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U.S. Department of Health and Human Services

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Enforcement Report for July 1, 2009

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.

July 1, 2009
09-26

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT
1) Rite Aid Chocolate Covered Peanuts Double Dipped. The product is sold in plastic bags 15 oz Item number 8009472, UPC 41008009472 and Item number 357538, UPC   1182235538; 15 oz plus 10% extra product UPC 1182289472; and 14 oz UPC 1182281008, Item number 8010008. Recall # F-399-9

2) Rite Aid Bridge Mix. The product is sold in plastic bags 14 oz UPC 1182289959, Item number 8009959 and 15 oz UPC 1182237539, Item number 357539. Recall # F-400-9
CODE
Code date: 0498, 0888, 1578, 2758, and 2768
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rite Aid Corporation, Camp Hill, PA, by e-mail and press release on February 3, 2009 and by press release on February 18, 2009.
Manufacturer: GKI Food, Inc., Brighton, MI. Firm initiated recall is complete.
REASON
Product was manufactured using peanuts recalled by Peanut Corporation of America,  because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
207,397 bags
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Roasted Red Peanuts (Jumbo Runner), salted and non-salted, packed in containers, bags and bulk. Item number 94004. Recall # F-401-9;

2) Roasted Blanched Peanuts (Jumbo Runner), salted and unsalted, sold in 12 oz. containers, bags and bulk. UPC 7 3980112009 6 - 12 oz; Item number 91010. Recall # F-402-9;

3) Red Flower Raw Blanched peanuts; Item number 91003. Recall # F-403-9;

4) Raw Peanuts (Jumbo Runner), Red Skin, packed in bags and bulk. UPC 7 39801 12009 8. Item number 91009. Recall # F-404-9;

5) Hot & Spicy Peanuts, sold in 6 oz. containers, bags and bulk. UPC 7 39801 51001 1 - 6 oz. Cacahuetes Picantes, & Sazonador. Item number 91001/51001. Recall # F-405-9;

6) Organic Blanched Raw Peanuts packed in bags and bulk. UPC 7 39801 01010 8 - 1 lb container, Item number 01010, 12003. Recall # F-406-9;

7) Honey Roasted Peanuts, packed in 6 oz. containers, bags and bulk. UPC 7 39801 51002- 6 oz, Item number 91002. Recall # F-407-9:

8) Red Flower Peanut Meal, (Flour) sold in 8 oz. containers, bulk and bags. UPC 7 39801 10011 3 - 8 oz. Item number 90011 Recall # F-408-9;

9) Jenny's Snack Mix, Salted and unsalted, Net. Wt. 1 lb. UPC 7 39801 93208 0.
Recall # F-409-9;

10) Red Flower Mixed Nuts, Net Wt. 9 oz. UPC 7 39801 53200 6; Ingredients: Salt, Peanut, Cashew, Raisin, Golden raisin, Green Pea, Apricot, Pineapple, Pumpkin Seeds, Banana Chips, Papaya, Cranberry. Recall # F-410-9;

