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U.S. Department of Health and Human Services

Safety

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Enforcement Report for May 25, 2011

 

May 25, 2011                                                                                        11-21
 
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
GFS Pecan Pieces, Net wt 40 oz, UPC 093901134837, Lot number 095 1094. Recall # F-1232-2011
CODE
Lot code 095 1095
RECALLING FIRM/MANUFACTURER
Nut Bar Company, Inc., Grand Rapids, MI, by telephone on May 3, 2011 and by press release on May 4, 2011. Firm initiated recall is ongoing.
REASON
A walnut containing product was distributed in packaging that did not reveal the presence of walnuts.
VOLUME OF PRODUCT IN COMMERCE
360 bags
DISTRIBUTION
AL, IL, IN, KS, KY, MT, OH, TN, WV
___________________________________
PRODUCT
CHERRY BERRIES GRAPE TOMATOES TOMATES RAISINS Product of USA Produit des E-U A Sweet Treat Naturally ***1 US DRY PINT (551 mL) 1 CHOPINE SECHE E-U (551 mL)***0 33383 65585 7***" Product Grape Tomato. Brand Name - Cherry Berries distributed in 1 pint clamshell, 10 lb, and 20 lb celo bags and then in paper cartons with 12 clams per case. Refrigerate at 55 degrees. The MDP sample consisted of 3 sub-samples (3 individual clamshells) of GRAPE tomatoes that came from a full wholesale tray (SIX L's label). The wholesale tray also had an identifying mark of DW-H. Recall # F-1246-2011
CODE
DW-H
RECALLING FIRM/MANUFACTURER
Recalling Firm: Six L's Packing Company, Inc., Immokalee, FL, by press release, telephone, and letters on April 29, 2011.
Manufacturer: Six L's Packing - Farm 2. Estero, FL. FDA initiated recall is ongoing.
REASON
The tomatoes have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
103,302 lbs
DISTRIBUTION
FL, NJ, CA, NY, CT, MI, TX and Canada
___________________________________
PRODUCT
Jalapeno Pepper. Shipping Carton: (Front/Back) "***Fresh Vegetables***”; (Right Side): "***1 1/9 BU. ***Product of U.S.A. Unless Marked***"; (Left Side) "***1 1/9 BU. ***"; (Top) "***Perishable Handle with Care***"; (Bottom) "***Coated with Food Grade Vegetable, Petroleum, Beeswax, and/or Shellac-Based Wax or Resin***". Was last shipped to retail on 02/18/2011 with a shelf life ending on 03/01/2011. Recall ## F-1247-2011
CODE
Unit: 1054811JJBT
RECALLING FIRM/MANUFACTURER
Thomas Produce Co., Boca Raton, FL, by telephone and letter on March 23, 2011. Florida initiated recall is ongoing.
REASON
FDA laboratory analysis of Jalapeno Peppers was positive for Salmonella Poly A.
VOLUME OF PRODUCT IN COMMERCE
320 boxes
DISTRIBUTION
NY, FL, NC, PA, MN
___________________________________
PRODUCT
1) Kabob Kit: Pineapple Pepper Zucchini Tomato. Safeway Item Code: 88800027. Recall # F-1253-2011;
2) Kabob Kit: Mushroom Peppers Tomato. Safeway Item Code: 88800028. Recall # F-1254-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Safeway Inc., Pleasanton, CA, by press release on May 3, 2011.
Manufacturer: Taylor Farms Pacific, Inc., Tracy, CA. Firm initiated recall is ongoing.
REASON
The grape tomatoes have a potential to be contaminated with salmonella. Safeway received grape tomatoes from a vendor who was supplied by Six L in Florida.
VOLUME OF PRODUCT IN COMMERCE
219 cases
DISTRIBUTION
CA, OR, NV, AZ, WA, WY, CO, WA
___________________________________
PRODUCT
Grape Tomatoes packaged as follows: One Pint Plastic Clamshells ("Fancy Sweet or "Cutie Brand") 2 Lb Plastic Clamshells ("Cutie Brand") 8 Lb Loose Bulk ("Cutie Brand") 10 Lb Loose Bulk ("Cutie Brand"). Recall # F-1255-2011
CODE
Master Carton Lot #202 GB (no codes on individual units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Northeast Produce Inc., Plainville, CT, by telephone, fax and letter on May 5, 2011.
Manufacturer: Six L's Packing Company, Inc., Immokalee, FL. Firm initiated recall is ongoing.
REASON
Product may be contaminated with salmonella.
VOLUME OF PRODUCT IN COMMERCE
10, 900 lbs
DISTRIBUTION
CT, MA, MD, NY, RI
___________________________________
PRODUCT
1) Raley's Seafood Louie Salad; 14 oz plastic tray. UPC: 46567504223. Recall # F-1267-2011;
2) Raley's Mediterranean Salad Kit, 11.5 oz plastic tray. UPC: 46567501192. Recall # F-1268-2011;
3) Raley's Family Size Green Salad Kit, 17 oz. plastic tray. UPC: 46567501222. Recall # F-1269-2011;
4) Raley's Tomato Caprese Salad Kit.Recall # F-1270-2011;
5) Raley's Grilled Artichoke and Vegetable Salad. Recall # F-1271-2011;
6) Raley's Greek Quinoa Salad Kit. Recall # F-1272-2011;
7) Raley's Mediterranean Orzo Salad Kit; Weight varies, sold at deli counter. Recall # F-1273-2011;
8) 2/2# Grape Tomatoes Packed for McDonald's. Recall # F-1274-2011;
9) Taylor Farms, Fresh Mozzarella and Tomato Salad; Packed for Sysco. Recall # F-1275-2011;
10) Safeway, Tomato/ Mozzarella kit. Weight varies, sold at deli counter. UPC: 21256300000. Recall # F-1276-2011;
11) Safeway, Turkey Parmesan Pasta Salad Kit. UPC: 48205016601. Recall # F-1277-2011;
12) Taylor Farms Seafood Salad Kit, 15 oz. plastic tray. UPC: 48205016601. Recall # F-1278-2011;
13) Sam's Greek Orzo Pasta 2 count salad kit, 2.5 lb plastic tray. Recall # F-1279-2011;
14) Marketside Seafood Salad Kit, 16.25 oz plastic tray. UPC code: 68113191702. Recall # F-1280-2011;
15) Signature Cafe Greek Salad, premade. Recall # F-1281-2011;
16) Signature Cafe Caprese salad, premade. Recall # F-1282-2011;
17) Signature Cafe Caprese salad kit, 2-4 ct., 8.25 oz plastic tray. UPC: 21130-06582. Recall # F-1283-2011;
18) Signature Cafe Greek Salad Kit, 2-4 ct/ 7 lbs., 13.5 oz plastic tray. UPC: 21130-06257. Recall # F-1284-2011;
19) Raley"s Fresh Vegetables with Peppercorn Ranch Dip; 28 oz plastic tray, UPC 465675610030. Recall # F-1285-2011;
20) Raley's Fresh Vegetables with Creamy Ranch Dip; 3 lb plastic tray, UPC 465675508474. Recall # F-1286-2011;
21) Signature Cafe Veggie Pleaser, 1 count, 23 oz. plastic tray, UPC 21130-06198. Recall # F-1287-2011;
22) Signature Cafe Veggie Pleaser, 4 count, 23 oz. plastic tray. Recall # F-1288-2011;
23) Signature Cafe, Greek Salad Seattle Kit 2-4. Recall # F-1289-2011;
24) Tomato, Mushroom, Red Bell pepper Kabob for Safeway.Recall #F-1290-2011
CODE
1) Expiration 5/5/2011;
2) Expiration 5/4/2011 and 5/5/2011;
3) Expiration 5/5/2011;
4) Expiration 5/5/2011;
5) Expiration 5/5/2011;
6) Expiration 5/5/2011;
7) Expiration 5/5/2011, 5/06/2011, 05/07/2011;
8) Expiration 5/1/2011, 5/2/2011 and 5/3/2011;
9) Expiration 5/6/2011;
