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U.S. Department of Health and Human Services

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Enforcement Report for September 10, 2008

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

 

September 10, 2008
08-36

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT 
KORICA brand Mut Gung Sweetened Ginger --- Net Wt: 7 oz (200g) --- UPC 8 935129 781542 --- Product of Vietnam --- Nutrition Facts: Serving size 85 g (3 oz) --- Servings Per Container about 3. The product is packaged in a plastic tub, Recall # F-533-8
CODE
UPC barcode only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Domega International Co., LTD. Brooklyn, NY, by press release and letter on July 16, 2008.
Manufacturer: Vinh Hiep Co., Ltd. Ho Chi Minh City, Vietnam. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (2278 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
25 cases (48 packages per case)
DISTRIBUTION
NY, PA, MA, CT
___________________________________
PRODUCT 
Bulk Jalapeno Peppers in 36lb. crates and 50lb. poly bags; no labeling, lots or product codes; Produce of Mexico, Recall # F-534-8
CODE
All products shipped since June 30, 2008.
RECALLING FIRM/MANUFACTURER
Agricola Zaragoza, McAllen, TX, by telephone on July 21, 2008 and letters on July 22, 2008. Firm initiated recall is ongoing.
REASON
Jalapeno peppers were found to be contaminated with Salmonella saintpaul based on FDA’s analysis.
VOLUME OF PRODUCT IN COMMERCE
941/36lb. crates and 37/50lb. bags
DISTRIBUTION
GA, TX
___________________________________
PRODUCT 
Little Bear brand Cilantro, Product code #4889 (this designates that the product is cilantro - it is not a specific manufacturing code). Product was sold in boxes, Recall # F-535-8
CODE
Product recalled was sold between 7/8/08 and 7/10/08.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Miami Growers Inc., Jersey City, NJ, by letters on July 31, 2008.
Manufacturer: Double J Farms, Bridgeton, NJ. Firm initiated recall is ongoing.
REASON
Cilantro collected by FDA on 7/8/08 was analyzed and found to be contaminated with  Salmonella muenchen.
VOLUME OF PRODUCT IN COMMERCE
71 boxes of approximately 60 x 1/2 pound bunches
DISTRIBUTION
NJ, PA
___________________________________
PRODUCT 
Cilantro was distributed in either 60 bunch boxes or in repacked 3 bunch plastic bags. Product distributed in 60 bunch boxes the label reads "Cascade Pacific Vegetables Produce of U.S.A. 5 Doz. Cilantro. Product distributed in 3 bunch plastic bags the label reads "Fresh Produce Fruits & Vegetables 5 a Day for Better Health! Nutra-Facts". Cilantro distributed in 3 bunch plastic bags was commingled with other produce to fill specific customer orders. Each specific customer order is shipped in cardboard boxes with no labeling, Recall # F-536-8
CODE
Not coded
RECALLING FIRM/MANUFACTURER
Recalling Firm: Triple B Corp., Portland, OR, by telephone, letter by e-mail or fax on July 31, 2008.
Manufacturer: Cal-Farms, Oregon City, OR. Firm initiated recall is complete.
REASON
The Oregon Department of Agriculture found the product contaminated with Salmonella muenchen.
VOLUME OF PRODUCT IN COMMERCE
28 cases – 7 cases comingled with 21 cases
DISTRIBUTION
OR, WA
___________________________________
PRODUCT 
Valle del Sol brand Jalapeno Peppers, Recall # F-537-8
CODE
Product purchased on or before August 1, 2008. No product code.
RECALLING FIRM/MANUFACTURER
Bashas’ Distribution Center, Chandler, AZ, by advising in retail stores on August 1, 2008. Firm initiated recall is complete.
REASON
Product has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
112 cases
DISTRIBUTION
AZ
___________________________________
PRODUCT 
Spaghetti Sauce Mix, Gold Medal brand, packaged in 1.37 ounce pouch, 24 pouches/case. UPC 0-52500-02104-7, Recall # F-538-8
CODE
Lot: 8119R
RECALLING FIRM/MANUFACTURER
C. F. Sauer Co., Inc., Richmond, VA, by telephone and e-mail on July 31, 2008 and August 1, 2008 and by press release on August 4, 2008. Firm initiated recall is ongoing.
REASON
Retail food product contains undeclared milk ingredients.
VOLUME OF PRODUCT IN COMMERCE
282 cases
DISTRIBUTION
OH, MS, MI, KY, AL, NC, TN
___________________________________
PRODUCT 
Vita Premium Quality Sliced Smoked Atlantic Nova Salmon; frozen or refrigerated cold smoked farm raised salmon of Chile; net wt. 3 oz. box with vacuum packed plastic inner wrapper, 12 boxes per case; UPC 0 22635-70022 3, Recall # F-539-8
CODE
Code Date on 3 oz. box: 11/16/08 198, FARM RAISED SALMON OF CHILE case codes: cases NAT NOVA NOV 16-08 01988A; NAT NOVA NOV 16-08 01988B; NAT NOVA NOV 16-08 01988C; 70022 sell by 11/16/08
RECALLING FIRM/MANUFACTURER
Vita Food Products, Inc., Chicago, IL, by press release on July 25, 2008. Firm initiated recall is complete.
REASON
The smoked salmon was found to be contaminated with Listeria monocytogenes bacteria.
VOLUME OF PRODUCT IN COMMERCE
391 cases
DISTRIBUTION
TX, NJ

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________
PRODUCT 
Nestle Pure Life Purified Water sold in 1 gallon plastic containers with UPC 68274-34661 and UPC 68274-73496, Recall # F-532-8
CODE
First line of code information 050508126WF024. Second line starts with 08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nestle Waters North America, Greenwich, CT, by press release, telephone and website on June 24, 2008.
Manufacturer: Nestle Waters North America, Breinigsville, PA. Firm initiated recall is ongoing.
REASON
Product may contain diluted cleaning solution.
VOLUME OF PRODUCT IN COMMERCE
138 bottles
DISTRIBUTION
CT, DE, NJ, NY, PA