11)Red Flower Chopped Peanuts; Net Wt. 6 oz. Product of USA UPC 7 39801 10013 7. Recall # F-411-9
CODE
1), 2), 5), 7), and 8) Code 1307 to 0509;
3) and 4) Code 3307 to 5307;
6), 9), 10), and 11) All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Red Flower Ltd, Linden, NJ, by e-mail on January 30, 2009, by letters and web site posting on February 5, 2009 and to the AP on February 6, 2009.
Manufacturer: First Food International, Linden, NJ. Firm initiated recall is ongoing.
REASON
Product was manufactured using peanuts recalled by Peanut Corporation of America, Blakely, GA, because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1600 + pounds
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Le Pain QUOTIDIEN brand Noir Belgian dark chocolate spread, net wt. 14.15 oz. (400 g), UPC 5 425018 441174 -- Produced in Belgium -- Best before: se lid -- Organic ingredients: sugar, vegetable oil (rapeseed and palm), low fat cocoa powder, soy lecithin.  The product is packaged in a glass jar. Recall # F-412-9;
CODE
Lot Code 9015 (printed on the lid of the jar); Production Date of "15.01.09" and Expiration Date of "15.01.10" (labeled on lid);
RECALLING FIRM/MANUFACTURER
Recalling Firm: Le Pain Quotidien, New York, NY, by e-mail on June 2, 2009 and by press release on June 5, 2009.
Manufacturer: boerinneke-marino, Sint-Amands, Belgium. Firm initiated recall is ongoing.
REASON
The specific lot code of Noir Belgian Dark Chocolate Spread contains undeclared milk based on FDA sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
2,952 jars
DISTRIBUTION
NY, CT, CA, VA, MD, and DC
___________________________________
PRODUCT
Pit bull Peanut Caramel Crunch Energy Bar ; Net Wt 2 oz, packed 10 bars per box and 12 boxes per case; UNIT USPC: 8 91125 00001 9; BOX USPC: 8 91125 00022 4; CASE USPC: 8 91125 00050 7. Recall # F-413-9
CODE
Date code: MAY XX 2009 and JUN XX 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm; Energy Lane, Hollywood, CA, verbally around March 3, 2009 and by press release on March 5, 2009.
Manufacturer: Aliments Multibar, Inc, ANJOU, Canada. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Approximately 190,000
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Pimento Spread Sandwiches under the following brand names: Mom's Deli Style (Pimento Spread on Wheat Sandwich), 5 oz., UPC #83898 00114; RaceTrac Fresh Sandwiches to Go (Pimento Spread on Wheat Sandwich), 5 oz., UPC #83898 00114; Crosby Food & Vending (Pimento Spread on Wheat Sandwich), 5 oz., 83898 00114; Outtakes Quick Quisine (Pimento Spread Sandwich), 4 oz., no UPC. Recall # F-414-9;

2) Tuna Salad Sandwiches under the following brand names: Mom's Deli Style (Tuna Salad on Wheat Sandwich), 5 oz., UPC #83898 00108; RaceTrac Fresh Sandwiches to Go (Tuna Salad on Wheat Sandwich), 5 oz., UPC #83898 00108; Two Podners (Tuna Salad on Wheat Sandwich), 5 oz., 83898 00108; Outtakes Quick Quisine (Tuna Salad Croissant), 4.5 oz., no UPC. Recall # F-415-9;

3) Mom's Deli Style Big Sub with Potato Salad, 8 oz., no UPC. Recall # F-416-9
CODE
All lots and date codes
RECALLING FIRM/MANUFACTURER
Mom’s Food Products, Inc., Fort Worth, TX, by press release on September 23, 2008. Firm initiated recall is ongoing.
REASON
Undeclared eggs
VOLUME OF PRODUCT IN COMMERCE
160,891 sandwiches
DISTRIBUTION
TX
___________________________________
PRODUCT
Larry’s Fajitas Spices & Seasonings, 1.27 oz. foil package, 24 pouches per shipping case, UPC Code 2150022500. Recall # F-418-9
CODE
BEST IF USED BY OCT0110PX62
RECALLING FIRM/MANUFACTURER
Recalling Firm: McCormick & Company, Inc, Hunt Valley, MD, by letter and telephone on April 23, 2009 and by press release on April 27, 2009.
Manufacturer: Power Packaging, Inc, Grand Prairie, TX. Firm initiated recall is ongoing.
REASON
Spice/Seasonings packet contains milk ingredients, which are undeclared on the label.
VOLUME OF PRODUCT IN COMMERCE
2,159 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Southern Maid Donut Flour Premium, Net Wt. 50 lb (22.68 kg). Recall # F-419-9
CODE
For products manufactured in 2008; 1-092 through 8-366. Products manufactured in 2009: 1-001 through 8-140.
RECALLING FIRM/MANUFACTURER
Southern Maid Donut Flour Company, Garland, TX, by telephone on May 21, 2009. Firm initiated recall is ongoing.
REASON
Product contains undeclared egg yolks.
VOLUME OF PRODUCT IN COMMERCE
30,813 50-lb bags
DISTRIBUTION
TX. TN, OK, LA, AR and Korea