10) Expiration 05/05/2011, 5/6/2011, 05/07/2011. 05/08/2011, 05/09/2011;
11) Expiration 05/07/2011. 05/08/2011;
12) Expiration 05/05/2011. 05/06/2011, 05/07/2011. 05/08/2011;
13) Expiration 05/08/2011;
14) Expiration 05/04/2011. 05/06/2011, 05/08/2011;
15) Expiration 04/27/2011;
16) Expiration 04/27/2011;
17) Expiration 05/05/2007; Expiration 05/07/2007;
18) Expiration 05/03/2011, 05/04/2011, 05/05/2007, 05/07/2007;
19) Expiration 05/11/2011;
20) Expiration 05/12/2011;
21) Expiration 05/09/2011, 05/10/2011, and 05/11, 2011;
22) Expiration 05/09/2011, 05/10/2011, and 05/11, 2011;
23) Expires 5/3/11 & 5/4/11;
24) Expires 5/9/11, 5/10/11, 5/11/11, 5/12/11
RECALLING FIRM/MANUFACTURER
Taylor Farms Pacific, Inc., Tracy, CA, by press release on May 4, 2011. Firm initiated recall is ongoing.
REASON
Taylor Farms was notified by supplier of grape tomatoes that one lot of the tomatoes may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
6465 cases, 1174 single units
DISTRIBUTION
CA, AZ, OR, NV, NM, UT, WA, CO, WY
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
Beiqi Asparagus Lettuce (90 gm plastic pouch); UPC 6921816800032. Recall # F-1223-2011
CODE
2009.10.23
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tristar Food Wholesale Co Inc., Jersey City, NJ, telephone on March 25, 2011.
Manufacturer: Beiqi (Fujian Foods) Company Ltd., Min Hou, China. Firm initiated recall is ongoing.
REASON
The firm distributed product that was labeled to contain sodium cyclamate which is a banned ingredient.
VOLUME OF PRODUCT IN COMMERCE
18 cases (90 bags per case)
DISTRIBUTION
NY
___________________________________
PRODUCT
Black Bean Sauce, 12 fl oz. glass jar (354 ml). Packaged with 2 labels: Ohana Flavors Black Bean Sauce and Barb’s Bean Sauce, Made in Hawaii.
Distributed by Barbs Favorite Recipes. Barb's UPC; 7 02003 72739 6; Ohana UPC: 6 75981 42491 8. Recall # F-1227-2011
CODE
All lot codes.
RECALLING FIRM/MANUFACTURER
Wing Coffee Co., Waipahu, HI, by press release on January 19, 2011 and letters on January 21, 2011. FDA initiated recall is ongoing.
REASON
Product is being recalled due to the potential for the growth of Clostridium Botulinum.
VOLUME OF PRODUCT IN COMMERCE
5944 x 12 oz jars
DISTRIBUTION
HI
___________________________________
PRODUCT
Walgreens Refreshing Diet Cola Classic Soda, Caffeine Free, Sweetened with Splenda; 20 Fl. oz. non-returnable plastic bottles/24 bottles per case; item 113244, UPC 0 49022 14144 5. Recall # F-1248-2011
CODE
Bottle codes: 10/20/20112011NL1, 10/27/201102711ML1, 11/04/201103511NL1, 11/15/201104611NL1 and 11/22/201105311NL1
RECALLING FIRM/MANUFACTURER
Recalling Firm Dr. Pepper Snapple Group Inc., Plano, TX, by telephone, letter and e-mail dated March 14, 2011.  
Manufacturer: American Bottling Co, Inc., Northlake, IL. Firm initiated recall is ongoing.
REASON
The diet cola was inadvertently labeled as "Caffeine Free" when the label should have read "Calorie Free". The product contains caffeine as an added ingredient.
VOLUME OF PRODUCT IN COMMERCE
12,172 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Cascabella Peppers, 50 lb Plastic Keg with Can Liner. Recall # F-1291-2011;
2) Sliced Pickles (crinkle cut pickle chips), 50 lb Plastic Keg with Can Liner. Recall # F-1292-2011
CODE
None
RECALLING FIRM/MANUFACTURER
A.G.S. Wholesalers, Inc., Compton, CA, by letter on May 13, 2011. Firm initiated recall is ongoing.
REASON
1) FDA lab analysis found the affected product to contain undeclared food color and ingredient, specifically Yellow #5, and sulfites.
2) FDA lab analysis found the affected product to contain undeclared food color and ingredients, specifically Yellow #5, potassium sorbate, and sodium benzoate. People who have allergies to these ingredients run the risk of moderate-severe reactions if they consume products containing these ingredients. 
VOLUME OF PRODUCT IN COMMERCE
120,000 lbs
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
1) Coca-Cola, packaged in 12-fl. oz. cans in 6-packs, 20-packs, and 24-packs, and in 12- fl. oz. plastic bottles. Recall # F-1224-2011;
2) Diet Coke, packaged in 12-fl. oz. cans in a Fridge pack and 2-liter bottles. Recall # F-1225-2011;
3) Coca-Cola cherry, packaged in 12-fl. oz. cans in a Fridge pack. Recall # F-1226-2011
CODE
1) Cans - OCT3111SLA, OCT3111SLD, and OCT3111SLF; Bottles - APR1111SLF;
2) MAY0211SLF;
3) OCT3111SLD
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Coca-Cola Co., Atlanta, GA, by visit and letter beginning March 3, 2011. 
Manufacturer: Coca-Cola Refreshments, Maryland Heights, MO. Firm initiated recall is complete.
REASON
The product had an off-taste (metallic).
VOLUME OF PRODUCT IN COMMERCE
85,168 cases
DISTRIBUTION
MO, IL, KS, NE
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
Fruta Planta/Reduce Weight Fruta Planta (all weight loss formulas) Dietary Supplement Capsules, 100% Pure Nature, 400 mg, 1) Fruta Planta, 30 Capsules/Box; 2) Reduce Weight Fruta Planta, 30 Capsules/Box; 30 Capsules/Bottle; 3) Reduce Weight Fruta Planta, 30 Capsules/Pink Box; 4) Reduce Weight Fruta Planta, 30 Capsules/Box With GMP Sticker; 5) Reduce Weights Fruta Planta, 30 Capsules/Box; 6) Reduce Weight, 30 Capsules/Box. Recall # D-511-2011
CODE
All Lots and All Codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Prock Marketing, LLC, Kissimmee, FL, by Press Release on December 30. 2010. 
Manufacturer: Guangzhou Yanxiang Biotechnology De, Guangdongguangdong, China. Firm initiated recall is ongoing.
REASON
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sibutramine based on FDA's sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
5,300 boxes estimate
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Celerite Slimming Capsules, 30 count boxes. Recall # D-512-2011
CODE
All codes/lots distributed up to and including product distributed through January 24, 2011.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shaping Beauty Inc, Huntingdon Valley, PA, by press release, web site and email beginning on January 24, 2011. 
Manufacturer: H & S GMP Factory, Kunming, China. FDA initiated recall is ongoing.
REASON
Product was collected and sampled by FDA and found to contain undeclared Sibutramine. It was marketed without an approved NDA/ANDA
VOLUME OF PRODUCT IN COMMERCE
Approximately 5040 boxes of 30
DISTRIBUTION
Nationwide distribution via internet sales
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
1) Retinoic Acid 0.025% (containing 0.025% Retin-A) Topical solution, 60 mL bottle, Recall # D-513-2011;
 
