Enforcement Report

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.

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February 23, 2005
05-08

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

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PRODUCT
Trader Joe's Shortbread Tea Cookies with Cranberries, net wt. 7 oz, packaged in a box with a decorative ribbon. Recall # F-177-5.
CODE
SKU: 071767.
RECALLING FIRM/MANUFACTURER
Trader Joes Company, Monrovia, CA, by press release on January 5, 2005. Firm initiated recall is complete.
REASON
Packages labeled as Shortbread Tea Cookies with Cranberries actually contained Pecan Shortbread Cookies with pecans as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
79,200 boxes.
DISTRIBUTION
Nationwide.

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PRODUCT
Kinnikinnick Foods Cinnamon Sugar donuts, in 480 g (16.5 or l7 oz.) plastic bags; 6 donuts per bag; 3 bags per case. UPC code on package is 620133002155. Recall # F-191-5.
CODE
Best before date between 04152005 and 08202005. Products in preprinted bags correctly label the ingredients and are not affected by this recall. Only products with applied labels are affected.
RECALLING FIRM/MANUFACTURER
Natures Best, Inc., Brea, CA, by letter dated December 28, 2004. Firm initiated recall is complete.
REASON
Product contains undeclared soy protein.
VOLUME OF PRODUCT IN COMMERCE
391 cases.
DISTRIBUTION
AZ, CO, MT, NM, NV, UT, and WA.

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PRODUCT
Chocolate Chip Cookies, Aunt Candice Cookies Casein and Gluten Free no Dairy Wheat Corn Soy No Additives or Preservatives Net. Wt. 10 oz. One box contains 10 individually wrapped cookies not labeled for individual sale. Recall # F-192-5.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Candice Foods LLC, McMinnville, OR, by telephone on October 15, 2004. Firm initiated recall is complete.
REASON
Cookies contain undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
24 boxes.
DISTRIBUTION
SC, and OR.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

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PRODUCT
Starwest brand Fenugreek Seeds in 100 capsule bottles, item #: 498400-06. The product is in 440 mg capsules. This is a dried herb that has been milled to a powder form. Recall # F-176-5.
CODE
C3816, Exp. 11/06.
RECALLING FIRM/MANUFACTURER
Starwest Botanicals Inc., Rancho Cordova, CA, by telephone and letter on beginning on December 15, 2004. Firm initiated recall is complete.
REASON
Product labeled as "Fenugreek Seeds" actually contains Scullcap.
VOLUME OF PRODUCT IN COMMERCE
47/100-capsule bottles.
DISTRIBUTION
CA, WA, IN, CT, and NY.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
Megace Oral Suspension (megestrol acetate) Each mL contains 40 mg of micronized megestrol acetate in a lemon-lime flavored oral suspension, 240 mL (8fl. Oz.) bottle, Rx only, NDC 0015-0508-42. Recall # D-129-5.
CODE
Lot 3K75331 Exp. Date 10/05; Lot 3K75337 Exp. Date 11/05; Lot 3K79118 Exp. Date 11/05; Lot 3L68577 Exp. Date 11/05; Lot 3L73761 Exp. Date 11/05.
RECALLING FIRM/MANUFACTURER
Bristol Myers Squibb Caribbean Company, Mayaguez, PR, by letter on December 30, 2004. Firm initiated recall is ongoing.
REASON
Product contains microbial contamination; mold and yeast.
VOLUME OF PRODUCT IN COMMERCE
23,439 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
a) Nefazodone HCl Tablets, 50 mg, 100 count
bottles, Rx only. Recall # D-125-5;
b) Nefazodone HCl Tablets, 100 mg, 100 count
bottles, Rx only. Recall # D-126-5;
c) Nefazodone HCl Tablets, 150 mg, 100 count
bottles, Rx only. Recall # D-127-5;
d) Nefazodone HCl Tablets, 200 mg, 100 count
bottles, Rx only. Recall # D-128-5.
CODE
a) Lot 118557A, Exp. Date 6/2005;
b) Lot 118550, Exp. Date 7/2005;
c) Lot 118552, Exp. Date 6/2005;
d) Lot 118555, Exp. Date 7/2005.
RECALLING FIRM/MANUFACTURER
Ivax Pharmaceuticals, Inc., Northvale, NJ, by letter on January 19, 2005 and by follow-up telephone calls. Firm initiated recall is ongoing.
REASON
Dissolution Failure: Lots may fail to meet requirements for dissolution throughout expiration.
VOLUME OF PRODUCT IN COMMERCE
a) 50 mg-949 units;
b) 100 mg-937 units;
c) 150 mg-1348 units;
d) 200 mg-1316 units.
DISTRIBUTION
Nationwide.

