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U.S. Department of Health and Human Services

Safety

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Enforcement Report for June 9, 2010

  June 9, 2010                                                                                        10-22

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

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PRODUCT 
1) Beef Base, packaged in 28-oz. bottles (6/case), 8-lb. bottles (3/case), and 50-lb. bulk boxes under the following labels: (1) Beef Base, Quejese la Base, 28-oz. bottles (no firm name listed); (2) Spicemaster, Baron Spices, Inc., Beef Base, Quejese la Base, 28-oz. bottles, (3) Baron Spices, Inc., Beef Style Base, 50-lb. boxes; (4) Ryan's Cash & Carry, Beef Base, Quejese la Base, 28-oz. bottles; (5) Ryan's Cash & Carry, Beef Style Base, 8-lb. boxes; (6) Golbon, Beef Base, Quejese la Base, 28-oz. bottles; (7) Golbon Beef Style Base, 50-lb. boxes (no city, state, and zip code listed). Recall # F-2201-2010;

2) Baron Spices, Inc., Beef Style Base, Reduced Salt, packaged in 10-lb. bulk boxes.
Recall # F-2202-2010;

3) Aus Jus labeled as follows: (1) Aus Jus, packaged in 16-oz bags (12/case) and 28-oz. bottles (6/case), no brand name or firm name on the label; (2) Baron Spices, Inc., Quick Au Jus Gravy, packaged in 10-lb. boxes; (3) Golbon, Quick Au Jus Gravy, packaged in 16-oz. bags and 50-lb. boxes; (4) Ryan's Cash & Carry, Aus Jus Gravy, packaged in 8-lb. bottles (3/case); and (5) Ray's Meats, Aus Jus Gravy, packaged in 8-lb. bottles. Recall # F-2203-2010;

4) Planter's Seed and Spice Meatloaf Seasoning, packaged in 50-lb. boxes (no city, state, and zip code on the label). Recall # F-2204-2010;

5) Code LaBamba Ground Beef Spice, packaged in 25-lb. boxes (no city, state, and zip code on the label). Recall # F-2205-2010;

6) Bandana's Bar-B-Q All Purpose Seasoning for poultry & meat, packaged in 6.75-oz. bottles, 12/case, Kuna Foodservice Bandana's Seasoned Salt (w/o M S G), packaged in 50-lb. boxes (no city, state, and zip code on the label). Recall # F-2206-2010;

7) Kuna Foodservice Bandana's Seasoned Salt (w/o M S G), packaged in 50-lb. boxes (no city, state, and zip code on the label). Kuna Foodservice Bandana's Seasoned Salt (w/o M S G), packaged in 50-lb. boxes (no city, state, and zip code on the label). Recall # F-2207-2010
CODE
1) Lots: 119-477, exp. 11/23/2010, 119-547, exp. 12/17/2010, and 020-911, exp. 2/23/2011;

2) Lots: 119-5127, exp. 11/19/2010;

3) Lots: 119-478, exp. 11/23/2010; 129-609, exp. 12/9/2010; and 020-894, exp. 12/17/2010;

4) 129-679, exp. 12/30/2010;

5) Lots: 109-435, exp. 11/18/2010; 119-519, exp. 11/19/2010; and 020-937, exp. 2/25/2011;

6) Lots: 119-534, exp 11/23/2010

7) Lots: 119-554, 129-702, and 010-806
RECALLING FIRM/MANUFACTURER
Baron Spices Inc., Saint Louis, MO, by telephone on February 26, 2010 and letter dated February 28, 2010 and e-mail or FAX on March 23, 2010. Firm initiated recall is complete.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
10,695 lbs
DISTRIBUTION
MO, IL, AK, AR, WA, and MT
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PRODUCT 
1) Kroger Garlic Powder California Seasoning Blend 2.5 oz plastic jar, UPC 0 11110 66599 0. Recall # F-2208-2010;

2) Kroger Lemon Pepper Special Seasoning Blend 2.25 oz plastic jar, UPC 0 11110 74492 0. Recall # F-2209-2010
CODE
1) DEC0311PS2 and DEC0411PS2;
2) NOV0512PS2, DEC0312PS2, and DEC2812PS2;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kroger Co, Cincinnati, OH, by e-mails on March 15, and March 16, 2009 and by press release on March 16, 2010.
Manufacturers: The Kroger Co/ Pontiac Foods. Elgin, SC; Kerry Inc., Beloit, WI. FDA initiated recall is ongoing.
REASON
An ingredient purchased from Kerry Ingredients (Lemon Pepper Seasoning) was recalled because it may have been contaminated with Salmonella. The Kroger Garlic Powder was packaged after one run of Lemon Pepper Seasoning and prior to cleaning and sanitizing.
VOLUME OF PRODUCT IN COMMERCE
3367 cs/6/2.5 oz jars of Garlic Powder & 6772 cs/6/2.25 oz jars of Lemon Pepper
DISTRIBUTION
Nationwide