2) Retinoic Acid 0.05% (Containing 0.05% Retin-A) Topical solution, 60 mL bottle, Recall # D-514-2011;
 
3) 2% Spironolactone Topical Solution, 60 mL bottle, Rx. Recall # D-515-2011; 
 
4) 5% Spironolactone Lotion, 2 oz jar, Rx. Recall # D-516-2011;
 
5) Treatment Shampoo (2% Ketoconazole and 3% Salicylic Acid) Topical Solution, 4 oz bottle, Rx. D-517-2011;
 
6) Minoxidil 5% Topical Solution, 65 ml bottle, Rx. Recall # D-518-2011;
 
7) Minoxidil 5% with 0.025% Retinoic Acid Topical Solution, 65 mL bottle, Rx. Recall # D-519-2011;
 
8) Minoxidil 5% Topical Solution without Propylene Glycol, 65 mL bottle, Rx. Recall # D-520-2011;
 
9) Xandrox (5% Topical Minoxidil Azelaic Acid Solution), Day Time Formulation, 65 ml bottle, Rx. Recall # D-521-2011;
 
10) Xandrox with .025 Retinoic Acid (5% Topical Minoxidil Azelaic Acid) Solution, Nigh Time formulation, 65 ml bottle, Rx. Recall # D-522-2011;
 
11) Xandrox without Propylene Glycol (5% Minoxidil Azelaic Acid) Solution, 65 ml bottle, Rx. Recall # D-523-2011;
 
12) 12.5% Minoxidil Solution, 125 mL bottle, Rx. Recall # D-524-2011;
 
13) 6% Minoxidil Plus Solution, 65 ml bottle, Rx. Recall D-525-2011;
 
14) Xandrox Medicated Lotion (12.5% Minoxidil and 5% Azelaic Acid), 30 mL and 125 mL bottle, Rx. Recall # D-526-2011;
 
15) Xandrox 15 (15% Minoxidil and 5% Azelaic Acid) Solution, 125 mL bottle. Recall # D-527-2011;
 
