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U.S. Department of Health and Human Services

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Enforcement Report for September 14, 2005

 

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.

September 14, 2005
05-37

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I

______________________________
PRODUCT
Tan Nam Fresh Soy Milk, with and without sugar, in 16 and 64 oz. plastic containers. Lids are color coded as to product as in red for Soy Milk with sugar, and green without, Recall # F-591-5
CODE
Stamped expiration dates between April 22 and June 3, 2005
RECALLING FIRM/MANUFACTURER
Tan Nam Tofu Co., Rosemead, CA, by Press release on May 5, 2005 and by letter beginning on May 7, 2005. Firm initiated recall is complete.
REASON
Product contains undeclared evaporated milk.
VOLUME OF PRODUCT IN COMMERCE
4,347-64 oz. and 150-16 oz. containers
DISTRIBUTION
CA

______________________________
PRODUCT
Smoked Salmon under the following labels: a) Product is Superior brand Salmon. Frozen and vacuum packed as smoked salmon skinless sliced sides in 2-4 lb individually wrapped packages. Product is labeled in part: ?***SMOKED SALMON NORWEGIAN CURE***READY TO SERVE HICKORY HOUSE***Processed by Hickory House Hialeah, SUPERIOR SMOKED SALMON SKINLESS SLICED SIDES ***?. b) Product is Imperial Salmon House brand Salmon. Vacuum packed in plastic bags weighing 2-4 lbs each. Product is labeled in part: ?***I.S.H. Imperial Salmon House SUPERIOR SCOTTISH CURE SMOKED SALMON***HICKORY HOUSE***Processed by Hickory Farms Hialeah, IMPERIAL SMOKED SALMON SLICED SIDES***Distributed by Waterside***: c) Product is Golden Eagle Smoked Salmon vacuum packaged in plastic bags weighing 2-4 lbs each. Product is labeled in part: ?HICKORY HOUSE GOLDEN EAGLE SMOKED SALMON SCOTTISH CURE***READY TO SERVE***Processed by Hickory House Hialeah, GOLDEN SMOKED SALMON SLICED SIDES***, Recall # F-597-5
CODE
Batch 21555
RECALLING FIRM/MANUFACTURER
Golden Eagle Smoked Foods, Inc., Hialeah, FL, by telephone beginning on July 15, 2005. Firm initiated recall is ongoing.
REASON
The product is contaminated with Listeria monocytogenes based on the Florida Department of Agriculture and consumer Services? analysis.
VOLUME OF PRODUCT IN COMMERCE
594.81 lbs.
DISTRIBUTION
FL, GA, VA, NY, and CA

_______________________________
PRODUCT
Kenmore 12-cup Stainless Steel Percolators, Model No. KCP12, Made in China, Recall # F-631-5
CODE
All date codes. The date code and model number are imprinted on the bottom of the percolator.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Salton, Inc., Lake Forest, IL, by press release on June 10, 2005 and notice to all stores on June 13, 2005.
Manufacturer: Chiaphua Industries Limited, Shenzen, China. Firm initiated recall is ongoing.
REASON
The percolator may leach lead due to the use of lead solder in the product?s manufacturing.
VOLUME OF PRODUCT IN COMMERCE
99,824 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II

______________________________
PRODUCT
Lakewood Organic Pure Apple Juice in 32-fluid-ounces glass bottles. Product is labeled with a stick-on label with red, black, green, and gold lettering, and labeled in part: ?***Lakewood ORGANIC Pure Apple Juice***PRODUCT OF THE USA***32FL OZ (1QT) 946 mL***? UPC Code 0 42608 45943 9, Recall # F-595-5
CODE
Lot numbers: 121R24ABA, 121S25ABA, 121S26ABA
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida Bottling, Inc., Miami, FL, by e-mail and/or fax beginning on June 15, 2005.
Manufacturer: Valley Processing Inc., Sunnyside, WA. Firm initiated recall is ongoing.
REASON
The product contains elevated patulin.
VOLUME OF PRODUCT IN COMMERCE
2,688 cases
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Kamison Lucky Candy, 14.1 oz. plastic bags. Product ingredients are listed in Chinese. Product label stated YISHA and nutritional label is in English, Recall # F-596-5
CODE
Product is not coded
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gemini Food Corporation Inc., Walnut, CA, by press release on February 24, 2005.
Manufacturer: Dong Guan Hsu-Chi Food Company Limited, Guangdong, China. Firm initiated recall is complete.
REASON
Product contains undeclared peanuts and does not bear an ingredient statement in English.
VOLUME OF PRODUCT IN COMMERCE
200 cases
DISTRIBUTION
NY

