• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for May 10, 2006

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.

May 10, 2006
06-19

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

______________________________
PRODUCT
NOW XyliWhite Mouthwash; an all natural, fluoride-free oral rinse; 16 fl. oz. plastic bottles with a foil seal, 9 bottles and 20 bottles per carton, UPC 33739-08095, Recall # F-152-6
CODE
Lot numbers 735906 and 736424
RECALLING FIRM/MANUFACTURER
NOW Foods, division of The Fruitful Yield, Inc., Bloomingdale, IL by letter dated March 10, 2006. Firm initiated recall is ongoing.
REASON
A breakdown in the product's preservative system allowed the growth of Enterobacter gergoviae bacteria in the mouthwash
VOLUME OF PRODUCT IN COMMERCE
1,266 bottles
DISTRIBUTION
Nationwide

__________________________________
PRODUCT
a) Grabber's brand 5 oz. tuna salad sandwiches, Allergy information: Manufactured with
nuts, soy, dairy, fish and or egg products, Recall # F-153-6
b) Grabber's brand 5 oz. egg salad sandwiches, Allergy information: Manufactured with
nuts, soy, dairy, fish and or egg products, Recall # F 154-6
c) Grabber's brand 5 oz. chicken salad sandwiches, Allergy information: Manufactured
with nuts, soy, dairy, fish and or egg products, Recall # F-155-6
CODE
All sandwiches with a pull date of 4/10/06 or earlier
RECALLING FIRM/MANUFACTURER
Eastside Deli Supply Inc. Lansing, MI by visit on March 16, 2006, by telephone on March 17, 2006 and by letter on March 20, 2006. Firm initiated recall is complete.
REASON
The product contains undeclared whey, but the label has a statement, "Manufactured with ...dairy..."
VOLUME OF PRODUCT IN COMMERCE
20, 654 sandwiches
DISTRIBUTION
MI

______________________________
PRODUCT
Hazelnut Tortellini's in 10 lb. cardboard case (case contains 2/5 lb. plastic bags) with stick on label stating MERLINO BRAND. Another stick on label states in part HAZELNUT TORTELLINI''S INGREDIENTS: NET WT 10 LBS/Cs KEEP FROZEN MAY BE REFRIGERATED. Recall # F-156-6
CODE
020 and 088 The code represents a Julian manufacture date.
RECALLING FIRM/MANUFACTURER
Carso's Pasta Company, Lynnwood, WA, by telephone and letter on April 3, 2006. Firm initiated recall is complete.
REASON
Product contains undeclared eggs but was used exclusively by a restaurant chain who served it with egg-containing sauce.
VOLUME OF PRODUCT IN COMMERCE
20/10 lb. cases
DISTRIBUTION
Seattle, WA

______________________________
PRODUCT
Dutch Treat Overwrap Brownie - 80 bars / case, Net Wt: 14 lb 13 oz/CASE. Product code 77028. For Institutional Use Only. Product of Canada. Recall # F-157-6
CODE
Lot codes: 2705, 2915, 3045, 3225, 3295
RECALLING FIRM/MANUFACTURER
Recalling Firm: Best Brands Corp. Minnetonka, MN, by telephone and letter on January 24, 2006.
Manufacturer: The Gourmet Baker Inc., Winnipeg, Canada. Firm initiated recall is ongoing.
REASON
The chocolate chips used in the Dutch Treat Brownie contain a milk ingredient that is not declared on the label for this product. The product was manufactured exclusively for a restaurant chain that served it as a component of a milk-containing dessert dish.
VOLUME OF PRODUCT IN COMMERCE
2067 cases
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Potato Cracker (Ajiyose), packaged in 4.05 oz (115gm) bags. Bags have the following UPC code: 4903614001509, Recall # F- 158-6
CODE
Item: #090910
RECALLING FIRM/MANUFACTURER
Recalling Firm: Golden Fortune Import & Export Corp., Bayonne, NJ, by visit between March 22, 2006 and March 31, 2006.
Manufacturer: Wakabato Confectionery Co., Aichi, Japan, New York State initiated recall is complete.
REASON
Potato Cracker contains undeclared colors certifiable as FD&C Yellow #5, Yellow #6, Blue #1 and Red #40.
VOLUME OF PRODUCT IN COMMERCE
720 bags
DISTRIBUTION
NY, NJ, PA, RI, VA, MD and FL