16) Xandrox 15-Plus (15% Minoxidil, 5% Azelaic Acid and 0.1% Finasteride) Solution, 125 mL bottle. Recall # D-528-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Regrowth, LLC, Whittier, CA, by letters on March 29, 2011. FDA initiated recall is ongoing.
REASON
Marketed Without an Approved NDA/ANDA: These products are unapproved drugs and may present potential health hazards.
VOLUME OF PRODUCT IN COMMERCE
57,999 bottles
DISTRIBUTION
Nationwide, Argentina France Malta South Africa Australia Germany Mauritius South Korea Austria Greece Mexico Spain Azerbaijan Guam Netherlands Sweden Bahrain Hong Kong New Zealand Switzerland Belgium Hungary Northern Ireland Taiwan Bolivia Iceland Norway Thailand Brazil Indonesia Peru Trinidad Bulgaria Ireland Philippines Turkey Canada Israel Poland UAE China Italy Portugal Ukraine Colombia Japan Puerto Rico United Kingdom Croatia Jordan Qatar Uruguay Cyprus Kuwait Republic of Georgia Vietnam Czech Republic Latvia Romania Yugoslavia Denmark Lebanon Russia Ecuador Lithuania Scotland Estonia Macau Serbia Faroe Islands Malaysia Singapore Finland Maldives Slovenia
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Aldactone (spironoloactone) tablets USP 50 mg, 100 Count Bottle, Rx only, and NDC 0025-1041-31. Recall # D-510-2011
CODE
Lot # C090548 Exp Date: September 2011
RECALLING FIRM/MANUFACTURER
Pfizer Pharmaceuticals LLC, Caguas, PR, by letter on April 13, 2011. Firm initiated recall is ongoing.
REASON
Superpotent (Single Ingredient Drug): Above specification for spironoloactone assay at 18 months stability time point.
VOLUME OF PRODUCT IN COMMERCE
2,496 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT   
a) P3 Plates Part Numbers ZM0473, ZM0470; b) P3B Plates Part Numbers MU8405; c) P4 Plates Part Numbers ZM0475, ZM0621; d) P4B Plates Part Numbers MU8406 for the PK7200 and PK7300 Automated Microplate System. Recall # B-1214-11 
CODE
a) Lot Numbers: 91A, 92A, 93A, 95D, 96D; b) Lot Numbers: 91A, 92A, 93A, 95D, 96D; c) Lot Numbers: 93B, 94B, 99C; d) Lot Numbers: 93B, 94B, 99C
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on April 23, 2010.  
Manufacturer: Beckman Coulter Mishima K.K., Sunto-gun, Japan. Firm initiated recall is ongoing.
REASON
Beckman Coulter PK microplates, with defects that may cause fold over or slip down of positive reaction patterns, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2,268 plates
DISTRIBUTION
Nationwide and Canada
 ___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-1270-11;
2) Fresh Frozen Plasma. Recall # B-1271-11
CODE
1) Units: 012KP08753; 012KP08744; 012KP08746; 012KP08745; 012KP08741; 012KP08751; 012KP08748; 012KP08729; 012KP08747; 012KP08738; 012KP08739; 012KP08750; 012KP08752; 012KP08727; 012KP08735; 012KP08733; 012KP08749;
 
2) Units: 012KP08746; 012KP08745; 012KP08744; 012KP08743
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on November 23, 2007 and by a follow up letter dated December 17, 2007 and January 4, 2008.
Manufacturer: Whole Blood Collections-Mobiles-Carolinas Region, Asheville, Asheville, NC. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with air during collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
NC
___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced. Recall # B-1300-11
CODE
1) Unit: W127811201509 (split unit)
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone on February 8, 2011 and letter on February 17, 2011. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1302-11
CODE
Units: W038610321196; W038610318817
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by e-mail and facsimile on March 10, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malarial, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT   
Red Blood Cells, Recall # B-1303-11
CODE
Unit: W038110016159
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida’s Blood Centers – Lake Park, Palm Beach Gardens, FL, by letter dated January 7, 2011.
Manufacturer: Florida’s Blood Centers, Inc., Stuart, FL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
 ___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced. Recall # B-1307-11
CODE
Unit: W065611025888
RECALLING FIRM/MANUFACTURER
Bergen Community Region Blood Center, Paramus, NJ, by e-mail dated March 11, 2011 and March 24, 2011. Firm initiated recall is complete.
REASON
Blood product, labeled as leukoreduced but which was not tested for White Blood Cell count as required, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1308-11
CODE
Unit: 002GG96524
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Wichita, KS, by facsimile on March 23, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KS
___________________________________
PRODUCT   
1) Platelets. Recall # B-1310-11;
2) Red Blood Cells. Recall # B-1311-11
CODE
1) and 2) Unit: W088411501571
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, HI, by letter on March 14, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
HI
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1312-11
CODE
Units: 20FW09792, 20FW16952, 20E69888
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by letters dated March 2, 2011 and March 4, 2011. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the human immunodeficiency virus (HIV), but were collected from a donor who previously tested positive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA, MD
 ___________________________________
PRODUCT   
1) Recovered Plasma. Recall # B-1313-11;
2) Plasma Frozen within 24 hours (FP24). Recall # B-1314-11
CODE
1) Unit: W038110315818;
2) Units: W038111013424, W038110229360, W038110115621
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on March 15, 2011 and by letter dated March 15, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
France, FL
___________________________________
PRODUCT   
1) Red Blood Cells. Recall # B-1332-11;
2) Platelets. Recall # B-1333-11
CODE
1) and 2) Unit: 1115173
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, HI, by letter on June 28, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had lived in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
HI
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1334-11
CODE
Unit: K11321
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter on April 20, 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
CA
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1335-11
CODE
Unit: K15156
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter on July 27, 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
CA
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1336-11
CODE
Units: 3691712; 3694113; 3688548; 3685640
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter dated August 23, 2006. Firm initiated recall is complete.
REASON
Blood products, which was collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MA
 ___________________________________
PRODUCT   
1) Red Blood Cells. Recall B-1338-11;
2) Platelets Pooled Leukocytes Reduced. Recall # B-1339-11
CODE
1) Unit: W036811096047;
2) Unit: W036810824202
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S Florida, Inc., Lauderhill, FL, by telephone on April 1, 2011. 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   
1) Platelets Pheresis Leukocytes Reduced. Recall # B-1345-11;
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1346-11
CODE
1) and 2) Unit: K16043
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter on May 2, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Pletal, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1347-11
CODE
Unit: W137510206542
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by letter on April 5, 2011. 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
OR
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1348-11
CODE
Unit: 084R12197
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by letter on March 16, 2011. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined subsequent to receiving information regarding a post donation information, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
 ___________________________________
PRODUCT   
Plasma Frozen within 24 hours (FP24). Recall # B-1349-11
CODE
Units: W071210058751; W071210060884; W071210060843
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on October 1, 2010 and by letter on October 4, 2010. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with air, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TN
___________________________________
PRODUCT   
Platelets Pheresis. Recall # B-1350-11
CODE
Unit: W287811000827
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, IL, by telephone on March 3, 2011. 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
IL
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-1351-11;
2) Red Blood Cells. Recall # B-1352-11;
3) Plasma. Recall # B-1353-11
CODE
1) Unit: W038511700644
2) and 3) Unit: W038510370779
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on April 18, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland, GA
___________________________________
PRODUCT   
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1354-11
CODE
Unit: W036809386933 Part 1; W036809386933 Part 2
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S Florida, Inc., Lauderhill, FL, by letter on April 1, 2011. 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
FL
 ___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1356-11
CODE
Unit: W117010181378
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific – Irwin Center, San Francisco, CA, by telephone on January 20, 2011 and a follow-up letter on January 26, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malaria endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT   
1) Red Blood Cells. Recall # B-1358-11;
2) Platelets Pooled Leukocytes Reduced. Recall # B-1359-11;
3) Cryoprecipitated AHF. Recall # B-1360-11
CODE
1) Units: W036810255209, W036810181617;
2) Unit: W036810810832;
3) Unit: W036810181617
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S Florida, Inc., Lauderhill, FL, by telephone on April 1, 2011 and by letter dated April 4, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Switzerland and FL
___________________________________
PRODUCT   
Red Blood Cells. Recall # B-1362-11
CODE
Unit: W036810164159
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Miami, FL, by telephone on April 1, 2011 and by letter dated April 1, 2011. 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
Switzerland, FL
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1376-11
CODE
Unit: W118810224761
RECALLING FIRM/MANUFACTURER
The Blood Alliance, Inc., Jacksonville, FL, by telephone on March 10, 2011. Firm initiated recall is complete.
REASON
Blood product, for which an incorrect result of syphilis testing was reported, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-1301-11
CODE
Unit: 29FF85334
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid Atlantic Region, Norfolk, VA, by electronic notification system on February 9, 2011. 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-1309-11
CODE
Unit: 55FG24507
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by e-mail on February 26, 2011. 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
AL
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1331-11
CODE
Units: LG62000; LG60992; LG60995; LG60999
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on June 30, 2005. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-1340-11
CODE
Unit: W036811096047
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S Florida, Inc., Lauderhill, FL, by telephone on April 1, 2011. 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
FL
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1355-11
CODE
Unit: W118810231484
RECALLING FIRM/MANUFACTURER
The Blood Alliance, Inc., Jacksonville, FL, by telephone on March 10, 2011. Firm initiated recall is complete.
REASON
Blood product, whose testing was performed, interpreted, or documented incorrectly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-1361-11
CODE
Units: W036810255209, W036810181617
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S Florida, Inc., Lauderhill, FL, by telephone on April 1, 2011 and by letter dated April 4, 2011. 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
Switzerland and FL
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-1363-11
CODE
Unit: W036810164159
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Miami, FL, by telephone on April 1, 2011 and by letter dated April 1, 2011. 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
Switzerland, FL
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1364-11
CODE
Unit: W045011012297
RECALLING FIRM/MANUFACTURER
Recalling Firm: Community Blood Center of Greater Kansas City, Kansas City, MO, by telephone on March 4, 2011 and by letter dated April 18, 2011.
Manufacturer: Community Blood Center of Greater Kansas City, Saint Joseph, MO. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KS
___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1385-11
CODE
Unit: 22KW00627; 22KW00630; 22KW00634; 22KW00635; 22LE66490; 22LE66882; 22LE67130
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone and letter on March 8, 2011. Firm initiated recall is complete.
REASON
Blood products, stored without continuous agitation some of which were also irradiated twice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
PA, NJ
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
DigiView software release 3.4.4.4 through 3.5.5.2. Digiview is a digital image management and reporting system with an associated clinical database. It provides capture, review and storage of images together with report creation and data basing. Recall # Z-2166-2011
CODE
DigiView software release numbers 3.6.4.4, 3.6.4.6, and 3.6.5.2
RECALLING FIRM/MANUFACTURER
Digisonics, Inc., Houston, TX, by telephone and e-mail on October 17, 2008. Firm initiated recall is ongoing.
REASON
Failure of software to update some measurements when tracings or points are amended after measurement calculations have been performed.
VOLUME OF PRODUCT IN COMMERCE
70 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Philips NM3 Monitors, Model 7900 PHILIPS NM3 Monitor, English - P/N 1051674 PHILIPS NM3 Monitor, English Refurbished - P/N U1051674 PHILIPS NM3 Monitor, English, Demo Unit - P/N DU1051674 PHILIPS NM3 Monitor, Spanish - P/N 1060462 NM3 is a multi-parameter patient monitor that utilizes the FloTrak Elite module to perform some of the calculations. Recall # Z-2167-2011;
 