_______________________________
PRODUCT
Multi-vitamin & multi-mineral dietary supplement. Distributed under the following labels & labeled in part: 1) CVS? pharmacy xxx SPECTRAVITE USP xxx MULTIVITAMIN/MULTIMINERAL xxx with antioxidant vitamins C, E & beta carotene ** xxx NOW WITH HEART HEALTHY LYCOPENE** xxx 60 TABLETS xxx DIETARY SUPPLEMENT xxx Prod. No. 41771 xxx Product No. 41771, UPC bar code # 0 50428 61854 7, (2) Sundown? xxx ADVANCED SunVite? xxx High in Antioxidants xxx Multi-Vitamin and Multi-Mineral Formula xxx 130 Tablets xxx MULTI SUPPLEMENT xxx, Product No. 44811, UPC bar code # 0 30768 13798 4, Recall # F-626-5
CODE
CVS brand: all lots; Sundown brand: lot numbers 67076-01, 66115-04, 66114-05, 66114-04, 66114-03, 66114-01
RECALLING FIRM/MANUFACTURER
NBTY Inc, Bohemia, NY, by telephone on August 17, 2005 and by letters dated August 22, 2005 and August 23, 2005. Firm initiated recall is ongoing.
REASON
The labeling of the dietary supplements failed to include the required accidental overdose warning statement for iron-containing products.
VOLUME OF PRODUCT IN COMMERCE
CVS SpectraVite: approx. 175,254 - 60 tablet bottles; Sundown SunVite: approx. 19,515 - 130 tablet bottles
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Frozen Farm Raised Basa Fish Fillets, 3-5 oz. which are bulk packed into 15 lb. boxes with production date 19/03/2005, Recall # F-628-5
CODE
Production Date: 19/03/2005
RECALLING FIRM/MANUFACTURER
Recalling Firm: John Seafood (835 Sp), Westwego, LA, by fax on July 27, 20005.
Manufacturer: Vinh Long Aqua Product Processing Factory, Vinh Long, Vietnam. Firm initiated recall is ongoing.
REASON
Product was found by FDA to contain ciprofloxacin and enrofloxacin drug residues.
VOLUME OF PRODUCT IN COMMERCE
300 cases
DISTRIBUTION
AZ, LA, MS, TX

_______________________________
PRODUCT
Kemps Bakery Classics French Silk Pie Ice Cream Half Gallon (1.89L) UPC code 41483 00407. Recall # F-629-5
CODE
All codes affected with UPC 41483 00407
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kemps, LLC, Minneapolis MN, by Press release on June 16, 2005.
Manufacturer: Kemps LLC, Rochester, MN. Firm initiated recall is ongoing.
REASON
The product contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
90,997 retail units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS III

_______________________________
PRODUCT
Brooks brand Dairy Digestive Supplement, Lactase Enzyme, chew or swallow; 3,000 FCC units per caplet in a bottle of 60 caplets; UPC # 8459700255, Recall # F-632-5
CODE
Lot 5EV0221; exp. 05/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Perrigo Company, Allegan, MI, by letter on July 18, 2005.
Manufacturer: JB Laboratories, Inc, Holland, MI. Firm initiated recall is ongoing.
REASON
The bottle label is mislabeled as extra strength, when the product is actually regular strength. The carton is labeled correctly.
VOLUME OF PRODUCT IN COMMERCE
2,160 bottles
DISTRIBUTION
Nationwide