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III

___________________________________
PRODUCT
Stonyfield Farm Organic Fat Free Plain Yogurt, 32 oz. (2 lb), UPC # 52159 00006. Recall # F-396-9
CODE
Used by May 06 09 Time stamped 22:17 thru 23:59 or Use by May 07 09 All time stamps
RECALLING FIRM/MANUFACTURER
Stonyfield Farm, Londonderry, NH, by letter on April 3, 2009. Firm initiated recall is complete.
REASON
Yogurt may be contaminated with a food grade sanitizer.
VOLUME OF PRODUCT IN COMMERCE
44,496 quarts
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT
Senna Laxative (Standardized Senna Concentrate) sennosides 8.6 mg. per tablet, OTC, packaged under distributor labels: Equaline brand, 50 tablets, NDC 41163-021-71; 100 tablets, NDC 41163-021-78 and 250 tablets, NDC 41163-021-85; Meijer brand, 100 tablets, NDC 41250-021-78; Hannaford brand, 100 tablets, NDC 41268-021-78; Natural brand, 100 tablets, NDC 38045-021-78; TopCare brand, 100 tablets, NDC 36800-021-78; GoodSense brand, 100 tablets, NDC 0113-0021-78; CareOne brand, 100 tablets, no NDC #; HyVee brand, 100 tablets, NDC 42507-021-78; Kroger brand, 100 tablets, NDC 30142-021-78; Longs brand, 100 tablets, NDC 12333-9611-1; and Sunmark brand, 100 tablets, NDC 49348-262-10. Recall # D-1221-2009
CODE
Lots 7JE0529, 7LE0537, 7ME0269, 8AE0404, 8BE0070, 8BE0071, 8BE0087, 8BE0746, 8CE0043, 8CE0501, 8CE0502, 8FE0688, 8GE0279, 8GE0526 and 8GE1213
RECALLING FIRM/MANUFACTURER
Recalling Firm: L Perrigo Co, Allegan, MI, by letter on April 22, 2009.
Manufacturer: Time-Cap Labs, Farmingdale, NY. Firm initiated recall is ongoing.
REASON
Product contains undeclared anhydrous lactose and tartaric acid.
VOLUME OF PRODUCT IN COMMERCE
218,220 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Baxter Potassium Chloride for Injection Concentrate, USP (2 mEq/mL); 250 mL Glass Pharmacy Bulk Package, Not for Direct Infusion; NDC 0338-0318-02. Recall # D-1224-2009
CODE
Lots: G075556 and G076539
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Round Lake, IL, by letters dated March 10, 2009.
Manufacturer: Baxter Healthcare Corporation, Cleveland, MS. Firm initiated recall is ongoing.
REASON
Stability data does not support expiration date (pH).
VOLUME OF PRODUCT IN COMMERCE
28,706 units
DISTRIBUTION
Nationwide, Canada, Hong Kong, Oman and Saudi Arabia
___________________________________
PRODUCT
1) Shop Rite Cough Formula DM Cough Suppressant Expectorant, (dextromethorphan HBr 10 mg and guaifenesin 100 mg), Cherry Flavor, 8 fl. oz (237 mL); UPC 0 41190 22044 1; Item code 7056191. Recall # D-1225-2009;