2) Philips FloTrak Elite modules: FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005 NM3 is a multi-parameter patient monitor that utilizes the FloTrak Elite module to perform some of the calculations. Recall # Z-2168-2011
CODE
1) Serial Numbers: 168-00041 168-00049 168-00055 168-00070 168-00071 168-00072 168-00073 168-00074 168-00075 168-00076 168-00077 168-00078 168-00079 168-00080 168-00081 168-00082 168-00083 168-00084 168-00085 168-00086 168-00087 168-00088 168-00089 168-00090 168-00091 168-00092 168-00093 168-00094 168-00096 168-00097 168-00098 168-00099 168-00100 168-00101 168-00102 168-00103 168-00104 168-00105 168-00106 168-00107 168-00108 168-00109 168-00111 168-00112 168-00113 168-00114 168-00115 168-00116 168-00117 168-00118 168-00119 168-00120 168-00121 168-00123 168-00125 168-00126 168-00127 168-00128 168-00129 168-00131 168-00132 168-00144 168-00145 168-00148 168-00164 168-00179 168-00181 168-00182 168-00183 168-00184 168-00186 168-00187 168-00188 168-00189 168-00190 168-00191 168-00193 168-00194 168-00195 168-00198 168-00203 168-00204 168-00205 168-00207 168-00208 168-00209 168-00211 168-00212 168-00218 168-00219 168-00222 168-00225 168-00237 168-00241 168-00242 168-00243 168-00244 168-00245 168-00246 168-00247 168-00248 168-00249 168-00250 168-00251 168-00252 168-00253 168-00254 168-00255 168-00256 168-00260 168-00261 168-00262 168-00263 168-00265 168-00266 168-00267 168-00269 168-00273 168-00274 168-00275 168-00277 168-00279 168-00280 168-00285 168-00286 168-00287 168-00288 168-00289 168-00290 168-00291 168-00293 168-00294 168-00295 168-00297 168-00298 168-00299 168-00300 168-00301 168-00302 168-00303 168-00304 168-00305 168-00306 168-00308 168-00309 168-00310 168-00311 168-00313 168-00314 168-00315 168-00316 168-00317 168-00318 168-00319 168-00320 168-00321 168-00322 168-00323 168-00331 168-00332 168-00333 168-00335 168-00336 168-00351 168-00352 168-00353 168-00354 168-00355 168-00357 168-00358 168-00359 168-00360 168-00361 168-00363 168-00364 168-00366 168-00367 168-00368 168-00369 168-00370 168-00373 and 168-00374;
 