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PRODUCT
Madame Pearl's brand Cough Syrup, OTC product. Product is amber liquid packed in a clear glass 120 ml bottle with a red cap, and green and white adhesive labels on the front and back of the bottle. Recall # D-130-5.
CODE
Old code: PD/BAT 19990805 Exp. D 20011105;
New code: PD/BAT 20030805 Exp.D20070605.
RECALLING FIRM/MANUFACTURER `
Great Kingsland, Inc., Brooklyn, NY, by letter on January 26, 2005. Firm initiated recall is ongoing.
REASON
The product has exceeded the label expiration date, and has been re-labeled with a new production and expiration date without any supporting data.
VOLUME OF PRODUCT IN COMMERCE
5 cases (6 x 12 bottles).
DISTRIBUTION
PA, IL, and MA.

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PRODUCT
Premarin 0.625 mg (Conjugated Estrogens Tablets, USP), Rx only, NDC 0046-0867-91. Recall # D-131-5.
CODE
Lot # 09748, Exp. 09/05; Lot 09913, Exp. 09/05; Lot 09912, Exp. 09/05; Lot 09911, Exp. 09/05; Lot 10043, Exp. 09/05; Lot 09749, Exp. 09/05.
RECALLING FIRM/MANUFACTURER
Rx PAK, Memphis, TN, by intranet on October 28, 2004. Firm initiated recall is complete.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
15,000,600 bottles of 100 tablets.
DISTRIBUTION
Nationwide.

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PRODUCT
Premarin 0.625 mg (Conjugated Estrogens Tablets, USP), Rx only. Recall # D-132-5.
CODE
Lot 08890, Exp. 09/05; Lot 08946, Exp. 09/05; Lot 08947, Exp. 09/05; Lot 06901, Exp. 03/05; Lot 07217, Exp. 03/05; Lot 07218, Exp. 03/05; Lot 08029, Exp. 03/05.
RECALLING FIRM/MANUFACTURER
Rx PAK, Memphis, TN, by intranet on December 13, 2004. Firm initiated recall is complete.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
210,581 bottles of 100 tablets.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0601-5;
b) Recovered Plasma. Recall # B-0602-5.
CODE
a) and b) Unit 04FV33396.
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by facsimile on October 6, 2004 or by the Logic system on October 5, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA and MA.

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PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0607-5.
CODE
Unit 4710672.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on November 24, 2004. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with gram positive cocci, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0608-5.
CODE
Unit number 2700282.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on September 24, 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
TN.

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0609-5.
CODE
Unit number 9541010.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on April 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
TN.

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PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0610-5.
CODE
Unit number LG01239.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center Providence, RI, by letter on October 5, 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
MA.

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PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0611-5.
CODE
Unit number 1199130.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone on January 25, 2002, and by letter on April 3, 2002. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

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PRODUCT
Red Blood Cells. Recall # B-0612-5.
CODE
Unit number 0777325.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone and letter on April 3, 2003. Firm initiated recall is complete.
REASON
Blood product, manufactured from an overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated. Recall # B-0618-5.
CODE
Unit numbers: 2046381, Parts A and B.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on July 20, 2004, and by letters, dated August 16, 2004. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.