2) Shop Rite Tussin Chest Congestion Formula, (Guaifenesin Oral Solution, USP), 100 mg, 8 fl. oz. (237 mL). UPC 0 41190 22151; Item Code 7055933. Recall # D-1226-2009
CODE
a) Lot number 106295, Exp. date 10/31/10;
b) Item Code 7055933 only
RECALLING FIRM/MANUFACTURER
Accumed Inc, Lawrenceville, NJ, by e-mail and telephone beginning November 20, 2008. Firm initiated recall is ongoing.
REASON
Mis-packed: Some boxes of Shop Rite Cough Formula DM Cough Suppressant Expectorant may actually contain 8 oz. bottles of Shop Rite Tussin Chest Congestion Formula.
VOLUME OF PRODUCT IN COMMERCE
10,128 8 oz bottles (844 x 12 oz cases)
DISTRIBUTION
NJ
___________________________________
PRODUCT
Adagen (pegademase bovine) injection, four 1.5 ml single-dose vials, 250 units per mL, sterile, refrigerate, Rx only; NDC 57665-001-01. Recall # D-1227-2009
CODE
Lot 8116A; exp 5/21/2009 and lot 8118A; exp 5/21/2009
 RECALLING FIRM/MANUFACTURER
Enzon Pharmaceuticals Inc, Indianapolis, IN, by letter dated March 27, 2009. Firm initiated recall is ongoing.
REASON
Exceeded Impurity Specification; 6 month stability testing.
VOLUME OF PRODUCT IN COMMERCE
308 4-vial packs
DISTRIBUTION
TN, Australia, Colombia and France

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT
1) Kids Kare Plus 0.4% Stannous Flouride Brush-on Dentifrice Anticavity Toothpaste; Net Wt. 4.3 oz. (122g); Mint flavor; NDC #59883-631-04, Reorder #2231MT. Recall # D-1215-2009;

2) Kids Kare Plus 0.4% Stannous Flouride Brush-on Dentifrice Anticavity Toothpaste; Net Wt. 4.3 oz. (122g); Bubblegum flavor; NDC #59883-633-04, Reorder #2231BG. Recall # D-1216-2009;

3) Kids Kare Plus 0.4% Stannous Flouride Brush-on Dentifrice Anticavity Toothpaste; Net Wt. 4.3 oz. (122g); Grape flavor; NDC #59883-636-04, Reorder #2231GR.  Recall # D-1217-2009;

4) PerioCheck 0.4% Stannous Flouride Preventative Treatment Brush On Gel; Net Wt. 4.3 oz. (122g); Mint flavor; NDC #59883-611-04, DIN #02117371, Reorder #2230MT. Recall # D-1218-2009;

5) Pro-Den Rx Neutral Sodium Fluoride Topical Gel (1.1% Sodium Fluoride (500 ppm Fluoride Ion)); Net Wt. 2.0 oz. (56g); Prescription; Cherry Limeade flavor; NDC #59883-807-02, Reorder #2240CL. Recall # D-1219-2009;
CODE
1) Lot #132122, 131120, 130102 and 130129;
2) Lot #130314, 130307, 131307 and 131314;
3) Lot #130808, 131817 and 131814;
4) Lot #68117;
5) Lot #810117, 810102, 811130, 810113, and 810111
RECALLING FIRM/MANUFACTURER
Zila Therapeutics, Inc. Batesville, AK, by telephone and letter beginning on November 7, 2008. Firm initiated recall is ongoing.
REASON
Subpotent Fluoride
VOLUME OF PRODUCT IN COMMERCE
23,424 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Diphenhydramine HCL, USP 25 mg, softgel capsules 12 counts blister cards. Recall # D-1220-2009
CODE
Lot # 28040096
RECALLING FIRM/MANUFACTURER
Banner Pharmacaps, Inc, High Point, NC, by telephone on February 10, 2009 and by letter on March 20, 2009. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution testing at 3-month stability timepoint.
VOLUME OF PRODUCT IN COMMERCE
599,040 soft gel capsules
DISTRIBUTION
NY
___________________________________
PRODUCT
Oxycodone Hydrochloride Oral Solution, USP, 5 mg/mL, C-II packaged in 5  mL unit dose cups (50 unit Dose Cups/case) and 500 mL bottles (12 bottles/case), Rx only, Unit dose NDC 66689-024-50, Bottle NDC 66689-024-16. Recall # D-1222-2009
CODE
Lot # 165300, exp 6/11; Lot # 165200, exp 6/11
RECALLING FIRM/MANUFACTURER
VistaPharm, Inc., Largo, FL, by letter on April 6, 2009. Firm initiated recall is ongoing.
REASON
The product is mis-labeled in that the expiration date issued exceeds the current expiration date duration that is assigned.
VOLUME OF PRODUCT IN COMMERCE
47,750 unit dose cups, and 24 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Xopenex (levalbuterol HC1) Inhalation Solution; 1.25mg/3mL; Sterile Unit-Dose Vials. Recall # D-1223-2009
CODE
Lot # S8F072, exp 22/09 (on pouch); exp. 12/09 (on vial/carton label)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sepracor, Inc., Marlborough, MA, by e-mail on May 7, 2009.
Manufacturer: Catalent Pharma Solutions, LLC, Woodstock, IL. Firm initiated recall is ongoing.
REASON
Incorrect Expiration Date
VOLUME OF PRODUCT IN COMMERCE
20,000 units
DISTRIBUTION
OH, TN