______________________________
PRODUCT
Asian Boy (EBQ) Roasted Melon Seed, Product of Vietnam. Packaged in 200 gram packages and in 170 gram plastic tubs. Recall # F-159-6
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: New B.C.N. Trading, Inc., S Plainfield, NJ by letter on April 6, 2006.
Manufacturer: Minh Nguyet Company aka M&N Co., Ho Chi Minh, Vietnam. New York State initiated recall is ongoing.
REASON
The New York State Department of Agriculture and Markets'analysis found this product to contain an undeclared and unapproved color additive, amaranth (formerly known as FD&C Red #2) which was delisted.
VOLUME OF PRODUCT IN COMMERCE
129 cases of 60 x 170 grams and 161 cases of 40 x 200 grams
DISTRIBUTION
Nationwide

______________________________
PRODUCT
John Frieda brand brilliant brunette, Starlit Waves, Wave Enhancing Spray packaged in a 6 fl. oz (177 ml) pump spray bottle. The product is packed and distributed a 6 x 6 fl. oz bottles per case. The cases are labeled as brilliant brunette, 10947-00, Starlit Waves Wave Enhancing Spray, and contains a UPC code of: 1 07 17226 0947 5. The case labeling also reads: JOHN FRIEDA PROFESSIONAL HAIR CARE. Recall # F-160-6
CODE
Lot #''s T314BM27, T315BM27, T316BM29, T317BM29, T317BM30, T318BM30, T004BM53, T005BM53, T006BM53, T007BM53, T008BM52, T008BM49, T009BM49, V022BM63, V023BM63, V024BM42 & V025BM43
RECALLING FIRM/MANUFACTURER
Recalling Firm: KAO Brands Company, Cincinnati, OH, by letter on February 23 and 24, 2006.
Manufacturer: Les Emballages Knowlton Inc., Canada. Firm initiated recall is ongoing.
REASON
Hair Spray is contaminated with Pseudomonas.
VOLUME OF PRODUCT IN COMMERCE
17,232 cases [103,392 bottles]
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Hannah's Pickled Eggs. The product is packed in beet flavor and artificially colored vinegar. The product is sold in 1 gallon jars. Recall # F-161-6.
CODE
Code 244 exp. 9/1/06 and Code 245 exp. 9/2/06
RECALLING FIRM/MANUFACTURER
Lehman's Egg Service Inc, Chambersburg, PA, by telephone on September 12, 2005. Firm initiated recall is complete.
REASON
The product was manufactured in a manner whereby it may have been contaminated with organisms of public health concern.
VOLUME OF PRODUCT IN COMMERCE
1728 jars
DISTRIBUTION
VA

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
Myoview (Kit for the Preparation of Technetium Tc99m Tetrofosmin for Injection), 10 mL vial, carton of five vials, for Intravenous Injection, Each lyophilized vial contains 0.23 mg Tetrofosmin, 0.03 mg Stannous chloride dihydrate, 0.32 mg Disodium sulphosalicylate, 1.0 mg, Sodium D-gluconate, 1.8 mg Sodium hydrogen carbonate, Rx ONLY, Recall # D-239-6
CODE
Lots: 1330; 1334. Expiration date or shelf life of Myoview is 10 months. When radioactive technetium is added to the Myoview vial, the shelf life is 12 hours.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ge Healthcare, Princeton, NJ, by letter on March 6, 2006.
Manufacturer: Amersham Health, United Kingdom. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility; firm used a non-sterile nitrogen gas filter during manufacturing of a sterile product.
VOLUME OF PRODUCT IN COMMERCE
22,055 kits
DISTRIBUTION
Canada, Netherlands, Belgium, Spain, Europe, and Japan, and Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
Phenylhistine DH, (each 5 mL contains: Codeine Phosphate 10mg, Pseudoephedrine Hydrochloride 30mg, Chlorpheniramine Maleate 2mg, Alcohol 5%), 4 fl oz., Rx only, NDC # 0603-1520-54, Recall # D-240-6
CODE
Lot numbers: L016J04A (exp 09/06), L023L04A (exp 11/06), L068M04A (exp 12/06), L005D05A (exp 12/06), L017K05B (exp 10/07), L051A06A (exp 07/07)
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals, Huntsville, AL, by letter on April 3, 2006, April 5, 2006 and April 11, 2006. Firm initiated recall is ongoing.
REASON
Subpotent: OOS (below specification) at 18 months for Codeine Phosphate.
VOLUME OF PRODUCT IN COMMERCE
101,462 units
DISTRIBUTION
Nationwide and PR