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III

___________________________________
PRODUCT 
Honey, Label Reads "FESTIVAL HONEY 100% Pure US Grade A Honey; Product of India". The product comes in 3 sizes, 12 oz. Honey Squeeze Bear, UPC 73723-36001; 35.3 oz. Honey PET jar, UPC 73723-36003;  and 5# Honey PET jug UPC 73723-36008, Recall #  F-531-8
CODE
Lot: B1-189, Expiration date Dec. 2009
RECALLING FIRM/MANUFACTURER
Acme Food Sales, Inc., Seattle, WA, by telephone and e-mail on July 2, 2008. Firm initiated recall is ongoing.
REASON
100% pure U.S. grade A honey is misbranded in that it actually consists in part of corn/cane sugar.
VOLUME OF PRODUCT IN COMMERCE
1,044 units
DISTRIBUTION
WA, MT, OR
___________________________________
PRODUCT 
CALCARB 600 brand Calcium Carbonate with Vitamin D in 30-tablet blister packs; UPC 018241412630; NDC 0182-4141-26 (Goldline), Recall # F-540-8
CODE
Lot # 717276902A, Exp. Date 12/31/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, Zanesville, OH, by letters on July 30, 2008.
Manufacturer: NBTY Manufacturing LLC, S Plainfield, NJ. Firm initiated recall is ongoing.
REASON
The label on the product’s carton listed the correct strength of 400 IU of Vitamin D while the label on the inside blister packs listed the strength as 200 IU, which was incorrect.
VOLUME OF PRODUCT IN COMMERCE
6,359 cartons of 30 tablets
DISTRIBUTION
FL, IL, IN, KY, MD, NJ, OH, PA, TN, VA, WV
___________________________________
PRODUCT 
a) Natural Caramelized Pear Flavor Base WONF, packaged in 5-gal. pails, net wt.
    50 lbs, Recall # F-541-8;
b) Natural & Artificial Grape Flavored Drink Base 1-12, packaged in 5-gal. pails, net
    weight 54.48 lbs., Recall # F-542-8;
c) Natural Fruit Smoothie Base, packaged in 5-gal. pails, net weight 50 lbs.,
    Recall # F-543-8;
d) Natural Marula Flavored Fruit Base, packaged in 5-gal. pails, net wt. 55 lbs.,
    Recall # F-544-8
CODE
a) Lot #’s: 6507069404, 6507069405, 6507071021, 6508072001;
b) Lot #’s: 6507069934 and 6508071532;
c) Lot #: 6507070533;
d) Lot #: 6507070131
RECALLING FIRM/MANUFACTURER
Recalling Firm: Givaudan Flavors Corp., Cincinnati, OH, by letters dated May 15, 2008 and telephone on May 16, 2008.
Manufacturer: Givaudan Flavors Inc., Bridgeton, MO. Firm initiated recall is complete.
REASON
Pear concentrate used in the manufacture of the products contained elevated levels of inorganic arsenic.
VOLUME OF PRODUCT IN COMMERCE
67,420 lbs. and 365 gal.
DISTRIBUTION
GA, IN, CA, NC
___________________________________
PRODUCT 
Natural Caramelized Pear Flavor Base WONF packaged in 5-gal. pails, net wt. 50 lbs., Recall # F-545-8
CODE
Lot #’s: 6508074083 and 6508074084
RECALLING FIRM/MANUFACTURER
Sensory Effects Flavor Co. (fka Givaudan Flavors, Inc.), Bridgeton, MO, by telephone and letter dated May 16, 2008. Firm initiated recall is ongoing.
REASON
Pear concentrate used in the manufacture of the product contained elevated levels of inorganic arsenic.
VOLUME OF PRODUCT IN COMMERCE
24,800 lbs
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I

___________________________________
PRODUCT 
2% Chlorhexidine Gluconate Cloth, equivalent to 500 mg chlorhexidine gluconate per cloth, Patient PreOperative Skin Preparation, Non-Sterile, packaged 2 disposable cloths per package, reorder #9705: 24 packs per dispensing box, 4 boxes per case;
reorder #9706: 24 packs per dispensing box, 2 boxes per case;
reorder # 9707: 3 packs per plastic bag multi-pack, 16 multi-packs per dispensing box, 2 boxes per case, Recall # D-347-2008
CODE
Lots: 10722, 10729;
Lot: 10718;
Lots: 10357, 10365, 10641, 10672, 10753, 10755, 10944
RECALLING FIRM/MANUFACTURER
Sage Products, Inc., Cary, IL, by press release and letters dated June 27, 2008. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Product; cloths found to be contaminated with bulkholderia cepacia
VOLUME OF PRODUCT IN COMMERCE
4,081 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Maxidus Herbal Supplement Capsules, 380 mg, 10 pills per blister pack, Recall # D-348-2008
CODE
Bth lib07015, MFG 16/11/2007, EXP 16/11/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: KG Enterprises LLC, Rancho Cordova, CA, by press release on April 23, 2008.
Manufacturer: Ginseng King, Selangor, Malaysia. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product contains active pharmaceutical ingredients Sildenafil and Tadalafil.
VOLUME OF PRODUCT IN COMMERCE
Approximately 6,000 packs
DISTRIBUTION
Nationwide, Canada, Australia, New Zealand, Finland, the UK
___________________________________
PRODUCT 
Blue Steel, Dietary Supplement, Extreme Sexual Stimulant, 400 mg Capsules, 2 capsule blister packs, Recall # D-349-2008
CODE
Lot # A070106, Exp. 01/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Active Nutraceuticals, Carrolton, GA, by telephone and e-mail on/about March 18, 2008 and by press release on March 27, 2008.
Net D Active Nutra Trading Co., Ningbo, China. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product found to contain analogs of sildenafil, the active ingredient in a FDA-approved product used to treat erectile dysfunction.
VOLUME OF PRODUCT IN COMMERCE
570 units
DISTRIBUTION
AZ, GA, IN, LA, NC, NY, TX, VA
___________________________________
PRODUCT 
Heparin Sodium Injection, USP -- 10,000 USP Units/mL (Derived from Porcine Intestinal Mucosa) -- For IV or SC Use -- 30 mL, Rx only, Multi Dose Vial -- NDC 63323-540-31—504031, Sterile, Nonpyrogenic, Recall # D-350-2008
CODE
Lots 405627, 405628, 405629 (exp. 5/2010)
RECALLING FIRM/MANUFACTURER
Recalling Firm: APP Pharmaceuticals LLC, Schaumburg, IL, by telephone on June 11, 2008 and June 12, 2008.
Manufacturer: APP Pharmaceuticals, LLC, Grand Island, NY. Firm initiated recall is ongoing.
REASON
Mislabeled; label error on declared strength; the potency block on vial and tray labels of 3 distributed lots incorrectly declare 10,000 USP Units/mL; the correct potency is 1,000 USP Units/mL which is correctly listed on the side description portion of the label.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
Dexamethasone Sodium Phosphate Injection USP 10 mg/ml in 10 mL Multiple Dose Vial, For IM or IV Use, Rx only; NDC 0703-3524-03, Recall # D-351-2008
CODE
Lot numbers: 05P114 exp 11/2008, 05S128 exp 12/2008, 06C101 exp 2/2009, 07A129 exp 1/2010, 07D125 exp 4/2010, 07E135 exp 5/2010, 07P117 exp 11/2010, and 08B105 exp 2/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, North Wales, PA, by letter on June 3, 2008.
Manufacturer: Teva Parenteral Medicines, Inc., Irvine, CA. Firm initiated recall is ongoing.
REASON
Presence of particulate matter.
VOLUME OF PRODUCT IN COMMERCE
1,200,690 vials
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
Phentermine Hydrochloride Capsules, 30 mg, packaged in blister packs of 7 and 14 and bottles of 30, a) Product no.0392-0: 30 capsules; b) Product no. 0392-2: 14 capsules;
c) Product no. 0392-3: 7 capsules; d) Product no. 0392-4: 28 capsules, Rx only, Recall # D-305-2008
CODE
a) Lots 6160064, 6248182, 6305021, 6363063, 7023214, 7081060, 7162190, 7242020,
    7365196, 8081123;
b) Lots 6240149, 6291221, 7023215, 7094130, 7176180;
c) Lot 7330149;
d) Lots 6179188, 6264144, 6317163, 7068025, 7136149, 7176179, 7242021, 7330148,
    8011095, 8078184
RECALLING FIRM/MANUFACTURER
Recalling Firm: Allscripts LLC, Libertyville, IL, by letters dated May 20, 2008.
Manufacturer: Actavis Totowa LLC, Totowa, NJ. Firm initiated recall is ongoing.
REASON
Superpotent; (recall by mfr Actavis various GMP deficiencies)
VOLUME OF PRODUCT IN COMMERCE
394,533 capsules
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1427-08
CODE
Units: 29GY56542; 29GY56535; 29GY56515; 29GY56521; 29GY56533; 29GY56527; 29GY56511; 29GY56506; 29GY56497; 29GY56494; 29GY56504; 29GY56501; 29GK67780; 29GK67777
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic, Norfolk, VA, by telephone on June 27, 2007 and letter on June 29, 2007. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with air, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 components
DISTRIBUTION
VA, NC

