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U.S. Department of Health and Human Services

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Enforcement Report for April 18, 2012

 

April 18, 2012                                                                                         12-16
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
TOPNOTCH Chocolate Chip Chunk Cookie INGREDIENTS: WHEAT FLOUR, CHOCOLATE (CHOCOLATE LECITHIN (AN EMULSIFIED) AND VANILLAN (AN ARTIFICIAL FLAVOR), MARGARINE (LIQUID SOYBEAN OIL, PARTIALLY HYDROGENATED SOY BEAN OIL), BROWN SUGAR, SUGAR, EGGS, WALNUTS, CORN SYRUP, BAKING SODA, SALT; Net wt. 3.4 oz.  Recall # F-1037-2012
CODE
Expiration dates: "3/27/12-4/10/12" and distribution dates March 13-27, 2012.
RECALLING FIRM/MANUFACTURER
Topnotch Cookies & Cakes, Westland, MI, by telephone on March 28, 2012. Firm initiated recall is ongoing.
REASON
The firm became aware that they were using an ingredient, "Butter and Vanillan" flavoring that contained "Milk" ingredients. The firm does not declare milk as an ingredient on their finished product labels for "Chocolate Chip Chunk Cookie" 3.4 oz.
VOLUME OF PRODUCT IN COMMERCE
2,000 cookies
DISTRIBUTION
IL, MI, OH
___________________________________
PRODUCT
1) Chocolate Fudge Egg with Nuts. This product contains walnuts, chocolate, and two edible sugar Easter-shaped decorations. The product is packaged in a box with a plastic transparent window. The net weight is 8 oz. There is no UPC. The 8 oz. package is labeled in parts: "***CHOCOLATE FUDGE EGG WITH NUTS***INGREDIENTS: SUGAR, WHIPPING CREAM, CONDENSED MILK, COCOA POWDER, CORN SYRUP, INVERT SUGAR, MILK & DARK CHOCOLATE (SUGAR, MILK, CHOCOLATE LIQUOR, COCOA BUTTER, BUTTER OIL, SOYA LECITHIN, PURE VANILLA), WALNUTS, VANILLA, SALT, TENOX. POTASSIUM SORBATE***NET WEIGHT 8 OZ (227 G)***". edible decorative items on the Chocolate Fudge Egg with Nuts contain egg whites, Yellow #5, Yellow #6, Blue #1 and Red #3 but the finished product label does not declare egg and color additives. Recall # F-1053-2012;
 
2) Chocolate Fudge Egg-No Nuts. This product contains chocolate and two edible sugar Easter-shaped decorations. The product is packaged in a box with a plastic transparent window. The net weight is 8 oz. There is no UPC. The 8 oz. packaged is labeled in parts: "***CHOCOLATE FUDGE EGG (NO NUTS)***INGREDIENTS: SUGAR, WHIPPING CREAM, CONDENSED MILK, COCOA POWDER, CORN SYRUP, INVERT SUGAR, MILK & DARK CHOCOLATE (SUGAR, MILK, CHOCOLATE LIQUOR, COCOA BUTTER, BUTTER OIL, SOY LECITHIN, PURE VANILLA, VANILLA, SALT, TENOX, POTASSIUM SORBATE***NET WEIGHT 8 OZ (227 G)***". Recall # F-1054-2012;
 