______________________________
PRODUCT
Zoloft (sertraline hydrochloride), Oral Concentrate, 20 mg/mL, 60 mL bottle, Rx only, NDC 0049-4940-23, Recall # D-241-6
CODE
Lot 0105475, Exp. Date 01DEC2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by letters on March 8, 2006.
Manufacturer: Pfizer Inc., Parsippany, NJ, Firm initiated recall is ongoing.
REASON
One lot of Zoloft Oral Concentrate was found to contain trace amounts of isopropyl alcohol.
VOLUME OF PRODUCT IN COMMERCE
9,237 bottles
DISTRIBUTION
Nationwide
___________________________
PRODUCT
a) Analpram HC Cream 1% (hydrocortisone acetate 1% and pramoxine HCl 1%) Net Wt.
1 oz metal tube, Rx only, NDC 0496-0778-04, Recall # D-242-6
b) Analpram HC Cream 1% (hydrocortisone acetate 1% and pramoxine HCl 1%)
Professional sample, Net wt. 3 gram metal tube, Rx only, NDC 0496-0778-33,
Recall # D-243-6
c) Analpram HC Cream 2.5% (hydrocortisone acetate 2.5% and pramoxine HCl 1%) Net
Wt. 1 oz metal tube, Rx only, NDC 0496-0800-04. Recall # D-244-6
d) Pramosone Cream 1% (hydrocortisone acetate 1% and pramoxine HCl 1%), Net wt.
1 ounce metal tube, Rx only, NDC 0496-0716-04. Recall # D-245-6
e) Pramosone Cream 2.5% (hydrocortisone acetate 2.5% and pramoxine HCl 1%), Net
wt. 1 ounce and 2 ounce tubes, Rx only, NDC 0496-0717-04 and 0496-0717-03.
Recall # D-246-6
CODE
a) Lots 04135A (exp. 08/07), 04136A (exp. 08/07), 04186A (exp. 11/07),
04189A (exp. 11/07), 04190A (exp. 11/07), 04191A (exp. 11/07),
04201A (exp. 12/07) and 04202A (exp. 12/07);
b) Lot 04187A (exp. 11/07);
c) Lots 04122A (exp. 07/06), 04123A (exp. 07/06), 04124A (exp. 07/06) and
04138A (exp. 08/06);
d) Lot 04045A (exp. 03/07);
e) Lots 04067A (exp. 05/06), 04068A (exp. 05/06), 04069A (exp. 05/06) and
04070A (exp. 05/06), and 04121A (exp. 07/06)
RECALLING FIRM/MANUFACTURER
Ferndale Laboratories, Inc., Ferndale, MI, by letters dated March 24, 2006. FDA initiated recall is ongoing.
REASON
Superpotent: The metal tubes may have pinhole defects, which would result in a superpotent product.
VOLUME OF PRODUCT IN COMMERCE
196,742 tubes
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I

______________________________
PRODUCT
Irradiated Cancellous Bone & Marrow, 0.25, 0.5, 1.0 and 2.0 gram vials, Recall # B-0809-6
CODE
Lot # 03049, 1.0 gram, Vial numbers: 1 thru 51
Lot # 03051, 0.25 gram, Vial numbers 1 thru 205
Lot # 04091, 0.25 gram, Vial numbers 1 thru 393
Lot # 04102, 0.5 gram, Vial numbers 1 thru 44
Lot # 04103, 1.0 gram, Vial numbers 1 thru 47
Lot # 04104, 1.0 gram, Vial numbers 1 thru 44
Lot # 04109, 1.0 gram, Vial numbers 1 thru 60
Lot # 04113, 2.0 gram, Vial numbers 1 thru 23
Lot # 04120, 1.0 gram, Vial numbers 1 thru 31
Lot # 04123, 2.0 gram, Vial numbers 1 thru 23
Lot # 04124, 0.5 gram, Vial numbers 1 thru 70
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rocky Mountain Tissue Bank, Aurora, CO, by telephone on October 5, 2005, and by letter dated November 1, 2005.
Manufacturer: BioMedical Tissue Services, Ltd., Fort Lee, NJ, firm initiated recall is complete.
REASON
Human tissues, procured from donors without adequate donor eligibility determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
991 vials
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
Source Plasma, Recall # B-0933-6
CODE
Unit number: 46874405
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by letter dated March 29, 2001, firm initiated recall is complete.
REASON
Blood product, with an elevated ALT result, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0934-6
CODE
Unit number: 12M36018
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on June 1, 2005 and by letter dated June 8, 2005,. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

______________________________
PRODUCT
Source Plasma, Recall # B-0980-6
CODE
Unit numbers: N36747097, N36788097, G85618097, G85964097, G86543097, G88293097, G88630097, G90047097, G90377097, G91542097, G92158097, G92485097, G93136097, G94053097, G94402097, and G98161097
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, San Diego, CA, by facsimile on July 16, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who engaged in multiple high risk behavior activities, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
NC and Spain

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0987-6;
b) Plasma Frozen, Recall # B-0988-6
CODE
a) and b) Unit number: 16GR21277
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Columbus, OH, by telephone on September 8, 2005 and by letter dated September 9, 2005. Firm initiated recall is complete.
REASON
Blood products, which were 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
OH