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1120-09
CODE
Unit: 06GL91220
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by electronic notification and telephone on December 17, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1122-09
CODE
Unit: W067309002391
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc, Amarillo, TX, by telephone on February 13, 2009. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Source Plasma. Recall # B-1123-09
CODE
Units: AB1119419, AB119718
RECALLING FIRM/MANUFACTURER
Bio-Save Resources of Albuquerque LLC, Albuquerque, NM, by electronic mail on September 22, 2008. Firm initiated recall is complete.
REASON
Blood products, which had not been tested for PCR Nucleic Acid Test (NAT), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
United Kingdom
___________________________________
PRODUCT
1) Plasma Frozen, Recall # B-1126-09; 
2) Fresh Frozen Plasma. Recall # B-1127-09;
3) Red Blood Cells Leukocytes Reduced, Recall # B-1128-09
CODE
1) Units: 5379342, 7356978, W117008101565;
2) Unit: W117008111615;
3) Units: 7356978, W117008101565, W117008111615
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on December 10, 2008 and by letter on December 12, 2008.
Manufacturer: Blood Centers of the Pacific - Cupertino Center, Cupertino CA. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who reported close contact with someone with a history of hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1146-09;
2) Plasma Frozen within 24 hours (FP24). Recall # 1147-09
CODE
1) and 2) Unit: 27S85749
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone on December 23, 2008 and by letter dated December 29, 2008. 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
WV, KY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1148-09
CODE
Unit: 3291680
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc, Orlando, FL, by telephone on January 12, 2009 and by letter dated January 13, 2009. 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
Source Plasma. Recall # B-1149-09
CODE
Unit: UQ032240
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc, Memphis, TN, by fax on June 4, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose annual physical examination was not performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-1151-09;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1152-09
CODE
1) and 2) Unit: 6585642
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc, Tyler, TX, by fax on April 23, 2007 and March 11, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Switzerland
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1153-09
CODE
Unit: 0385705
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by fax on June 26, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1154-09
CODE
Unit: 0361163
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by letter on July 3, 2007. 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
TX
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1156-09;
2) Plasma Frozen. Recall # 1157-09
CODE
1) and 2) Units: FR48100, FM65723
RECALLING FIRM/MANUFACTURER
Piedmont Blood Center, Inc, Spartanburg, SC, by telephone on December 4, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, SC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1159-09
CODE
Unit: 6554449
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc, Tyler, TX, by letter on August 30, 2006. 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
TX
___________________________________
PRODUCT
Source Plasma. Recall# B-1164-09
CODE
Units: KP113800, KZ052245
RECALLING FIRM/MANUFACTURER
Plasma Biological Services Inc, Memphis, TN, by fax on July 3, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, Ireland
___________________________________
PRODUCT
Source Plasma. Recall # B-1167-09
CODE
Unit: 08DILB8608
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Dekalb, IL, by fax on February 3, 2009. 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
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-1169-09
CODE
Units: 08PMIC1228; 08PMIC0193; 08PMIB9230; 08PMIB8181; 08PMIB6385;  08PMIB5321; 08PMIB3209; 08PMIB2154; 08PMIB0820; 08PMIA9482
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Mount Pleasant, MI, by email and facsimile on January 26, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
CA, Austria

