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U.S. Department of Health and Human Services

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Enforcement Report for March 19, 2008

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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March 19, 2008
08-12

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT
Baby Elephant brand Mango Sheets, product of Thailand, net w. 165G/5.81 oz. UPC 8 852740 500010. Nutrition Facts serving size (82.5g) – Servings per Container: 2. The product is packaged in a plastic wrapped tray, Recall # F-222-8
CODE
MFD: 02 07 07, EXP: 05 07 08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hoque & Sons, Inc., Maspeth, NY, by letters dated September 7, 2007 and a Consumer Alert on September 10, 2007.
Manufacturer: Nongmon SMJ Products Co., LTD, Thailand. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (239 ppm) based on sampling & analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY, NJ, CT, MD, FL, OH, and Canada
___________________________________
PRODUCT
King Chief brand Dried Kudzu, Net wt. 6oz. UPC 6 881234 001896, Recall # F-223-8
CODE
UPC code only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Domega International Ltd. Inc., Brooklyn, NY, by press release on December 12, 2007.
Manufacturer: Unknown
REASON
The product contained undeclared sulfites based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY, MA, PA, IL, OH
___________________________________
PRODUCT
Giant Cashews in box labeled Harry & David Giant Cashews net wt. 4 OZ., Recall # F-224-8
CODE
Lot codes: 2507 MSL 15:00 through 2507 MSL 18:00 with a use by date of 6/28/08
RECALLING FIRM/MANUFACTURER
Bear Creek Operations, Inc. DBA Harry and David's, Medford, OR, by letter on January 18, 2008. Firm initiated recall is complete.
REASON
Some packages labeled as Giant Cashews contain another product, Whole Mixed Nuts (peanuts, pecans, brazil nuts, almonds, and cashews) in box labeled as Giant Cashews.
VOLUME OF PRODUCT IN COMMERCE
2130 Boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Sanford Limited Sustainable Seafood Mussel Meat, New Zealand Greenshell Mussels, Perna canaliculus; individually quick frozen raw mussel meat; 10 x 1 kg plastic bags per carton, Recall # F-225-8
CODE
PH No. 177, production dates of 23 May 2007 through 21 November 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Central Seaway Co., Inc. Northfield, IL, by telephone on November 27, 2007.
Manufacturer: Sanford South Island Limited, Havelock Wharf, Havelock, New Zealand. Firm initiated recall is complete.
REASON
The frozen raw mussel meat was found to be contaminated with Listeria monocytogenes bacteria.
VOLUME OF PRODUCT IN COMMERCE
1,725 cartons
DISTRIBUTION
WA and IL
___________________________________
PRODUCT
Organic Unhulled Sesame, USDA/QAI organic, Kosher, Net wt. 25 lbs and 5 lbs, Recall # F-226-8
CODE
Lot # 10706BPR725300
RECALLING FIRM/MANUFACTURER
Recalling Firm: Harvest Time Natural Foods, Eaton Rapids, MI, by telephone on January 4, 2008 and by letter on January 29, 2008.
Manufacturer:  Shares! (U) Ltd., Kauga Sub Country, Mukono, Uganda. Firm initiated recall is ccomplete.
REASON
FDA testing of a portion of this lot found it to be contaminated with salmonella.
VOLUME OF PRODUCT IN COMMERCE
17/25 lbs bags and 10/5 lb bags.
DISTRIBUTION
MI, IL, OH
___________________________________
PRODUCT
Certified Organic Natural Sesame, Net Wt. 25 lb, Recall # F-227-8
CODE
Lot# 10706BPR725300.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health & Nutrition Inc., Eaton Rapids, MI, by telephone on January 24, 2008.
Manufacturer: Shares! (U) Ltd., Mukono, Uganda. Firm initiated recall is complete.
REASON
An FDA sample of this lot tested positive for Salmonella.
VOLUME OF PRODUCT IN COMMERCE
87 - 25 pound bags.
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Shiloh Farms Organic Sesame Seeds Unhulled. The product is sold in 12 oz. plastic bags and shipped in cases containing 6 bags; UPC 047593303545, Recall # F-228-8
CODE
Lot #’s: 17503 and 17133
RECALLING FIRM/MANUFACTURER
Garden Spot Distributors, Inc., New Holland, PA, by press release on January 28, 2008 and by telephone on January 25-28, 2008. Firm initiated recall is ongoing.
REASON
An FDA sample of this lot tested positive for Salmonella.
VOLUME OF PRODUCT IN COMMERCE
196 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Bell's Fishery brand Smoked Whitefish Pate in 8 ounce and 16 ounce clear plastic tubs. Recall # F-229-8
CODE
Lots 100607, exp. 10/20/07 and 100807, exp. 10/28/07
RECALLING FIRM/MANUFACTURER
LTBB, Mackinaw City, MI, by shelf posting on October 23, 2007 and press release on October 25, 2007. Firm initiated recall is complete.
REASON
Product contains undeclared sub-ingredients including egg yolk and milk. Egg yolk is a sub-ingredient of salad dressing and horseradish sauce, which were used in manufacturing the pate. This product also utilized cream cheese, which contains milk.
VOLUME OF PRODUCT IN COMMERCE
120 pounds
DISTRIBUTION
MI
___________________________________
PRODUCT
"Green Paradise label" Fresh Italian basil, 12 x 1 lb box marked with lot # 1219 on the side of the box. Recall # F-230-8
CODE
Lot number: 1219
RECALLING FIRM/MANUFACTURER
Recalling Firm: Topline Specialty Produce, Los Angeles, CA, by telephone on December 18, 2007 and by letter and press release on December 19, 2007.
Manufacturer: Green Paradise S. de R.L. de C.V., Pescadero, Mexico. Firm initiated recall is ongoing.
REASON
This product is contaminated with Salmonella based on the FDA's analysis.
VOLUME OF PRODUCT IN COMMERCE
459 cartons (12 x 1 lb box /carton)
DISTRIBUTION
CA, IL and NY
___________________________________
PRODUCT
Peregrina Cheese, QUESO FRESCO, Fresh Cheese, foil wrapped in a plastic container, Weight - 14 oz., Plant # 36-8431, UPC 81742400246. INGREDIENTES: LECHE, CUAJO, SAL, Pasteurized Milk, Rennet, Salt, Added. Recall # F-231-8
CODE
Dairy Code: 3973
RECALLING FIRM/MANUFACTURER
Peregrina Cheese Company, Brooklyn New York, by visit on December 3, 2007. NY initiated recall is complete.
REASON
The cheese was found to be contaminated with Listeria monocytogenes based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
150 units - 14 oz. each
DISTRIBUTION
NY

___________________________________
PRODUCT
a) Weis Baker's Basket 18-count Fruit Miniatures. The product is available in four
    varieties - Nut Diamonds, Cheese Raspberry, Apricot and Mixed assortment.
    Product is a bakery dessert items that are received frozen, thawed, and sold for human
    consumption. UPC 210100-00000, Recall # F-232-8
b) Weis Baker's Basket two-pound platters of Mini-Fruit Diamonds. The product is
    available in four varieties - Nut Diamonds, Cheese Raspberry, Apricot and Mixed
    assortment. Product is a bakery dessert items that are received frozen, thawed, and
    sold for human consumption. UPC 210112-00000, Recall # F-233-8
CODE
a) and b)  Sell by date prior to and including Jan 5, 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Weis Markets Inc., Sunbury, PA, by press release on December 31, 2007.
Manufacturer: Mini Frost Foods Corp, North Haledon, NJ. Firm initiated recall is complete.
REASON
Product contains undeclared walnuts.
VOLUME OF PRODUCT IN COMMERCE
22,176 lbs
DISTRIBUTION
PA, NY, NJ, MD, and WV
___________________________________
PRODUCT
a) Frozen Salted Wild Yellow Croaker 2.2 lbs (35.2 oz) 1 kg Yeonggwang Gun; Product  
    Code BG1103, Recall # F-234-8;
b) Polar Bird Dried Yellow Croaker Product Code BG1121 - 2.2 lbs (1 kg) Size 200-
    300g; Product Code BGF1121B - Nt. Wt. 4.5 lbs (2.04kg) Size 200-300g, Recall
    # F-235-8;
c) Choripdong Frozen Yellow Croaker Product Code BG1124 - Bulk 29.73 pound case;
    Product Number BG1124A - Bulk 31.6 pound case; and Product Number BG1123 –
    Bulk 30.83 pound case. Recall # F-236-8
CODE
No lot codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Seoul Shik Poom Inc., Hillside, NJ, by telephone and letter beginning on January 18, 2008.
Manufacturer: Yu Myoung Fisheries, Beooseong Myun, Jeollanamdo
Korea. NY initiated recall is ongoing.
REASON
New York State Department of Agriculture and Markets sampled fish and found it to be uneviscerated.
VOLUME OF PRODUCT IN COMMERCE
4902 cases
DISTRIBUTION
NJ, NY, PA, MD, VA, GA, WA