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0989-6;
b) Fresh Frozen Plasma, Recall # B-0990-6
CODE
a) and b) Unit number: 1173839
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, Cincinnati, OH, by telephone on June 23, 2005. Firm initiated recall is complete.
REASON
Blood products which were 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
OH
_____________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0991-6;
b) Platelets Leukocytes Reduced, Recall # B-0992-6
CODE
a) and b) Unit number: 1153953
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, Cincinnati, OH, by letter dated July 13, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0993-6
CODE
Unit numbers: 1095505, 1103417, and 1076168
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, Cincinnati, OH, by letter dated March 10, 2005. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OH

______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0999-6
CODE
Unit numbers: K75730 and K76608
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Community Blood Center of Carolinas, Charlotte, NC, by letter dated May 24, 2004. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from associated blood components that exhibited clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1000-6;
b) Cryoprecipitated AHF, B-1001-6;
c) Recovered Plasma, Recall # B-1002-6
CODE
a), b), and c) Unit number: 50V03694
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Toledo, OH, by telephone and facsimile on November 19, 2004 and November 24, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had tested positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OH, TX, and Switzerland

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1003-6;
b) Recovered Plasma, Recall # B-1004-6
CODE
a) and b) Unit number: 13GN03072
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit, MI, by telephone or electronic mail on November 8, 2005 and by letter dated November 10, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a tattoo within twelve months of the donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI and CA

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1005-6;
b) Platelets Leukocytes Reduced, Recall # B-1006-6
CODE
a) and b) Unit number: 13FX28625
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit, MI, by telephone on October 28, 2005 and by letter dated November 2, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1015-6
CODE
Unit numbers: 2163570 (Parts A and B)
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by telephone on January 4, 2005. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Propionibacterium acnes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY

______________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-1016-6;
b) Plasma, Cryoreduced, Recall # B-1017-6
CODE
a) Unit number: 0217920;
b) Unit number: 0872029
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by telephone on July 8, 2005. Firm initiated recall is complete.
REASON
Blood products, associated with units that were found to contain clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC, and SC

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-1019-6
CODE
Unit numbers: 09FC06820, 09FC06822, 13X07559, and 13X08008
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on November 21, 2005 and letter dated December 5, 2005. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly irradiated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MI

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1020-6;
b) Platelets, Recall # B-1021-6;
c) Fresh Frozen Plasma, Recall # B-1022-6;
d) Recovered Plasma, Recall # B-1023-6
CODE
a) Unit numbers: 36GQ20986, 36R66115;
b) and c) Unit number: 36GQ20986;
d) Unit number: 36R66115
RECALLING FIRM/MANUFACTURER
American National Red Cross, South Carolina Region, Columbia, SC, by telephone on November 22, 2000 or by letter dated December 1, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA, PR, and SC

______________________________
PRODUCT
a) Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-1024-6;
b) Platelets Pheresis, Leukocytes Reduced, Recall # B-1025-6
CODE
a) and b) Unit number: 2730423
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Ventura, CA, by telephone on November 15, 2004, Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1026-6
CODE
Unit number: 33FP51310
RECALLING FIRM/MANUFACTURER
American National Red Cross, Connecticut Region, Farmington, CT, by telephone on December 30, 2005, and by letter dated January 9, 2006. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
a) Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0899-6;
b) Platelets Pheresis, Leukocytes Reduced, Recall # B-0900-6
CODE
a) and b) Unit number: 12LT52911
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on January 31, 2004 and by letter dated February 10, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a low body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC

______________________________
PRODUCT
Recovered Plasma, Recall # B-0935-6
CODE
Unit number: 12M36018
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by email on June 1, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0936-6;
b) Recovered Plasma, Recall # B-0937-6
CODE
a) Unit numbers: 12LF05089, 12LF05090, 12LF05091, 12LF05092, 12LF05093,
12LF05094, 12LF05095, 12LF05096, 12LF05098, 12LF05099, 12LF05100;
b) Unit numbers: 12LF05089, 12LF05090, 12LF05091, 12LF05092, 12LF05093,
12LF05094, 12LF05095, 12LF05096, 12LF05098, 12LF05099, 12LF05100
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone or electronic notification on June 3, 2005. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood which may have reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
CA, GA, and NC

______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced, Recall # B-0972-6;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0973-6
CODE
Unit numbers: 10048-3902, 10048-3898, 10048-3901;
Unit numbers: 10048-3902, 10048-3901
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on April 28, 2004 and by letter dated May 25, 2004. Firm initiated recall is complete.
REASON
Platelets, which reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
AZ