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PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0619-5.
CODE
Unit number: 2043318.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on May 20, 2004, and by letter, dated May 28, 2004. Firm initiated recall is complete.
REASON
Platelets, with a positive bacterial culture, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0625-5.
CODE
Unit number 01GQ88843.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY, by facsimile on January 26, 2004.
Manufacturer: American Red Cross Blood Services, Albany, NY. 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
NY.

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PRODUCT
Source Plasma. Recall # B-0627-5.
CODE
Unit number ST339750.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., San Antonio, TX, by facsimile on November 24, 2003. Firm initiated recall is complete.
REASON
Blood product was collected in a manner that may compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

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PRODUCT
a) Red Blood Cells Leukocytes Reduced.
Recall # B-0629-5;
b) Recovered Plasma. Recall # B-0630-5.
CODE
a) and b) Unit C38498.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by electronic mail on September 10, 2004, and by letters dated September 13 and October 8, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had taken the medication Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA, and Switzerland.

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0631-5;
b) Fresh Frozen Plasma. Recall # B-0632-5.
CODE
a) and b) Unit number: K84749.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on April 21, 2004. Firm initiated recall is complete.
REASON
Blood products, in which the corresponding platelet product was possibly contaminated with Enterobacter cloacae, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
GA.

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PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
Recall # B-0633-5;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-0634-5.
CODE
a) Unit number: 2049523, Part B;
b) Unit number: 2049523, Part A.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on September 21, 2004, and by letter, dated September 23, 2004. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.

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PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
Recall # B-0635-5;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-0636-5.
CODE
a) Unit number: 2041358, Part B;
b) Unit number: 2041358, Part A.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on April 3, 2004, and by letter, dated April 13, 2004. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.

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PRODUCT
Platelets. Recall # B-0652-5.
CODE
Unit number: L24221.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on September 23, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to the use of the medication, Gabitril, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

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PRODUCT
a) Red Blood Cells. Recall # B-0653-5;
b) Fresh Frozen Plasma. Recall # B-0654-5.
CODE
a) and b) Unit FT58209.
RECALLING FIRM/MANUFACTURER
Innova Health Care Services, Blood Donor Services, Annandale, VA, by letters dated August 24, 2004 and December 15, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a history of melanoma, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD and VA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

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PRODUCT
Source Plasma. Recall # B-0613-5.
CODE
Unit numbers WSG009908 and WSG009430.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by telephone on November 2, 2004, and by facsimile on November 10, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer the medical history questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Spain.

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0624-5.
CODE
Unit number K39627.
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Bank, Springfield, IL, by facsimile on October 20, 2004. Firm initiated recall is complete.
REASON
Blood product possibly exposed to unacceptable shipping temperatures was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

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PRODUCT
Recovered Plasma. Recall # B-0626-5.
CODE
Unit number 0538408.
RECALLING FIRM/MANUFACTURER
Somerset Medical Center Blood Bank, Somerville, NJ, by letter on April 29, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT
Advanced D-Dimer. Fibrinogen and fibrin split products, Catalog numbers OQWM11 AND OQEM13. Recall # Z-0538-05.
CODE
Lot numbers 544531 to 544548 and 544502 to 544504.
RECALLING FIRM/MANUFACTURER
Dade Behring, Inc., Newark, DE, by letter on December 3, 2004. Firm initiated recall is ongoing.
REASON
Decrease in product stability after reconstitution and reduced stability on board certain instrument systems.
VOLUME OF PRODUCT IN COMMERCE
25,381 units.
DISTRIBUTION
Nationwide.