2) Serial Numbers: 167-000475 167-000496 175 235 236 237 238 239 240 356 376 389 414 483 502 510 511 686 693 700 723 724 725 612 146 155 171 173 and 178
RECALLING FIRM/MANUFACTURER
Respironics Novametrix, LLC., Wallingford, CT, by letter on January 4, 2011. Firm initiated recall is ongoing.
REASON
Software: two displayed respiratory parameters are incorrect due to errors in the system software: MValv (alveolar minute ventilation) and Vt/kg (tidal volume/patient weight). In both instances, the displayed parameters are higher than actual.
VOLUME OF PRODUCT IN COMMERCE
220 units
DISTRIBUTION
Nationwide, Belgium, China, Columbia, Egypt, England, India, Italy, Saudi Arabia, and Spain
___________________________________
PRODUCT
COULTER LYSE S III diff Lytic Part Number: 8546796. COULTER LYSE S III diff Lytic Reagent For use as an erythrocyte lytic agent for the quantitative determination of hemoglobin and for leukocyte counting and sizing on COULTER GEN S, MAXM, HmX, LH500, LH 750, and LH 780 hematology analyzers. Use with only ISOTON III or LH Series diluent. Refer to your instrument product manuals and/or online help, as applicable. Recall # Z-2213-2011
CODE
Lot Number: 101554F
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated December 28, 2010.
Manufacturer: Beckman Coulter Inc., Florence, KY. Firm initiated recall is ongoing.
REASON
The recall was initiated by Beckman Coulter because the COULTER LYSE III diff Lytic Reagent Lot number 101554F was released for distribution to customers between November 17 and December 1, 2010 prior to completion of QC testing.
VOLUME OF PRODUCT IN COMMERCE
1,296 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Baxter Colleague, Colleague CX and Colleague CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: a) 2M8151, b) 2M8161 and c) 2M9161. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications. Recall # Z-2222-2011
CODE
a) Serial numbers 10090647CS, 10115635CS, 10115962CS, 10116082CS, 10116632CS, 10121619CS, 11011446CS, 11013479CS, 11030809CS, 11050013CS, 11050408CS, 11080071CS, 11080504CS, 11080881CS, 11081127CS, 11081178CS, 11081341CS, 11081358CS, 11081693CS, 11091827CS, 12010687CS and RA01705CS; b) Serial numbers 11120207CC, 11120577CC, 11120679CC, 11121015CC, 11121486CC, 11121539CC, 12030561CC, 12030888CC, 12030893CC, 12041367CC, 12041749CC, 12050038CC, 12050219CC, 12050223CC, 12050664CC, 12050681CC, 12051057CC, 12090119CC, 12090405CC, 12090427CC, 12091053CC, 12091075CC, 12091148CC, 12091405CC, 12091556CC, 12100117CC, 12100982CC, 12101088CC, 12101206CC, 12101594CC, 12101640CC, 12101697CC, 13010436CC, 13010685CC, 13021534CC, 13030933CC, 13040553CC, 13040621CC, 13040858CC, 13040959CC, 13050740CC, 13050540CC, 13070265CC, 13070294CC, 13071355CC, 13080673CC, 13090662CC, 13100920CC, 13101054CC, 13101261CC, 13110978CC, 13120218CC, 13121245CC, 13121377CC, 13121543CC, 13121871CC, 13122235CC, 13122390CC, 13123119CC, 13124082CC, 14040190CC, 14040232CC, 14040382CC, 14040631CC, 14051452CC, 14062542CC, 14073731CC, 14092140CC, 14100120CC, 14101408CC, 14110357CC, 14112103CC, 14120740CC, 14120849CC, 14121202CC, 14121225CC, 14121577CC, 14121865CC, 14123040CC, 14124070CC, 15033184CC, 15050130CC, 15060217CC, 15072249CC, 15072698CC, 15072852CC, 15081325CC, 15084164CC, 15092830CC, 15102333CC and 17110473CC; c) Serial numbers 17040756CP, 7041105CP, 17085496CP and 17088142CP
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by telephone on April 14, 2011 and by letter dated April 27, 2011.
Manufacturer: Baxter Healthcare SA, Singapore, Singapore. FDA initiated recall is ongoing.
REASON
The Hi-Pot safety testing may not have been conducted on the affected pumps during service, prior to being returned to the end user.
VOLUME OF PRODUCT IN COMMERCE
117 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
V-CATH Insertion Kits, Sterile; Product Code Number: 301-00. Recall # Z-2223-2011
CODE
Lot # Expiration Date 2009092850 5/31/2011 2010012950 5/31/2011 2010030150 8/31/2011 2010043050 8/31 2011 2010061850 12/31/2011 2010062950 12/31/2011 2010082650 12/31/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Neo Medical, Inc., Fremont, CA, by fax on April 5, 2011, by telephone on April 7, 2011 and letters on April 11, 2011.
Manufacturer: Centurion Medical Products, Salisbury, NC. Firm initiated recall is ongoing
REASON
Firm received recall notice from their contract manufacturer due to visible particulates in Bacteriostatic Sodium Chloride Injection, USP 0.9%, 30 mL vials that are included in insertion kits.
VOLUME OF PRODUCT IN COMMERCE
1990 units; 199 cases/10 per case
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Varian brand Clinac and TrueBeam, High Energy Linear Accelerator, Model Numbers: H14, H19, H29; Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall # Z-2224-2011
CODE