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

_______________________________
PRODUCT
Zomig ZMT (Zolmitritan) 5 mg tablets. The product is sold as a three tablet blister card with one card per carton, Rx only, Recall # D-479-5
CODE
Lot number KN0086 exp 4/30/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: AstraZeneca Pharmaceuticals, LP, Newark, DE, by letter dated August 18, 2005.
Manufacturer: Cima Laboratories, Inc., Eden Prairie, MN. Firm initiated recall is ongoing.
REASON
Short Fill; Complaints of empty blister packs.
VOLUME OF PRODUCT IN COMMERCE
86,544 cartons
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Prednisolone Sodium Phosphate Oral Solution (prednisolone sodium phosphate, USP) * 6.7 mg/5 mL (equivalent to 5 mg prednisolone base) * 5 mL unit dose and 120 mL bottles* non-alcoholic, dye free, sugar free * Rx Only * * NDC 0121-0711-04 * NSN 6505-01-268-3713 *, Recall # D-480-5
CODE
NDC 0121-0711-05, Lot: 4F07, 4J47 & 5B08 (5mL Unit Dose); NDC 0121-0711-04, Lot: 4F06, 4J48 & 5B07 (120 mL bottle); NDC 59196-011-04, Lot: 4H50 (120 mL bottle)
RECALLING FIRM/MANUFACTURER
Pharmaceutical Associates, Inc., Greenville, SC, by letter on August 10, 2005. Firm initiated recall is ongoing.
REASON
Impurity; the product exceeds the specification for impurity.
VOLUME OF PRODUCT IN COMMERCE
46,411 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1991-5
CODE
Unit number: 6933779
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by letter dated February 5, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1992-5
CODE
Unit number: 6981627
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by letter dated March 17, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced, Recall # B-2014-5;
b) Recovered Plasma, Recall # B-2015-5
CODE
a) and b) Unit numbers: 4638263, 4568044
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax and letter on April 5, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for exposure to variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NY, CA, OK, and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced, Recall # B-2079-5;
b) Recovered Plasma, Recall # B-2080-5
CODE
a) and b) Unit numbers: 55L34605, 55V15093
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock, AR, by telephone and letter on July 14, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had previously tested positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AR, CA, and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced, Recall # B-2102-5;
b) Red Blood Cells (Apheresis) Leukocytes Reduced,
Recall # B-2103-5
c) Platelets, Recall # B-2104-5;
d) Fresh Frozen Plasma, Recall # B-2105-5
e) Fresh Frozen Plasma Apheresis, Recall # B-2106-5
CODE
a) Unit numbers: 261153610, 261153639, 261153614,
261153621, 261153694, 261153909, 261153700,
261153917, 261153710, 261153941, 261153952,
261154139, 261154163, 261154141, 261154784,
261154144, 261154788, 261154149, 261154791,
261154156, 261154793, 261154157, 261154794,
261154159, 261154796, 261154799, 261155451,
261155840, 261156132, 261156395, 261156152,
261156160, 261156610, 261156677, 261156613,
261156618, 261156623, 261156806, 261156632,
261156811, 261156636, 261156815, 261156639,
261156817, 261156642, 261156819, 261156646,
261156821, 261156836, 261156897, 261156838,
261156842, 261157041, 261157099, 261157045,
261157112, 261157114, 261157116, 261157133,
261157119, 261157134, 261157180, 261157382,
261157184, 261157384, 261157193, 261157196,
261161094, 261161214, 261161109, 261161116,
261161295, 261161347, 261161329, 261161501,
261161617, 261161504, 261161507, 261161520,
261161737, 261161743, 261161821, 261161756,
261161832, 261161761, 261161835, 261161764,
261161839, 261161774, 261161785, 261161885,
261161947, 261161896, 261161963, 261161898,
261161900, 261162321, 261162918, 261162324,
261162919, 261162327, 261162329, 261164486,
261164581, 261164490, 261164491, 261164492,
261164494, 261164632, 261164657, 261164633,
261164659, 261164635, 261164662, 261164636,
261164665, 261164637, 261164670, 261164639,
261164641, 261164643, 261164697, 261164644,
261164645, 261164646, 261164647, 261164648,
261164649, 261164650, 261164800, 261164818,
261164801, 261164821, 261164802, 261164827,
261164807, 261164829, 261164811, 261164833,