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________
PRODUCT
a) Biscotti, Sweet Nana brand Dark Chocolate Dipped Hazelnut Biscotti, in 3.9 oz.
    plastic bags. Product is sold 24/3.9 oz. packages/case and 2/3.9 oz. bags/box  and
    12 boxes/case, Recall # F-241-8;
b) Biscotti, Tuscan Bakery brand White Chocolate Dipped Cappuccino Biscotti,
    sold 6 - 7.8 oz. paper bags/case, Recall # F-242-8;
c) Biscotti, Tuscan Bakery brand Orange Hazelnut Biscotti, in 8.0 oz. paper bags
    Product is sold 6 – 8.0 oz. bags/case, Recall # F-243-8;
d) Biscotti, Tuscan Bakery brand Gourmet Assortment Biscotti (one each of almond 
    amaretto, anise, cappuccino, chocolate hazelnut, cranberry pecan, lemon, orange
    hazelnut, and original biscotti in each bag) 8 oz. paper bag. Product sold 12 bags/case
    and individual 8 oz bags, Recall # F-244-8
CODE
a) Date codes of 03/16/08 through 06/12/08;
b) Date codes of 03/09/08 through 05/11/08; 
c) and d) Date codes of 04/14/08 through 07/05/08; 
RECALLING FIRM/MANUFACTURER
Edesia Foods, LLC, Portland, OR, by telephone on February 21, 2008 and by visit on February 25, 2008. Firm initiated recall is complete.
REASON
Products do not declare milk as sub-ingredient of butter. Butter is listed on label.
VOLUME OF PRODUCT IN COMMERCE
Hazelnut – 36 cs/24 pkg/3.9 oz, 79 cs/12 pkg/7.8 oz;
White chocolate – 12 cs/6 pkgs/7.8 oz;
Orange hazelnut – 18 cs/6 pkg/8 oz.;
Assortment – 7 cs/12 pkg/8 oz.
DISTRIBUTION
OR

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III

___________________________________
PRODUCT
a) OCP brand New Zealand Greenshell Mussels, Individually Quick Frozen on the Half
    Shell in cartons with net wt. 2 lb. (907g/32 oz.). UPC 826160 6002 3, Recall #
    F-237-8;
b) Greenshell Mussels (Perna Canaliculus). The product is referred to in the recall letter
    as “Meat (B Grade)”, Recall # F-238-8
CODE
a) Lot #’s: 13/25, 14/25, 60/18, 61/18;
b) Lot #’s: 13/25, 60/18, 61/18, 70/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mark Foods, Inc., by telephone on February 21, 2008 and by letters on February 22, and March 5, 2008.
Manufacturer: Centre Island Seafoods Limited, Whitianga, New Zealand. Firm initiated recall is ongoing.
REASON
The mussel meat supplier recalled the product because it exceeded New England’s standard of 230 cfu/100g E. coli.
VOLUME OF PRODUCT IN COMMERCE
1,126 cases
DISTRIBUTION
CA, GA, NJ, PA
___________________________________
PRODUCT
Fresh Express brand Gourmet Café Orchard Harvest Salad in 4.8 oz plastic package; Production code of S057 A 28, Recall # F-239-8
CODE
Best-if-used-by-date of March 09
RECALLING FIRM/MANUFACTURER
Fresh Express Fresh Foods, Salinas, CA, by letters on March 2, 2008. Firm initiated recall is ongoing.
REASON
Product contains “lightly frosted Almonds”, but does not declare in the ingredient label affixed to the bottom of the package, however, the primary display label on the top of the package and on the side of the package, and also on the top label of the inner ingredient tray reads, “LIGHTLY FROSTED ALMONDS”.
VOLUME OF PRODUCT IN COMMERCE
503 cases totaling 3,018 units
DISTRIBUTION
CA, CO, WA, NV
___________________________________
PRODUCT
Walgreens Refreshing Diet Cola Classic Soda, Caffeine Free, Sweetened with Splenda; 20 Fl. Oz. non-returnable plastic bottles/24 bottles per case; item 113244, UPC 0 49022 14144 5, Recall # F-240-8
CODE
Lots 082808 and 090208
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dr Pepper/ Seven Up, Inc., Plano, TX, by telephone and by e-mail on December 13, 2007.
Manufacturer: Cadbury Schweppes Bottling Group, Inc., Northlake, IL. Firm initiated recall is ongoing.
REASON
The diet cola was inadvertently labeled as "Caffeine Free" when the label should have read "Calorie Free". The product contains caffeine as an added ingredient.
VOLUME OF PRODUCT IN COMMERCE
1,055 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT
Carbon Dioxide USP in either 50 pound syphon cylinders, E size cylinders, or 50 pound cylinders, Recall # D-172-2008
CODE
All cylinders from US Welding in inventory as of 02/21/2008
RECALLING FIRM/MANUFACTURER
United States Welding, Incorporated, Denver, CO. by telephone and letter on February 21, 2008. Firm initiated recall is ongoing.
REASON
cGMP Deviation; Cylinders were not properly re-qualified prior to filling with Carbon Dioxide USP.
VOLUME OF PRODUCT IN COMMERCE
17/50 pound syphon cylinders, 308/E size cylinders, 214/50 pound cylinders
DISTRIBUTION
CO, ID, KS, NE, UT, and WY
___________________________________
PRODUCT
Caraco brand Metformin HCl tablets, USP, 1000 mg, in bottles of 100 (NDC 57664-474-88), 500 (NDC 57664-474-13) and 1000 (NDC 57664-474-18), Rx; Recall # D-176-2008
CODE
Lots 71810, 72015, 72017, 72022, 72080, 72082 and 72083
RECALLING FIRM/MANUFACTURER
Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI, by letter on February 20, 2008. Firm initiated recall is ongoing.
REASON
Tablet Weight; Some tablets may be undersized or oversized, which will result in the patient not receiving the expected dose.
VOLUME OF PRODUCT IN COMMERCE
22,156 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT
Sinus & Allergy Nasal Spray, Homeopathic, 0.8 fl. oz; NDC 59853-708-11, Recall # D-171-2008
CODE
Lot #: 28188W
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nutraceutical Corporation, Park City, UT, by telephone beginning February 4, 2008.
Manufacturer: Botanical Laboratories, Inc., Ferndale, WA. Firm initiated recall is ongoing.
REASON
Superpotent; benzalkonium chloride
VOLUME OF PRODUCT IN COMMERCE
8,840 bottles
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
a) Citracal® Prenatal Rx, Prenatal Prescription multi-vitamin and multi-mineral tablets,
    100 oral tablets, Rx only, NDC 0178-0852-01; Item #085201; Recall # D-173-2008;
b) Citracal® Prenatal + DHA, Rx Prenatal Vitamin Tablet and 250mg DHA Capsule;,
    Six 5-day Blister Packs per package, Rx only, NDC 0178-2300-30; Item #230030;
    Recall # D-174-2008;
c) Citracal® Prenatal 90 + DHA, Rx Prenatal Vitamin Tablet and 250mg DHA
    Capsule; Six 5-day Blister Packs per package, contains 90mg Carbonyl Iron,
    Rx only; NDC 0178-4200-30; Item #420030, Recall # D-175-2008
CODE
a) Lot #7A078, 7A079, 7B062, 7D045 and 7E047;
b) Lot #7A079, 7A118, 7B060, 7B061, 7C097, 7C098, 7D043, 7D044, 7E046,
    7E047, 7G010A, and 7G011A;
c) Lot #7A041, 7B033, 7D042 and 7D042A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mission Pharmacal Co., San Antonio, TX, by letter starting on December 28, 2007.
Manufacturer: Mission Pharmacal Co., Boerne, TX. Firm initiated recall is ongoing.
REASON
Potency of Vitamin A is not assured through labeled expiration.
VOLUME OF PRODUCT IN COMMERCE
14,329,007 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Breckenridge Pharmaceutical, Inc. Sulfatol Gel (Sodium Sulfacetamide 10% and Sulfur 5%) Net Wt. 1.5 fl. oz (45 ml, Rx. Contains100 mg of sodium sulfacetamide and 5% of sulfur in an emulsion base containing Urea 10%. NDC 51991-172-45, Recall # D-177-2008
CODE
Lot #: 60608E05/08
RECALLING FIRM/MANUFACTURER
Sheffield Laboratories, Division of Faria Limited LLC, New London, CT, by letter on February 21, 2008. Firm initiated recall is ongoing.
REASON
Subpotent; sodium sulfacetamide
VOLUME OF PRODUCT IN COMMERCE
23,256 tubes
DISTRIBUTION
CT