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1516-08
CODE
Unit: 2317959
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark, DE, by telephone on February 6, 2008. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-1588-08;
b) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1589-08;
c) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1590-08
CODE
a) Units: 17FJ82455, 17FJ82458, 17FJ82463, 17FJ82466, 17FJ82471, 17FJ82499,
    17FJ824501, 17FJ82503, 17FJ82507, 17FJ82509, 17FJ82518, 17FJ82520,
    17FJ82528, 17FJ82529, 17FJ82544, 17FJ82546, 17FJ82596, 17FJ82603,
    17FJ82605, 17FJ82608, 17FJ82610, 17FJ82616, 17FJ82621, 17FJ82638,
    17FJ82714, 17FJ82745, 17FJ82748, 17FJ82752, 17FJ82754;
b) Units: 17FJ82534, 17FJ82537, 17FJ82614;
c) Units: 17FS23648 (Split unit), 17FS23651 (Split unit)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, Saint Paul, MN, by letter on December 1, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose arm scrub procedures were performed incorrectly, were distributed.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
PA, NJ, MI, MA, MN, MD
___________________________________
PRODUCT 
Corneas, Human Tissue, Recall # B-1653-08
CODE
07080457 OD, 07080457 OS
RECALLING FIRM/MANUFACTURER
Recalling Firm: Old Dominion Eye Foundation, Inc., Richmond, VA, by letter on April 7, 2008.
Manufacturer: Washington Regional Transplant Consortium, Annandale, VA. Firm initiated recall is complete.
REASON
Donor history indicated increased risk factors for Creutzfeldt-Jacob disease but the donor was deemed eligible to donate. Tissues had been distributed for transplantation.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
Lima, Peru
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-1688-08
CODE
Units: 8989212 and 8997520
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St. Petersburg, FL, by facsimile on January 25, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
a) Recovered Plasma, Recall # B-1794-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1795-08
CODE
a) and b) Unit: 206634400
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lafayette, LA, by telephone, letter, or electronic mail on September 26, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who subsequently reported a previously reactive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA, Switzerland
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1856-08
CODE
Unit: 0688290
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by facsimile and electronic mail on December 14, 2007 and January 12, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT 
Red Blood cells, deglycerolized, leukocytes reduced, Recall # B-1875-08
CODE
Unit: 2030991
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on January 8, 2008 and by letter dated January 18, 2008. Firm initiated recall is complete.
REASON
Blood product, which had been deglycerolized did not undergo quality control testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT 
Fresh Frozen Plasma, Recall # B-1877-08
CODE
Unit: 160291195
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on December 28, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B1878-08
CODE
Unit: 026FZ11770
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone and letter on May 12, 2007.
Manufacturer: The American National Red Cross, Mobile, AL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had previously tested reactive for Hepatitis C antibody (anti-HCV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-1894-08;
b) Plasma Cryoprecipitate Reduced, Recall # B-1895-08;
c) Cryoprecipitated AHF, Recall # B-1896-08
CODE
a) Units: 2907256, 2706464;
b) Unit: 2706464;
c) Unit: 2706464
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter or fax on November 29, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TN
___________________________________
PRODUCT 
Plasma Frozen, Recall # 1897-08
CODE
Unit: 2452953
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on December 5, 2007 and by letter on December 18, 2007. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1898-08;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-1899-08
CODE
a) Unit: 2096541 Part A;
b) Unit: 2096541 Part B
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on July 26, 2007 and by letter on January 25, 2007. Firm initiated recall is complete.
REASON
Blood products, with platelet count below the specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1900-08
CODE
Unit: 1408541
RECALLING FIRM/MANUFACTURER
Recalling Firm: Indiana Blood Center, Indianapolis, IN, by telephone on March 5, 2008 and by letter dated March 12, 2008.
Manufacturer: Indiana Blood Center, Muncie, IN. Firm initiated recall is complete.
REASON
Blood product, found to be contaminated with Corynebacterium species using the BacT ALERT System, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1987-08
CODE
Unit: 5769298
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone and facsimile on May 18, 2007 and September 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1989-08
CODE
Units: 161666793; 161666789
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on September 26, 2007. Firm initiated recall is complete.
REASON
Blood products, processed more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1991-08
CODE
Units: 161671745 (Split unit)
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on December 5, 2007. Firm initiated recall is complete.
REASON
Blood products, which were contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT 
a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1992-08;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-1993-08
CODE
a) Unit: X38765 Part 3;
b) Units: X38765 (Split unit)
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone on December 6, 2007. Firm initiated recall is complete.
REASON
Blood products, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TN, GA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1997-08
CODE
Unit: 71X200802
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL, by facsimile on January 9, 2006. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Red Blood Cells (Apheresis), Recall # B-1998-08
CODE
Unit: 1405724
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by telephone on November 26, 2007 and by letter on December 20, 2007. Firm initiated recall is complete.
REASON
Blood product, for which Quality Control was not performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 component
DISTRIBUTION
OH
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1999-08
CODE
Unit: 16LP14689
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by telephone on August 22, 2006 and follow-up letter on August 24, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area which may have been endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1689-08
CODE
Units: 8989212 and 8997520
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St. Petersburg, FL, by facsimile on January 25, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1745-08
CODE
Units: C76121, C76059, C76089, N00542, C76071, C76067, C76058, C76069
RECALLING FIRM/MANUFACTURER
Recalling Firm: South Bend Medical Foundation, South Bend, IN, by interdepartmental mail and/or in person on April 17, 2007.
Manufacturer: South Bend Medical Foundation, Mishawaka, IN. Firm initiated recall is complete.
REASON
Blood products, collected using a genesis mixer scale that had unacceptable quality control results documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
IN
___________________________________
PRODUCT 
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1777-08:
b) Red Blood Cells Leukocytes Reduced, Recall # B-1778-08
CODE
a) Unit: 221050901
b) Unit: 221052351
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on May 25, 2005. Firm initiated recall is complete.
REASON
Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NV
___________________________________
PRODUCT 
Plasma Frozen, Recall # B-1817-08
CODE
Unit: 038KF08381
RECALLING FIRM/MANUFACTURER
American National Red Cross Indiana-Ohio Region, Fort Wayne, IN, by email on May 7, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1855-08
CODE
Unit: 0688290
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by facsimile and electronic mail on December 14, 2007 and January 12, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1893-08
CODE
Unit: 2907256
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter or fax on November 29, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Israel
___________________________________
PRODUCT 
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1923-08;
b) Platelets, Recall # B-1924-08
CODE
a) and b) Unit: 54KH39288
RECALLING FIRM/MANUFACTURER
American National Red Cross, Puerto Rico Region, Rio Piedras, PR, by telephone on September 21, 2006 and by letter dated October 4, 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
PR
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1986-08
CODE
Units: 165503392 (Split unit)
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on April 08, 2008. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Diptheroid bacilli, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1988-08
CODE
Unit: 5769298
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone and facsimile on May 18, 2007 and September 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1990-08
CODE
Unit: 166466922
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on March 24,
2008. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Diptheroid bacilli, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-1994-08;
b) Platelets Pooled Leukocytes Reduced, Recall # B-1995-08;
c) Fresh Frozen Plasma, Recall # B-1996-08
CODE
a) Units: 0712693; 0712694; 0712696; 0712697; 0712698; 0712699;
b) Units: 1006703; 1006702; 1006706; 1006705;
c) Units: 0712694; 0712696; 0712697; 0712698; 0712699
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter on October 9, 2007. Firm initiated recall is complete.
REASON
Blood products, manufactured from Whole Blood units that were stored at an incorrect temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 components
DISTRIBUTION
OH

