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U.S. Department of Health and Human Services

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Enforcement Report for December 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.

December 14, 2005
05-50

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

______________________________
PRODUCT
Diet Coke * Sweetened with Splenda, 12/12oz can PACK. Each can labeled Diet Coke with Lemon 12oz (355 ml). Recall # F-035-6
CODE
MAR0606 RX E
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Coca-Cola Company (Corporate Offices), Atlanta, GA, by visit and letter on/about October 19, 2005.
Manufacturer: Coca Cola Bottling Co of Chicago, Alsip, IL. Firm initiated recall is complete.
REASON
Cans labeled as Diet Coke with Lemon actually contained Diet Coke with Splenda (undeclared sucralose).
VOLUME OF PRODUCT IN COMMERCE
283 cases/12 cans per case
DISTRIBUTION
IL and IN

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
Zoloft (Sertraline HCl) 60 mL, oral concentrate, 20mg/mL, Rx only, NDC 0049-4940-23, Recall # D-042-6
CODE
Lot numbers 0105082, 0105083 and 0105084 NDC 0049-4940-23
RECALLING FIRM/MANUFACTURER
U.S. Pharmaceuticals Group, New York, NY, by letter on October 14, 2005. Manufacturer: Pfizer Inc., Parsippany, NJ. Firm initiated recall is ongoing.
REASON
Presence of particulate matter: there is a potential that a small number of pouches containing the glass droppers used to dispense the medication may contain small fragments of glass.
VOLUME OF PRODUCT IN COMMERCE
Lot 0105082 - 10,824 units; Lot 0105083 - 13,583 units; 0105084- 1,835 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
GenTeal GelDrops Lubricant Eye Drops, Sterile 15 mL and 25 mL vials, OTC, NDC 0078-0425-24 and 0078-0425-16. Recall# D-044-6
CODE
Lot 51139, exp. JUL 07; Lot 51283, exp. JUL 07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Pharmaceuticals Corporation, East Hanover, NJ, by letter on November 2, 2005 and by press release November 16, 2005.
Manufacturer: Ciba Vision Sterile Pharmaceuticals, Mississauga, Ontario, Canada. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility
VOLUME OF PRODUCT IN COMMERCE
11832
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