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0781-08
CODE
Lot numbers: 0330797; 0363693; 0278933; 0283597; 0269498; 0366966
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on August 8, 2006. Firm initiated recall is complete.
REASON
Blood products, leukoreduced after the required post collection time limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
LA and MS
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0787-08
CODE
Lot: 49GK12784
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by letter on August 31, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0789-08;
b) Platelets, Recall # B-0790-08;
c) Fresh Frozen Plasma, Recall # B-0791-08;
d) Recovered Plasma, Recall # B-0792-08
CODE
a) and b) Units: 8781502, 5575898;
c) Unit: 8781502;
d) Unit: 5575898
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, IL, by facsimile and telephone on November 27, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
IL and Switzerland
___________________________________
PRODUCT
Bone Talus, Part Code: 32647002 and Bone, Right ankle set/distal tibia talus, Part Code: 32747002, Recall # B-0795-08
CODE
Units: 070160001 and 070160-002,003
RECALLING FIRM/MANUFACTURER
AlloSource, Inc., Centennial, CO, by letter on October 29, 2007. Firm initiated recall is complete.
REASON
Human tissue, recovered from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and WI
___________________________________
PRODUCT
Platelets, Recall # B-0810-08
CODE
Units: V39628; V39417; V40927
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by fax on December 13, 2006. Firm initiated recall is complete.
REASON
Platelets, processed at an incorrect centrifuge setting, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TN and GA
___________________________________
PRODUCT
Corneal tissue for transplant, Recall # B-0844-08
CODE
Lots: 04-2015, 04-2016, 05-2031, 05-2032, 05-2185, 05-2186 06-2661, 06-2662
RECALLING FIRM/MANUFACTURER
Recalling Firm: Georgia Eye Bank, Atlanta, GA, by telephone and letter on/about October 19, 2007.
Manufacturer: Emory Clinic, Decatur, GA. Firm initiated recall is complete.
REASON
Human tissues from donors, tested using diagnostic test kits rather than FDA licensed or cleared screening tests for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc total), were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 corneas
DISTRIBUTION
GA and TN
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0849-08
CODE
Lot: 3822688
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on June 20, 2006. Firm initiated recall is complete.
REASON
Blood product, leukoreduced after the required post collection time limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Skin (Posterior Leg), Recall # B-0950-08
CODE
Lot: 20060013
RECALLING FIRM/MANUFACTURER
Transplant Services Center UT Southwestern Medical Center, Dallas, TX, by letter on November 8, 2006. Firm initiated recall is complete.
REASON
Skin allografts, with a positive fungus culture, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 allografts
DISTRIBUTION
IL
___________________________________
PRODUCT
Cornea, Recall # B-0962-08
CODE
Lot: 20060014
RECALLING FIRM/MANUFACTURER
Transplant Services Center UT Southwestern Medical Center, Dallas, TX, by letter on January 17, 2006. Firm initiated recall is complete.
REASON
Human cornes, positive for Staphylococcus aureus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 cornea
DISTRIBUTION
TX
___________________________________
PRODUCT
Sunquest Laboratory Blood Bank and Blood Donor Module v6.0.1 and v6.0.2, Recall # B-0963-08
CODE
Sunquest Blood Bank and Blood Donor version 6.0.1 distributed with Sunquest Laboratory version 6.1 (Specific Build 6.1.0.0131) and version 6.2 (Specific Build 6.2.0.0114 and 6.2.0.0119) and Blood Donor version 6.0.2 distributed with Sunquest Laboratory version 6.3 (Specific Build 6.3.0082 and 6.3.0086)
RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc., Tucson, AZ, by letter on January 23, 2008. Firm initiated recall is ongoing.
REASON
Software, with a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
129 clients had the affected code
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) OC Fem Hemi Condyle, Recall # B-0964-08;
b) Femur Distal Right, Recall # B-0965-08;
c) Bone-Tendon-Bone, Recall # B-0966-08;
d) Posterior Tibialis, Recall # B-0967-08;
e) Achilles Tendon w/ Calc, Recall # B-0968-08;
f) Anterior Tibialis, Recall # B-0969-08;
g) C/C Chips 1.7-10mm 30 cc, Recall # B-0970-08;
h) Canc crushed .1-4mm 30cc, Recall # B-0971-08;
i) Dowel 13mm (diam), Recall # B-0972-08
CODE
a) Serial numbers 002641371002 and 002641371001;
b) Serial number 002641371003;
c) Serial numbers 002641370011a, 002461379913a, 002641370014a;
d) Serial numbers 002641370018a and002641370017a;
e) Serial numbers: 002645170007a and 002645170008a;
f) Serial number 002641370020a and 002641370019a;
g) Serial numbers: 002641370046a, 002641370047a, 002641370048a, 002641370049a;
h) Serial numbers: 002641370027a, 002641370028a, 002641370029a, 002641370030a;
i) Serial numbers: 002641370037a and 002641370038a
RECALLING FIRM/MANUFACTURER
Musculoskeletal Transplant Foundation, Edison, NJ, by letter and telephone on October 29, 2007. Firm initiated recall is ongoing.
REASON
Tissue allografts associated with a pre-processing culture positive for group D Enterococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
NJ, LA, CA, UT, AZ, MS, CT, AR and Mexico
___________________________________
PRODUCT
Skin Non-Meshed (Burn Unit), Part Code: 5101-9B, Recall # B-0987-08
CODE
Lot: 0945110101
RECALLING FIRM/MANUFACTURER
AlloSource, Inc., Centennial, CO, by letter on December 31, 2007. Firm initiated recall is complete.
REASON
Human tissue distributed from a donor whose eligibility was questionable.
VOLUME OF PRODUCT IN COMMERCE
1 allograft
DISTRIBUTION
OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1001-08
CODE
Lot: 4847391
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on August 3, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
a) Platelets, Recall # B-1002-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1003-08
CODE
a) and b) Lot: 4255835
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on July 2, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Cornea, Recall # B-1017-08
CODE
Lot: 07130OD; 07130OS
RECALLING FIRM/MANUFACTURER
Upstate NY Transplant Service, Inc., Buffalo, NY, by letter on May 2, 2007. Firm initiated recall is complete.
REASON
Tissue products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
CA
___________________________________
PRODUCT
Sunquest Laboratory Blood Bank and Blood Donor  version 6.0.1 and 6.0.2, Recall # B-1031-08
CODE
Blood Bank and Blood Donor version 6.0.1 distributed with Sunquest Laboratory version 6.1 and version 6.2; Blood Bank and Blood Donor, version 6.0.2 distributed with Sunquest Laboratory version 6.3
RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc., Tucson, AZ, by letter on February 11, 2008. Firm initiated recall is ongoing.
REASON
Software, with a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
283 clients had the affected product
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Source Plasma, Recall # B-1042-08
CODE
Units: 7030429377, 7030428939, 7030427655, 7030426403, 7030423635, 7030422804, 7030422335, 7030420964, 7030419541, 7030417731, 7030417258, 7030416356, 7030415581, 7030414958, 7030414185, 7030412758, 7030411271, 7030406334, 7030404839, 7030404613, 7030402827, 7030402140, 7030401020, 7030400171, 7030399555, 7030398309, 7030397581, 7030396915, 7030395681, 7030394873, 7030394541, 7030393726, 7030393317, 7030389143, 7030388834, 7030388109, 7030387708, 7030386993, 7030386631, 7030384670, 7030381972, 7030381429, 7030380993, 7030380436, 7030375833, 7030373473, 7030373230
RECALLING FIRM/MANUFACTURER
ZLB Plasma Services, San Antonio, TX, by facsimile on February 13, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received piercings within one year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
47 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Plasma, Recall # B-1059-08
CODE
Unit: 027LQ34799
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone on November 3, 2007 and by letter on November 14, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected in a collection system that may have a potential defect which could compromise the sterility of the closed system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-1060-08
CODE
Unit: 027KJ34268
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone on November 14, 2007 and by letter dated November 15, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected in a collection system that may have a potential defect which could compromise the sterility of the closed system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WV
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1061-08
CODE
Unit: 027LH33676
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone on November 21, 2007 and by letter dated November 23, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected in a collection system that may have a potential defect which could compromise the sterility of the closed system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-1062-08
CODE
Unit: 027KN09716
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone on December 5, 2007 and by letter dated December 6, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected in a collection system that may have a potential defect which could compromise the sterility of the closed system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WV