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT 
GE Precision 500D Classical Radiographic-Fluoroscopic X-ray System. Model #2289299-2, with console computer and touch screen fully integrated. The GE Precision 500D Classical Radiographic-Fluoroscopic X-ray System is used to perform radiographic and fluoroscopic x-ray examinations, Recall # Z-0369-2008
CODE
2023567F53 203576P500 205783PRF4 208227ROOM6 208678500D 210916BRF1 218741P500 252847PR7 256880CR4 260463PRE 269657P500D 281401T500D 303450RM3DIG 303825P500 303837P50010 305325RM10 305325RM7 352401RF1 352402RM1 352596RF1 386HPORF 402481BP500 404785P500D1 406863P500 414649ENDOP1 419291FL1 503513RM4 504897RF 505627RF1 509525VP500 510267VARF 510797RM3 512943GTP500 570574PREC1 570574PREC2 580548P500B 601445PRF1 601853RF1 601853RF2 605333RM8 606759P500 606789PRE 606878P500 608756P500 609597P500 610378RF3 610378RF4 615446NRF 617414ENDO1 617789RFE 618964MPRF1 631427P500D 631444P500D 651220P500 662751RF1 671GMHAP5D 678454P500D1 678454P500D2 703558ROOM3 706335RF1 706774UB8 707443STJ2 712472P500 713441MMRF1 716878WCRF2 732840P5D 757314SRM1 757398RM1 773962PR1 801292PR5 801465RM1 801479RM5 805546P500 812825PRE500 814938RM1 815741P500 817545P500 818409RF1 828213AIRF2 843374P500 845561P500D 850431RM9 850934P500A 863902RF 864366ARF2 870864P500 908647500D 910452CFR3 918274500D 937440RM2 972981P500 973661500D 973676500D 979282P500D MONT500D USFREEDOM500 KW1013RX15 KW1085RX01 00490FLU01 C5123628 FP970407 00824FLU02 00471FLU03 00090FLU02 05229FLU02 705356PR500
RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI, by letter dated October 4, 2007. Firm initiated recall is complete.
REASON
It was reported that when the GE Precision 500D foot pedal is repeatedly activated, a defect in the fluoro-timer will cause the dose measurement to report a higher value than was actually received by the patient. Patient will receive a lower dosage irradiation time which will result in indication of cumulative air kerma higher than that to which the patient was actually exposed.
VOLUME OF PRODUCT IN COMMERCE
106 systems
DISTRIBUTION
Nationwide, Italy, Kuwait, Great Britain, Spain and Canada
___________________________________
PRODUCT 
a) GE Healthcare Definium 5000 Digital Radiographic Imaging System.
    Model numbers 5220493. The Definium 5000 System is designed to handle
    radiographic applications using the digital system. The system configuration
    includes a choice of elevating or non-elevating or no table, a floor column
    stand with rotating U-arm, and GE's patented Digital detector that captures
    radiographic images in digital form, as well as an X-ray generator/power unit,
    Recall # Z-1133-2008;
b) GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model number:   
     5220493-2. The Definium 5000 System is designed to handle radiographic applications
    using the digital system. The system configuration includes a choice of elevating or non-
    elevating or no table, a floor column stand with rotating U-arm, and GE's patented Digital
    detector that captures radiographic images in digital form, as well as an X-ray generator/
    power unit, Recall # Z-1134-2008
CODE
a) PC0127XR06, M1973721;
b) 0002695030, 904321DEF5, 480543XR1, 254965D5000, 601855D5K, 914864D5000,
    614293D5KX, 239482D5000, 239432D5000, 0002697145, RADNETDEF1, and 239596D5000
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, by letter dated December 12, 2007.
Manufacturer: Sedecal S.A., Algete, Spain. Firm initiated recall is complete.
REASON
GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
MD, FL, AZ, TX, MS, NY, OH, CA, Germany, France
___________________________________
PRODUCT 
Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system, Product Number: 1760, Recall # Z-1475-2008
CODE
Lot Number: 97266, Exp. March 12, 2008
RECALLING FIRM/MANUFACTURER
Siemens Medical Solution Diagnostics, Norwood, MA, by e-mail on October 17, 2007. Firm initiated recall is ongoing.
REASON
False positive hCG results.
VOLUME OF PRODUCT IN COMMERCE
3,065 kits
DISTRIBUTION
Nationwide, Canada, France, Korea, Netherlands, UK
___________________________________
PRODUCT 
a) CryoValve, Aortic Valve & Conduit. Donor number 87732, Recall # Z-1523-2008;
b) CryoValve, Pulmonary Valve & Conduit. Donor number 87732, Recall # Z-1524-2008
CODE
a) Serial number 8895131;
b) Serial number 8895391
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letter on March 24, 2008. Firm initiated recall is complete.
REASON
Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
DE, TN

