRM/MANUFACTURER
Ortho Development Corporation, Draper, UT, by telephone, and letters on September 15, 2003. Firm initiated recall is ongoing.
REASON
The guide pin which rotationally constrains the tibial punch within the punch guide, has fallen out on several parts of the Balanced Knee System.
VOLUME OF PRODUCT IN COMMERCE
27.
DISTRIBUTION
Nationwide and Japan.
_______________________________
PRODUCT
LifeSite Hemodialysis Cannula Exchange Kit Part Number: LHCEK0000. Recall Z-0045-04.
CODE
Lot Number: 30956.
RECALLING FIRM/MANUFACTURER
Vasca, Inc., Tewksbury, MA, by letter on September 22, 2003. Firm initiated recall is ongoing.
REASON
Outer kit mislabeled with an extended expiration date.
VOLUME OF PRODUCT IN COMMERCE
81 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Brodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length: 350 cm. Sideports: 10, Standard wire Guide: .035"/480 cm. Disposable - Single use only, Rx Only. Catalog # CDSB-10. Recall # Z-0048-04.
CODE
Lot # 1589467.
RECALLING FIRM/MANUFACTURER
Wilson-Cook Medical Inc., Winston-Salem, NC, by email on October 8, 2003. Firm initiated recall is ongoing.
REASON
Product may be packaged with an incorrect instructions for use (IFU) booklet.
VOLUME OF PRODUCT IN COMMERCE
9 pieces.
DISTRIBUTION
CA, NC, PA, and WI.
_______________________________
PRODUCT
a) Channel Neuroendoscope, Standard Resolution, 21.6 cm.
Catalog No. 2232-001. Recall # Z-0049-04;
b) Channel Neuroendoscope, Standard Resolution, 13 cm.
Catalog No. 2232-003. Recall # Z-0050-04.
CODE
a) A20284;
b) A22148.
RECALLING FIRM/MANUFACTURER
Medtronic Neurosurgery, Goleta, CA, by hand delivery on September 15, 2003. FDA initiated recall is complete.
REASON
Size mix-up. 13cm product may be labeled as 21.6 mm and visaversa.
VOLUME OF PRODUCT IN COMMERCE
20.
DISTRIBUTION
TN, CO, GA, and Japan.
END OF ENFORCEMENT REPORT FOR OCTOBER 29, 2003
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