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0939-08;
b) Fresh Frozen Plasma, Recall # B-0940-08
CODE
a) and b)  Lot: 2300711
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter on May 4, 2005. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving information regarding a post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Source Plasma, Recall # B-1036-08
CODE
Units: 4170039868, 4170039493
RECALLING FIRM/MANUFACTURER
ZLB Plasma, Tulsa, OK, by facsimile on January 25, 2006. 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
2 units
DISTRIBUTION
Germany

PRODUCT
Source Plasma, Recall # B-1037-08
CODE
Units: 364000434, 364009385, 364009829, 364013968
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Fort Worth, TX, by facsimile on November 29, 2006. 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
4 units
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

***CORRECTION***

Reference FDA Enforcement Report 08-11, March 12, 2008, Recall Z-0576-2008, Roche COBAS 6000 Clinical Chemistry analyzer. For the Distribution of this recall, the code listed as NB should be NE (Nebraska).
___________________________________
PRODUCT
a) Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size
    (diameter x length) 8 x 35, Catalog Number LG-PR0835, Recall # Z-0186-2008;
b) Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size
    (diameter x length) 8 x 40, Catalog Number LG-PR0840, Recall # Z-0187-2008;
c) Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size
    (diameter x length) 8 x 45, Catalog Number LG-PR0845, Recall # Z-0188-2008;
d) Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size
    (diameter x length) 8 x 50, Catalog Number LG-PR0850, Recall # Z-0189-2008;
e) Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size
    (diameter x length) 8 x 55, Catalog Number LG-PR0855, Recall # Z-0190-2008;
f) Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size
    (diameter x length) 8 x 80, Catalog Number LG-PR0880, Recall # Z-0191-2008
CODE
a) Lot Numbers:10294-1,10294-2,10294-3,10294-4 and 10294-5;
b) Lot Numbers: 10295-1,10295-2,10295-3,10295-4, and 10295-5;
c) Lot Numbers: 10296-1,10296-2,10296-3,10296-4, and 10296-5;
d) Lot Numbers: 10297-1,10297-2,10297-3,10297-4, and 10297-5;
e) Lot Numbers: 10298-1,10298-2,10298-3,10298-4, and 10298-5;
f) Lot Number: 10528
RECALLING FIRM/MANUFACTURER
Allez Spine, LLC, Irvine, CA, by email on July 30, 2007 and February 29, 2008. Firm initiated recall is complete.
REASON
Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation.
VOLUME OF PRODUCT IN COMMERCE
1, 578 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Abbott - CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators and CELL-DYN 16 Controls. Part/Model Number: 07H77-01, Recall # Z-0455-2008
CODE
Serial Numbers: 20835AY 19307AY 21801AY 21741AY 21739AY 22240AY 21698AY 19423AY 19490AY 18890AY 18332AY 19797AY 18112AY 19202AY 19960AY 22233AY 21224AY 21232AY 21212AY 21207AY 21276AY 22202AY 18871AY 18607AY 21349AY 19484AY 22226AY 19895AY 19623AY 18207AY 19125AY 22131AY 21197AY 20412AY 19189AY 19320AY 21347AY 22017AY 21936AY 19725AY 21354AY 20060AY 18310AY 19338AY 21758AY 21957AY 22013AY 18105AY 18169AY 18730AY 19288AY 18268AY 19386AY 20072AY 18992AY 21087AY 19633AY 18448AY 18991AY 19754AY 18763AY 18408AY 18705AY 18549AY 21287AY 19160AY 18735AY 18731AY 18847AY 18738AY 19392AY 19594AY 18182AY 18930AY 18706AY 21749AY 18627AY 18204AY 19650AY 18187AY 18197AY 18422AY 18551AY 18959AY 18558AY 19834AY 19839AY 20746AY 18579AY 19287AY 19153AY 19154AY 19501AY 18287AY 18957AY 20188AY 18255AY 19073AY 20730AY 19621AY 18589AY 18641AY 18477AY 18054AY 20784AY 20839AY 19001AY 18397AY 20806AY 20807AY 20841AY 19222AY 19836AY 18934AY 18699AY 18253AY 19319AY 20080AY 18592AY 22213AY 19665AY 18273AY 22217AY 18106AY 18838AY 18512AY 18307AY 18042AY 18440AY 18507AY 18936AY 18526AY 18774AY 19123AY 19405AY 18240AY 18506AY 18335AY 20763AY 18190AY 21891AY 21152AY 19654AY 19012AY 18196AY 18302AY 18511AY 18877AY 18893AY 19015AY 19090AY 19452AY 18721AY 18853AY 18598AY 19401AY 19402AY 19471AY 18591AY 19395AY 18725AY 18983AY 22181AY 18988AY 19622AY 21396AY 19661AY 21377AY 21375AY 18710AY 20272AY 19693AY 18740AY 21003AY 18286AY 18183AY 19391AY 18575AY 18113AY 20193AY 19284AY 19054AY 21962AY 20416AY 18257AY 18236AY 18176AY 21963AY 18226AY 18184AY 18075AY 18101AY 18467AY 21992AY 18615AY 18792AY 21763AY 18516AY 19018AY 18529AY 19612AY 18921AY 18420AY 18291AY 19916AY 19626AY 19741AY 18686AY 19037AY 18981AY 20253AY 18767AY 21348AY 18382AY 19728AY 18403AY 20641AY 19215AY 19466AY 19628AY 18117AY 19528AY 18033AY 18230AY 18719AY 19667AY 18819AY 18689AY 18829AY 19036AY 21746AY 18008AY 20065AY 20095AY 19717AY 20785AY 22045AY 20787AY 18732AY 18788AY 18670AY 18334AY 20900AY 21296AY 20097AY 19028AY 18623AY 22027AY 18508AY 22047AY 18329AY 18377AY 18192AY 18172AY 21368AY 20911AY 19174AY 19703AY 19595AY 19611AY 21331AY 20187AY 21525AY 18316AY 19706AY 19117AY 18053AY 21378AY 19389AY 18491AY 20759AY 19698AY 19252AY 18469AY 18348AY 19774AY 19716AY 18637AY 18944AY 20109AY 18049AY 19731AY 19099AY 19332AY 19306AY 19629AY 18711AY 20744AY 20203AY 19590AY 18284AY 21359AY 20654AY 19543AY 18295AY 18666AY 18037AY 18035AY 18304AY 18271AY 20939AY 19905AY 19101AY 20034AY 22214AY 18544AY 19045AY 21278AY 21106AY 20003AY 18064AY 18044AY 18441AY 18672AY 19600AY 18412AY 19166AY 18749AY 18758AY 19750AY 18779AY 18793AY 20907AY 19233AY 19685AY 21186AY 18750AY 21337AY 20876AY 20874AY 18742AY 18744AY 18743AY 21150AY 18604AY 22095AY 20754AY 21358AY 18879AY 18449AY 19586AY 19312AY 21342AY 20018AY 19134AY 19014AY 18910AY 18426AY 18880AY 18185AY 21423AY 18395AY 21330AY 19300AY 21340AY 