261164812, 261164834, 261164814, 261164839,
261164815, 261164817, 261164904, 261165490,
261164906, 261165494, 261164911, 261165497,
261165501, 261165612, 261165745, 261165616,
261165759, 261165626, 261165762, 261165629,
261165764, 261165634, 261165768, 261165640,
261165771, 261165646, 261165772, 261165654,
261165659, 261165674, 261165679, 261165837,
261165879, 261165842, 261165882, 261165845,
261165884, 261165855, 261165886, 261165856,
261165888, 261165858, 261165892, 261165860,
261165894, 261165864, 261165898, 261165866,
261165868, 261165870, 261165877, 261165878,
261165905, 261167218, 261165908, 261167221,
261165909, 261167232, 261165914, 261165916,
261165917, 261168006, 261165919, 261168011,
261165922, 261168015, 261165923, 261168019,
261165924, 261165926, 261165927, 261168207,
261165928, 261168209, 261168218, 261168219,
261168449, 261168521, 261168457, 261168524,
261168474, 261168533, 261168483, 261168487,
261168491, 261174713, 261174738, 261174801,
261175308, 261175418, 261175850, 261175420,
261175862, 261175423, 261175868, 261175424,
261175426, 261175428, 261175429, 261175431,
261175433, 261175435, 261175438, 261175440,
261175442, 261175445, 261175446, 261175448,
and 261175455;
b) Unit numbers: 261153612, 261164485, 261164624,
261164626 (2 units), 261164631, 261164804 (2 units),
261164908 (2 units), 261164914 (2 units), 261165499,
261165650 (2 units), 261165669 (2 units), 261165671
(2 units), 261165848 (2 units), 261165890 (2 units),
261165904 (2 units), 261165913 (2 units), 261167228,
261168420, and 261168454;
c) Unit numbers: 261168204, 261168207, 261168209,
261168217, 261168218, 261168220, and 261168222;
d) Unit numbers: 261153610, 261153614, 261153621,
261153622, 261153639, 261153641, 261153658,
61153660, 261153664, 261153694, 261153698,
261153700, 261153708, 261153710, 261153909,
261153917, 261153922, 261153925, 261153941,
261153944, 261153952, 261154139, 261154141,
261154144, 261154149, 261154152, 261154156,
261154157, 261154159, 261154163, 261154784,
261154788, 261154791, 261154793, 261154794,
261154796, 261154797, 261154799, 261155451,
261156083, 261156085, 261156087, 261156093,
261156099, 261156121, 261156132, 261156147,
261156152, 261156156, 261156160, 261156172,
261156175, 261156610, 261156395, 261156613,
261156618, 261156623, 261156630, 261156677,
261156632, 261156636, 261156639, 261156680,
261156642, 261156646, 261156806, 261156836,
261156808, 261156838, 261156809, 261156839,
261156811, 261156842, 261156813, 261156845,
261156815, 261156817, 261156890, 261156819,
261156891, 261156821, 261156897, 261156823,
261156898, 261156900, 261156907, 261157027,
261157032, 261157031, 261157040, 261157041,
261157045, 261157099, 261157133, 261157101,
261157134, 261157104, 261157136, 261157112,
261157138, 261157114, 261157140, 261157115,
261157143, 261157116, 261157146, 261157118,
261157119, 261157120, 261157121, 261157180,
261157380, 261157184, 261157382, 261157193,
261157383, 261157196, 261157384, 261161094,
261157994, 261161109, 261161347, 261161116,
261161135, 261161249, 261161214, 261161259,
261161272, 261161295, 261161329, 261161501,
261161617, 261161504, 261161507, 261161511,
261161730, 261161520, 261161737, 261161742,
261161821, 261161743, 261161825, 261161748,
261161831, 261161756, 261161832, 261161761,
261161835, 261161764, 261161839, 261161774,
261161842, 261161785, 261161847, 261161852,
261161854, 261161885, 261161918, 261161890,
261161894, 261161896, 261161947, 261161898,
261161963, 261161900, 261162321, 261162799,
261162324, 261174801, 261162327, 261174814,
261162329, 261162917, 261164486, 261162918,
261162919, 261162920, 261164645, 261162923,
261164646, 261162926, 261164659, 261165674,
261165855, 261165914, 261165868, 261165877,
261168027, 261168217, 261168029, 261174546,
261174591, 261174669, 261174713, 261174714,
261174738, 261175305, 261175308, 261175418,
261175850, 261175420, 261175861, 261175424,
261175862, 261175426, 261175868, 261175428,
261175431, 261175438, 261175939, 261175445,
and 261175946;
e) Unit numbers: 261153612 and 261153644
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on April 14, 2003. Firm initiated recall is complete.
REASON
Blood Products, which were collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
499 units
DISTRIBUTION
TX, AR, AZ, MS, NV, OK, and Switzerland