___________________________________
PRODUCT 
Deltec Cozmo® Insulin Pump, model 21-1700. A syringe infusion pump designed
    for Continuous Subcutaneous Insulin Infusion for the control of diabetes. Reorder
    Numbers: 21-1701-02/32/33/36/44/49/51/54/62/63/66/81 21-1702-02//49/51 21-
    1703-02/32/33/36/44/49/51/54/62/63/66/81 21-1704-
    02/32/33/36/44/49/51/54/62/63/66/81 21-1705-79 21-1706-79 21-1707-79 21-1711-
    01/02/03/06/14/50 21-1712-01/02 21-1713-01/02/03/06/14/50 21-1714-
    01/02/03/06/14/50 21-1715-19 21-1716-19 21-1717-19, Recall # Z-1590-2008;
b) Deltec Cozmo® Insulin Pump, model 21-1800. This is similar to the currently
    distributed Deltec Cozmo® Insulin Pump Model 1700, with the exception of
    updated software that enhanced certain features and added a food data base to allow
    users to better manage dietary requirements in conjunction with the use of their
    insulin pump. Reorder Numbers: 21-1801-81 21-1803-81 21-1804-81 21-1805-
    49/51/81 21-1806-49/51/81 21-1807-49/51/81 21-1815-01/50 21-1816-01/50 21-
    1817-01/50, Recall # Z-1591-2008
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul, MN, by letter on February 22, 2008. Firm initiated recall is ongoing.
REASON
Smith Medical has received reports of Deltec Cozmo® Insulin Pumps powering down without an alarm. Investigation concluded that if the battery cap is not fully tightened, the Pump may power down and a brief "chirp" will sound. This may occur if the user has not sufficiently tightened the battery cap or if the battery cap is damaged. If a patient is asleep or does not regularly check their blood glucose, as trained, there is a potential risk of harm to the patient if the Pump's powering down goes unnoticed. When the Pump is powered down, delivery of insulin is interrupted.
VOLUME OF PRODUCT IN COMMERCE
39,646 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
a) InCompass® Spinal Fixation System T-Handle Driver; Part #2151-4 (9.5" shaft)
    and 2151-5 (13" shaft); Non-sterile, Reusable Instrument; Recall # Z-1592-2008;
b) PathFinder® Spinal Fixation System T-Handle Driver; Part 2151-7 (13" shaft);
    Non-sterile, Reusable Instrument; Recall # Z-1593-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Abbott Spine, Austin, TX, by letters on March 24, 2008. Firm initiated recall is ongoing.
REASON
Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.
VOLUME OF PRODUCT IN COMMERCE
502 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Boston Scientific SteeroCath-T Ablation Catheter. This catheter is indicated for
    general indications, treatment of supraventricular tachycardia (svt) and ventricular
    tachycardia (vt). This product in not indicated for use as an ablation catheters
    indicated for treatment of atrial flutter or for atrial fibrillation; Model Numbers:
   M004EPT63030; M004EPT6303N40 and M004EPT6304K20, Recall # Z-1617-2008;
b) Boston Scientific SteeroCath-Dx Diagnostic Catheter, Model Numbers
    M0042027BL0 and M0042028BL0, Recall # Z-1618-2008
CODE
a) Lot #’s: 0011058480, 0011118994; Lot# 0011106106; Lot# 0011058482;
b) Lot #’s: 0011092878, 0011092882, 0011107097;
    Lot #’s: 0011036506, 0011036507, 0011036585, 0011036586, 0011043535,
    0011043537, 0011046910, 0011046913, 0011049772, 0011049773, 0011054879,
    0011055000, 0011059409, 0011059410, 0011061991, 0011061992, 0011065023,
    0011065024, 0011069509, 0011069510, 0011073729, 0011073730, 0011078604,
    0011078605, 0011081318, 0011081445, 0011083742, 0011083743, 0011087354,
    0011087355, 0011088108, 0011088109, 0011096360
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., San Jose, CA, by letter on February 14, 2008. Firm initiated recall is complete.
REASON
Package sterile barrier may be breached, compromising sterility.
VOLUME OF PRODUCT IN COMMERCE
827 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
a) OEC9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC
    FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800MD Motorized C-arm
    System), Recall # Z-1705-2008;
b) OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900
    Elite Fluoroscopy System and 9900 EliteMD Motorized C-arm System),
    Recall # Z-1706-2008
CODE
a) Serial numbers: 82-0886, 82-1387, 82-1471, 82-1827, 82-1837, 82-2088, 82-2091-C,
    82-2219, 82-2265, 82-2298, 82-2308, 82-2330, 82-2342, 82-2418, 82-2633, 82-2764,
    82-2902, 82-2919, 82-2982, 82-3012-N, 82-3033, 82-3062, 82-3147, 82-3185,
    82-3311, 82-3313, 82-3314, 82-3411, 82-3428-E, 82-3509, 82-3510, 82-3576,
    82-3739, 82-3763, 82-3765, 82-3830, 82-3880, 82-7106, 82-7179-MH, 89-0014,
    89-0017, 89-0938, 89-1128, 89-1451, 89-2212, 89-2402, 89-2773, 89-2989,
    89-3078, 89-3083, 89-3164, 89-3301, 89-3356, 89-3487, 8S-0271, 8S-0488,
    8S-0974, 8S-1460, 8S-1487, 8S-1508-N, 8S-1582, 8S-1932-N, 8S-2425,
    8S-2507, 8S-3054, 8S-3236, 8S-3242, 8S-7141-MH, 8S-7199-MH;
b) Serial numbers: E2-0034, E2-0088, E2-0109, E2-0258, E2-0270, E2-7019-MH,
    E2-7020-MH, E2-7034-CMH, E2-7037-MH, E2-7043-MH, E9-0029, E9-0047,
    E9-0169, E9-0171, E9-0172, E9-0173, E9-0177, ES-0113, ES-7015-MH
RECALLING FIRM/MANUFACTURER
OEC Medical Systems, Inc., Salt Lake City, UT, by letter on March 21, 2007. Firm initiated recall is ongoing.
REASON
Use of existing four-pedal footswitch on a different machine may cause various operational errors.
VOLUME OF PRODUCT IN COMMERCE
112 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760 The Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens, Recall # Z-1715-2008
CODE
Lot 97552 Exp 05/16/08; Lot 97574 Exp 05/17/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solution Diagnostics, Norwood, MA, by letter dated April 3, 2008.
Manufacturer: Wampole Laboratories, Princeton, NY. Firm initiated Recall is ongoing.
REASON
False negative hCG results due to decreased sensitivity.
VOLUME OF PRODUCT IN COMMERCE
8,180 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Zimmer Spine Cyclone anterior cervical plate, 1 Level, 14MM (Ti-6Al-4V);
    REF 600-01-114, Recall # Z-1717-2008;
2) Zimmer Spine Cyclone anterior cervical plate, 1 Level, 16MM (Ti-6Al-4V);
    REF 600-01-116, Recall # Z-1718-2008;
3) Zimmer Spine Cyclone anterior cervical plate, 1 Level, 18MM (Ti-6Al-4V);
    REF 600-01-118, Recall # Z-1719-2008;
4) Zimmer Spine Cyclone anterior cervical plate, 1 Level, 20MM (Ti-6Al-4V);
    REF 600-01-120, Recall # Z-1720-2008;
5) Zimmer Spine Cyclone anterior cervical plate, 1 Level, 22MM (Ti-6Al-4V);
    REF 600-01-122, Recall # Z-1721-2008;
6) Zimmer Spine Cyclone anterior cervical plate, 1 Level, 24MM (Ti-6Al-4V);
    REF 600-01-124, Recall # Z-1722-2008;
7) Zimmer Spine Cyclone anterior cervical plate, 1 Level, 26MM (Ti-6Al-4V);
    REF 600-01-126, Recall # Z-1723-2008;
8) Zimmer Spine Cyclone anterior cervical plate, 1 Level, 28MM (Ti-6Al-4V);
    REF 600-01-128, Recall # Z-1724-2008;
9) Zimmer Spine Cyclone anterior cervical plate, 2 Level, 30MM (Ti-6Al-4V);
    REF 600-02-130, Recall # Z-1725-2008;
10) Zimmer Spine Cyclone anterior cervical plate, 2 Level, 32MM (Ti-6Al-4V);
     REF 600-02-132, Recall # Z-1726-2008;
11) Zimmer Spine Cyclone anterior cervical plate, 2 Level, 34MM (Ti-6Al-4V);
    REF 600-02-134, Recall # Z-1727-2008;
12) Zimmer Spine Cyclone anterior cervical plate, 2 Level, 36MM (Ti-6Al-4V);
    REF 600-02-136, Recall # Z-1728-2008;
13) Zimmer Spine Cyclone anterior cervical plate, 2 Level, 38MM (Ti-6Al-4V);
    REF 600-02-138, Recall # Z-1729-2008;
14) Zimmer Spine Cyclone anterior cervical plate, 2 Level, 40MM (Ti-6Al-4V);
     REF 600-02-140, Recall # Z-1730-2008;
15) Zimmer Spine Cyclone anterior cervical plate, 2 Level, 42MM (Ti-6Al-4V);
     REF 600-02-142, Recall # Z-1731-2008;
16) Zimmer Spine Cyclone anterior cervical plate, 2 Level, 44MM (Ti-6Al-4V);
    REF 600-02-144, Recall # Z-1732-2008;
17) Zimmer Spine Cyclone anterior cervical plate, 3 Level, 45MM (Ti-6Al-4V);
     REF 600-03-145, Recall # Z-1733-2008;
18) Zimmer Spine Cyclone anterior cervical plate, 3 Level, 48MM (Ti-6Al-4V);
     REF 600-03-148, Recall # Z-1734-2008;
19) Zimmer Spine Cyclone anterior cervical plate, 3 Level, 51MM (Ti-6Al-4V);
     REF 600-03-151; Recall # Z-1735-2008;
20) Zimmer Spine Cyclone anterior cervical plate, 3 Level, 54MM (Ti-6Al-4V);
     REF 600-03-154, Recall # Z-1736-2008;
21) Zimmer Spine Cyclone anterior cervical plate, 3 Level, 57MM (Ti-6Al-4V);
     REF 600-03-157, Recall # Z-1737-2008;
22) Zimmer Spine Cyclone anterior cervical plate, 3 Level, 60MM (Ti-6Al-4V);
     REF 600-03-160, Recall # Z-1738-2008;
23) Zimmer Spine Cyclone anterior cervical plate, 3 Level, 63MM (Ti-6Al-4V);
     REF 600-03-163, Recall # Z-1739-2008;
24) Zimmer Spine Cyclone anterior cervical plate, 3 Level, 66MM (Ti-6Al-4V);
     REF 600-03-166, Recall # Z-1740-2008;
25) Zimmer Spine Cyclone anterior cervical plate, 4 Level, 60MM (Ti-6Al-4V);
     REF 600-04-160, Recall # Z-1741-2008;
26) Zimmer Spine Cyclone anterior cervical plate, 4 Level, 64MM (Ti-6Al-4V);
     REF 600-04-164, Recall # Z-1742-2008;
27) Zimmer Spine Cyclone anterior cervical plate, 4 Level, 68MM (Ti-6Al-4V);
     REF 600-04-168, Recall # Z-1743-2008;
28) Zimmer Spine Cyclone anterior cervical plate, 4 Level, 72MM (Ti-6Al-4V);
     REF 600-04-172, Recall # Z-1744-2008;
29) Zimmer Spine Cyclone anterior cervical plate, 4 Level, 72MM (Ti-6Al-4V);
     REF 600-04-176, Recall # Z-1745-2008;
30) Zimmer Spine Cyclone anterior cervical plate, 4 Level, 80MM (Ti-6Al-4V);
      REF 600-04-18, Recall # Z-1746-2008;
31) Zimmer Spine Cyclone anterior cervical plate, 4 Level, 84MM (Ti-6Al-4V);
     REF 600-04-184, Recall # Z-1747-2008;
32) Zimmer Spine Cyclone anterior cervical plate, 4 Level, 88MM (Ti-6Al-4V);