18305AY 18219AY 18040AY 19095AY 20743AY 19512AY 21735AY 19406AY 22002AY 22156AY 22172AY 18157AY 19457AY 18484AY 20335AY 18384AY 18168AY 18862AY 18380AY 18048AY 18166AY 18388AY 19156AY 18392AY 18356AY 19745AY 19410AY 20250AY 18256AY 18698AY 18625AY 20064AY 18707AY 18755AY 20779AY 18045AY 19175AY 20768AY 19813AY 18201AY 21190AY 22211AY 20032AY 18703AY 19474AY 21748AY 19598AY 18509AY 18818AY 19898AY 20107AY 18947AY 19686AY 20755AY 18167AY 18752AY 19486AY 20340AY 20341AY 19620AY 18695AY 18471AY 18161AY 20054AY 20652AY 18205AY 18682AY 18567AY 21853AY 19753AY 22164AY 18431AY 20940AY 22227AY 19707AY 18885AY 19185AY 19701AY 18520AY 18430AY 18514AY 18708AY 21379AY 19510AY 18447AY 18260AY 19644AY 18841AY 18571AY 18425AY 18626AY 20750AY 19159AY 19023AY 19161AY 19659AY 18924AY 18125AY 19426AY 19089AY 21204AY 18022AY 19587AY 19885AY 21115AY 21886AY 18308AY 21740AY 21981AY 22117AY 18211AY 19718AY 19221AY 18999AY 19920AY 19103AY 18810AY 20068AY 20073AY 20076AY 20057AY 20051AY 18134AY 20052AY 20078AY 18202AY 18023AY 18684AY 18177AY 18527AY 18252AY 21068AY 19124AY 19411AY 18562AY 19092AY 20384AY 18958AY 18635AY 22104AY 19422AY 18178AY 18242AY 18648AY 21972AY 18111AY 19766AY 19842AY 18654AY 18649AY 18123AY 20386AY 18194AY 19816AY 18998AY 18265AY 19071AY 19438AY 18386AY 18590AY 19453AY 19894AY 21946AY 21743AY 22229AY 18303AY 18843AY 18913AY 22239AY 18438AY 18919AY 18418AY 18107AY 18564AY 19939AY 18778AY 19854AY 18296AY 19393AY 19923AY 18424AY 20309AY 18114AY 21353AY 21365AY 22212AY 22241AY 21952AY 21926AY 19335AY 19513AY 20053AY 18153AY 18771AY 18360AY 18608AY 18034AY 18174AY 18381AY 20844AY 18918AY 19030AY 19645AY 18428AY 18299AY 18239AY 18870AY 18138AY 18796AY 18270AY 18126AY 22201AY 19196AY 18410AY 18692AY 18005AY 20777AY 19087AY 18995AY 20079AY 18517AY 19636AY 18565AY 20323AY 20901AY 18519AY 18228AY 21528AY 18873AY 21392AY 18867AY 19102AY 18633AY 18681AY 19596AY 18697AY 21293AY 18503AY 19106AY 21987AY 18881AY 18722AY 22210AY 18415AY 18537AY 19121AY 18306AY 20278AY 19279AY 19719AY 19843AY 18845AY 18218AY 19192AY 21706AY 21333AY 21336AY 19082AY 18815AY 20071AY 18704AY 20997AY 21290AY 21745AY 21199AY 21943AY 19585AY 18096AY 18324AY 19936AY 18680AY 19127AY 20734AY 19418AY 19056AY 18780AY 19080AY 18421AY 19646AY 18094AY 18450AY 21114AY 19773AY 20736AY 21383AY 18617AY 18876AY 21366AY 19442AY 18777AY 21877AY 18274AY 21284AY 19263AY 21882AY 21009AY 18411AY 19712AY 18496AY 22150AY 18130AY 19640AY 19086AY 19088AY 18132AY 20992AY 22191AY 19815AY 19216AY 21279AY 18759AY 18135AY 19967AY 18555AY 18466AY 22028AY 19165AY 19137AY 18691AY 18552AY 18074AY 18683AY 18046AY 20357AY 18030AY 18293AY 20173AY 21265AY 18602AY 18609AY 20040AY 18227AY 19008AY 18530AY 18267AY 21264AY 20216AY 18605AY 19062AY 22220AY 18687AY 18290AY 20208AY 19357AY 21145AY 18976AY 18827AY 18175AY 18990AY 20113AY 19624AY 20056AY 21143AY 18933AY 18003AY 19325AY 18146AY 21335AY 21125AY 19145AY 18492AY 18500AY 19172AY 21308AY 18997AY 18320AY 19072AY 19079AY 20349AY 20994AY 19409AY 19733AY 18926AY 18155AY 18399AY 18741AY 19740AY 18596AY 21560AY 21213AY 21397AY 21666AY 21985AY 20108AY 19699AY 21205AY 20106AY 18419AY 18109AY 22004AY 18018AY 19060AY 18982AY 19053AY 18432AY 18693AY 18060AY 19310AY 19132AY 19074AY 20256AY 18024AY 18646AY 21990AY 19200AY 20012AY 18726AY 18437AY 18235AY 19991AY 19425AY 18163AY 19220AY 18390AY 19637AY 19503AY 19647AY 22208AY 19993AY 18766AY 18642AY 18566AY 22133AY 21975AY 20808AY 18522AY 19544AY 18854AY 18878AY 19777AY 19445AY 20672AY 18468AY 19852AY 20659AY 19935AY 18674AY 18675AY 19592AY 19403AY 18765AY 18912AY 19760AY 19934AY 19999AY 21210AY 19758AY 20321AY 19100AY 20125AY 18524AY 19237AY 18632AY 18355AY 18824AY 18911AY 18769AY 18546AY 18041AY 19732AY 18523AY 18414AY 18950AY 18214AY 18800AY 18237AY 19919AY 19020AY 21211AY 19492AY 18181AY 19734AY 19736AY 19702AY 19126AY 18210AY 18821AY 18143AY 19264AY 18550AY 20663AY 18199AY 22183AY 20765AY 18668AY 21958AY 20274AY 18209AY 18860AY 19440AY 21927AY 19499AY 18213AY 19232AY 19104AY 20175AY 19470AY 20006AY 21839AY 20000AY 19521AY 19588AY 20224AY 18232AY 18811AY 19901AY 19833AY 18224AY 19107AY 18573AY 20761AY 19917AY 21549AY 19197AY 19238AY 22006AY 18043AY 19094AY 19954AY 21274AY 21708AY 18948AY 18259AY 18417AY 20235AY 19947AY 19437AY 18393AY 20081AY 19173AY 18188AY 20653AY 19000AY 18090AY 19496AY 22145AY 19404AY 18739AY 18754AY 19579AY 21928AY 20201AY 18715AY 19241AY 18855AY 18017AY 20668AY 20662AY 20669AY 20075AY 18076AY 21555AY 21835AY 19911AY 19721AY 19108AY 20424AY 18531AY 18521AY 21754AY 19964AY 19962AY 19961AY 21974AY 19897AY 21854AY 18916AY 18857AY 20099AY 19966AY 19972AY 19985AY 20026AY 20788AY 19697AY 19687AY 19708AY 19696AY 20330AY 21790AY 19272AY 20197AY 20035AY 22132AY 20206AY 18541AY 20356AY 20242AY 20764AY 20783AY 19658AY 19555AY 18311AY 19950AY 20437AY 20667AY 20651AY 21262AY 19414AY 18327AY 18353AY 21188AY 20083AY 18165AY 20902AY 20211AY 19081AY 19282AY 20851AY 19679AY 20741AY 20747AY 19609AY 18198AY 18775AY 18830AY 18545AY 20649AY 20773AY 20774AY 20103AY 20611AY 21104AY 18217AY 21198AY 22166AY 21146AY 21182AY 21183AY 21178AY 18909AY 18317AY 18923AY 20311AY 20647AY 19384AY 21847AY 20269AY 18004AY 21922AY 21848AY 21889AY 20903AY 21175AY 20027AY 20031AY 20039AY 19913AY 18429AY 18072AY 20082AY 21949AY 22129AY 21381AY 21116AY 20233AY 21394AY 21285AY 19352AY 21548AY 22174AY 21369AY 19063AY 18832AY 21712AY 18292AY 19005AY 18886AY 18179AY 21075AY 21703AY 21910AY 19061AY 18673AY 21676AY 21734AY 22046AY 21794AY 21846AY 21773AY 19505AY 21857AY 18283AY 18200AY 21793AY 19946AY 21948AY 19236AY 21969AY 22123AY 20007AY 20732AY 19957AY 21940AY 18756AY 21947AY 18762AY 18574AY 19762AY 18278AY 22215AY 21067AY 19003AY 21924AY 22022AY 