______________________________
PRODUCT
Source Plasma, Recall # B-0975-6
CODE
Unit numbers: F-20641-014, F-23223-014, F-24710-014
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, National City, CA, by facsimile on May 29, 2003, Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Sweden

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0994-6
CODE
Unit number: 3100117
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on January 26, 2006. Firm initiated recall is complete.
REASON
Blood product, which did not have a white blood cell count performed, but was labeled as leukocyte reduced, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

______________________________
PRODUCT
a) Platelets Leukocytes Reduced, Recall # B-0996-6;
b) Fresh Frozen Plasma, Recall # B-0997-6
CODE
a) and b) Unit number: 13GV67457
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit, MI, by telephone on November 2, 2005 and by letter dated November 11, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected in a manner in which the collection time was not appropriately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI and AZ

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0998-6
CODE
Unit numbers: 13GL29724, 13GL29727, 13GL29728, 13GL29729, 13GL29730, 13GL29731, 13GL29732 and 13GL29735
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit, MI, by telephone on October 18, 2005 and by letter dated October 25, 2005. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from whole blood units that may have been exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
MI

______________________________
PRODUCT
Source Plasma, Recall # B-1018-6
CODE
Unit numbers: 0360045037, 0360045238, 0360046299, 0360046529
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc. South Bend, IN, by facsimile on August 4, 2005,. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for unacceptable test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Spain

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1027-6
CODE
Unit number: 1134047
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, Cincinnati, OH, by letter dated May 24, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a history of Thrombotic Thrombocytopenic Purpura (TTP), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