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PRODUCT 
1) Del Rancho Steak Breading, 50 pound bags. Recall # F-2210-2010;
2) Charlie's #2 Spice Flour, 50 pound bags. Recall # F-2211-2010
CODE
1) Best By 03-02-2011;
2) Best By 02-15-2011 and Best By 02-16-2011
RECALLING FIRM/MANUFACTURER
Shawnee Milling Co., Shawnee, OK, by phone on March 23, 2010. FDA initiated recall is ongoing.
REASON
The product was manufactured using black pepper recalled by Mincing Overseas Spice Company because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
561 bags, 28,050 pounds
DISTRIBUTION
OK
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PRODUCT 
Chilli Man Seasoning Mix, Net Wt 1-1/4 oz (35g). Recall # F-2212-2010
Unit: W0004Q
RECALLING FIRM/MANUFACTURER
Recalling Firm: Faribault Foods, Inc., Faribault, by press release and by letter dated March 18, 2010
Manufacturer: C H Guenther & Son, San Antonio, TX. Firm initiated recall is ongoing.
REASON
The product was manufactured using black pepper recalled by Mincing Overseas Spice Company because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1941 units
DISTRIBUTION
IA, IL, IN, MI, MO, OH, PA
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PRODUCT 
Lemon Pepper SHK FLT DO 10 #, 13902-AL, PO 25X612902, HEB Item 102304, Net Wt: 10 lbs. (4.54 kgs) (the product is bulk packed marinated catfish filets). Recall # F-2213-2010
CODE
Lots: 030510, 030910
RECALLING FIRM/MANUFACTURER
Heartland Catfish Alabama LLC, Greensboro, AL, by telephone on March 12, 2010. Firm initiated recall is complete.
REASON
Product was manufactured using black pepper recalled by Mincing Overseas Spice Company because the pepper has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1100 lbs
DISTRIBUTION
TX
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PRODUCT 
1) McCain Deli Roasters All American Potatoes, product code MCR03733, GTIN number 10072714037334. Recall # F-2214-2010;

2) McCain Deli Roasters Oven Roast Potatoes, Reduced Sodium, product code MCF03927, GTIN number 10072714839273. Recall # F-2215-2010;

3) McCain Deli Roasters 5 Spice Oven roast Cube, product code MCF04003, GTIN number 10055773039273. Recall # F-2216-2010;

4) McCain Deli Roasters 5 Spice Oven Roast Wedge, product code MCF04004, GTIN number 10055773039273. Product of U.S.A. Recall # F-2217-2010
CODE
1) Case Code: W91125;
2) Case Code: W91124, W91125, W91208, W91209, W00216;
3) Case Code: W91209, W91222, W00110, W00111;
4) Case Code: W00117
RECALLING FIRM/MANUFACTURER
Recalling Firm: McCain Foods USA, Lisle, IL, by press release and email beginning March 19, 2010.
Manufacturer: McCain Foods USA, Plover, WI. FDA initiated recall is ongoing.
REASON
The product was manufactured using black pepper recalled by Mincing Overseas Spice Company because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
27,252 cases
DISTRIBUTION
Nationwide, Canada, Germany, Korea

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
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PRODUCT 
1) Pastel Jordan Almonds (Candy Coated Almonds): 7 oz plastic/glass jars available in gift baskets, 8 oz plastic bag for in-store purchase, 10 oz  plastic bags for internet purchase, and 13 oz plastic bags available in gift baskets, SKU 46298-60103. Recall # F-2218-2010;

2) Christmas Jordan Almonds (Candy Covered Almonds): 7 oz plastic/glass jars available in gift baskets, 8 oz plastic bag for in-store purchase, 10 oz plastic bags for internet purchase, and 13 oz plastic bags available in gift baskets; SKU 46298-60106. Recall # F-2219-2010;

3) Boston Beans (Candy Coated peanuts): 12oz plastic bags for in store purchase, SKU 46298-60009. Recall # F-2220-2010;

4) Chocolate Fruit Basket: 6oz plastic bags for in-store purchase, 10 oz plastic bags for internet purchase, SKU 46298-64931. Recall # F-2221-2010

5) French Burnt Peanuts (Candy Coated peanuts): 12oz plastic bags for in-store purchase, SKU 46298-60910. Recall # F-2222-2010
CODE
UPC code only
RECALLING FIRM/MANUFACTURER
Melvin T. Meyer dba, Orland, CA, by letters on December 31, 2009 and press release to AP in early 2010. FDA initiated recall is ongoing.
REASON
1) Products contain undeclared colors including Red 3, Yellow 5 Lake, Blue 1 & 2 Lake, and Titanium Dioxide;
2) Products contain undeclared colors including Red 40 Lake, Yellow 5 & 6 Lake, Blue 1 Lake, and Titanium Dioxide;
3) Products contain undeclared colors including Red 3, Red 40, Yellow 6, Blue 2, Red 40 Lake, and Titanium Dioxide;
4) Products contain undeclared colors including Red 40 Lake, Yellow 6 Lake, Blue 2 Lake, and Titanium Dioxide;
5) Products contain undeclared colors including Red 3 and 40, Yellow 6, and Blue 2
VOLUME OF PRODUCT IN COMMERCE
Not known
DISTRIBUTION
CA
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PRODUCT 
Purity Atomic Blast, 100% Juice Blend from Concentrate with Other Added Ingredients, 4 fl oz (118mL) and 6.75 fl oz (200mL). Recall # F-2224-2010
CODE
05/01/10, 05/12/10, 05/19/10, 05/26/10
RECALLING FIRM/MANUFACTURER
Purity Dairies Inc., Nashville, TN, by telephone and letter on May 6, 2010. Firm initiated recall is complete.
REASON
Product contains undeclared Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
50,239 units
DISTRIBUTION
TN, AL, KY