21904AY 19227AY 18901AY 21944AY 20661AY 18223AY 20067AY 22048AY 22125AY 21984AY 21991AY 19971AY 22231AY 21726AY 22225AY 22146AY 22234AY 19545AY 18745AY 20623AY 22000AY 20655AY 21566AY 18398AY 22121AY 19509AY 19295AY 19502AY 18225AY 18110AY 20769AY 21753AY 22207AY 21148AY 18636AY 18050AY 21189AY 18139AY 21725AY 21913AY 21911AY 19642AY 21187AY 22189AY 18446AY 18319AY 22029AY 19230AY 18951AY 19729AY 18300AY 18315AY 21070AY 21154AY 21000AY 21765AY 18532AY 22248AY 21898AY 21986AY 18443AY 19385AY 19776AY 19727AY 19164AY 19421AY 19477AY 18093AY 18277AY 20753AY 18553AY 21373AY 21977AY 20923AY 21372AY 19318AY 19561AY 18644AY 20931AY 18288AY 21147AY 18786AY 18372AY 22107AY 18611AY 22237AY 20002AY 19424AY 20665AY 20666AY 18554AY 18770AY 19035AY 19285AY 18504AY 19710AY 18733AY 19400AY 19388AY 21918AY 18433AY 21956AY 21180AY 18389AY 19847AY 18028AY 18052AY 18027AY 18001AY 18011AY 18002AY 18016AY 18010AY 18006AY 20648AY 18015AY 18678AY 18047AY 18019AY 18029AY 18009AY 18020AY 18014AY 18012AY 18137AY 22170AY 18026AY 18039AY 18021AY 19536AY 18013AY 18063AY 19677AY 18133AY 18038AY 18025AY 18036AY 18031AY 18098AY 18056AY 18059AY 18055AY 18032AY 18058AY 18057AY 18121AY 18071AY 18078AY 18080AY 18776AY 18062AY 18136AY 18089AY 18103AY 18097AY 18095AY 18100AY 18099AY 18084AY 18085AY 18083AY 18077AY 18092AY 18104AY 19303AY 18081AY 18091AY 18119AY 18115AY 18108AY 18127AY 18131AY 18122AY 18118AY 18102AY 19198AY 18144AY 18140AY 18164AY 18150AY 19451AY 18141AY 18193AY 18148AY 18322AY 18152AY 18173AY 18162AY 18158AY 21184AY 18171AY 18191AY 18170AY 18195AY 18189AY 18186AY 19356AY 18203AY 18836AY 18208AY 18206AY 18238AY 18241AY 18254AY 18212AY 18269AY 18258AY 18337AY 18289AY 18285AY 18294AY 18264AY 18282AY 18297AY 18313AY 18312AY 18280AY 18331AY 18298AY 18379AY 18336AY 18333AY 18321AY 18309AY 18301AY 18374AY 18376AY 18383AY 18350AY 18387AY 18351AY 19887AY 18396AY 18391AY 18394AY 18314AY 18400AY 18318AY 18401AY 18378AY 18385AY 18439AY 18407AY 18406AY 18416AY 18409AY 18434AY 18462AY 18534AY 18357AY 18402AY 18436AY 18435AY 20775AY 18442AY 20252AY 18444AY 18404AY 18423AY 18445AY 18427AY 18405AY 18452AY 18413AY 18486AY 18470AY 18485AY 18483AY 18472AY 18465AY 18451AY 18655AY 18505AY 18479AY 18475AY 18515AY 18513AY 20059AY 18494AY 18510AY 18518AY 18528AY 20237AY 19069AY 18525AY 18568AY 19224AY 18533AY 18630AY 18538AY 18535AY 18547AY 18539AY 18536AY 18543AY 18542AY 18599AY 18540AY 18548AY 18556AY 18557AY 19943AY 18570AY 18624AY 18563AY 18572AY 18569AY 19171AY 18601AY 18600AY 18914AY 18634AY 18696AY 18595AY 18593AY 18613AY 18594AY 18606AY 18616AY 18652AY 20025AY 18618AY 20024AY 18628AY 18629AY 18657AY 18638AY 18728AY 18631AY 18639AY 18645AY 18650AY 18640AY 18651AY 18667AY 18647AY 18643AY 18679AY 19093AY 18653AY 18748AY 18671AY 18656AY 18702AY 18694AY 18669AY 18677AY 18685AY 18688AY 18709AY 18712AY 18713AY 18690AY 18720AY 18676AY 18700AY 20243AY 18734AY 18723AY 18747AY 18736AY 20234AY 21001AY 18789AY 18714AY 18753AY 18751AY 18737AY 19013AY 18941AY 18746AY 18757AY 18791AY 18761AY 18760AY 18764AY 18768AY 18773AY 18781AY 18795AY 18798AY 18797AY 21073AY 18802AY 18809AY 19350AY 18814AY 18834AY 18869AY 18931AY 18816AY 18822AY 18820AY 18823AY 18817AY 18828AY 18852AY 18825AY 18826AY 18831AY 18833AY 18835AY 18837AY 18839AY 18840AY 18863AY 18855AY 18868AY 18861AY 18858AY 18866AY 18994AY 19273AY 19522AY 18907AY 18875AY 19096AY 18865AY 18864AY 21341AY 18986AY 18859AY 18883AY 18897AY 18884AY 18889AY 18872AY 18882AY 18915AY 18949AY 18892AY 18906AY 18902AY 19339AY 18917AY 18888AY 18856AY 18922AY 18920AY 18929AY 18908AY 18935AY 22149AY 22153AY 19032AY 18928AY 18927AY 18932AY 18966AY 18962AY 18955AY 18961AY 18980AY 20770AY 18985AY 18979AY 18989AY 18984AY 18987AY 18993AY 19025AY 18996AY 19002AY 19004AY 19019AY 19024AY 19021AY 19026AY 19022AY 19031AY 19029AY 19033AY 19034AY 19048AY 19046AY 19067AY 19068AY 19047AY 19057AY 19058AY 19122AY 19193AY 19064AY 19070AY 19075AY 19076AY 19065AY 19077AY 19078AY 19085AY 19083AY 19118AY 19129AY 19091AY 19097AY 19098AY 19130AY 19105AY 19109AY 19136AY 19110AY 19111AY 19113AY 19116AY 19119AY 22003AY 19128AY 19155AY 19120AY 19605AY 21475AY 19131AY 19761AY 19458AY 19135AY 19133AY 19147AY 19146AY 19148AY 19167AY 19168AY 19162AY 19460AY 19163AY 19169AY 19170AY 19190AY 19184AY 19187AY 22101AY 19186AY 19188AY 19191AY 19194AY 19195AY 21120AY 19562AY 19203AY 19206AY 19218AY 19217AY 19219AY 19226AY 19225AY 19229AY 19223AY 19231AY 19235AY 19234AY 19242AY 19240AY 19239AY 19464AY 19243AY 19280AY 19278AY 19277AY 19276AY 19265AY 19283AY 19281AY 19286AY 20418AY 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RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letter on October 27, 2006. Firm initiated recall is ongoing.
REASON
Incorrect Results: Hemoglobin results in donor samples assayed on the CELL-DYN 1800 System vary more than expected across the range of claimed operating temperatures of 18 degrees Celcius to 30 degrees Celcius.
VOLUME OF PRODUCT IN COMMERCE
4,224 Systems
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
a) Biomet RINGLOC + Instrumentation Impactor Plate, Size 20; REF/Part #: 31-400620,
    Recall # Z-0700-2008;
b) Biomet RINGLOC + Instrumentation Impactor Plate, Size 21; REF/Part #: 31-400621,
    Recall # Z-0701-2008;
c) Biomet RINGLOC + Instrumentation Impactor Plate, Size 22; REF/Part #: 31-400622,
    Recall # Z-0702-2008;
d) Biomet RINGLOC + Instrumentation Impactor Plate, Size 23; REF/Part#: 31-400623,
    Recall # Z-0703-2008;
e) Biomet RINGLOC + Instrumentation Impactor Plate, Size 26; REF/Part#: 31-400626,
    Recall # Z-0704-2008;
f) Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628,
    Recall # Z-0705-2008
CODE
a) Lot Number: 038670;