______________________________
PRODUCT
Ventilator-PLV Continuum (PLVC I), Model Number: P1000. The PLVC I is a microprocessor controlled, compressor-based, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. It utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The PLVC I user interface has a membrane keypad with indicator Light Emitting Diodes for the selection and acceptance of patient settings and for the display of alarm conditions. PLVC I provides the following types of ventilatory support: 1) Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece ). 2) Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV)or Continuous Positive Airway Pressure (CPAP) modes of ventilation. 3) Volume-Controlled (VC). Available in AlC and SIMV. 4) Pressure-Controlled (PC). Available in AlC and SIMV. 5) Pressure Support (PS). Available in SIMV and SPONT, Recall # Z-0808-6
CODE
VS4702502, VS4700835, VS4700809, VS4700653, VS4700833, VS4700819, VS4700580, VS4700776,VS4700554, VS4700754, VS4702535, VS4702512, VS4702523, VS4702556, VS4702568, VS4700608, VS4700729, VS4700760, VS4700620, VS4702586, VS4702677, VS4702750, VS4702784, VS4702848, VS4700773, VS4700852, VS4700549, VS4700552, VS4700555, VS4700569, VS4700643, VS4700681, VS4700718, VS4700823, VS4700836, VS4702776, VS4700802, VS4700588, VS4700789, VS4700849, VS4700622, VS4700642, VS4702604, VS4700687, VS4700838, VS4702528, VS4702545, VS4700663, VS4700694, VS4700725, VS4700822, VS4700853, VS4702572, VS4700624, VS4700738, VS4702553, VS4702570, VS4700566, VS4700578, VS4702591, VS4700558, VS4700615, VS4702800, VS4702505, VS4700783, VS4700791, VS4700821, VS4702580, VS4700774, VS4702589, VS4700834, VS4700840, VS4700596, VS4700785, VS4700846, VS4702501, VS4702519, VS4702548, VS4700786, VS4702650, VS4702590, VS4700565, VS4702525, VS4702557, VS4702574, VS4700767, VS4700721, VS4702594, VS4702709, VS4700724, VS4700814, VS4702573, VS4700824, VS4700536, VS4700574, VS4700585, VS4700595, VS4700625, VS4700698, VS4700736, VS4700744, VS4700827, VS4700855, VS4702555, VS4702575, VS4700842, VS4700790, VS4700544, VS4702552, VS4702567, VS4702571, VS4700843, VS4702566, VS4700650, VS4700811, VS4700817, VS4700850, VS4702857, VS4700635, VS4700796, VS4700816, VS4700649, VS4702689, VS4702583, VS4702981, VS4702551, VS4702532, VS4702543, VS4702599, VS4700708, VS4702600, VS4702811, VS4700770, VS4702623, VS4700673, VS4700617, VS4700539, VS4700548, VS4700646, VS4700660, VS4700739, VS4700590, VS4700577, VS4702859, VS4700782, VS4700780, VS4700614, VS4702647, VS4702805, VS4700813, VS4702688, VS4700844, VS4700607, VS4700847, VS4700841, VS4702809. INTERNATIONAL DISTRIBUTION: VS4700553, VS4700628, VS4700645,
VS4700717, VS4702915, VS4702962, VS4703006, VS4703023, VS4703041, VS4703056, VS4703064, VS4702500, VS4702828, VS4702858, VS4700792, VS4702605, VS4702608, VS4702609, VS4702631, VS4702632, VS4702634, VS4702642, VS4702643, VS4702659, VS4702719, VS4702754, VS4702759, VS4702722, VS4700696, VS4700601, VS4700563, VS4700644, VS4700839, VS4702645, VS4703027
RECALLING FIRM/MANUFACTURER
Respironics California Inc., Carlsbad, CA, by letters on March 20, 2006. Firm initiated recall is ongoing.
REASON
Flow valve failures- When failure occurs, air flow from the ventilator ceases resulting in the PLVC I transitioning into a 'Vent Inop' mode whereby the safety valve is activated, opening the circuit to ambient air. Ventilator dependent patients may not receive adequate ventilatory support if this problem occurs.
VOLUME OF PRODUCT IN COMMERCE
191 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
a) Haemonetics Cell Saver 5 Autologous Blood Recovery System
Model Numbr: LN02005-110-E. Recall # Z-0822-6;
b) Haemonetics Cell Saver 5+ Autologous Blood Recovery System
Model Number: LN02005-110EP, Recall # Z-0823-06
CODE
a) Serial Numbers: 94H180CD-1; 95A048CS; 95J177CS;
b) Serial Numbers: 05F022-1; 05F023-1; 05H103; 05C083-05C084;
05C087-05C089;05D006-05D011;05D037--05D040; 05D043-05D047;
05D060-05D068;05D080--05D081; 05D085-05D089; 05E026-05E035;05E054-1;
05E055-1; 05E056; 05E061-05E070; 05E091-05E095; 05F021; 05F066-05F072;
05F098-05F107; 05F142-05F144; 05F147; 05F149; 05F150; 05F157-05F159;
05G008-1; 05G009-05G012; 05G035-05G037; 05G038-1; 05G055-1; 05G057-
05G059; 05G080-05G084; 05H018; 05H022; 05H024- 05H027; 05H073-05H077;
05H100-05H101; 05H104; 05H163; 05J185-05J189; 05K011-05K013; 05K015-
05K017; 05K092-05K096; 05K168-05K173; 05K175; 05K201
RECALLING FIRM/MANUFACTURER
Haemonetics Corporation, Braintree, MA, by letter on December 21, 2005. Firm initiated recall is ongoing.
REASON
Device emits radiofrequency which exceeds the IEC 60601-1-2 International Standard
VOLUME OF PRODUCT IN COMMERCE
160 devices
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Hobbs Medical 3 Prong Looped Retriever, a disposable device to be used by physician to remove foreign object or cauterize polyp specimens from the GI tract. REF: 5030 and 5030S, Recall # Z-0824-06
CODE
Lot Numbers: H11-05-040; H11-05-138; H11-05-139; H11-05-140; H11-05-141; H11-05-205.
RECALLING FIRM/MANUFACTURER
Hobbs Medical, Inc., Stafford Springs, CT, by letter on March 15, 2006. Firm initiated recall is ongoing.
REASON
Diameter of device at the distal end would prevent it from passing through the endoscope's working channel.
VOLUME OF PRODUCT IN COMMERCE
254 units
DISTRIBUTION
AK, IA, KY, MI, NH, NC, UT, WI, Canada, and UK