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PRODUCT 
Juice Pac (TM) Atomic Blast, 100% Juice Blend From Concentrate With Other Added Ingredients, 6.75 fl oz (200mL). Recall # F-2225-2010
CODE
MAY 19, 19 MAY
RECALLING FIRM/MANUFACTURER
Dairy Fresh Corp., Cowarts, AL, by e-mail and visit on May 6, 2010. Firm initiated recall is complete.
REASON
Undeclared Yellow #5 in their ingredient statement on the cartons.
VOLUME OF PRODUCT IN COMMERCE
297 cases
DISTRIBUTION
AL, GA

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
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PRODUCT 
Chocolate Cherries: 8oz plastic/glass jars for in-store purchase or internet in gift baskets, SKU 46298-64126. Recall # F-2223-2010
CODE
UPC code only
RECALLING FIRM/MANUFACTURER
Melvin T. Meyer dba, Orland, CA, by letters on December 31, 2009 and press release to AP in early 2010. FDA initiated recall is ongoing.
REASON
Product contain undeclared certified colors including Red 40
VOLUME OF PRODUCT IN COMMERCE
Not known
DISTRIBUTION
CA
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PRODUCT 
Anderson Erickson Grade A Cheddar French Onion Sour Cream Dip, packaged in 8-oz. containers. Recall # F-2226-2010
CODE
Code dates of 4/21, 4/28, and 5/19
RECALLING FIRM/MANUFACTURER
Anderson Erickson Dairy Co., Des Moines, IA, by e-mail, telephone or visit on April 19, 2010. Firm initiated recall is complete.
REASON
The products were manufactured containing a black pepper ingredient recalled by Mincing Overseas Spice Company because it has the potential to be contaminated with Salmonella. Although the spice blend was irradiated before use, irradiation is not approved for all the ingredients of the spice blend.
VOLUME OF PRODUCT IN COMMERCE
15,856/8-oz containers
DISTRIBUTION
IA, IL, KS, MO, NE

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
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PRODUCT 
Sulfamethoxazole and Trimethoprim Injection, USP, 80mg/16 mg/mL, Vials, Rx Only, NDC # 0703-9514-01 single vials; NDC # 0703-9514-03 pkg. of 10 vials. Recall # D-557-2010
CODE
Lot number: 31308526B, Exp. Date: 9/2012
RECALLING FIRM/MANUFACTURER
Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter April 28, 2010. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: Defective/loose crimps.
VOLUME OF PRODUCT IN COMMERCE
54000 Vials
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
Glycopyrrolate Tablets, USP, 2mg, 100 tablets (10 x 10) Carton, Rx Only; NDC 68084-232-01. Recall # D-558-2010
CODE
Lot #096785 Exp. Date 06/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, by letters on February 26, 2010.
Manufacturer: Rising Pharmaceuticals, Inc., Allendale, NJ. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Some lots of Glycopyrrolate 2 mg tablets have the potential to exceed specifications for Impurity-I content over the shelf life of the product.
VOLUME OF PRODUCT IN COMMERCE
74 cartons
DISTRIBUTION
Nationwide
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PRODUCT 
1) Daytrana (Methylphenidate Transdermal System), 10 mg (1.1 mg/hr), 30 count cartons, Rx only, NDC# 54092-552-30. Recall # D-577-2010;

2) Daytrana (Methylphenidate Transdermal System), 15 mg (1. 6 mg/hr), 30 count cartons, Rx only, NDC# 54092-553-30. Recall # D-578-2010;

3) Daytrana (Methylphenidate Transdermal System), 20 mg (2. 2 mg/hr), 30 count cartons, Rx only, NDC # 54092-554-30. Recall # D-579-2010;

4) Daytrana (Methylphenidate Transdermal System), 30 mg (3. 3 mg/hr), 30 count cartons, Rx only, NDC # 54092-555-30. Recall # D-580-2010
CODE
1) Lot # 33985, Expiration Date Jan-2011; Lot # 34167, Expiration Date Jan-2011; Lot # 2994211, Expiration Date Mar-2010; Lot #3014711, Mar-2010; Lot #3014811, Expiration Date May-2010;

2) Lot # 33986, Expiration Date Dec-2010; Lot # 34168, Expiration Date Dec-2010, Lot #38127, Expiration Date Aug-2011; Lot #38697, Expiration Date Aug-2011;

3) Lot # 33989, Expiration Date Dec-2010; Lot # 34173, Expiration Date Dec-2010; Lot # 37611, Expiration Date Apri-2011; Lot #37686, Expiration Date May-2011; Lot# 37743, Expiration Date July-2011; Lot # 38126, Expiration Date Jul-2011; Lot #38700, Expiration Date Aug-2011; Lot #39098, Expiration Date Aug-2011; Lot #2819711, Expiration Date Jan-2010;

4) Lot #33040, Expiration Date Nov-2010; Lot #33047, Expiration Date Nov-2010; Lot #33209, Expiration Date Nov-2010; Lot #33210, Expiration Date Nov-2010; Lot #33993, Expiration Date Dec-2010; Lot # 33995, Expiration DateDec-2010; Lot #34178, Expiration Date Dec-2010; Lot #34191, Expiration Date Apri-2011; Lot #37788, Expiration Date Apri-2010; Lot #3073611, Expiration Date May-2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shire PLC, Wayne, PA, by press release and letter on December 3, 2009.
Manufacturer: Noven Pharmaceuticals, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
Miscalibrated and/ or Defective Delivery System no longer meets the release liner removal specification.
VOLUME OF PRODUCT IN COMMERCE
182431
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT 
1) EMBEDA (morphine sulfate and naltrexone hydrochloride, 20 mg/0.8 mg), Extended Release Capsules, 100 count bottle, Rx only; NDC 60793-430-01. Recall # D-581-2010;