b) Lot Number: 038680;
c) Lot Number: 038690;
d) Lot Number: 038700;
e) Lot Number: 038710;
f) Lot Number: 038730;
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated October 18, 2007. Firm initiated recall is complete.
REASON
The instrument will not lock onto the impactor handle; the device was distributed without assembly of the Bal Seal component.
VOLUME OF PRODUCT IN COMMERCE
141 units
DISTRIBUTION
Nationwide, Germany, The Netherlands, Sweden and The United Kingdom
___________________________________
PRODUCT
a) GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model 7600,
    Recall # Z-0716-2008;
b) GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC, Model 7700,
    Recall # Z-0717-2008
CODE
a) All serial numbers;
b) All Serial Numbers beginning with 79-, which is followed by 2006, 2008, 2009, 2011, 2013, 2014, 2015, 2016, 2018, C0513-C, C0878, C0986, C1016, C1017, C1021, C1037, C1038, C1043, C1044, C1052, C1053, C1054, C1055, C1056, C1060, C1061, C1062, C1063, C1065, C1068, C1069, C1070, C1080, C1082, C1083, C1087, C1088, C1091, C1155, C1162, C1165, C1170, C1176, C1180, C1181, C1184, C1187, C1188, C1189, C1190-M, C1192, C1193, C1195, C1196, C1197, C1198, C1199, C1201, C1203, C1204, C1207, C1208, C1209, C1210, C1212, C1213, C1214, C1216, C1219, C1236, C1238, C1241, C1246, C1248, C1249, C1254, C1255, C1259, C1260, C1263, C1265, C1266, C1269, C1271, C1272-RC, C1275, C1279, C1281, C1306, C1427, C1434, C1437, C144, C1446, C1461, C1476, C1501, C1507-M, C1511, C1529, C153, C1557, C1571, C1578, C158-RC, C1697, C1703, C1716, C1721, C1835, C1841, C1883, C189, C1903, C193, C2058, C2061, C3005, C3050, C3052a, C3053, C3055C3056, C3057, C3058, C3059, C3062, C3063, C3073, C3074, C3075, C3076, C3077, C3078, C3081, C3082, C3084, C3094, C3112, C3114, C3124, C3126, C3130, C3138, C3142, C3144, C3279, C601, C604, C605, C606-RC, C608, C609, C610, C613, C614, C616, C617, C618, C619, C620, C625, C626, C631, C633, C636, C640, C641, C647, C647-RC, C648, C651, C656, C666, C667, C669, C675, C676, C679, C680, C681, C682, C683, C684, C685, C689, C691, C692, C693, C694, C698, C699, C7084, C727, C744, C753, C774, C787, C800, C807, C808, C819, C855, C860, C863, C870, C873-RC, C878, C883-M, C886, C895-M, C904, C905, C906, C907-M, C911, C913, C916, C917-M, C922, C923-M, C926, C927, C928, C930, C933, C937, C938, C942, C943, C948, C949, C953-C, C953-M, C954, C955, C957-M, C970-M, C976, C982, C986, C987, S0607, S0970M, S1000, S1001, S1020, S1024, S1058, S1059, S1071, S1077, S1078, S1098, S1108, S1145, S1169-M, S1221-M, S1287, S1322, S1497, S1545, S1581, S1686, S271, S300, S418, S605, S615, S621, S622, S627, S628, S629, S630, S632, S634, S635, S637, S638, S639, S643, S644, S645, S646, S649, S649a, S650, S652, S653, S655, S657, S658, S659, S660, S661, S662, S663, S664, S668, S670, S671, S672, S674, S676, S677, S678, S686, S687, S696, S699, S700, S705, S732, S738, S746, S748, S766, S773, S779S766-RC, S791, S792, S798, S805-RC, S806, S814, S815, S816, S817, S818, S823, S824, S825, S829, S831, S838, S843, S845, S846, S846-M, S853, S854, S858, S859, S862, S863, S865-M, S867, S869, S874, S875, S879, S882, S884, S885-M, S891, S896, S900, S901, S901-M, S959, S964, S965, S969, S981, S988, S992, and S997
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Inc., Salt Lake City, UT, by letters on or about September 6, 2007. Firm initiated recall is ongoing.
REASON
Unnecessary operator exposure; X-ray machine may allow unwanted x-ray exposure to the operator.
VOLUME OF PRODUCT IN COMMERCE
709 systems
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Bayer Contour TS blood glucose monitoring system with 10 blood glucose test strips
    enclosed; Products 1802 and 1802N (U.S.), 1810 (Korea), 1811 (India, Korea and
    Mexico) and 1825 (Mexico), Recall # Z-0931-2008;
b) Bayer Contour TS blood glucose test strips packaged in packs of 10, 25, 50 and 100
    strips; U.S. Product codes 1820, 1823, 1825 and 9578; 1835 and 1836 (Korea);
    1832, 1833 and 1837 (India); 1823 and 1825 (Mexico), Recall # Z-0932-2008
CODE
a) Test strip lots: WK7DD3E31A, WK7DD3E31B, WK7DD3E31D, WK7DD3E51C,
    WK7DD3E51D, WK7ED3E02A, WK7ED3E04A, WK7ED3E51B, WK7ED3E52A,
    WK7ED3E52C, WK7ED3E52D, WK7ED3E52E, WK7ED3E53C, WK7ED3E53F,
    WK7FD3E01C, WK7FD3E01D, WK7FD3E01E, WK7FD3E04A, WK7FD3E31C,
    WK7FD3E31D, WK7FD3E31E, WK7FD3E31F, WK7FD3E31H, WK7FD3E32C,
    WK7FD3E34A, WK7FD3E34B, WK7FD3E51A, WK7FD3E51B, WK7GD3E01A,
    WK7GD3E02A, WK7GD3E05A, WK7GD3E51A and WK7GD3E51B;
b) Test strip lots: WK7DD3E31A, WK7DD3E31B, WK7DD3E31D, WK7DD3E51C,
    WK7DD3E51D, WK7ED3E02A, WK7ED3E04A, WK7ED3E51B, WK7ED3E52A,
    WK7ED3E52C, WK7ED3E52D, WK7ED3E52E, WK7ED3E53C, WK7ED3E53F,
    WK7FD3E01C, WK7FD3E01D, WK7FD3E01E, WK7FD3E04A, WK7FD3E31C,
    WK7FD3E31D, WK7FD3E31E, WK7FD3E31F, WK7FD3E31H, WK7FD3E32C,
    WK7FD3E34A, WK7FD3E34B, WK7FD3E51A, WK7FD3E51B, WK7GD3E01A,
    WK7GD3E02A, WK7GD3E05A, WK7GD3E51A and WK7GD3E51B
RECALLING FIRM/MANUFACTURER
Bayer Healthcare LLC, Mishawaka, IN, by press release and letter on December 21, 2007. Firm initiated recall is ongoing.
REASON
Inaccurate Test Strips Results: Results in blood glucose readings with a positive bias are outside the product specifications. Patient test results may demonstrative results 5 percent to 17 percent higher.
VOLUME OF PRODUCT IN COMMERCE
97,000 bottles of test strips
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232, Recall # Z-0933-2008
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sound Surgical Technologies, LLC, Louisville, CO, by letter on December 28, 2007.
Manufacturer: Linemaster Switch Corporation, Woodstock, CT. Firm initiated recall is ongoing.