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PRODUCT
Most Options System Porous and Non-Porous Revision Stem Adapters. Catalog Numbers: 5000-50-100 and 5000-50-200. Recall # Z-0539-05.
CODE
Lot Numbers: 1529444, 1536181, 1538936, 1538937, 1542189, 1568350, 1568351, 1569597, 1596886, 1596890, 1601839, 1601841, 1610470, 1616609, and 1617691.
RECALLING FIRM/MANUFACTURER
Zimmer Austin, Inc., Austin, TX, by letter on December 17, 2004. Firm initiated recall is ongoing.
REASON
Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications.
VOLUME OF PRODUCT IN COMMERCE
121 units.
DISTRIBUTION
AZ, CA, NY, IL, FL, MD, OH, MI, WI, MO, TX, Canada and Portugal.

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PRODUCT
UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm. Recall # Z-0540-05.
CODE
All of specific lot 044843.
RECALLING FIRM/MANUFACTURER
Plus Orthopedics, San Diego, CA, by telephone and personal visit, on January 4, 2005. Firm initiated recall is complete.
REASON
Knee tibial insert is mislabeled completely as different device.
VOLUME OF PRODUCT IN COMMERCE
24 units.
DISTRIBUTION
CA, ID, IL, WI, and OR.

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PRODUCT
Rapid Syphilis Test Kit, per insert, contents of the kit are 1 Rapid Syphilis test cassette, 1 alcohol swab, 1 buffer container, 1 lancet (needle), 1 zipped bag, 1 pipette (plastic) (included with cassette). There is no firm identified on the product packaging. Recall # Z-0542-05.
CODE
All lots are subject to recall.
RECALLING FIRM/MANUFACTURER
Ups Supply Chain Solutions, Alpharetta, GA, by letters dated February 4, 2005. Firm initiated recall is ongoing.
REASON
The kits are not approved for use in the United States.
VOLUME OF PRODUCT IN COMMERCE
79 kits.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

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PRODUCT
IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB 2, L2KVB6. Recall # Z-0537-05.
CODE
Kit lot 186 only.
RECALLING FIRM/MANUFACTURER
Diagnostic Products, Corp, Los Angeles, CA, by telephone, email or fax on January 24 and 25, 2005. Firm initiated recall is ongoing.
REASON
A low CPS limit was not incorporated in the kit barcode for IMMULITE 2000 Vitamin B12 L2KVB 2, 6 kit lot 186 only.
VOLUME OF PRODUCT IN COMMERCE
189 kits.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Legionella ELISA Test System. The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert. Recall # Z-0541-05.
CODE
Lot # 91803Z and 30804/30804Z.
RECALLING FIRM/MANUFACTURER
Diamedix Corp., Miami, FL, by letter on December 23, 2004. Firm initiated recall is ongoing.
REASON
The kits may lose activity, after one or two usages, causing the OD values for the Cut-Off Calibrator and/or Positive Control to be recovered below their specified ranges.
VOLUME OF PRODUCT IN COMMERCE
178 kits.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Waterlase MD, dental laser unit, Model #6200218. Recall # Z-0543-05.
CODE
Serial Numbers: 10500210 to 10502680,inclusive.
RECALLING FIRM/MANUFACTURER
Biolase Technology, Inc., San Clemente, CA, by firm representative visit, on January 17, 2005. Firm initiated recall is ongoing.
REASON
Reports that the Waterlase MD, a dental laser unit, water bottle broke under pressure during installation.
VOLUME OF PRODUCT IN COMMERCE
209 units.
DISTRIBUTION
Nationwide and Internationally.

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PRODUCT
SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons containing 6 lenses each. Cartons/blister packs are labeled with --3.25 DS, -1.25DC, 170 degree Axis. Recall # Z-0544-05.
CODE
Carton lot: W44090230; Blister Lot W44089478.
RECALLING FIRM/MANUFACTURER
Bausch & Lomb, Inc., Rochester, NY, by letters dated February 4, 2003. Firm initiated recall is ongoing.
REASON
Portion of lot contains lenses with incorrect refractive power.
VOLUME OF PRODUCT IN COMMERCE
798/6 packs.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR February 23, 2005

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