2) EMBEDA (morphine sulfate and naltrexone hydrochloride, 30 mg/1.2 mg), Extended Release Capsules, 100 count bottle, Rx only; NDC 60793-431-01. Recall # D-582-2010;

3) EMBEDA (morphine sulfate and naltrexone hydrochloride, 60 mg/2.4 mg), Extended Release Capsules, 100 count bottle, Rx only; NDC 60793-434-01. Recall # D-583-2010;

4) EMBEDA (morphine sulfate and naltrexone hydrochloride), 50 mg/2.0 mg, Extended Release Capsules, 100 count bottle, Rx only; NDC 60793-433-01. Recall # D-584-2010;

5) EMBEDA (morphine sulfate and naltrexone hydrochloride), 80 mg/3.2 mg, Extended Release Capsules, 100 count bottle, Rx only; NDC 60793-435-01. Recall # D-585-2010

6) EMBEDA (morphine sulfate and naltrexone hydrochloride), 100 mg/4 mg, Extended Release Capsules, 100 count bottle, Rx only; NDC 60793-437-01. Recall # D-586-2010
CODE
1) Lots 581H91, 158G91 and 582H91, Exp. 07/2011;
2) Lots 159G91 and 585H91, Exp. 07/2011;
3) Lots 616H91, 503H91 and 617H91, Exp. 07/2011;
4) Lots 160G91, 586H91 and 587H91, Exp. 07/2011;
5) Lot 583H91, Exp. 07/2011;
6) Lot 588H91, Exp. 07/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals Inc., Bristol, TN, by letters on March 23, 2010 and May 10, 2010.  
Manufacturer: Actavis Elizabeth LLC, Elizabeth, NJ. Firm initiated recall is ongoing.
REASON
Failed dissolution testing for Morphine Sulfate during stability testing.
VOLUME OF PRODUCT IN COMMERCE
44,184 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT 
Source Plasma. Recall # B-0470-10
CODE
Unit:  0141473269
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Tulsa, OK, by letter dated August 26, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have an acceptable physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
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PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-0568-10;
2) Plasma Frozen. Recall # Recall # B-0569-10
CODE
1) and 2) Unit: 50LC29816
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by facsimile on August 21, 2009 and October 31, 2009. 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
OH

 ___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-0629-10
CODE
Unit: 72K733014
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on July 31, 2009. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-0836-10
CODE
Unit: 72J389876
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on December 8, 2009. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
1) Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-0857-10;
2) Red Blood Cells. Recall # B-0858-10
CODE
Unit: 1) and 2) W141609375213
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle WA, by letter dated November 18, 2009.
Manufacturer: Puget Sound Blood Center and Program, Federal Way, WA, Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0863-10
CODE
Unit: 012KQ74758
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by fax on October 9, 2009 and October 13, 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
NC  
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0897-10
CODE
Unit: W039808005862
RECALLING FIRM/MANUFACTURER
North Colorado Medical Center BB, Greeley, CO, by telephone on December 18, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
___________________________________
PRODUCT 
1) Cryoprecipitated AHF, Pooled. Recall # B-0952-10;
2) Recovered Plasma. Recall # B-0953-10
CODE
Unit: W036309244038X
RECALLING FIRM/MANUFACTURER
Recalling Firm: BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on June 28, 2009.
Manufacturer: BloodCenter of Wisconsin, Inc., Brown Deer, WI. 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
WI, Switzerland
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-0963-10
CODE
Unit: 9165678
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Port Charlotte, FL, by telephone on April 9, 2009. Firm initiated recall is complete.
REASON
Blood product, contaminated by air during collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1258-10
CODE
Units: 17FP10692 (2 units), 17FP10693
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by facsimile on November 4, 2005. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MN

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________
PRODUCT 
Source Plasma. Recall # B-0680-10
CODE
Unit: TQ055151
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma Corp., Knoxville, TN, by facsimile dated October 23, 2009. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who subsequently tested negative for HIV and HCV NAT, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0864-10
CODE
Unit: 012KQ74758
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by e-mail on October 9, 2009 and October 13, 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
CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0880-10
CODE
Units: 6750586, 6751153, 6757510, W116509100809
RECALLING FIRM/MANUFACTURER
Ogden Medical Center, Inc., Ogden, UT, by letter on August 18, 2009. Firm initiated recall is complete.
REASON
Blood products, with an unacceptably low red cell recovery rate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
UT
___________________________________
PRODUCT 
Platelets Leukocytes Reduced. Recall # B-1259-10
CODE
Unit: 032KS30549
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by telephone on May 1, 2006 and by facsimile on May 2, 2006. Firm initiated recall is complete.
REASON
Blood product, which may have reached an unacceptable temperature during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS I
___________________________________
PRODUCT 
1) Bard Mesh Monofilament Knitted Polypropylene; Contents: size 2" x 4", 3 units per box. Intended as reinforcement of soft tissue where weakness exists. Item Code: 0112650. Recall # Z-1647-2010;

2) Bard Mesh Monofilament Knitted Polypropylene; size 10 x 14", 3 units per box; Intended as reinforcement of soft tissue where weakness exists. Item Code: 0112660. Recall # Z-1648-2010;

3) Bard Mesh Monofilament Knitted Polypropylene; size 3" x 6", 3 units per box. Intended as reinforcement of soft tissue where weakness exists. Item Code: 0112680. Recall # Z-1649-2010;