REASON
Failure to shut-off: Surgical equipment, activated by a wireless foot switch with VASER system, may remain powered on when switch is no longer depressed.
VOLUME OF PRODUCT IN COMMERCE
127 switches
DISTRIBUTION
Nationwide, Colombia, Costa Rica and Switzerland
___________________________________
PRODUCT
a) Stryker VertePort, 10 G Access Cannula w/Long Stylet System, REF 306-400, Qty 6;
    For use with the Stryker PCD Precision System and ACM Delivery System, Rx only,
    sterile, Recall # Z-1192-2008;
b) Stryker VertePort, 10 G Cement Cannula, REF 306-410, Qty 18; For use with the
    Stryker PCD Precision System and ACM Delivery System, Rx only, sterile,
    Recall # Z-1193-2008
c) Stryker VertePort, 10 G Access Canula (short), REF 306-430, Qty 6; For use with
    the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile,
    Recall # Z-1194-2008;
d) Stryker VertePort , 11 G Cement Cannula, REF 306-510 , Qty 18; For use with the
    Stryker PCD Precision System and ACM Delivery System, Rx only, sterile,
    Recall # Z-1195-2008
CODE
a) All Lots- BCWD and BENC;
b) All Lots-BDB4, BDMA, BF4C, BF80, BFA4, BMWH and BQ5L;
c) All Lots-BCXE and BENB;
d) All Lots-BB43, BDL5, BE0M, BE1D, BE77, BF4K, BMWJ, BNW8, BNW9 and
    BQ5W
RECALLING FIRM/MANUFACTURER
Stryker Instruments Division of Stryker Corporation, Portage, MI, by letter dated February 13, 2008. Firm initiated recall is ongoing.
REASON
Mis-labeling; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy).
VOLUME OF PRODUCT IN COMMERCE
953 boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999LV1,
    Exu-Dry Large Burn Vest, Recall # Z-1199-2008;
b) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999LJ1,
    Exu-Dry Large Burn Jacket, Recall # Z-1200-2008;
c) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999LPL,
    Exu-Dry Leg Dressing, Recall # Z-1201-2008;
d) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L72,
    Exu-Dry Sheet 36"x72" Non-Permeable, Recall # Z-1202-2008;
e) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L73,
    Exu-Dry Sheet 36"x72" Non-Permeable with Straps, Recall # Z-1203-2008;
f) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L74,
    Exu-Dry Sheet 36"x72" Permeable with Straps Quilted, Recall # Z-1204-2008;
g) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999MJ1,
    Exu-Dry Medium Burn Jacket, Recall # Z-1205-2008;
h) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M36,
    Exu-Dry Pad 24"x36" Non-Permeable Heavy Absorbency, Recall # Z-1206-2008;
i) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999BP1,
    Exu-Dry Adult Buttocks Dressing, Recall # Z-1207-2008;
j) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999028,
    Exu-Dry Dressing, 20" x 28", Recall # Z-1208-2008;
k) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999018,
    Exu-Dry Dressing, 15" x 18", Recall # Z-1209-2008;
l) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999024,
    Exu-Dry Dressing, 15" x 24", Recall # Z-1210-2008;
m) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M09,
    Exu-Dry Dressing, 15" x 9", Recall # Z-1211-2008;
n) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M18,
    Exu-Dry Dressing, 15" x 18", Recall # Z-1212-2008;
o) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M24,
    Exu-Dry Dressing, 15" x 24", Recall # Z-1213-2008;
p) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M28,
    Exu-Dry Dressing, 15" x 28", Recall Z-1214-2008;
q) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M37,
    Exu-Dry Pad 24"x36" Non-Permeable Medium Absorbency, Recall Z-1215-2008;
r) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M38,
    Exu-Dry Pad 24"x36" , Permeable Medium Absorbency, Recall # Z-1216-2008;
s) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999SJ1,
    Exu-Dry Small Burn Jacket, Recall # Z-1217-2008
CODE
a) Lot Numbers: 70720, and 70704;
b) Lot Numbers: 70612, and 70702;
c) Lot Numbers:070613, 070512, and 070418;
d) Lot Numbers: 70702, 70609, 70508, and 70424;
e) Lot Numbers: 70703, 70610, and 70509;
f) Lot Numbers: 70718, 70611, and 70510;
g) Lot Numbers: 70709, and 70523;
h) Lot Numbers: 70708, 70620, and 70520;
i) Lot Numbers: 70607, 70506, and 70629;
j) Lot Number; 70628;
k) Lot Number; 70501;
l) Lot Number; 70502;
m) Lot Number; 70516;
n) Lot Number; 70517;
o) Lot Number: 70518;
p) Lot Numbers; 70707, 70723, and 70805;
q) Lot Numbers; 70414, 70521, 70621, and 70708;
r) Lot Numbers; 70522, and 70622;
s) Lot Number 70710
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith and Nephew, Inc., Wound Management Division, Largo, FL, by letter dated November 21, 2007.
Manufacturer: Winer Industries (Shenzhen) Co., Ltd., Shenzhen, China. Firm initiated recall is ongoing.
REASON
Sterility (package integrity) compromised: Distribution of product that did not meet specifications, open seals.
VOLUME OF PRODUCT IN COMMERCE
12,840 individual dressings
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III

__________________________________
PRODUCT
Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Recall # Z-0572-2008
CODE
Lot Number: 474042
RECALLING FIRM/MANUFACTURER
Exactech, Inc. Gainesville, FL, letter on October 31, 2007. Firm initiated recall is ongoing.
REASON
Mislabeled: A ten piece lot of 140-32-03, 12/14 BIOLOXforte Alumina Femoral Heads 32mm (1069020 - 1069029), from Ceramtec were incorrectly labeled as 140-28-03 12/14 BIOLOXforte Alumina Femoral Heads, 28mm.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
NY, OH and TN

END OF ENFORCEMENT REPORT FOR MARCH 19, 2008

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