_______________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-2113-5;
b) Recovered Plasma, Recall # B-2114-5
CODE
a) and b) Unit number: FE53870
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by telephone and electronic mail on July 21, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received insulin of unknown origin for gestational diabetes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL and Switzerland

_______________________________
PRODUCT
Source Plasma, Recall # B-2118-5
CODE
Unit numbers 0016712, 0016918, 0017083, 0017353, 0017574, and 0017759
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Nacogdoches, TX, by facsimile on January 18, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
KY

_______________________________
PRODUCT
Source Plasma, Recall # B-2119-5
CODE
Unit numbers NG0049992, NG0050553, NG0050599, and NG0051159
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Nacogdoches, TX, by telephone and facsimile on December 18, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an donor that was not adequately screening regarding recent tattoos, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
KY

_______________________________
PRODUCT
Human tissue for transplantation of the following types:
a) Femoral Hemi Condyle Lateral Left - FS/A;
b) Femoral Hemi Condyle Lateral Right - FS/A;
c) Talus Right - FS/A;
d) Meniscus Medial Right - FS/A;
e) Cancellous Chips 4-9.5 15cc - FZ/A;
f) Cancellous Chips 4-9.5 30cc - FZ/A;
g) Cancellous Crushed 1-4 15cc - FZ/A;
h) Dowel Without Cartilage 14mm Diameter;
i) Achilles Tendon - FZ/A;
j) Tibialis Tendon Posterior - FZ/A;
k) Tibialis Tendon Anterior - FZ/A;
l) Patellar Ligament Hemi - FZ/A;
m) Tendon Double Bundle Semitendinosus/Gracilis - FZ/I
Recall # B-2120-5
CODE
a) Part 32147002, number 044630-001;
b) Part 32147001, number 044630-003;
c) Part 32647001, number 044630-004;
d) Part 28225001, number 044630-005;
e) Part 27616015, numbers 044630-115 and 044630-117;
f) Part 27616030, numbers 044630-119, 044630-120,
044630-121, 044630-122, 044630-123, 044630-124,
044630-125, and 044630-126;
g) Part 27716015, number 044630-129;
h) Part 14211014, numbers 044630-130, 044630-131,
044630-132, and 044630-133;
i) Part 10016000, numbers 044630-162 and
044630-163;
j) Part 41616000, numbers 044630-164 and
044630-165;
k) Part 41516000, numbers 044630-166, 044630-167;
l) Part 17816000, numbers 044630-168, 044630-169,
044630-170, and 044630-171;
m) Part 44217002, numbers 044630-172 and 044630-173
RECALLING FIRM/MANUFACTURER
AlloSource, Inc., Centennial, CO, by letter on July 28, 2005. Firm initiated recall is ongoing.
REASON
Human tissue for transplantation was incorrectly tested for viral markers in that the blood sample used for testing was hemodiluted.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
MN, CA, CO, IL, MA, MO, NC, and WI

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-2121-5
CODE
Unit numbers: 55P42733, 55P42740, 55P42750, 55P42758, 55P42759, 55P42762, 55P42767, 55P42775, 55P42776, 55P42780, 55P42781, 55P42784, 55P42788, 55P42790, 55P42796, 55P42806, 55P42815, 55P42821, 55P42838, 55P42840, 55P42845, 55P42850, 55P42852, 55P42860, 55P42866, 55P42976, 55P42985, 55P42990, 55P43045, 55P43099, 55P43119, 55P43135, 55P43146, 55P43149, 55P43169, 55P43174, 55P43175, 55P43179, 55P43181, 55P43183, 55P43189, 55P43191, 55P43193, 55P43197, 55P43200, 55P43207, 55P43227, 55P43231, 55P43242, 55P43243, 55P43249, 55P43251, 55P43255, 55P43265, 55P43270, 55P43271, 55P43281, 55P43284, 55P43297, 55P43298, 55P43301, 55P43303, 55P43313, 55P43315, 55P43316, 55P43321, 55P43326, 55P43331, 55P43338, 55P43387, 55P43395, 55P43411, 55P43412, 55P43418, 55P43428, 55P43441, 55P43448, 55P43459, 55P43465, 55P43471, 55P43477, 55P43485, 55P43497, 55P43506, 55P43507, and 55P43514; and the following units were distributed as two split products: units 55P42731, 55P42743, 55P42792, 55P42803, 55P42839, 55P42876, 55P42970, 55P43108, 55P43163, 55P43201, 55P43214, 55P43215, 55P43222, 55P43228, 55P43253, 55P43261, 55P43264, 55P43277, 55P43289, 55P43304, 55P43308, 55P43328, 55P43339, 55P43349, 55P43352, 55P43357, 55P43380, 55P43397, 55P43403, 55P43420, 55P43423, 55P43429, 55P43489, 55P43491, and 55P43499
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Ozarks- Arkansas Region, Little Rock, AR, by telephone and letter on December 23, 2003. Firm initiated recall is complete.
REASON
Blood products, collected during a period when quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
156 units
DISTRIBUTION
AR, and TN

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
Recall # B-2122-5;
b) Platelets Pheresis Leukocytes Reduced,
Recall # B-2123-5;
c) Fresh Frozen Plasma, Recall # B-2124-5
CODE
a), b), and c) Unit 55P43135
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Little Rock, AR, by telephone and by letter dated September 17, 2003. Firm initiated recall is complete.
REASON
Blood products, which, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AR

_______________________________
PRODUCT
Source Plasma, Recall # B-2125-5
CODE
Unit numbers: 04MUSA0982, 04MUSA1123, 04MUSA1241, 05MUSA0408, 05MUSA2732, 05MUSA4642, 07324321, 07325328, 07327414, 07329098, 09880955, 09883086, 09884694, 09886346, 09887794, 09889361, 10010655, 10012512, 10014264, 10016190, 10017746, 10019030, 10020173, 19041940, 19042749, 19044842, 19046068, 19047867, 19049052, 19770741, 19772301, 19890999, 19891910, 19893587, 19896113, 19899596, 19901640, 19904139, 19904931, 19907192, QP034346, QP034424, QP034476, QP034503, QP034515, QP034538, QP034549, QP034568, QP034575, QP034607, QP034655, QP034667, QP034690, QP034717, QP034740, QP034766, QP034779, QP034805, QP034821, QP034842, QP034855, QP034883, QP034908, QP034928, QP034956, QP034995, QP035014, QP035036, and QP043804 [69 units]
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Muskegon, MI, by facsimile on May 18, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had engaged in high risk behavior activities, were distributed.
VOLUME OF PRODUCT IN COMMERCE
69 units
DISTRIBUTION
CA and Germany