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT
Recovered Plasma, Recall # B-1121-09
CODE
Unit: 06GL91220
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by electronic notification and telephone on December 17, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1155-09
CODE
Unit: 5848897
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by fax on March 21, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1158-09
CODE
Unit: 6581531
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc, Tyler, TX, by telephone on July 14, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with missing documentation for body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1160-09;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1161-09;
3) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1162-09
4) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1163-09
CODE
1) Units: 027LT64086, 027LT64088, 027LT64090, 027LT64092, 027LT64093, 027KX00848;

2) Units: 027P94563, 027KC12304, 027KC12306 (2 units), 027KC12309, 027KC12308, 027P94570, 027KC12307 (2 units), 027LN29109 (2 units);

3) Units: 027LC76185 (2 units), 027LK32600 (2 units), 027LK32601 (2 units);

4) Units: 027P94570, 027LN29110 (2 units), 027GE26558
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by letter dated November 18, 2008. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for human T lymphotropic virus, type I and II (HTLV-I/II), were distributed.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
MD, PA, WV
___________________________________
PRODUCT
Source Plasma. Recall # B-1165-09
CODE
KZ051159, KZ051082, KZ050747, KZ048621, KZ047821, KZ045149, KZ042539, KZ040159, KZ039948, KZ039344, KZ037890, KZ036805, KZ036522, KZ036181, KZ035696, KZ035385, KZ035144, KZ034839, KZ034543, KZ034130, KZ034007, KZ033620, KZ033357, KZ033052, KZ032891, KZ032222, KZ031974, KZ031578, KZ031286, KZ031069, KZ030416, KZ030067, KZ029044, KZ028330, KZ028082, KZ027911, KZ027368, KZ027283, KZ026899, KZ026786, KZ026308, KZ026094, KZ025971, KZ025729, KZ025608, KZ025396, KZ025228, KP107235
RECALLING FIRM/MANUFACTURER
Plasma Biological Services Inc, Memphis, TN, by fax on June 19, 2008. 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
48 units
DISTRIBUTION
Austria, CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1166-09
CODE
Unit: 08DILB6901
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Dekalb, IL, by facsimile on February 25, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-1168-09
CODE
Units: 08MOHG8960, 08MOHG8189
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Lima, OH, by facsimile on February 19, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an unacceptable arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT
Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10"). Recall # Z-1389-2009
CODE
Blown fuse serial numbers: 008577 - 013143 inclusive. Voice prompt serial numbers: 002002 - 008286 inclusive, and 008289 008291 008293 008296 008297 008298 008299 008300 008301 008302 008303 008304 008305 008306 008307 008308 008309 008310 008311 008312 008313 008314 008315 008316 008322 008323 008324 008325 008326 008327 008328 008329 008330 008331 008332 008333 008334 008335 008336 008337 008339 008340 008362 008363 008364 008365 008366 008367 008368 008369 008370 008372 008373 008374 008375 008376 008377 008378 008379 008402 008403 008404 008405 008406 008407 008411 008413 008414 008415 008416 008417 008418 008419 008420 008421 008422 008423 008424 008425 008426 008427 008428 008429 008430 008431 008432 008435 008446 008524 008525 008583 008656 008671 008712 008714 008724 008742 008743 008744 008792 008856 008864 008911 008913 008943 008988 009007 009009 009010 009015 009016 009017 009066 009067 009070 009071 009072 009073 009074 009075 009076 009079 009081 009083 009085 009086 009087 009122 009123 009124 009126 009127 009128 009129 009130 009139 009715 009813 010108 010168 012603 013659 013665 013727 016604 019508 020910 020911 020912 022356 and 027224.
RECALLING FIRM/MANUFACTURER
Welch Allyn Protocol, Inc, Beaverton, OR, by letter dated February 26, 2009. Firm initiated recall is ongoing.
REASON
Issue #1: AED 10 displayed a "Do Not Use" symbol as a result of a blown F1 fuse. Issue #2: AED 10 models that incorporate a spring connector with the speaker experienced intermittent electrical connection to the circuit board causing a loss of voice prompts.
VOLUME OF PRODUCT IN COMMERCE
9,754 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Sybaritic, Inc, SlimLine Health Environment Capsule, a dry heat body chamber with facial and body chamber LED panels. Recall # Z-1423-2009
CODE
Serial Number: 2109257
RECALLING FIRM/MANUFACTURER
Sybaritic, Inc, Bloomington, MN, by letter on June 18, 2008. Firm initiated recall is ongoing.
REASON
Misbranded and sale without pre-market notification.
VOLUME OF PRODUCT IN COMMERCE
1Unit
DISTRIBUTION
UT
___________________________________
PRODUCT
Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits. Recall # Z-1424-2009
CODE
Lot number: 10279571, Use By 2012-01-31
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Cardiovascular Revascularization & Surgical Therap, Brooklyn Park, MN, by letter dated March 5, 2009.
Manufacturer: Medtronic Mexico, S. De R. L. De C.V., Tijuana, Baja California, Mexico. Firm initiated recall is ongoing. 
REASON
Sterility may be compromised. Non-vented caps that connect to the 3-way stopcock attached to the transfer spike could prevent Ethylene Oxide from contacting the inside surfaces of the stopcock during sterilization, leading to a potentially non-sterile product. Use of the product may cause serious health consequences from potential sepsis/infection and the associated remote risk of death.
VOLUME OF PRODUCT IN COMMERCE
20 kits
DISTRIBUTION
MN
___________________________________
PRODUCT
1) Arrow Embolectomy Catheters: 5 French, 2 Lumen x 40cm, Product Number: W01800, Single use, Latex Free, Rx only. The arterial embolectomy catheter is intended for use in removing arterial emboli Recall # Z-1471-2009;