     REF 600-04-188, Recall # Z-1748-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN, by voicemail and letter on March 26, 2008 and by letter dated June 18, 2008.
Manufacturer: Zimmer Spine, Inc., Minneapolis, MN. Firm initiated recall is ongoing.
REASON
The screw locking cap may fracture when the surgeon rotates it into the locked position.
VOLUME OF PRODUCT IN COMMERCE
1,185 units
DISTRIBUTION
AZ, CA, FL, GA, LA, MI, MN, MT, NH, NC, OK, PA, TN, TX, UT, WA, WI
___________________________________
PRODUCT 
UBiT®-IR300 Infrared Spectrophotometer, Software Versions 7.0, 7.01 and 7.11, Recall # Z-1749-2008
CODE
300292 300427 300129 300159 300502 300055 300378 300586 300262 300326 300219 300239 300356 300339 300318 300439 300511 300547 300294 300672 300697 300699 300460 300633 300004 300519 300531 300344 300525 300596 300597 300644 300303 300662 300208 300606 300389 300381 300281 300594 300247 300061 300534 300627 300438 300501 300599 300602 300616 300646 300566 300443 300541 300176 300283 300409 300050 300065 300072 300105 300099 300086 300182 300375 300342 300423 300428 300429 300454 300456 300479 300503 300543 300601 300588 300071 300276 300031 300217 300178 300703 300175 300025 300563 300059 300168 300437 300017 300641 300416 300570 300348 300268 300467 300325 300202 300684 300266 300497 300114 300398 300155 300560 300637 300676 300073 300704 300705 300698 300204 300696 300316 300604 300665 300367 300695 300211 300232 300581 300611 300457 300308 300229 300490 300227 300162 300180 300286 300371 300504 300651 300515 300079 300317 300512 300170 300104 300106 300571 300465 300625 300666 300068 300088 300293 300003 300327 300430 300028 300070 300022 300011 300592 300530 300090 300132 300681 300372 300257 300148 300164 300192 300273 300297 300359 300481 300518 300285 300678 300223 300447 300385 300100 300545 300265 300365 300319 300382 300558 300289 300081 300638 300579 300120 300506 300655 300027 300468 300037 300002 300542 300131 300514 300436 300500 300110 300084 300145 300141 300307 300230 300331 300082 300115 300540 300632 300476 300631 300380 300048 300045 300167 300284 300374 300393 300421 300441 300451 300006 300173 300305 300144 300657 300420 300445 300634 300483 300347 300111 300238 300156 300653 300161 300498 300546 300459 300603 300058 300677 300101 300242 300691 300660 300431 300220 300433 300237 300405 300522 300189 300379 300109 300188 300218 300251 300391 300508 300656 300264 300639 300707 300685 300716 300158 300412 300138 300089 300121 300244 300551 300046 300263 300693 300370 300153 300493 300345 300619 300116 300195 300163 300418 300146 300562 300181 300198 300174 300240 300333 300613 300313 300051 300557 300669 300670 300295 300673 300113 300614 300246 300635 300568 300190 300710 300302 300213 300322 300361 300595 300309 300186 300026 300408 300667 300572 300555 300536 300054 300341 300362 300593 300455 300569 300346 300394 300260 300640 300659 300464 300582 300446 300112 300624 300323 300205 300160 300658 300005 300179 300528 300654 300462 300224 300349 300415 300626 300014 300469 300486 300553 300565 300016 300314 300452 300407 300123 300396 300152 300623 300494 300527 300664 300561 300142 300717 300706 300709 300564 300649 300585 300269 300127 300133 300009 300234 300321 300255 300397 300406 300417 300400 300529 300267 300587 300366 300600 300335 300612 300067 300643 300008 300136 300605 300711 300499 300384 300475 300584 300256 300607 300216 300085 300183 300134 300143 300474 300392 300310 300278 300130 300628 300093 300575 300097 300609 300424 300444 300702 300701 300708 300117 300047 300215 300470 300690 300556 300466 300567 300387 300154 300007 300682 300687 300353 300184 300434 300689 300012 300686 300035 300700 300013 300191 300029 300549 300340 300091 300448 300487 300226 300139 300636 300610 300271 300228 300312 300249 300137 300092 300080 300185 300020 300668
RECALLING FIRM/MANUFACTURER
Recalling Firm: Otsuka America Pharmaceutical, Inc., Rockville, MD, by letter on March 14, 2008 and March 26, 2008.
Manufacturer: Otsuka Electronics Co., Ltd., Shiga, Japan. Firm initiated recall is ongoing.
REASON
Medical device power supply may overheat and cause smoke to be emitted from the device.
VOLUME OF PRODUCT IN COMMERCE
463 units
DISTRIBUTION
Nationwide and Mexico
___________________________________
PRODUCT 
a) Hall Easy-Fit® Prosthetic Heart Valve - Aortic A7700. The device uses a single
    pyrolytic carbon disc occluder pivoting within a titanium housing. The housing is
    machined into final configuration from a single piece of solid titanium and has no
    welds or introduced bends. It is an open-membered design in which all members
    project centrally without distal attachment. A rotatable fabric sewing ring is
    affixed to the valve. The valve is provided on a holder (collect) to facilitate
    insertion and to provide protection during shipping and handling. The valve is
    sterile and non-pyrogenic if seal and package are not opened, damaged, or broken,
    Recall # Z-1774-2008;
b) Hall Easy-Fit® Prosthetic Heart Valve - Mitral M7700. The device uses a single
    pyrolytic carbon disc occluder pivoting within a titanium housing. The housing is
    machined into final configuration from a single piece of solid titanium and has no
    welds or introduced bends. It is an open-membered design in which all members
    project centrally without distal attachment. A rotatable fabric sewing ring is affixed
    to the valve. The valve is provided on a holder (collect) to facilitate insertion and to
    provide protection during shipping and handling. The valve is sterile and non-
    pyrogenic if seal and package are not opened, damaged, or broken, Recall # Z-1775-
    2008
CODE
a) USA 19A554013J 19A554110J 19A554192J 19A554193J 19A554196J 19A554287J 19A554292J 19A554298J 21A553685J 21A553921J 21A553982J 21A553985J 21A554133J 21A554959J 21A555003J 21A555206J 21A555473J 21A555711J 21A555821J 21A555906J 21A555914J 23A553480J 23A553533J 23A553611J 23A553837J 23A553987J 23A554034J 23A554663J 23A555403J 23A555772J 23A556211J 23A556271J 25A554669J 25A555417J 25A556058J 25A556107J 27A549092J 27A549340J 27A553554J 27A554155J 27A554159J 27A554224J 27A554225J 27A554232J 27A554236J 27A554436J 27A554507J 27A555286J 27A555289J 27A556046J 27A559810J 27A559811J 27A559812J 27A559918J 29A549102J 29A549192J 29A549193J 29A549242J 29A551836J 29A551988J 29A554151J 29A554156J 29A554158J 29A554226J 29A554231J 29A554435J 29A554438J 29A554439J, and 29A554440J EUROPE 19A554058J 19A554109J 19A554126J 19A554201J 19A554289J 19A554290J 19A554604J 19A554654J 19A554749J 19A554754J 19A560318J 19A560981J 19A560992J 19A561161J 19A561162J 19A561172J 19A561230J 19A561233J 19A561237J 19A561246J 21A553907J 21A554016J 21A555382J 21A555395J 21A555637J 21A555719J 21A555723J 23A553121J 23A553122J 23A553200J 23A553412J 23A553478J 23A553531J 23A553539J 23A553605J 23A553616J 23A553838J 23A554137J 23A554331J 23A554493J 23A554658J 23A554709J 23A554716J 23A554720J 23A554843J 23A554965J 23A554968J 23A555025J 23A555251J 23A555263J 23A555516J 23A555519J 23A555523J 23A555524J 23A555527J 23A555531J 23A555532J 23A555613J 23A555622J 23A555623J 23A555675J 23A555681J 23A555735J 23A555773J 23A555775J 23A555915J 23A555917J 23A555922J 23A555924J 23A555926J 23A555927J 23A555928J 23A555929J 23A556008J 23A556011J 25A554042J 25A554044J 25A554047J 25A554139J 25A554144J 25A554217J 25A554220J 25A554221J 25A554425J 25A554426J 25A554428J 25A554429J 25A554431J 25A554432J 25A554503J 25A554554J 25A554556J 25A554557J 25A554558J 25A554561J 25A554562J 25A556030J 25A556035J 25A556038J 25A556101J 25A556116J 27A549104J 27A549189J 27A549194J 27A549245J 27A549339J 27A549341J 27A551835J 27A551989J 27A553552J 27A553553J 27A554157J 27A554223J 27A554230J 27A554237J 27A554976J 27A555291J, and CANADA 21A554071J 23A555518J 25A554143J 27A551991J, and 27A555283J OTHER 19A553455J 19A553748J 19A553881J 19A553901J
19A553998J 19A554000J 19A554001J 19A554010J 19A554059J 19A554063J 19A554064J 19A554108J 19A554113J 19A554122J 19A554194J 19A554202J 21A553173J 21A553181J 21A553405J 21A553466J 21A553525J 21A553598J 21A553687J 21A553790J 21A553825J 21A553828J 21A553832J 21A553905J 21A553910J 21A553913J 21A553920J 21A553977J 21A553981J 21A553983J 21A553984J 21A554089J 21A554131J 21A554308J 21A554309J 21A554311J 21A554312J 21A554313J 21A554314J 21A554320J 21A554607J 21A554702J 21A554703J 21A554706J 21A554758J 21A554793J 21A554794J 21A554797J 21A554800J 21A554837J 21A554839J 21A554840J 21A554841J 21A554887J 21A554889J 21A554893J 21A554895J 21A554896J 21A554899J 21A554954J 21A554962J 21A555002J 21A555004J 21A555005J 21A555006J 21A555007J 21A555014J 21A555203J 21A555205J 21A555375J 21A555378J 21A555385J 21A555386J 21A555388J 21A555397J 21A555477J 21A555478J 21A555483J 21A555494J 21A555496J 21A555499J 21A555500J 21A555504J 21A555507J 21A555580J 21A555581J 21A555583J 21A555584J 21A555626J 21A555627J 21A555630J 21A555633J 21A555634J 21A555673J 21A555674J 21A555706J 21A555708J 21A555709J 21A555716J 21A555717J 21A555726J 21A555806J 21A555909J 21A555913J 21A555992J 21A555993J 21A555994J 21A555995J 21A555997J 21A556053J 21A556085J 21A556151J 23A553484J 23A554024J 23A554027J 23A554028J 23A554031J 23A554136J 23A554206J 23A554208J 23A554213J 23A554329J 23A554334J 23A554339J 23A554340J 23A554344J 23A554383J 23A554384J 23A554386J 23A554488J 23A554489J 23A554612J 23A554657J 23A554661J 23A554664J 23A554711J 23A554717J 23A555027J 23A555529J 23A555680J 23A555732J 23A555738J 23A555916J 23A555918J 23A555923J 23A555925J 23A556005J 23A556006J 23A556009J 23A556013J 23A556015J 23A556019J 23A556021J 23A556023J 23A556024J 23A556096J 23A556206J 23A556208J 23A556210J 25A554563J 25A554666J 25A555279J 25A555280J 25A555282J 25A555419J 25A555428J 25A555826J 25A555939J 25A555940J 25A556039J 25A556112J 27A549240J 27A554506J 27A554977J, and 29A554434J;