3) Rocky Road Eggs is the chocolate fudge egg contains pecans, marshmallows, chocolate, and two edible sugar Easter-shaped decorations. The product is packaged in a box with a plastic transparent window. The net weight is 8 oz. There is no UPC. The 8 oz package is labeled in parts: "***ROCKY ROAD EGGS***INGREDIENTS: SUGAR, WHIPPING CREAM, CONDENSED MILK, COCOA POWDER, CORN SYRUP, INVERT SUGAR, MILK & DARK CHOCOLATE (SUGAR, MILK, CHOCOLATE LIQUOR, COCOA BUTTER, BUTTER OIL, SOYA LECITHIN, PURE VANILLA), PECANS, MARSHMALLOWS, VANILLA, SALT, TENOX, POTASSIUM SORBATE***Net Wt 8 oz (227 G)***". Recall # F-1055-2012
CODE
No codes
RECALLING FIRM/MANUFACTURER
Kane Investments, LLC dba Halletts Chocolate Factory, Spokane, WA, by telephone on March 28, 2012. FDA initiated recall is ongoing.
REASON                                                                                                                                               The edible decorative items on the Chocolate Fudge Egg-No Nuts contain egg whites, Yellow #5, Yellow #6, Blue #1 and Red #3 but the finished product label does not declare egg and color additives.
VOLUME OF PRODUCT IN COMMERCE
124 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Vanilla Cream Puffs sold under the following brand names: 1) Creme Curls Bakery vanilla cream puffs, 13.2 oz ( 374 g), Keep Frozen, Bavarian Filling inside A Flaky European Style Pastry, UPC Code #0-70109-60055-5; 2) Simply Enjoy vanilla cream puffs, 30 CT box, 19.4 oz (550 g), Keep Frozen, Bavarian Filling inside A Flaky European Style Pastry Puff, UPC Code #6-88267-12409-9. Recall # F-1058-2012
CODE
1) All lots and expiration dates 2) all lots and expiration dates including lots M1010D, M1019A, M1019B, M1019C, M1019D, M1046A, M1074A, M1074B, M1074C, M1074D, M1074E, M1076A, M1076B, M1076C, M1076D, M1130A, M1130B, M1130C, M1130D, M1140A, M1140B, M1140C, M1151A, M1151B, M1151C, M1157A, M1157B, M1157C, M1201A, M1201B, M1201C, M1228A, M1228B, M1245A, M1250A, M1256A, M1259A, M1259B, M1259C, M1259D, M1266A, M1266B, M1266C, M1279A, M1279B, M1279C, M1279D, M1291A, M1291B, M1305A, M1305B, M1311A, M1318A, M1318B, M1318C, M1318D, M1326A, M1326B, M1326C, M1326D, M1332A, M1332B, M1339A, M1339B, M1339C, M1346A, M1346B, M1347A, M1353A, M1353B, M1353C, M1361A, M1361B, M1361C, M2003A, M2003B, M2003C, M2003D, M2009A, M2009B, M2009B, M2009C, M2009D, M2016A, and M2016B
RECALLING FIRM/MANUFACTURER
Creme Curls Bakery, Inc., Hudsonville, MI, by telephone and E-mail beginning March 30, 2012 and press release on March 31, 2012. Firm initiated recall is ongoing.
REASON
The source of the sodium caseinate ingredient on the label is not listed as milk, an allergen.
VOLUME OF PRODUCT IN COMMERCE
10,343 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Crispy TWI Foods Almond Cake Rusk , Biscotte Croustillante Almande, Net wt. 750 g, Product of Canada; UPC 6 27265 00217 6. Recall # F-1059-2012;
 
2) Crispy TWI Foods Almond Cookies, Biscuit, Net wt. 200 g, 7 oz, Product of Canada, UPC 6 27265 00520 7. Recall # F-1060-2012:
 
3) Crispy TWI Foods Pistachio Cookies, Biscuit, Net wt. 200 g, 7 oz, Product of Canada, UPC 6 27265 00161 2. Recall # F-1061-2012;
 
4) Crispy TWI Foods Coconut Cookies, Biscuit, Net wt. 200 g, 7 oz., Product of Canada, UPC 6 27265 00521 47. Recall # F-1062-2012
CODE
1) All codes, best before March 27, 2013;
2), 3) All codes, best before March 29, 2013;
4) All codes, best before March 23, 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nuts and Spice Co., Inc., Union City, CA, by letter on March 29, 2011.
Manufacturer: Twi Foods Inc., Mississauga, Ontario, Canda. Firm initiated recall is ongoing. 
REASON
The cookies and cake rusk did not declare milk and/or milk and almonds on the labeling.
VOLUME OF PRODUCT IN COMMERCE
45 cases
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
________________________________
PRODUCT
1) Coconut Peanut Brittle is a candy snack product. It is packaged in a plastic container. Net Wt. 8 oz. There is NO UPC. The product is labeled in parts: "SNOQUALMIE FALLS candy factory***COCONUT PEANUT BRITTLE***The BEST caramel corn EVER and more***INGREDIENTS: Coconut (preserved with sodium metabisulfate), peanuts, white sugar, glucose, water, butter (cream, salt), vanilla, salt***Net Wt. 8 oz***.” Recall # F-0961-2012;
 
2) Coconut Brittle is a candy snack product. It is packaged in a plastic container. Net Wt. 8 oz. There is NO UPC. The product is labeled in parts: "SNOWQUALMIE FALLS candy factory***COCONUT BRITTLE***The BEST caramel corn EVER and more***INGREDIENTS: Coconut (preserved with sodium metabisulfate), white sugar, glucose, water, butter (cream, salt), vanilla, salt***Net Wt. 8 oz***.”Recall # F-0962-2012;
 