2) Arrow Embolectomy Catheters: 5 French, 2 Lumen x 80cm, Product Number: W01801, Single use, Latex Free, Rx only. The arterial embolectomy catheter is intended for use in removing arterial emboli. Recall # Z-1472-2009;

3) Arrow Embolectomy Catheters: 4 French, 2 Lumen x 40cm, Product Number: W01798, Single use, Latex Free, Rx only. The arterial embolectomy catheter is intended for use in removing arterial emboli. Recall # Z-1473-2009
CODE
1) Lot Numbers: CF8024537, CF8035837, CF8036331, CF8036759, CF8047807, CF8059710, CF8060585, CF8062240, CF8072762, CF8074445, CF7084561, CF8096988, CF8097442, CF8097705, CF8100439, CF8109029, CF8109961, CF8110887, CF8111320, CF8111840 and CF8112312;

2) Lot Numbers: CF8025431, CF8036321, CF8036744, CF8047808, CF8059711, CF8061823, CF8072763, CF80845363, CF8085910, CF8096987, CF8097704, CF8098581, CF8100407, CF8109030 and CF8112750;

3) Lot Numbers: CF8036225, CF8036752, CF8059712, CF8061821, CF8084535, F8096770, CF8098599, CF8109960, CF8111317 and CF8112749
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International Inc, Reading, PA, by letter dated March 25, 2009.
Manufacturer: Clinical Instruments, Southbridge, MA. Firm initiated recall is ongoing.
REASON
The inflation arm tubing may separate from the stopcock adapter.
VOLUME OF PRODUCT IN COMMERCE
6,910 units
DISTRIBUTION
Nationwide and Panama
___________________________________
PRODUCT
1) Boston Scientific Fort Guide Wire, Floppy Marker Wire, 300cm x 2 cm, REF 34949-02, for use in intravascular interventional procedures. Recall # Z-1486-2009;