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PRODUCT
Equate brand Ibuprofen Liquid Softgels, 200 mg, 180 Liquid Filled Capsules, Pain Reliever/Fever Reducer, over-the-counter, Recall # D-043-6
CODE
4NB0562, 4PB0418, 4PB0618, 5CA0271, 5CA0390, 5BA0360, 5BA0631, 5CA0225, 5CA0227, 5CA0229, 5CA0230, 5CA0231, 5CA0232, 5CA0233, 5CB0273, 5CB0274, 5CB0275, 5DA0571, 5DA0951, 5DA0952, 5DA0954, 5DA0960, 5DB0251, 5DB0252, 4NB0563, 5AB0386, 5BB0786, 5CB0281, 5DB0537, 4NB0565, 5AB0083, 5BB0785, 5CB0830, 5DB0256, 4NB0558, 5BB0475, 5BB0787, 5CB0823, 5DB0255, 5EB0673, 4NB0564, 4PB0312, 4PB0624, 5AB0603, 5BB0784, 5EB0672, 4NB0539, 4NB0538, 4MB0711, 4MB0712, 4MB0713, 4NB0945, 4NB1049, 4PB0300, 5AB0602, 5BB0019, 5BB0470, 5CB0552, 5CB0827, 5BD0004, 5DB0538, 5EB0058, 5EB0258, 5EB0671, 5FB0097, 5FB0405, 5FB0949, 5GB0292, 4NB0943, 5AB0079, 5AB0217, 5AB0498, 5AB0586, 5BB0021, 5CB0283, 5CB0553, 5CB0825, 5DB0005, 5DB0259, 5EB0257, 5EB0370, 5EB0668, 5FB0095, 5FB0403, 5GB0109, 4NB0944, 5AB0080, 5AB0594, 5BB0020, 5CB0826, 5DB0006, 5DB0539, 5EB0291, 5EB0667, 5FB0202, 5FB0726, 5FB0948, 5GB0108, 4PB0309, 5EB0368, 5FB0204, 5GB0285, 4PB0313, 5EB0057, 4NB0567, 4PB0303, 5AB0356, 5DB0535, 5EB0051, 5EB0365, 5EB0663, 5FB0098, 4NB0561, 4PB0307, 5DB0254, 5DB0533, 5EB0053, 4NB0566, 4PB0305, 5EB0289, 4NB0340, 5AB0084, 4MB0660, 4MB0661, 4MB0662, 4MB0657, 4MB0658, 4MB0659, 4NB0261, 4NB0341, 4NB1045, 5AB0081, 5AB0599, 4NB0261, 4NB0262, 4NB0263, 4NB0264, 4PB0311, 5BB0476, 5BB0791, 5CB0282, 5EB0669, 4NB0338, 4PB0302, 5EB0366, 5FB0407, 4NB0559, 5EB0055, 5EB0675, 5GB0688, 4NB0560, 4NB0339, 5AB0355, 5CB0278, 5CB0829, 5EB0670, 4MB0669, 4MB0670, 4BP0621, 5BB0789, 5CB0824, 5EB0290, 4NB0164, 4PB0304, 4PB0619, 5BB0471, 5CB0280, 5DB0257, 5BD0536, 5EB0052, 5EB0367, 5FB0727, 4MB0663, 4MB0664, 4NB0555, 4PB0622, 5BB0473, 5BB0788, 5CB0822, 5DB0253, 5DB0534, 5EB0054, 5CB0754, 5DB0292, 5DB0590, 5EB0020, 5EB0498, 4NB0336, 4PB0301, 5AB0082, 5BB0472, 5BD0258, 5EB0666, 5FB0096, 5FB0725, 4MB0556, 4PB0310, 5AB0357, 5BB0474, 5GB0474, 5GB0284, 4NB0337, 5CB0279, 4NB0335, 4PB0623, 5FB0099, 5FB0728
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leiner Health Products Llc, Carson, CA, by letter on September 9, 2005.
Manufacturer: Banner Pharmacaps Inc, High Point, NC. Firm initiated recall is ongoing.
REASON
Subpotent; clumping and leaking softgels
VOLUME OF PRODUCT IN COMMERCE
2,502,692 bottles
DISTRIBUTION
Nationwide

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PRODUCT
Altace, Ramipril Capsules, 2.5mg, unit dose pack (10s), Rx only, NDA 19-901, NDC 61570-111-56, Recall # D-045-6
CODE
Lot Number: 1068711
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals Inc, Bristol, TN, by letter on August 25, 2005.
Manufacturer: Aventis Pharmaceuticals, Inc., Kansas City, MO. Firm initiated recall is ongoing.
REASON
Expiry date not clearly printed.
VOLUME OF PRODUCT IN COMMERCE
12,179 units (cartons)
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Tylenol Arthritis Extended Relief Caplets 100 count bottle, Acetaminophen 650 mg per caplet, McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil-PPC, INC, Fort Washington, PA 19034, NDC 50580-112-10, Recall # D-046-6
CODE
Lot number JHM048 exp 2/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer & Specialty Pharmaceuticals, Division of McN, Fort Washington, PA, by letter dated September 19, 2005.
Manufacturer: McNeil Consumer and Specialty Pharmaceuticals, Las Piedras, PR. Firm initiated recall is ongoing.
REASON
Product intended for destruction due to bulk containers being torn was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0224-6;
b) Recovered Plasma, Recall # B-0225-6
CODE
a) and b) Unit number: 0813720
RECALLING FIRM/MANUFACTURER
The Blood Connection Inc., Greenville, SC, by letter and fax on July 6, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
SC and NY

_______________________________
PRODUCT
Red Blood Cells Leukocyte Reduced, Recall # B-0280-6
CODE
Unit numbers: 7092981, 6663118, 7074486
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on January 19, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO and FL

_______________________________
PRODUCT
Red Blood Cells Leukocyte Reduced, Recall # B-0281-6
CODE
Unit number: 6661058
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on January 17, 2005. 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
CO