Serial Numbers H140126 ,H140869 ,H140919 ,H294300 ,H294348 ,H294396 ,H294443 ,H294494 ,H294541 ,H294596 ,H294644 ,H140151 ,H140870 ,H140920 ,H294301 ,H294349 ,H294397 ,H294444 ,H294495 ,H294542 ,H294597 ,H294645 ,H140820 ,H140871 ,H140921 ,H294302 ,H294350 ,H294398 ,H294445 ,H294496 ,H294543 ,H294598 ,H294646 ,H140825 ,H140872 ,H191001 ,H294303 ,H294351 ,H294399 ,H294446 ,H294497 ,H294544 ,H294599 ,H294647 ,H140826 ,H140873 ,H191002 ,H294304 ,H294352 ,H294400 ,H294447 ,H294498 ,H294545 ,H294600 ,H294648 ,H140827 ,H140874 ,H191003 ,H294305 ,H294353 ,H294401 ,H294448 ,H294499 ,H294546 ,H294601 ,H294649 ,H140828 ,H140875 ,H191005 ,H294306 ,H294354 ,H294402 ,H294449 ,H294500 ,H294547 ,H294602 ,H294650 ,H140829 ,H140876 ,H191006 ,H294307 ,H294355 ,H294403 ,H294450 ,H294501 ,H294548 ,H294603 ,H294651 ,H140830 ,H140877 ,H191007 ,H294308 ,H294356 ,H294404 ,H294451 ,H294502 ,H294549 ,H294604 ,H294652 ,H140831 ,H140878 ,H290168 ,H294309 ,H294357 ,H294405 ,H294452 ,H294503 ,H294550 ,H294605 ,H294653 ,H140832 ,H140879 ,H290246 ,H294310 ,H294358 ,H294406 ,H294454 ,H294504 ,H294551 ,H294606 ,H294654 ,H140833 ,H140881 ,H290282 ,H294311 ,H294359 ,H294407 ,H294458 ,H294505 ,H294552 ,H294607 ,H294655 ,H140834 ,H140882 ,H291040 ,H294312 ,H294360 ,H294408 ,H294459 ,H294506 ,H294553 ,H294608 ,H294656 ,H140835 ,H140883 ,H293427 ,H294313 ,H294361 ,H294409 ,H294460 ,H294507 ,H294554 ,H294610 ,H294657 ,H140836 ,H140884 ,H293608 ,H294314 ,H294362 ,H294410 ,H294461 ,H294508 ,H294555 ,H294611 ,H294658 ,H140837 ,H140886 ,H293884 ,H294315 ,H294363 ,H294411 ,H294462 ,H294509 ,H294556 ,H294612 ,H294659 ,H140838 ,H140887 ,H293885 ,H294316 ,H294364 ,H294412 ,H294463 ,H294510 ,H294557 ,H294613 ,H294660 ,H140839 ,H140888 ,H294043 ,H294317 ,H294365 ,H294413 ,H294464 ,H294511 ,H294564 ,H294614 ,H294661 ,H140840 ,H140889 ,H294084 ,H294318 ,H294366 ,H294414 ,H294465 ,H294512 ,H294565 ,H294615 ,H294662 ,H140841 ,H140890 ,H294088 ,H294319 ,H294367 ,H294415 ,H294466 ,H294513 ,H294567 ,H294616 ,H294663 ,H140842 ,H140891 ,H294154 ,H294320 ,H294368 ,H294416 ,H294467 ,H294514 ,H294568 ,H294617 ,H294664 ,H140843 ,H140892 ,H294206 ,H294321 ,H294369 ,H294417 ,H294468 ,H294515 ,H294569 ,H294618 ,H294665 ,H140844 ,H140893 ,H294274 ,H294322 ,H294370 ,H294418 ,H294469 ,H294516 ,H294570 ,H294619 ,H294666 ,H140845 ,H140895 ,H294275 ,H294323 ,H294371 ,H294419 ,H294470 ,H294517 ,H294571 ,H294620 ,H294667 ,H140846 ,H140896 ,H294276 ,H294324 ,H294372 ,H294420 ,H294471 ,H294518 ,H294572 ,H294621 ,H294668 ,H140847 ,H140897 ,H294277 ,H294325 ,H294373 ,H294421 ,H294472 ,H294519 ,H294573 ,H294622 ,H294669 ,H140848 ,H140898 ,H294278 ,H294326 ,H294374 ,H294422 ,H294473 ,H294520 ,H294574 ,H294623 ,H294670 ,H140849 ,H140899 ,H294279 ,H294327 ,H294376 ,H294423 ,H294474 ,H294521 ,H294575 ,H294624 ,H294671 ,H140850 ,H140900 ,H294280 ,H294328 ,H294377 ,H294424 ,H294475 ,H294522 ,H294576 ,H294625 ,H294672 ,H140851 ,H140901 ,H294281 ,H294329 ,H294378 ,H294425 ,H294476 ,H294523 ,H294577 ,H294626 ,H294673 ,H140852 ,H140902 ,H294283 ,H294330 ,H294379 ,H294426 ,H294477 ,H294524 ,H294579 ,H294627 ,H294674 ,H140853 ,H140903 ,H294284 ,H294331 ,H294380 ,H294427 ,H294478 ,H294525 ,H294580 ,H294628 ,H294675 ,H140854 ,H140904 ,H294285 ,H294332 ,H294381 ,H294428 ,H294479 ,H294526 ,H294581 ,H294629 ,H294676 ,H140855 ,H140905 ,H294286 ,H294333 ,H294382 ,H294429 ,H294480 ,H294527 ,H294582 ,H294630 ,H294677 ,H140856 ,H140906 ,H294287 ,H294334 ,H294383 ,H294430 ,H294481 ,H294528 ,H294583 ,H294631 ,H294678 ,H140857 ,H140907 ,H294288 ,H294335 ,H294384 ,H294431 ,H294482 ,H294529 ,H294584 ,H294632 ,H294679 ,H140858 ,H140908 ,H294289 ,H294336 ,H294385 ,H294432 ,H294483 ,H294530 ,H294585 ,H294633 ,H294680 ,H140859 ,H140909 ,H294290 ,H294337 ,H294386 ,H294433 ,H294484 ,H294531 ,H294586 ,H294634 ,H294681 ,H140860 ,H140910 ,H294291 ,H294338 ,H294387 ,H294434 ,H294485 ,H294532 ,H294587 ,H294635 ,H294682 ,H140861 ,H140911 ,H294292 ,H294339 ,H294388 ,H294435 ,H294486 ,H294533 ,H294588 ,H294636 ,H294683 ,H140862 ,H140912 ,H294293 ,H294340 ,H294389 ,H294436 ,H294487 ,H294534 ,H294589 ,H294637 ,H294684 ,H140863 ,H140913 ,H294294 ,H294341 ,H294390 ,H294437 ,H294488 ,H294535 ,H294590 ,H294638 ,H294685 ,H140864 ,H140914 ,H294295 ,H294342 ,H294391 ,H294438 ,H294489 ,H294536 ,H294591 ,H294639 ,H294686 ,H140865 ,H140915 ,H294296 ,H294343 ,H294392 ,H294439 ,H294490 ,H294537 ,H294592 ,H294640 ,H294687 ,H140866 ,H140916 ,H294297 ,H294345 ,H294393 ,H294440 ,H294491 ,H294538 ,H294593 ,H294641 ,H294688 ,H140867 ,H140917 ,H294298 ,H294346 ,H294394 ,H294441 ,H294492 ,H294539 ,H294594, H294642, H294689, H140868, H140918, H294299, H294347, H294395, H294442, H294493, H294540, H294595, H294643, H294690, H294691, H294718, H294747, H294774, H294802, H294831, H294858, H294885, H294692, H294719, H294748, H294775, H294803, H294832, H294859, H294886, H294693, H294720, H294749, H294776, H294804, H294833, H294860, H294887, H294694, H294721, H294750, H294777, H294806, H294834, H294861, H294888, H294695, H294723, H294751, H294778, H294807, H294835, H294862, H294889, H294696, H294724, H294752, H294779, H294808, H294836, H294863, H294890, H294697, H294726, H294753, H294780, H294809, H294837, H294864, H294891, H294698, H294727, H294754, H294781, H294810, H294838, H294865, H294892, H294699, H294728, H294755, H294782, H294811, H294839, H294866, H294