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2126-5
CODE
Unit numbers: 6597209, 6593686, and 6590896
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on December 12, 2004. 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
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2127-5
CODE
Unit number: 6590986
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on October 7, 2004. 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
FL

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-2128-5
CODE
Unit number: 4276718
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on April 14, 2005. Firm initiated recall is complete.
REASON
Blood product, which was labeled as irradiated with no documentation that the irradiation process was adequate, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

_______________________________
PRODUCT
Cornea, Recall # B-2129-5
CODE
Unit number: IN200410111
RECALLING FIRM/MANUFACTURER
Indiana Lions Eye and Tissue Transplant Bank, Indianapolis, IN, by telephone on June 17, 2005 and by letter dated July 4, 2005. Firm initiated recall is complete.
REASON
Human tissue, which was collected from a donor who had discordant test results for hepatitis B surface antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________________
PRODUCT
Source Plasma, Recall # B-1972-5
CODE
Unit number: VP182095
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by fax on September 15, 2003. 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
Austria

_______________________________
PRODUCT
Source Plasma, Recall # B-1973-5
CODE
Unit number: VP182166
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by fax on September 3, 2003. 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
Austria

_______________________________
PRODUCT
Recovered Plasma, Recall # B-2107-5
CODE
Unit numbers: 261156896, 261156973, 261157106, 261157108, 261157117, 261157128, 261157130, 261157187, 261157396, 261157397, 261157339, 261157462, 261157466, 261157469, 261157475, 261157479, 261157986, 261157998, 261161210, 261161381, 261161384, 261161444, 261161458, 261161462, 261161466, 261161471, 261161476, 261161484, 261161601, 261161628, 261161629, 261161633, 261161634, 261161642, 261161651, 261161684, 261161687, 261161691, 261161726, 261161731, 261161853, 261161875, 261161879, 261161881, 261161906, 261161910, 261161915, 261161970, 261161974, 261164650, 261164800, 261165616, 261165634, 261165640, 261165645, 261165762, 261165888, 261165892, 261165898, 261165908, 261165922, 261174589, 261174642, 261174651, 261174656, 261174657, 261174658, 261174663, 261174675, 261174680, 261174682, 261174698, 261175429, 261175433, 261175911, 261161302, 261161434, 261161533, 261161769, 261162392, 261165879, 261155882, 261165884, 261165886, 261175455, and 261175915
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on April 14, 2003. Firm initiated recall is complete.
REASON
Blood Products, which were collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
86 units
DISTRIBUTION
TX, AR, AZ, MS, NV, OK, and Switzerland

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2112-5
CODE
Unit numbers: 40LE18972 and 40LE18984
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of American Region, Peoria, IL, by telephone on June 20, 2005, and by letter on June 27, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from donors in which Copper Sulfate QC was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