_______________________________
PRODUCT
Red Blood Cells Leukocyte Reduced, Recall # B-0282-6
CODE
Unit: 6895488
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on January 19, 2005. 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
CO

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PRODUCT
Red Blood Cells, Recall # B-0283-6
CODE
Unit number: 7034166
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on April 7, 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
CO

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PRODUCT
Red Blood Cells Leukocyte Reduced Irradiated, Recall # B-0284-6
CODE
Unit number: 04GF50973
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on August 16, 2005 and follow-up letter on August 17, 2005. 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
MA

_______________________________
PRODUCT
Red Blood Cells Leukocyte Reduced, Recall # B-0285-6
CODE
Unit number: 6594225
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on January 19, 2005. 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
CO

_______________________________
PRODUCT
a) Red Blood Cells Leukocyte Reduced, Recall # B-0286-6;
b) Red Blood Cells, Recall # B-0587-6
CODE
a) Unit numbers: 6862387, 6865369, 6869764, 6872875;
b) Unit number: 6867651
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on April 12, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CO

_______________________________
PRODUCT
a) Red Blood Cells Leukocyte Reduced,
Recall # B-0288-6
b) Red Blood Cells, Recall # B-0289-6
CODE
a) Unit number: 7032156;
b) Unit number: 7044038
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on December 10, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO and AL

_______________________________
PRODUCT
a) Red Blood Cells Leukocyte Reduced,
Recall # B-0290-6;
b) Red Blood Cells, Recall # B-0291-6
CODE
a) Unit number: 7032157;
b) Unit number: 7044039
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on December 10, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO and AL

_______________________________
PRODUCT
a) Red Blood Cells Leukocyte Reduced, Recall # B-0292-6;
b) Red Blood Cells, Recall # B-0293-6
CODE
a) Unit number: 7062085;
b) Unit numbers: 6658302, 6636830
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on December 21, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO, NY, and TN

_______________________________
PRODUCT
Red Blood Cells Leukocyte Reduced, Recall # B-0294-6
CODE
Unit numbers: 6846967, 6846191
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on January 10, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO and IL

_______________________________
PRODUCT
Source Plasma, Recall # B-0306-6
CODE
Unit numbers: 0150041326, 0150041575, 0150041732, 0150042118, 0150042398, 0150042744, 0150043012, 0150043423, 0150043668, 0150043844, 0150044270, 0150045611, 0150045927, 0150046339, 0150055312, 0150055774, 0150056136, 0150056431, 0150056819, 0150057193, 0150057570, 0150057826, 0150058218, 0150058842, 0150059062, 0150059470, 0150059779, 0150060256, 0150060613, 0150060909, 0150061229, 0150061470, 0150066356, 0150066522, 0150066892, 0150067499 0150067589
RECALLING FIRM/MANUFACTURER
Biomat USA Inc., Kalamazoo, MI, by fax on or about December 3, 2004. Firm initiated recall is complete
REASON
Blood products, collected from a donor who had previously been deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
37 units
DISTRIBUTION
Spain

_______________________________
PRODUCT
Red Blood Cells Leukocyte Reduced Irradiated, Recall # B-0310-6
CODE
Unit number: 04LE59368
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by fax on August 16, 2005 and follow-up letter on August 17, 2005. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit that of plasma that exhibited hemolysis was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0189-6
CODE
Unit number: 12468-5217
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by letter dated October 3, 2001.
Manufacturer: Blood Systems Inc., Albuquerque, NM. Firm initiated recall is complete.
REASON
Blood product, which was mislabeled as Jka negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NM

_______________________________
PRODUCT
Platelets Pheresis Leukoreduced, Recall # B-0247-6
CODE
Unit number: X20095
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by phone on December 1, 2004 and follow-up letter on December 17, 2004. Firm initiated recall is complete
REASON
Blood product, possible contaminated with Bacillus species, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0309-6
CODE
Unit numbers: 18227-5941, 18227-5942, 18227-5943
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Cheyenne, WY, by letter dated January 31, 2002. Firm initiated recall is complete.
REASON
Blood products, lacking assurance of acceptable temperatures during shipping, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