2) Boston Scientific Fort Guide Wire, Floppy, 300cm x 2 cm, REF 34949-04, for use in intravascular interventional procedures. Recall # Z-1487-2009
CODE
1) Lot #W2405148;
2) Lot # 01403876
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Maple Grove, MN, by letter dated ay 19, 2009.
Manufacturer: Lake Region Manufacturer, Inc, Chaska, MN. Firm initiated recall is ongoing.
REASON
Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque marker bands, has the marker bands. Since the marker bands issue would not be visually apparent to the physician there is a potential for prolongation or delay of the procedure in order to exchange the guide wire for a new guide wire.
VOLUME OF PRODUCT IN COMMERCE
45 units or 9 boxes (5 units per box)
DISTRIBUTION
AR, MO, CA, FL, and NV
___________________________________
PRODUCT
BD 20 ml Syringe Luer-Lok Tip Sterile, Do not reuse; Catalog Number 309661. Recall # Z-1488-2009
CODE
Lot numbers: 9065361, 9065362, 9065366, 9065367, 9065380
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on April 30, 2009 and May 12, 2009.
Manufacturer: Becton Dickinson & Company, Columbus, NB. Firm initiated recall is ongoing.
REASON
Potential for compromised sterility: Insufficient packaging seals.
VOLUME OF PRODUCT IN COMMERCE
201,600 units – portions of 5 lots
DISTRIBUTION
OK, TX, NM, IL, PA, KY, FL, TN, MA, MO, ID, TN, WI, VA, NE, OH and SC
___________________________________
PRODUCT
AccuSure, U-100 31 Gauge, Icc Insulin Syringe, 5/16” (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7002-2. Recall # Z-1504-2009
CODE
Lot  A07001, exp 07/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals, Huntsville, AL, by press release and letter on April 9, 2009.
Manufacturer: Feel Tech, Chungnam, Republic of South Korea. Firm initiated recall is ongoing.
REASON
Needles separate from the barrel of the syringe.
VOLUME OF PRODUCT IN COMMERCE
559,500 syringes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Siemens Medical Solutions E.CAM Patient Handling System (PHS) Field of View (FOV) indicator bars; a component of the E.CAM Emission Computed Tomography System; part number 43 66 618 (right) and 43 81 088 (left). Recall # Z-1505-2009
CODE
Serial numbers 00001 to 04031  
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Hoffman Estates, IL, by letters dated December 18, 2008. Firm initiated recall is ongoing.
REASON
Patient fingers can get pinched if they attempt to pull themselves up from the patient handling system without any assistance and grabbing onto the flip-up FOV indicator bars.
VOLUME OF PRODUCT IN COMMERCE
1,107 units
DISTRIBUTION
Nationwide, Guam, Argentina, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Great Britain, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Latvia, Lebanon, Mauritius, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Turkey and United Arab Emirates
___________________________________
PRODUCT
Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic. Recall # Z-1506-2009
CODE
All lots: 196070, 196071, 196073, 196074, and 198052 expire 05/31/09; 196278, 196279, 196280, and 196281, expire 06/30/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Binax, Inc. dba IMPD, Scarborough, ME, byletter on April 6, 2009.
Manufacturer: Inverness Medical BioStar Inc, Louisville, CO. Firm initiated recall is ongoing.
REASON
Potential for false positive Strep A results
VOLUME OF PRODUCT IN COMMERCE
1,729 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Zimmer NexGen Complete Knee Solution Legacy Knee - Posterior Stabilized LPS-Flex Femoral Component Precoat, Size D left, sterile; REF 00-5960-014-51. Recall # Z-1520-2009;

2) Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS-FLEX Femoral Component Option Size D Left, sterile; REF 00-5964-014-51. Recall # Z-1521-2009;

3) Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS-FLEX Femoral Component Option Size G Left, sterile; REF 00-5964-017-51. Recall # Z-1522-2009;

4) Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS Femoral Component Option Size D Left, sterile; REF 00-5996-014-51. Recall # Z-1523-2009
CODE
1) Lot # 61208295;
2) Lot # 61219714;
3) Lot #’s 61204820, 61215983, 61219677, 61219684 and 61227758;
4) Lot # 61207901
RECALLING FIRM/MANUFACTURER
Zimmer, Inc, Warsaw, IN, by telephone on April 17, 2009 and e-mail and letter on April 22, 2009 and by letter dated April 28, 2009. Firm initiated recall is ongoing.
REASON
The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation.
VOLUME OF PRODUCT IN COMMERCE
37 units
DISTRIBUTION
Nationwide and Canada

END OF ENFORCEMENT REPORT FOR JULY 1, 2009

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