b) USA 23M546512J 23M547083J 23M547084J 23M547626J 23M547629J 23M547631J 23M547896J 23M547905J 25M553329J 25M553855J 25M554621J 27M555072J 27M555079J 27M555083J 27M555646J 27M555654J 27M555789J 27M555842J 29M554274J 29M560938J 29M561157J 29M561320J 29M561328J 29M561456J 31M552397J 31M553444J 31M553650J 31M553713J 31M553762J, and 31M555548J EUROPE 23M546513J 23M547076J 23M547088J 23M547195J 25M553559J 25M553640J 25M553854J 25M553931J 25M553946J 25M554246J 25M554629J 25M554858J 25M554910J 25M555060J 25M553850J 27M553375J 27M553383J 27M553562J 27M553570J 27M553572J 27M554161J 27M554172J 27M554173J 27M554176J 27M554181J 27M554182J 27M554185J 27M554187J 27M554189J 27M554260J 27M554262J 27M554263J 27M554264J 27M554265J 27M554267J 27M554269J 27M554271J 27M554351J 27M554354J 27M554358J 27M554450J 27M554454J 27M554458J 27M554511J 27M554518J 27M554642J 27M554643J 27M554645J 27M554646J 27M554810J 27M554863J 27M554870J 27M554923J 27M554992J 27M554993J 27M555069J 27M555315J 27M555330J 27M555333J 27M555341J 27M555342J 27M555347J 27M555350J 27M555353J 27M555439J 27M555440J 27M555441J 27M555442J 27M555443J 27M555444J 27M555538J 27M555540J 27M555541J 27M555543J 27M555545J 27M555546J 27M555641J 27M555642J 27M555644J 27M555647J 27M555652J 27M555691J 27M555743J 27M555744J 27M555745J 27M555746J 27M555754J 27M555755J 27M555763J 27M555787J 27M555791J 27M555852J 27M555858J 27M559405J 27M559440J 27M559448J 29M550088J 29M550209J 29M551061J 29M552565J 29M552612J 29M552648J 29M552649J 29M552717J 29M552722J 29M552922J 29M552927J 29M552937J 29M553239J 29M553240J 29M553289J 29M553295J 29M553353J 29M553355J 29M553442J 29M553763J 29M553857J 29M553858J 29M554079J 29M554080J 29M554369J 29M554400J 29M554578J 29M554679J 29M554680J 29M554683J 29M554684J 29M554734J 29M554736J 29M554737J 29M554744J 29M554783J 29M554871J 29M554872J 29M554874J 29M554875J 29M554877J 29M554879J 29M554929J 29M554930J 29M554931J 29M554932J 29M554933J 29M554935J 29M554936J 29M554937J 29M554939J 29M554940J 29M554941J 29M555095J 29M555099J 29M555101J 29M555107J 29M555110J 29M555153J 29M555154J 29M555158J 29M555556J 29M555560J 29M555561J 29M555656J 29M555657J 29M555665J 29M555984J 29M553354J 31M550204J 31M550207J 31M551255J 31M551256J 31M552714J 31M553351J 31M553443J 31M553446J 31M553576J 31M553657J 31M553711J 31M554466J 31M554471J 31M554577J 31M554876J 31M554880J 31M554934J 31M555371J 31M555372J 31M555549J 31M555980J, and 31M556181J CANADA 27M555436J 31M553577J, and 31M555160J OTHER 25M553700J 25M553796J 25M553798J 25M553799J 25M553841J 25M553933J 25M553943J 25M553948J 25M554348J 25M554565J 25M554619J 25M554626J 25M554633J 25M554721J 25M554729J 25M554731J 25M554733J 25M554775J 25M554803J 25M554804J 25M554805J 25M554806J 25M554856J 27M553374J 27M554676J 27M554922J 27M554926J 27M554989J 27M555001J 27M555084J 27M555313J 27M555314J 27M555316J 27M555317J 27M555331J 27M555332J 27M555337J 27M555338J 27M555339J 27M555340J 27M555343J 27M555345J 27M555348J 27M555349J 27M555430J 27M555433J 27M555437J 27M555542J 27M555643J 27M555645J 27M555649J 27M555687J 27M555689J 27M555690J 27M555741J 27M555748J 27M555749J 27M555751J 27M555752J 27M555759J 27M555786J 27M555790J 27M555843J 27M555846J 27M555851J 27M555854J 27M555945J 27M559304J 29M553712J 29M554078J 29M554085J 29M554086J 29M554087J 29M554784J 29M554928J 29M555098J 29M555108J 29M555159J 31M553761J 31M554280J 31M554465J 31M554468J 31M554685J 31M554735J 31M555370J 31M555373J 31M555547J 21A555222J 23A555240J 23A555676J 25A554043J 27M555544J 29A554153J 31M549988J, and 31M550134J
RECALLING FIRM/MANUFACTURER
Medtronic Heart Valve Division, Spring Lake Park, MN, by letter dated March 24, 2008. Firm initiated recall is ongoing.
REASON
Medtronic has identified an issue with 685 Hall Easy-Fit® valves Models A7700 and M7700 in which the holder of the valve was incorrectly secured to the valve. This could potentially make it difficult to easily disengage the holder from the valve.
VOLUME OF PRODUCT IN COMMERCE
685 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III