______________________________
PRODUCT
a) Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE
(models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Sterile EO. Cardiac resynchronization therapy defibrillators (CRT-D) provide
ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular
tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and
ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death
(SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and
uses biventricular electrical stimulation to synchronize ventricular contractions.
Cardioversion/defibrillation therapies include a range of low-and high-energy shocks
using either a biphasic or monophasic waveform, Recall # Z-0825-06;
b) Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE
(model H197). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO.
Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular
tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia
therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation
(VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac
resynchronization therapy is for the treatment of heart failure (HF) and uses
biventricular electrical stimulation to synchronize ventricular contractions.
Cardioversion/defibrillation therapies include a range of low-and high-energy shocks
using either a biphasic or monophasic waveform, Recall # Z-0826-06;
c) Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac Resynchronization
Therapy Defibrillator (CRT-D). Sterile EO. Cardiac resynchronization therapy
defibrillators (CRT-D) provide both atrial and ventricular tachyarrhythmia and cardiac
resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment
of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are
associated with sudden cardiac death (SCD). Atrial tachyarrhythmia therapy is for the
treatment of supraventricular tachycardia (SVT) and atrial fibrillation (AF). Cardiac
resynchronization therapy is for the treatment of heart failure (HF) and uses
biventricular electrical stimulation to synchronize ventricular contractions. This device
also uses accelerometer-based adaptive-rate bradycardia therapy.
Cardioversion/defibrillation therapies include a range of low-and high-energy shocks
using either a biphasic or monophasic waveform, Recall # Z-0827-06;
d) Guidant VITALITY HE Implantable Cardioverter Defibrillator (model T180). Sterile
EO. This ICD is designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. The device offers dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing), Recall # Z-0828-06
CODE
a) Model H170, serial numbers: 364406, 364446, 364542, 364576, 364582,
364586, 364587, 364590, 364591, 364593, 364595, 364596, 364597,
364599, 364600, 364601, 364602, 364604, 364605, 364606, 364607,
364608, 364609, 364611, 364613, 364615, 364623, 364625, 364632,
364633, 364634, 364636, 364643, 364680, 364732, 364735, 364752.
Model H175, serial numbers: 315437, 315438, 315452, 315454, 315455,
315456, 315461, 315462, 315464, 315470, 315473, 315480, 315482,
315489, 315496, 315497, 315500, 315580, 315588, 315605.
Model H177, serial number: 285055
Model H179 serial numbers: 114267, 114268, 114269, 114270,
114271, 114280, 114470;
b) Model H190, serial numbers: 311739, 311740, 311742, 311743, 311744, 311745,
311747, 311748, 311751, 311769, 311811, 311834, 311850, 311852, 311853,
311884, 311895, 311900,
Model H195 serial number: 353166.
Model H197, serial number: 310331;
c) Serial numbers: 200099, 200103, 200104;
d) Serial numbers: 204707, 204711, 204751, 204754, 204908
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, Saint Paul, MN, by visit on April 10-12, 2006, and by letters April 11-14, 2006.
Manufacturer: Guidant-Ireland, Clomel, Ireland, firm initiated recall is ongoing.
REASON
77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as during routine capacitor formation or for defibrillation. This would likely render the device non-functional, resulting in no output and/or telemetry communications.
VOLUME OF PRODUCT IN COMMERCE
77 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements. Catalog number 9012P2121, Recall # Z-0830-06
CODE
Lot 0001491
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Gastroenterology/Urology, Shoreview, MN, by letter on January 25, 2006.
Manufacturer: Catheter & Disposal Technology, Plymouth, MN, firm initiated recall is ongoing.
REASON
Lot 0001491 has a manufacturing defect in the sensor spacing. Sensors have been placed 5 cm apart instead of 15 cm apart. Medtronic has determined that patient safety is not compromised. Clinicians however should review and reassess the results of any patient studies for which catheters from lot 0001491 were used.
VOLUME OF PRODUCT IN COMMERCE
25 individual catheters
DISTRIBUTION
MI, PA, and TX

______________________________
PRODUCT
a) RenalSoft Observational Study v.2.0 - HD Module, PD Module and Medical
Record Module; clinical data management software, Recall # Z-0831-06;
b) RenalSoft v.1.1 - PD Module; clinical data management software,
Recall # Z-0832-06;
c) Renal Software Suite v.3.1 - HD Module; clinical data management software,
Recall # Z-0833-06
CODE
a) Version 2.0 - HD Modules, PD Modules and Medical Record Modules only;
b) Version 1.1 - PD Module only;
c) Version 3.1 - HD Module only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw Park, IL, by letters dated March 29, 2006.
Manufacturer: Baxter Healthcare Corporation, Largo, FL, firm initiated recall is ongoing.
REASON
There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.
VOLUME OF PRODUCT IN COMMERCE
25 -- U.S., 157 - International
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. Catalog Number: 050-87028, Recall # Z-0834-06
CODE
Lot Numbers: 5SR119; 52R124; 5SR125; 5SR149; 5SR150; 5SR173; 6AR014; 6AR015; 6AR032; 6AR044; 6AR045; 6AR055; 6AR069; 6AR085; 06AR086; 6AR267; 6AR280;6AR298; 6BR013;6BR031; 6BR040; 6BR043; 6BR064; 6BR075; 6BR091; 6BR092; 6BR110; 6BR127; 6BR141; 6BR281
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresenius Medical Care North America, Lexington, MA, by telephone on March 24, 2006 and letter dated March 30, 2006.
Manufacturer: Erika De Reynosa S. A. de C. V., Reynosa, Tamps, Mexico. Firm initiated recall is ongoing.
REASON
Stay safe trigger body may not connect to the extension set and result in associated peritonitis
VOLUME OF PRODUCT IN COMMERCE
106,770 units
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
a) 18F Tri-Funnel Replacement Gastrostomy Tube, Product Code 000718,
Recall # Z-0836-06;
b) 20F Tri-Funnel Replacement Gastrostomy Tube, Product Code 000720,
Recall # Z-0837-06;
c) 22F Tri-Funnel Replacement Gastrostomy Tube, Product Code 000722,
Recall # Z-0838-06;
d) 24F Tri-Funnel Replacement Gastrostomy Tube, Product Code 000724
Recall # Z-0839-06
CODE
a) Lot numbers: NGPL1892, NGPL2765;
b) Lot number: NGPL2270;
c) Lot number: NGPL1161;
d) Lot numbers: NGPL2272, NGPL2556
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bard Access Systems, Inc., Salt Lake City, UT, by letter on April 6, 2006.
Manufacturer: Bard Medical, Nogales, Sonora, Mexico. Firm initiated recall is ongoing.
REASON
Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated balloon allows the tube to be placed, or slip into, the stomal tract and not the stomach, there is a risk of infusion of fluids into the peritoneum. This carries the risk of infection.
VOLUME OF PRODUCT IN COMMERCE
514 units
DISTRIBUTION
Nationwide, Canada, and Australia