_______________________________
PRODUCT
Product labeled in part: "**Banicide ADVANCED, A Reusable Sterilizing & Disinfecting Solution***Active Ingredient: Glutaraldehyde (1,5 Pentanedial) 3.5%***NET CONTENTS: 3.8l (ONE U.S. GALLON)*** Recall # Z-1588-05
CODE
The following 3 codes were recalled initially: (LOT EXP 110305, LOT EXP 110605, LOT EXP 110705) On October 3, 2005 the firm expanded the recall to include all product produced between October 2004 through August 2005. Following are all the recalled lot codes. 100105, 100205, 100305, 100405, 100505, 100605, 110105, 110205, 110305, 110405, 110505, 110605, 110705, 120105, 120205, 120305, 010106, 010206, 010306, 010406, 010506, 020106, 020206, 020306, 020406, 020506, 020606, 020706, 020806, 030106, 030206, 030306, 030406, 030506, 030606, 030706, 030806, 030906, 031006, 031106, 040106, 040206, 040306, 050106, 050206, 050306, 050406, 060106, 060206, 060306, 060406, 060506, 070106, 070206, 070306, 070406, 080106
RECALLING FIRM/MANUFACTURER
Pascal Company, Inc., Bellevue, WA, by telephone on August 10, 2005 and October 3, 2005 and by letters on August 12, 2005 and October 6, 2005. Firm initiated recall is ongoing.
REASON
The product, Banicide Advanced, a reusable sterilizing and disinfecting solution, is likely to be ineffective for its intended use because testing found it failed testing for sporicidal use.
VOLUME OF PRODUCT IN COMMERCE
89,992 units (each unit is one gallon)
DISTRIBUTION
Nationwide and Israel

_______________________________
PRODUCT
Custom heart lung perfusion packs, Recall # Z-0265-06
CODE
210 unique catalog numbers with 779 unique lot numbers
RECALLING FIRM/MANUFACTURER
Cobe Cardiovascular, Inc, Arvada, CO, by letter on October 6, 2005. Firm initiated recall is ongoing.
REASON
One way valve in the heart lung pack assembly may be missing.
VOLUME OF PRODUCT IN COMMERCE
21,512 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Symphony DR model 2550 and ELA Rhapsody DR model 2510.
A dual chamber rate-responsive pacemaker that uses both
minute ventilation and accelerometer sensors.
Sterilization with Ethylene Oxide Gas. Sorin Group,
ELA medical, 98, rue Maurice Amoux, 92120 Montrouge --
France. Made in France. Recall # Z-0266-06;
b) ELA Rhapsody SR model 2210. A single chamber
rate-responsive pacemaker that uses both minute
ventilation and accelerometer sensors. Sterilization
with Ethylene Oxide Gas. Sorin Group, ELA medical, 98,
rue Maurice Amoux, 92120 Montrouge - France. Made in
France. Recall # Z-0267-06
CODE
a) Symphony DR 2250 serial numbers: 238WG020, 243WG055,
246WG094, 246WG109, 250WG029, 303WG027, 303WG038, 303WG074,
303WG078, 306WG073, 309WG262, 314WG057, 315WG188 and
320WG220. Rhapsody DR 2510 Serial numbers: 318WJ010,
318WJ060 and 318WJ061;
b) Rhapsody SR 2210 Serial numbers: 244WE078, 249WE059,
309WE066, 309WE145, 316WE215, 316WE233 AND 321WE080
RECALLING FIRM/MANUFACTURER
Recalling Firm: ela Medical Llc, Plymouth, MN, by letter dated October 25, 2005.
Manufacturer: ELA Medical, S.A.S., Montrouge, France. Firm initiated recall is ongoing.
REASON
Through post-market surveillance, ELA Medical has observed that a no-output condition could occur in a limited number of Symphony or rhapsody pacemakers. The no-output condition could occur due to metal migration caused by a specific manufacturing process.
VOLUME OF PRODUCT IN COMMERCE
28
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Bard UroForceT Balloon Dilation Catheter with GlissandoT Coating * BARD * Sterile/EO, Recall # Z-0268-06
CODE
Catalog #887504, Lot #GFPG2394; Catalog #887510, Lot #GFPG2399; Catalog #887604, GFPG2401, GFPG2402, GFPG2403, GFPG2404, GFPG2405, GFPG2424; Catalog #887610, Lot #GFPF3439, GFPG2406; Catalog #888404, Lot #GFPG2409, Catalog #888604, Lot #GFPG2411, GFPH1415; Catalog #888510, Lot #GFPG2415, GFPH2024; Catalog #888604, Lot #GFPG2417, GFPG2418; Catalog #888610, Lot #GFPF3451
RECALLING FIRM/MANUFACTURER
C.R. Bard, Urological Division, Covington, GA, by letter on November 7/8, 2005. Firm initiated recall is ongoing.
REASON
There is a potential for the lumen to collapse and prevent passage over a guidewire.
VOLUME OF PRODUCT IN COMMERCE
480 units
DISTRIBUTION
Nationwide, Belgium, Canada