_______________________________
PRODUCT
a) Bac T/ALERT' 3D Control Module, Recall # Z-0612-05;
b) Bac T/ALERT' 3D Combination Module,
Recall # Z-0613-05;
c) Bac T/ALERT' 3D 60, Recall # Z-0614-05;
CODE
All Models
RECALLING FIRM/MANUFACTURER
Biomerieux, Inc, Durham, NC, by letter on May 27, 2005. Firm initiated recall is ongoing.
REASON
A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric Bac T/ALERT PF bottle.
VOLUME OF PRODUCT IN COMMERCE
2,745 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) Biomet Vanguard microplasty slidex femoral
4-in-1 block, 57.5 mm, stainless steel;
Ref. 32-485101, Recall # Z-1445-05;
b) Biomet Vanguard microplasty slidex femoral
4-in-1 block, 60 mm, stainless steel;
Ref. 32-485102, Recall # Z-1446-05;
c) Biomet Vanguard microplasty slidex femoral
4-in-1 block, 62.5 mm, stainless steel;
Ref. 32-485103, Recall # Z-1447-05;
d) Biomet Vanguard microplasty slidex femoral
4-in-1 block, 80 mm, stainless steel;
Ref. 32-485108, Recall # Z-1448-05;
e) Biomet Ascent SI knee instruments sliding femoral
4-in-1 block, x-small, stainless steel;
Ref. RD140629, Recall # Z-1449-05;
f) Biomet Ascent SI knee instruments sliding femoral
4-in-1 block, small, stainless steel;
Ref. RD140630, Recall # Z-1450-05;
g) Biomet Ascent SI knee instruments sliding femoral
4-in-1 block, medium, stainless steel;
Ref. RD140631, Recall # Z-1451-05;
h) Biomet Ascent SI knee instruments sliding femoral
4-in-1 block, large, stainless steel; Ref. RD140632,
Recall # Z-1452-05;
i) Biomet Ascent SI knee instruments sliding femoral
4-in-1 block, x-large, stainless steel;
Ref. RD140633, Recall # Z- 1453-05;
j) Biomet Maxim SI knee instruments sliding femoral
4-in-1 block 55 mm, stainless steel; Ref. RD140529,
Recall # Z-1454-05;
k) Biomet Maxim SI knee instruments sliding femoral
4-in-1 block, 60 mm, stainless steel;
Ref. RD140530, Recall # Z-1455-05
CODE
a) Lots 193410, 244080, 341450, 335660, 775440,
775480, 624750 and 987550;
b) Lots 800030, 107960, 150150, 244090, 341470,
340460, 110160, 089070, 150560, 246460, 246470,
281680, 128100, 281670, 281690, 289650, 299480,
302850, 480060, 480070, 480080, 333930, 490710,
490720, 521300, 571400, 208950, 059810, 208940,
471980, 667580, 649910, 822020, 851780, 939010,
952030, 710250, 783350, 858300 and 104360;
c) Lots 834410, 199180, 200390, 341490, 341480,
351390, 302860, 302870, 302880, 302890, 302900,
302910, 353490, 480090, 480120, 480100, 490730,
480110, 353970, 353980, 490740, 333940, 383660,
477620, 521410, 571420, 059820, 667590, 667600,
208960, 471990, 851770, 886160, 897780, 561320,
710300, 783390 and 973480;
d) Lots 244100, 351430, 521170, 521090, 521160
and 911330;
e) Lots 147360, 201140, 310920, 238700, 238710,
397060, 467290, 481540, 523300, 607880, 024490,
560790 and 761870;
f) Lots 074170, 117920, 117580, 170730, 191880,
232930, 439220, 409710, 441190, 468560, 523310,
608390, 602560, 024500, 278400 and 840090;
g) Lots 061800, 300150, 191900, 192030, 542470,
439240, 443030, 481530, 608400, 024540, 278410
and 761860;
h) Lots 061810, 217860, 170830, 195550, 467300,
481550, 450420, 602570, 608410, 576640, 024590,
388080 and 840080;
i) Lots 117650, 170870, 229660, 238680, 467310,
491720, 608420, 542570, 491721, 024600, 351170
and 561190;
j) Lots 140370, 007450, 165140, 104620 and 458200;
k) Lots 692030, 847270, 893240, 991260, 103470,
103440, 136560, 271330, 170710, 356500, 399630,
399640, 564090, 712190, 744790, 757850, 770410,
994540 and 863650
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated May 16, 2005. Firm initiated recall is complete.
REASON
The instrument may have been assembled improperly, which may result in reversed resection cuts on the femur and affect implant performance, resulting in the need for revision surgery.
VOLUME OF PRODUCT IN COMMERCE
1,993 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400, catalog number 26-240, Recall # Z-1456-05
CODE
Lots 7575613, 7583594, 7715339 and 7730068
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Spencer, IN, by letter dated July 25, 2005. Firm initiated recall is ongoing.
REASON
The distal tip may dislodge from the device during use and the firm has received complaints of electrical errors.
VOLUME OF PRODUCT IN COMMERCE
115 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Pioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP, Recall # Z-1457-05
CODE
Lots 306456, 306457, 306613, 306712, 306713, 306714, 306816, 306817, 306818, 306819, 306820, 306821, 306822, 307526, 307527, 307528, 307667, 307668, 308510, 308938, 310662, 310663, 310664, 310665, 311718, 312169, 519935 and 521042
RECALLING FIRM/MANUFACTURER
Pioneer Surgical Technology, Marquette, MI, by letter dated July 29, 2005. Firm initiated recall is ongoing.
REASON
The product has a higher than normal locking torque, which may cause the saddle to malfunction or to break intraoperatively.
VOLUME OF PRODUCT IN COMMERCE
5,069 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box, Recall # Z-1458-05
CODE
Lot #5140549, Exp 8/17/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton-Dickinson & Co., Sparks, MD, by fax, e-mail, and letters on July 28, 2005.
Manufacturer: Becton-Dickinson Diagnostics, Madison, WI. Firm initiated recall is ongoing.
REASON
Microbiological media for antibiotic susceptibility testing gives false test results.
VOLUME OF PRODUCT IN COMMERCE
20,930 agar plates
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
VITROS Chemistry GENT Reagent REF 680 1711, *** Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Recall # Z-1460-05
CODE
01-5846, Exp. 31 May 2006; 01-6036 Exp 31 October 2006; 01-6239 Exp 31 January 2007
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letters dated July 19, 2005. Firm initiated recall is ongoing.
REASON
Negatively biased results can be observed when the reagent pack has less than 12 tests remaining and has been on the analyzer greater than 24 hours.
VOLUME OF PRODUCT IN COMMERCE
443 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) Magnetom Avanto. Magnetic Resonance Imaging
System. Model number 7391167, Recall # 1528-05;
b) Magnetom Espree. Magnetic Resonance Imaging System.
Model number 10018165, Recall # Z-1529-05
CODE
a) Serial numbers 25007 to 25557;
b) Serial numbers 30001 to 30075
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on August 12, 2005.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
There is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore. As a result, there may be gaps between the patient table and the magnet cover. If this occurs, there is an increased risk that fingers or other body parts may become caught in the gap when moving the patient table.
VOLUME OF PRODUCT IN COMMERCE
209 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac), Recall # Z-1530-05
CODE
Affected Serial Numbers: H140001, H140002, H140003, H140004, H140005, H140006, H140007, H140009, H140022, H140010, H14001, H140012, H140013, H140014, H140015, H140016, H140017, H140018, H140019, H140021, H140023, H140024, H140025
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc., Palo Alto, CA, by letters on March 16, 2005. Firm initiated recall is complete.
REASON
Emergency Off Switch located on the device may not function correctly resulting in the device remaining powered on after the switch is activated.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Nationwide, Denmark, Hong Kong, and Japan