4) Bard Mesh Monofilament Knitted Polypropylene Flat Mesh; size 6" x 6", 3 per box; Intended as reinforcement of soft tissue where weakness exists. Item Code: 0112720. Recall # Z-1650-2010
CODE
1) Lot Numbers: 48HVS036 and 43APD007;

2) Lot Numbers: HUSD0629 and HURL0336;

3) Lot Numbers: 43HPD027, 43HPD032, 43HPD034, HUSG0540, 43HDP027, HUSE0532, 43LPD507, HUSF0763, 43IOD011, 43IPD038, 43HPD034;

4) Lot Number: 43FQD327
RECALLING FIRM/MANUFACTURER
Ram Medical Inc., Wayne, NJ, by telephone beginning March 4, 2010 and letters beginning March 8, 2010. Firm initiated recall is ongoing.
REASON
Counterfeit product mixed with authentic product. The problem was recognized by the mismatching of expiration dates and the subtle differences in packaging.
VOLUME OF PRODUCT IN COMMERCE
411 boxes
DISTRIBUTION
CO, IL, NY, MO, FL

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT 
1) Bausch & Lomb Millennium Basic Venturi Phaco Pack, Models DP4305 and DP4305E, 12 packs/box, RX, Sterile. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1708-2010;
 
2) Bausch & Lomb Millennium Premium Venturi Phaco Pack, Model DP4310 and DP4310E, 6 packs/box, RX, Sterile. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1709-2010;

3) Bausch & Lomb Millennium Advanced Flow System Phaco Pack, Model CX5310, 6 packs/box, RX, Sterile. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1710-2010;

4) Bausch & Lomb Millennium Micro Incision Premium Venturi Pack, Model CX4320, 6 packs/box, RX, Sterile. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1711-2010;

5) Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Model BL5110, 6 packs/box, RX, Sterile. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1712-2010;

6) Bausch & Lomb Stellaris Vacuum Phaco Pack, Model BL5111, 6 packs/box, RX, Sterile. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1713-2010;

7) Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Model BL5112, 6 packs/box, RX, Sterile. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1714-2010;

8) Bausch & Lomb Stellaris Premium AFS Phaco Pack, Model BL5120, 6 packs/box, RX, Sterile. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1715-2010;

9) Bausch & Lomb Stellaris Basic AFS Phaco Pack, Model BL5121, 6 packs/box, RX, Sterile. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1716-2010;

10) Bausch & Lomb Stellaris 1.8mm StableChamber Phaco Pack with MICS Needle, Model BL5113, 6 packs/box, RX, Sterile. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1717-2010;

11) Bausch & Lomb Stellaris 1.8mm StableChamber Phaco Pack with MICS Angled Needle, Model BL5113A, 6 packs/box, RX, Sterile. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1718-2010;

12) Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Model BL5114, 6 packs/box, RX, Sterile. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1719-2010;

13) Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Angled Needle, Model BL5114A, 6 packs/box, RX, Sterile. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1720-2010;

14) Bausch & Lomb Stellaris 1.8mm Micro Incision AFS Phaco Pack with MICS Needle, Model BL5123, 6 packs/box, RX, Sterile. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1721-2010;

15) Bausch & Lomb Stellaris 1.8mm Micro Incision AFS Phaco Pack with MICS Angled Needle, Model BL5123A, 6 packs/box, RX, Sterile. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1722-2010;

16) Bausch & Lomb 19G Standard 30 Phaco Needle, Model DP8130S, 6 pouches/box. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1723-2010;

17) Bausch & Lomb 19G Standard 45 Phaco Needle, Model DP8145S, 6 pouches per box. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1724-2010;

18) Bausch & Lomb MicroFlow 30 Phaco Needle, Model DP8230S, 6 pouches/box. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1725-2010;

19) Bausch & Lomb MicroFlow 45 Phaco Needle, Model DP8245S, 6 pouches/box. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1726-2010;

20) Bausch & Lomb MicroFlow Plus 30 Phaco Needle, Model DP8330S, 6 pouches/box. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1727-2010;

21) Bausch & Lomb Thin Tip 30 Phaco Needle, Model DP8430S, 6 pouches/box. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1728-2010;

22) Bausch & Lomb Thin Tip 30 angled Phaco Needle, Model DP8430AS, 6 pouches/box. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1729-2010;

23) Bausch & Lomb MicroFlow 2.2 30 Phaco Needle, Model DP8730S, 6 pouches/box. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery. Recall # Z-1730-2010
CODE
1) U2604 and U2603;
2) U2608 and U2599;
3) U2663;
4) U2605;
5) U1578;
6) U1577 and U1605;
7) U1603 and U1612;
8) U1642;
9) U1643;
10) U1604;
11) U2336;
12) U2331;
13) U2337;
14) U1644;
15) U2338;
16) U2503;
17) U2519;
18) U2518;
19) U2613;
20) U2578;
21) U2149;
22) U2150;
23) U2583
RECALLING FIRM/MANUFACTURER