_______________________________
PRODUCT
Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, List Numbers: 99226-01, 08H17-01,(on box), 99226-01, 08H17-02 (on bottle); Recall # Z-0269-06
CODE
(List Number On the Box---List Number On the bottle---Lot Number): 99226-01---99229-01---15632I2; 08H17-01---08H17-02---15631I2; 08H17-01---08H17-02---15661I2; 08H17-01---08H17-02---16823I2; 08H17-01---08H17-02---17906I2; 08H17-01---08H17-02---17907I2; 08H17-01---08H17-02---18089I2; 08H17-01---08H17-02---19184I2; 08H17-01---08H17-02---19296I2; 08H17-01---08H17-02---20413I2; 08H17-01---08H17-02---21540I2; 08H17-01---08H17-02---22739I2; 08H17-01---08H17-02---23889I2
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letters on September 20, 2005. Firm initiated recall is ongoing.
REASON
The product failed 12-month stability testing that can lead to falsely reduced hemoglobin (Hgb) test results.
VOLUME OF PRODUCT IN COMMERCE
50,437 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
LifeScan OneTouch SureSoft Lancing Device, single use lancing device. Recall # Z-0271-06
CODE
Part Number 021-139-01 OT SureSoft Hospital, Regular 200, Lot numbers, SW2764, SW3427, SW2779, SW2785, SW3339, SW3342, SW3394, SW3395. Part number 021-140-01, OT SureSoft Hospital, Gentle 200, Lot numbers, SW2846, SW2833, SW2774, SW2868, SW2834, SW2765, SW2869, SW2894, SW2896.
RECALLING FIRM/MANUFACTURER
Lifescan Inc, Milpitas, CA, by letters on October 11, 2005. Firm initiated recall is ongoing.
REASON
In some cases, the needles in the single use lancing device may not retract, causing a potential for needle sticks.
VOLUME OF PRODUCT IN COMMERCE
1,301 boxes
DISTRIBUTION
Nationwide and Canada

_______________________________
PRODUCT
KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system. The major components are: operator console; digital imaging capture device; tilting table with floating top; ceiling-mounted x-ray tube; x-ray generator timing and distribution unit. Recall # Z-0274-06
CODE
s/n DR71000121 and DR71000123.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eastman Kodak Co, Rochester, NY, by letters dated October 20, 2005.
Manufacturer: Analogic Corporation, Peabody, MA. Firm initiated recall is complete.
REASON
Potential weld defect in the Overhead Tube Support assembly which connects the tube assembly to the telescoping arm. This could cause the tube assembly to fall, injuring anyone near the unit.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL, KY, MI, NY, OH, PA, and SC and China