______________________________
PRODUCT
Elasto-Gel Wound Dressings, 3 product codes: Elasto-Gel Plus, Product DR8050, Elasto-Gel, DR 8000, and Elasto-Gel, DR 8000LV (for foreign distribution only), 4'' x 4'', Sterile, each package contains 1 wound dressing, 5 packages per intermediate box, 20 intermediate boxes (100 pkgs) per case, Recall # Z-0841-06
CODE
Lot 111004A, Lot 110904A., Lot 102504A
RECALLING FIRM/MANUFACTURER
Southwest Technologies, Inc., N. Kansas City, MO, by letters on March 27, 2006. Firm initiated recall is ongoing.
REASON
The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit.
VOLUME OF PRODUCT IN COMMERCE
174 cases
DISTRIBUTION
Nationwide and Belgium

______________________________
PRODUCT
Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry. Model Number: 9914-00-0300, Recall # Z-0842-06
CODE
Serial Number: SN 9998; 9914-0300-0001 through 9914-0300-0058
RECALLING FIRM/MANUFACTURER
Candela Laser Corporation, Wayland, MA, by email on January 17, 2006, firm initiated recall is complete.
REASON
Handle fires even when the finger is off the switch.
VOLUME OF PRODUCT IN COMMERCE
59 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The IntraStent DoubleStrut LD Biliary Stent is a balloon expandable stent. It is intended as a permanently implanted device. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is designed to be crimped onto a non-compliant PTA balloon catheter that is indicated for biliary stent expansion. After mounting onto a balloon catheter, it is deployed and expanded by inflating the balloon. Model S15-36, Recall # Z-0829-06
CODE
Lot number: 494438
RECALLING FIRM/MANUFACTURER
Ev3, Inc, Plymouth, MN, by a Field Action Form on December 29, 2005. Firm initiated recall is ongoing.
REASON
IntraStent product S15-36 (P/N 90-1341-02) lot 494428 was labeled as IntraStent product S15-26 (P/N 90-1341-001). The stent is 10 mm longer than labeled.
VOLUME OF PRODUCT IN COMMERCE
6 devices
DISTRIBUTION
AR, GA, IN, MA, TN, and UT

______________________________
PRODUCT
EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit, Catalog #201-204, Recall # Z-0835-06
CODE
catalog #201-204: kit lot 09055514, exp. 14-JUL-2006, serum diluent lot 09055546, exp 04-OCT-2006; and kit lot 12055603, exp. 09-NOV-2006, serum diluent lot 11055595, exp. 18-NOV-2007
RECALLING FIRM/MANUFACTURER
Thera Test Laboratories, Inc., Lombard, IL, by telephone on October 26, 2005, and between January 4-9, 2006, and by letters dated January 9, 2006. Firm initiated recall is complete.
REASON
The specimen diluent contained in the kits was contaminated with a fungal growth. Also, a portion of kit lot 09055514 was shipped without the Data Sheet, part #201-204.
VOLUME OF PRODUCT IN COMMERCE
53 kits
DISTRIBUTION
CA, CT, MD, PA, OH, NJ and FL

______________________________
PRODUCT
Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043, Recall # Z-0840-06
CODE
Lot number: A3667
RECALLING FIRM/MANUFACTURER
Straumann Manufacturing, Inc, Andover, MA, by letter dated March 30, 2006.
Straumann Ag Inst, Basel, Switzerland. Firm initiated recall is ongoing.
REASON
The occlusal screw is inserted in the bottom of the healing cap body rather than correctly through the top.
VOLUME OF PRODUCT IN COMMERCE
103 units
DISTRIBUTION
Nationwide

 

ENFORCEMENT REPORT FOR MAY 10, 2006

###