Recalling Firm: Bausch & Lomb Inc., Rochester, NY, by letter dated January 7, 2010.
Manufacturer: Bausch & Lomb Inc., Saint Louis, MO. Firm initiated recall is ongoing.
REASON
Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate.
VOLUME OF PRODUCT IN COMMERCE
582,744 units
DISTRIBUTION
Nationwide and Germany, France, Italy, Norway, Sweden, Finland, The Netherlands, Switzerland, U.K., Austria, Luxembourg, Ireland, Hong Kong, New Zealand, India, Australia, and Japan
___________________________________
PRODUCT 
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis. Recall # Z-1747-2010
CODE
Serial Numbers: 000000A9316002 000000A9316008 000000F9314002 000000F9314013 000000Q9309007 000000Q9309012 000000Q9309013 000000Q9309015 000000W9321002 000000W9321004 000000A9316004 000000A9316014 000000A9316015 000000A9345002 000000A9345003 000000A9345007 000000A9345009 000000A9345019 000000A9345020 000000F9314005 000000F9314010 000000F9314014 000000Q9309002 000000Q9309003 000000Q9309006 000000W9321003 000000P9300003 000000A9316012 000000P9300002 000000F9314011 000000W9321001 000000W9321007 000000W9321008 000000W9321010 000000W9321006 000000A9316006 000000A9316003 000000A9316005 000000P9300001 000000Q9309010 000000Q9309014 000000A9345015 000000Q9309005 000000A9316011 000000A9345012 000000A9345013 000000A9345014 000000A9345016 000000A9345018 000000F9314004 000000Q9309001 00000D10011003 00000D10011006 000000A9316001 000000F9314008 000000F9314012 000000P9300004 000000W9321009 000000A9316010 000000F9314007 000000W9321005 000000A9316007 000000A9316009 000000F9314015 000000F9314006 000000Q9356005 00000ZA9260001 000000Q9309008 000000A9345001 000000A9345017 000000F9314001 000000Q9309004 000000Q9356001
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated February 8, 2010.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. When using the Print Image or Print Screen feature on SenoAdvantage 2.2, the Scale factor annotation printed on hard copy images is inaccurate. Secondary Capture (SCPT) images displayed on the screen and Secondary Capture hard copy images may also contain the inaccurate Scale factor annotation. This issue may result in a potential miscalculation of size.
VOLUME OF PRODUCT IN COMMERCE
73 devices
DISTRIBUTION
CA, FL, GA, MD, NJ, NM, NY, NC, OK, TX. and Internationally
___________________________________
PRODUCT 
Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit", "Xenon Circuit", and Needleless Xenon Diagnostic Circuit" Manufactured for RAF MEDICAL, INC., (Model number's RAF2306, RAF2304, RAF2380, RAF2300, RAF2370, RAF2372, RAF2350, RAF2341, RAF2302, RAF2340 RAF2306, RAF2304, RAF2361), or Medico-Mart, Inc. ("Xenon Curcuit" Model number's 2304, 2306). Xenon Diagnostic Circuit Kit: Used in specific Nuclear Medicine Procedures. ViroMax: For use on all patient populations, in conjunction with other respiratory devices containing standard 15 mm and/or 22 mm fittings (such as breathing circuits and the like) to filter respiratory gases where infection from airborne bacteria and viruses is a concern. Recall # Z-1754-2010
CODE
Lot #'s for RAF Medical, Inc.: 1002092, 1001211, 1002011, 1002192, 1003081, 1003231, 1002012, 1003085, 1001263, 1003186,1004051, 1002112, 1003086, 1003082, 1003245, 1003291, 1002081, 1002111, 1001222, 1002193, 1003083, 1003241, 1002013, 1003084, 1003242, 1001181, 1003296, Lot #'s for Medico-Mart: 10020414, 1002191, 1003088
RECALLING FIRM/MANUFACTURER
Continental Medical Labs, Inc., Waterford, WI, by letters one dated March 31, 2010 and the other dated April 7, 2010. Firm initiated recall is ongoing.
REASON
A component of the Xenon Kit (ViroMax viral and bacterial filter) is being recalled because the filters may have a leak at the seam where the two halves of the filter are bonded together.
VOLUME OF PRODUCT IN COMMERCE
5520 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool Pain Management introducers, and 1 Pain Management Tube Kit. Model/Catalogue Number: LUK-17-150-4 The LumbarCool Pain Management System, a cooled radiofrequency pain management system, in combination with the Baylis Pain Management Generator-TD (PMG-TD), is indicated for use to create RF lesions in nervous tissue. Recall # Z-1755-2010
CODE
Lot Number: LKFA160310
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baylis Medical Corp *, Montreal, Canada, by letter dated May 12, 2010. 
Manufacturer: Baylis Medical Company Inc., Mississauga Ontario, Canada. Firm initiated recall is ongoing.
REASON
Name of the device reflected on the product packing sleeve is incorrect.
VOLUME OF PRODUCT IN COMMERCE
58 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Boston Scientific, Back-Up Meier Steerable Guidewires, Sterilized using ethylene oxide. The steerable guidewires are made of a stainless-steel, PTFE-coated proximal shaft, which tapers down to a very flexible and shapeable distal tip. The tip area consists of a radio-opaque gold-plated tungsten spring coil wound around a stainless-steel inner core. The usable length of the guidewire is 185 cm, 260 cm and 300 cm. Material (UPN) H965SCH306000; Catalog # SCH-30600; Product Description / Number BACK-UP MEIER .035 in, 185cm FLEX J TIP, Single / Single. Material (UPN) H965SCH306001; Catalog # SCH-30600; Product Description / Number BACK-UP MEIER .035 in, 185cm, J TIP B5 /5 per Box. Material (UPN) H965SCH306010; Catalog # SCH-30601; Product Description / Number BACK-UP MEIER .035 in, 300cm EX, FLEX C, Single/ Single. Material (UPN) H965SCH306011; Catalog # SCH-30601; Product Description / Number BACK-UP MEIER .035 in, 300cm EX C TIP B5/5 per Box. Material (UPN) M001306020; Catalog # 30-602; Product Description / Number MEIER WIRE 260 cm .035 w/C TIP, SINGLE/Single. Material (UPN) M001306021; Catalog # 30-602; Product Description / Number MEIER WIRE 260 cm .035 w/C TIP 5 PER BX/5 per Box. Recall # Z-1760-2010
CODE
Lot/Batch 13188299 13188448 13188850 13189372 13191119 13191900 13214230 13215622 13217713 13218224 13218422 13218654 13230493 13231032 13231763 13235212 13237044 13237266 13237865 13244785 13245496 13250396 13250705 13250811 13255106 13188299 13188448 13188850 13189372 13191119 13191900 13214230 13215622 13217713 13218224 13218422 13218654 13230493 13231032 13231763 13235212 13237044 13237266 13237865 13244785 13245496 13250396 13250705 13250811 13255106 13168826 13188292 13189005 13191912 13192123 13192691 13194328 13205603 13212484 13212647 13214988 13220752 13223805 13224584 13225209 13230183 13230872 13235343 13235437 13237414 13240493 13241294 13244517 13245964 13253646 13260267 13168826 13188292 13189005 13191912 13192123 13192691 13194328 13205603 13212484 13212647 13214988 13220752 13223805 13224584 13225209 13230183 13230872 13235343 13235437 13237414 13240493 13241294 13244517 13245964 13253646 13260267 13189367 13200586 13213574 13217494 13241577 13254666 13189367 13200586 13213574 13217494 13241577 13254666
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Maple Grove MN, letter dated April 19, 2010. 
Manufacturer: Boston Scientific Corp., Miami Fl. Firm initiated recall is ongoing.
REASON
Boston Scientific Corporation is conducting a Medical Device Recall of certain lots/batches of its Back-up Meier Steerable Guidewires. Through their internal inspection process, they identified that the polytetrafluoroethylene (PTFE) coating on the gold plated distal coil of the Back-up Meier Steerable Guidewires of the identified lots/batches have the potential for PTFE delamination. Inconsistent adherence of PTFE coating to this coil portion of the guidewire may cause the PTFE coating to flake or fall off from delamination. Injury to the brain, kidneys and other organs could, potentially, be caused if the PTFE coating flakes or falls off the guidewire and if, consequently, PTFE particulates are released into the blood stream. In the most severe cases, injuries could include stroke, irreversible impairment to brain or renal function, blue toe syndrome and/or other ischemic effects.
VOLUME OF PRODUCT IN COMMERCE
US 885 single units (177 boxes), OUS 630 single units (126 boxes)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
1) DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 22 cm Straight Basic Kit, Catalog Number/REF 10302802, 510 (k) 080400, Sterile. Recall # Z-1761-2010;

2) DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 24 cm Straight Basic Kit, Catalog Number/REF 10302803, 510 (k) 080400, Sterile. Recall # Z-1762-2010;

3) DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 28 cm Straight Basic Kit, Catalog Number/REF 10302804, 510 (k) 080400, Sterile. Recall # Z-1763-2010;

4) DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 32 cm Straight Basic Kit, Catalog Number/REF 10302805, 510 (k) 080400, Sterile. Recall # Z-1764-2010;

5) DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 36 cm Straight Basic Kit, Catalog Number/REF 10302806, 510 (k) 080400, Sterile. Recall # Z-1765-2010;

6) DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 40 cm Straight Basic Kit, Catalog Number/REF 10302807, 510 (k) 080400, Sterile. Recall # Z-1766-2010;

7) DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 55 cm Straight Basic Kit, Catalog Number/REF 10302809, 510 (k) 080400, Sterile. Recall # Z-1767-2010;

8) DURAMAX (TM) Hemodialysis Catheters, Stack Tip 24 cm Pre-Curve Basic Kit, Catalog Number/REF 10302812, 510 (k) 080400, Sterile. Recall # Z-1768-2010;

9) DURAMAX (TM) Hemodialysis Catheters, Stack Tip 28 cm Pre-Curve Basic Kit, Catalog Number/REF 10302813, 510 (k) 080400, Sterile. Recall # Z-1769-2010;

10) DURAMAX (TM) Hemodialysis Catheters, Stack Tip 32 cm Pre-Curve Basic Kit, Catalog Number/REF 10302814, 510 (k) 080400, Sterile. Recall # Z-1770-2010;

11) DURAMAX (TM) Hemodialysis Catheters, Stack Tip 36 cm Pre-Curve Basic Kit, Catalog Number/REF 10302815, 510 (k) 080400, Sterile. Recall # Z-1771-2010
CODE
1) Lots 978907, 981842, 981962, 978908;
2) Lots 978909, 980646, 981113, C68432, C68433, C68434, 981843;
3) Lots 978911, 980647, 981114, 981844, 982372, C68435, C68436, C68437, C68438, C68439, 981964;
4) Lots 978913, 980648, 981115, C68440, C68441;
5) Lots 978915, 981116, C68443;
6) Lots 978917, 981117, 981847, 981967, 982367;
7) Lots 981859, 982375, 978919;
8) Lots 978920, 981848, C68444, C68445, 981968;
9) Lots 978922, 981849, C68446, C68447, 981969;
10) Lots 978924, 981851, 981970, C68448, C68449;
11) Lots 981860, C68450
RECALLING FIRM/MANUFACTURER
Angiodynamics, Inc., Queensbury, NY, by letters dated January 7, 2010. Firm initiated recall is ongoing.
REASON
The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers were used during the manufacturing 100% leak test.
VOLUME OF PRODUCT IN COMMERCE
2378
DISTRIBUTION
Nationwide and St. Thomas, VI