___________________________________
PRODUCT 
Impax® 6.x Clients including: 6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2.1 SU14 and 6.0 all versions. The Impax Systems are Picture Archiving and Communications system (PACs). PAC systems are used in the acceptance, transfer, display, storage and digital processing of medical images. Catalog Numbers for Impax 6.x Client Software: Radiologist Viewer - R6.0 Concurrent User, Package Code: 60+000250353, Product Code: L8DTC; Breast Imaging Radiologist Viewer - R6.0 Concurrent User, Package Code: 60+00025055, Product Code: L8DGM; Orthopeadic Viewer - R6 Concurrent User, Package Code: 60+00025056, Product Code: L8DEH, L4NVL; Radiologist w/QC Viewer - Concurrent User: Product Code: EW43C; Breast Imaging Radiologist w/QC Viewer - Concurrent User, Product Code: EW44E; Enterprise Viewer - Concurrent License, Product Code: L8DP3; Impax® 6 Orthopeadic Center Client Site License, Product Code: EW21Y; Impax® 6 Site License (includes client site license above - L8FEQ), Package Code: 60+00025123, and Product Code: L8FEQ, Recall # Z-2180-2008.
CODE
6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2.1 SU14 and 6.0 all versions.
RECALLING FIRM/MANUFACTURER
AGFA Corp., Greenville, SC, by letter on/about June 4, 2008 and June 9, 2008. Firm initiated recall is ongoing.
REASON
The IMPAX client failed to “refresh” the image area upon receiving a study retrieved from archive. The system also erroneously displays this study retrieved from archive as the “active” study.
VOLUME OF PRODUCT IN COMMERCE
371 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR SEPTEMBER 10, 2008

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