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

_______________________________
PRODUCT
TM-300 Traction System; an Rx software driven device used for patient traction, Product No. A501-009, Recall # Z-1444-05
CODE
Serial numbers 1000 through 1207
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sammons Preston Rolyan, Bolingbrook, IL, by letters dated July 13, 2005.
Manufacturer: ITO Co., Ltd, Inashiki-gun, Japan. Firm initiated recall is ongoing.
REASON
The traction device may malfunction, producing oscillation and a jerking motion.
VOLUME OF PRODUCT IN COMMERCE
208 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
E-Z-EM brand, Basic biopsy tray, catalog no. 4125. Recall # Z-1523-05
CODE
Lot number 0324 on the package. The correct lot number is 0424.
RECALLING FIRM/MANUFACTURER
North Coast Medi-Tek, Inc., Mentor, OH, by telephone on June 23, 2004. Firm initiated recall is ongoing.
REASON
Product contains the incorrect lot number.
VOLUME OF PRODUCT IN COMMERCE
350 devices
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

______________________________
PRODUCT
Triple Play Blocks with Rumensin, medicated feed blocks for beef animals, sheep and goats, Recall # V-106-5
CODE
No product labeling or lot coding
RECALLING FIRM/MANUFACTURER
A-C Feed Ltd, Winters, TX, by telephone and by letter beginning June 2, 2005. Firm initiated recall is complete.
REASON
Distribution of a medicated free choice feed block for which there is no New Animal Drug Application on file.
VOLUME OF PRODUCT IN COMMERCE
70.41 tons of Triple Play Blocks and 704.1 pounds of Rumensin 80
DISTRIBUTION
TX

______________________________
PRODUCT
a) Procaine Penicillin - 10, Type B Medicated Feed,
containing penicillin (from 10 g/lb. procaine
penicillin), 6.0 g/lb., packaged in 50-lb. bags.
Recall # V-107-5;
b) Deccox 10X, Type B Medicated Feed, containing
decoquinate, 2,271 mg/lb., packaged in 10-lb.
and 50-lb. bags. Recall # V-108-5
CODE
a) All product that is not labeled with the warning;
b) All product that does not include sheep (as well as
cows and goats) producing milk for food in the
warning statement
RECALLING FIRM/MANUFACTURER
International Nutrition, Inc., Omaha, NB, by telephone on August 3, 2005 and by fax on August 4, 2005. Firm initiated recall is ongoing.
REASON
a) Labels lacked required warning to not feed to
chickens or turkeys producing eggs for human consumption;
b) Labels lacked required warning to not feed to sheep
producing milk for food. Cows and goats were properly
listed on the label.
VOLUME OF PRODUCT IN COMMERCE
111/50-lb. bags Procaine Penicillin -- 10;
19887/50-lb. bags and 3,710/10-lb.s Deccox 10X
DISTRIBUTION
KS, NE, MN, IA, CO, MO, and AZ

END OF ENFORCEMENT REPORT FOR SEPTEMBER 14, 2005

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