894, H294700, H294729, H294756, H294783, H294812, H294840, H294867, H294895, H294701, H294730, H294757, H294784, H294813, H294841, H294868, H294896, H294702, H294731, H294758, H294786, H294814, H294842, H294869, H294898, H294704, H294732, H294759, H294787, H294815, H294843, H294870, H294899, H294705, H294733, H294760, H294788, H294816, H294844, H294871, H294900, H294706, H294734, H294761, H294789, H294817, H294845, H294872, H294901, H294707, H294735, H294762, H294790, H294818, H294846, H294874, H294902, H294708, H294736, H294763, H294792, H294820, H294847, H294875, H294904, H294709, H294737, H294764, H294793, H294821, H294848, H294876, H294965, H294710, H294738, H294765, H294794, H294822, H294850, H294877, H294972, H294711, H294739, H294766, H294795, H294823, H294851, H294878, H294712, H294740, H294768, H294796, H294824, H294852, H294879, H294713, H294742, H294769, H294797, H294825, H294853, H294880, H294714, H294743, H294770, H294798, H294826, H294854, H294881, H294715, H294744, H294771, H294799, H294827, H294855, H294882, H294716, H294745, H294772, H294800, H294829, H294856, H294883,  H294717, H294746, H294773, H294801, H294830, H294857, and H294884
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc., Oncology Systems, Palo Alto, CA. by letter and on-site visit on March 31, 2011. Firm initiated recall is ongoing.
REASON
The coolant may leak. The resulting coolant leak presents a risk of electrical shock to any person working within the protective housing.
VOLUME OF PRODUCT IN COMMERCE
718 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
SYNCHRON Systems Calibrator 1, Part Numbers: 468405, The Beckman Coulter SYNCHRON Calibrator 1 (CAL 1), used in conjunction with SYNCHRON reagents, is intended for the calibration of immunoprotein tests on SYNCHRON LX and UniCel DxC Systems. Recall # Z-2226-2011
CODE
Lots prior to M005558
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA, by letter on the week of March 14, 2011. Firm initiated recall is ongoing.
REASON
The recall was initiated because standardization of the Synchron Systems Calibrator 1, used for both the Synchron LX and UniCel DxC systems, has been established to the new IFCC Reference Preparation for Plasma Proteins, ERM-DA470k (formerly CR470) beginning with lot number M005558. During the standardization to the new IFCC standard, ERM-DA470k, we confirmed that Complement C4 (C4) had been recovering low compared to the old IFCC standard, CRM470. However, beginning with Synchron Systems Calibrator 1 lot M005558, the setpoint for C4 has been value-assigned to produce C4 assay recovery to match the ERM-DA470k target value. Internal studies show Quality Control and patient sample recovery for the other analytes defined in LX Calibrator 1 were not affected. The Synchron Systems Calibrator 1 lots listed above would have resulted in approximately 30% lower results. Revised Quality Control ranges and a patient correlation for C4 are attached for your convenience.
VOLUME OF PRODUCT IN COMMERCE
96,173 units
DISTRIBUTION
Nationwide and Argentina, Australia, Belgium, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Czech Republic, Denmark, Eritrea, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Republic of Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Namibia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Poland, Puerto Rico, Qatar Reunion, Russian Federation, Rwanda, Serbia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Viet Nam
___________________________________
PRODUCT
COULTER Ac"T" 5diff Fix Reagent. Part Number: 8547171 COULTER AC"T" 5diff Fix, Instructions for Use, PN 772264. Intended for use as a leukocyte reagent to differentiate subpopulations of cells on COULTER Ac"T 5diff hematology analyzers. Intended for use only with specific Ac"T 5diff reagents. Refer to the instrument product manuals and/or online help, as applicable. Recall # Z-2231-2011
CODE
Lot # 16602E, 16702E, 16802E
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on April 8, 2011.
Manufacturer: Horiba ABX SAS, Montpellier, France. Firm initiated recall is ongoing.
REASON
The recall was initiated because Beckman Coulter has confirmed that an issue has been identified with one of the raw materials used to manufacture the Coulter A T 5 diff PN 8547171.
VOLUME OF PRODUCT IN COMMERCE
4662 units total (2278 in US)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube and CO2 sample tube with male luer connector 22mm (I.D) x 6mm (O.D) Adaptor. Single Patient Use. Do not Sterilize. Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help. Product Code: 4707-7-7-25. Recall # Z-2237-2011
CODE
Lot code 012411
RECALLING FIRM/MANUFACTURER
Salter Laboratories, Division of Regulatory Affairs, Arvin, CA, by letter dated April 19, 2011. Firm initiated recall is ongoing.
REASON
Complaint received that the product in the box was different from labeled product.
VOLUME OF PRODUCT IN COMMERCE
22,150 pieces
DISTRIBUTION
Nationwide
 
END OF ENFORCEMENT REPORT FOR MAY 25, 2011
 
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