___________________________________
PRODUCT 
1) Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Inner Pouch 240cm, Box 20 UPN/Catalog Number: M00513331. Recall # Z-1772-2010;

2) Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Box 80, 240cm UPN/Catalog Number: M00513334. Recall # Z-1773-2010;

3) Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps UPN/Catalog Number: MOO513330 The Radial Jaw 4 Large Capacity Inner Pouch, 240cm UPN M00513330 Is a single unit which Is packaged into a Box of 20 units (UPN M00513331), and a Box of 80 units (UPN M00513334). Single packaged units of M00513330 are not sold individually. Recall # Z-1774-2010
CODE
1) Lot: 13244654;
2) Lots: 13361332, 13361334;
3) Lot: 13244654
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Marlborough, MA, by letters on May 6, 2010.
Manufacturer: Boston Scientific Corp., El Coyol, Costa Rica. Firm initiated recall is ongoing.
REASON
Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result.
VOLUME OF PRODUCT IN COMMERCE
4,320 units
DISTRIBUTION
Nationwide Panama
___________________________________
PRODUCT 
1) MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator that provides negative pressure for the application of wound drainage; Models 769600 (with Truseal), 759600 (refurbished), 769600 Rental, 769601 (rental), 769602 (evaluation pump with Truseal) and 769610 (sales unit with case). Recall # Z-1777-2010;

2) NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Model 769709. Recall # Z-1778-2010
CODE
1) Serial numbers NPJ0001 through NPJ0348 and NPK0001 through NPK0095;
2) All units
RECALLING FIRM/MANUFACTURER
Ohio Medical Corp., Gurnee, IL, by letters dated May 7, 2010 5/10/10, May 13, 2010 and May 14, 2010, and telephone on May 11, 2010. Firm initiated recall is ongoing.
REASON
Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during use.
VOLUME OF PRODUCT IN COMMERCE
375 pumps, 218 bags
DISTRIBUTION
Nationwide and Qatar and Oman
___________________________________
PRODUCT 
Rayhack Drill Guide Angled, Ref 4010-0206, 1 Each, Rx Only, Non-Sterile, Intended use: Preparation of the Radius prior to device implantation. Recall # Z-1779-2010
CODE
Lot numbers: 0495581514, 089669448
RECALLING FIRM/MANUFACTURER
Wright Medical Technology Inc., Arlington, TN, by letter on April 8, 2010. Firm initiated recall is ongoing.
REASON
Drill guides from 2 lots may not seat properly on the compression block.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
Nationwide and The Netherlands
___________________________________
PRODUCT 
St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized with Ethylene Oxide. Single-use. The Ultra Wand LP device is designed for use with the Epicor Cardiac Ablation System. Recall # Z-1780-2010
CODE
Products with a serial number lower than 93859
RECALLING FIRM/MANUFACTURER
St. Jude Medical Atrial Fibrillation Division Inc., Sunnyvale, CA, by letters dated June 15, 2009 and November 6, 2009. Firm initiated recall is ongoing.  
REASON
The firm states that overheating of cardiac tissue is caused by inadequate cooling. The potential exists when the UltraWand is run using off-label cooling methods (gravity saline flow instead of N pump) that cooling flow to one or both cells can be decreased based on pressure applied by the physician to the device. To reflect this information to the user, the Atrial Fibrillation Division (AFD) has implemented revisions to the Instructions for Use (IFU) for the UltraWand LP Handheld Ablation Device. Five revisions have been made to the IFU.
VOLUME OF PRODUCT IN COMMERCE
1813 (1155 US, 658 OUS)
DISTRIBUTION
Nationwide and Australia, Canada, Japan, Korea, Singapore

 RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS I
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PRODUCT 
1) Nature's Variety Raw Frozen Diet, Chicken Formula, packaged in 3-lb. plastic bags containing approximately 48 medallions, 9 bags/case, UPC 769949601302, and Nature's Variety A Taste of Raw, packaged in .75 lb. plastic bags containing 12 medallions, 10 bags/case, UPC 769949601319. Recall # V-074-2010

2) Nature's Variety Raw Frozen Diet, Chicken Formula, packaged in 6-lb. plastic bags containing 12 patties, 6 bags/case, UPC 769949601203. Recall # V-075-2010;

3) Nature's Variety Raw Frozen Diet, Chicken Formula, packaged in 2-lb. chubs, 6/2-lb. chubs/retail box, 3 retail boxes/case, UPC 769949601210. Recall # V-076-2010
CODE
1) Best If Used By 10/29/10, 11/9/10, and 11/10/10;
2) Best If Used By 10/29/10, 11/9/10, and 11/10/10;
3) Best If Used By 10/29/10 and 11/10/10
RECALLING FIRM/MANUFACTURER
Natures Variety, Lincoln, NB, by Associated Press and PR Newswire, posted on Facebook, Twitter, and the firm's website, by telephone and letter dated February 11, 2010 and a second press release and letters dated March 8, 2010. Firm initiated recall is complete.
REASON
Contaminated with Salmonella
VOLUME OF PRODUCT IN COMMERCE
Medallions - 1,576 cases (14,184 retail 3-lb) & 134 cases (1,340 retail .75-lb); Patties - 1,457 cases (8,742 retail); Chubs - 248 cases (5,940 retail)
DISTRIBUTION
Nationwide and Canada

END OF ENFORCEMENT REPORT FOR JUNE 9, 2010

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