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

_______________________________
PRODUCT
Fusion OMNI- GT * DOME TIP: ERCP Catheter: 6.0 FR./200 CM. 8 Minimum Accessory Channel: 4.2 MM * Disposable - Single Use Only * Compatible Wire Guide: .035" * Rx Only, Recall # Z-0270-06
CODE
Lot number: W2073307, W2073308, W2074626, W2074627, W2074628, W2074629, W2074630, W2075126, W2075127, W2075128, W2075129, W2075130, W2076301, W2076302, W2076303, W2076304, W2076305, W2076306, W2076843, W2076844, W2076845, W2076846, W2076847, W2076848, W2076849, W2076850, W2076851, W2076852, W2076853, W2076854, W2076855, W2076856, W2076857, W2101351, W2103706, W2104274, W2104275, W2108267, W2108774, W2109312, W2109313, W2111333, W2114602, W2114603, W2116350, W2118471, W2121588, W2121589, W2122051, W2122052, W2122053, W2124537, W2125592, W2125593, W2125594, W2125595, W2129956, W2125597, W2129958
RECALLING FIRM/MANUFACTURER
Wilson-Cook Medical Inc, Winston Salem, NC, by letter on/about November 4, 2005. Firm initiated recall is ongoing.
REASON
Misbranded; The catheter size listed on the product label is 6 French, which is inaccurate. The catheter size is 7 French.
VOLUME OF PRODUCT IN COMMERCE
1045 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter, Recall # Z-0272-06
CODE
Listing Number B026094, Code 90273 Kaban, all demo kits shipped between 04/08/2005 and 08/23/2005
RECALLING FIRM/MANUFACTURER
Lifescan Inc, Milpitas, CA, by letter dated October 10, 2005. Firm initiated recall is ongoing.
REASON
Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters.
VOLUME OF PRODUCT IN COMMERCE
2843 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
LifeScan brand OneTouch Ultra Test strips, 25 strips per vial, part number 020-245-07, Recall # Z-0273-06
CODE
Lot number 2591755
RECALLING FIRM/MANUFACTURER
Lifescan Inc, Milpitas, CA, by letter on October 19, 2005. Firm initiated recall is ongoing.
REASON
Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips.
VOLUME OF PRODUCT IN COMMERCE
5799 vials
DISTRIBUTION
NY, KY, MO, AL, TN, LA and IL

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

_______________________________
PRODUCT
Dairy Cattle Rumensin Premix 10000, Medicated Type B Premix, net wt 50 lbs., Recall # V-013-6
CODE
4287592997
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tennessee Farmers Cooperative, La Vergne, TN, by telephone on November 16, 2005.
Manufacturer: Tennessee Farmers Cooperative, Rockford, TN. Firm initiated recall is ongoing.
REASON
Dairy cattle feed premix was below specification for monensin.
VOLUME OF PRODUCT IN COMMERCE
107/50# bags
DISTRIBUTION
TN

_______________________________
PRODUCT
Co-op Chick Starter/Grower, Medicated, Recall # V-014-6
CODE
Lot numbers 43045104 and 43055104
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tennessee Farmers Cooperative, La Vergne, TN, by telephone on November 18, 2005.
Manufacturer: Tennessee Farmers Cooperative, Rockford, TN. Firm initiated recall is ongoing.
REASON
Amount of Amprolium is below specification in chicken feed.
VOLUME OF PRODUCT IN COMMERCE
420/50# bags
DISTRIBUTION
TN

______________________________
PRODUCT
Co-op 16% Pelleted Goat Ration - DEC, Medicated, Recall # V-015-6
CODE
Lot number 4313593840
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tennessee Farmers Cooperative, La Vergne, TN, by telephone on November 18, 2005.
Manufacturer: Tennessee Farmers Cooperative, Rockford, TN. Firm initiated recall is ongoing.
REASON
Decoquinate was below specification in goat feed.
VOLUME OF PRODUCT IN COMMERCE
134 50# bags
DISTRIBUTION
TN and NC

______________________________
PRODUCT
Fort Dodge Kopertox Water-Resistant Protection Without Bandaging, containing 37.5% copper naphthenate, packaged in 16-oz. bottles, 12 bottles per case, NADA 12-991, NDC 0856-9910-02, OTC. Recall # V-016-6
CODE
075522, Exp. Apr 09
RECALLING FIRM/MANUFACTURER
Fort Dodge Laboratories Inc, Fort Dodge, IA, by letters on September 12, 2005. Firm initiated recall is ongoing.
REASON
Some of the bottles may be superpotent
VOLUME OF PRODUCT IN COMMERCE
11,675/16-oz. bottles
DISTRIBUTION
Nationwide and Mexico

END OF ENFORCEMENT REPORT FOR DECEMBER 14, 2005

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