3) Almond Brittle is a candy snack product. It is packaged in a plastic container, Net Wt. 8 oz. There is NO UPC. The product is labeled in parts: "SNOQUALMIE FALLS candy factory***ALMOND BRITTLE***The BEST caramel corn EVER and more***INGREDIENTS: Sugar, corn syrup, almonds, brown sugar, butter (cream, salt), baking soda, salt***NO PRESERVATIVES ADDED***Net Wt. 8 oz***.” Recall # F-0963-2012;
 
4) Pecan Brittle is a candy snack product. It is packaged in a plastic container and the Net Wt. is 8 oz. There is NO UPC. The product is labeled in parts: "SNOQUALMIE FALLS candy factory***PECAN BRITTLE***The BEST caramel corn EVER and more***INGREDIENTS: Sugar, corn syrup, pecans, brown sugar, butter (cream, salt), baking soda, salt***NO PRESERVATIVES ADDED***Net Wt. 8 oz***.” Recall # F-0964-2012;
 
5) Cashew Brittle is a candy snack product. It is packaged in a plastic container, Net Wt. 8 oz. The UPC is 7 18122 08362 6. The product is labeled in parts: "SNOQUALMIE FALLS candy factory***CASHEW BRITTLE***The BEST caramel corn EVER and more***INGREDIENTS: Sugar, corn syrup, cashews, brown sugar, butter (cream, salt), baking soda, salt***This product is manufactured on shared equipment also used for milk, eggs, peanuts, and tree nuts***NO PRESERVATIVES ADDED***Net Wt. 8 oz***.” Recall # F-0965-2012;
 
6) Peanut Brittle is a candy snack product. Net Wt. 8 oz. The UPC is 7 18122 08352 7. The product is labeled in parts: "SNOQUALMIE FALLS candy factory***PEANUT BRITTLE***The BEST caramel corn EVER and more***INGREDIENTS: Sugar, corn syrup, peanut, brown sugar, butter (cream, salt), baking soda, salt***This product is manufactured on shared equipment also used for milk, eggs, peanuts, and tree nuts***NO PRESERVATIVES ADDED***Net Wt. 8 oz***". Recall # F-0966-2012;
 
7) Caramel Corn is a popcorn product. The product is sold either in the 5 oz or 1 lb package. The 1 lb. package has the UPC 7 18122 08342 8. The product is labeled in parts: "SNOQUALMIE FALLS candy factory***CARAMEL CORN***The BEST caramel corn EVER and more***INGREDIENTS: Sugar, corn syrup, brown sugar, coconut oil, butter (cream, salt), popcorn, baking soda, salt, soy lecithin***This product is manufactured on shared equipment also used for milk, eggs, peanuts, and treenuts***NO PRESERVATIVES ADDED***Net Wt. 16 oz. (1 lb.) 453 g***". Recall # F-0967-2012;
CODE
None
RECALLING FIRM/MANUFACTURER
Snoqualmie Falls Candy Factory LLC, Snoqualmie, WA, by telephone on February 16, 2012. FDA Initiated recall is ongoing.
REASON
Butter is declared but milk is not listed and Corn is not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
3037 units for all 8 products
DISTRIBUTION
WA
___________________________________
PRODUCT
Gold Peak Sweet Tea, 16.3 fl. oz., 500mL, Case UPC: 83900 1065 4, Unit UPC: 83900 00645-7. Recall # F-1021-2012
CODE
Lot Code: APR1312 AM7 G.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coca-Cola Refreshments USA, Inc., Atlanta, GA, by letter on March 2, 2012.
Manufacturer: Coca Cola North America, Auburndale, FL. Firm initiated recall is ongoing.
REASON
Consumer complaints were received of foreign matter observed in a number of bottles from this specific lot.
VOLUME OF PRODUCT IN COMMERCE
10,319 cases - 12 bottles per case
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
1) Mix 1 brand of All Natural Protein Shake, blueberry-vanilla flavor, in 11 Fl. Oz. plastic bottles; 12 bottles per pack. Recall # F-1007-2012;
 
2) Mix 1 brand of All Natural Protein Shake, strawberry-banana flavor, in 11 Fl. Oz. plastic bottles; 12 bottles per pack. Recall # F-1008-2012;
 
3) Mix 1 brand of All Natural Protein Shake, mixed berry flavor, in 11 Fl. Oz. plastic bottles; 12 bottles per pack. Recall # F-1009-2012;
 
4) Mix 1 brand of All Natural Protein Shake, mango flavor, in 11 Fl. Oz. plastic bottles; 12 bottles per pack . Recall # F-1010-2012;
 
5) Mix 1 brand of All Natural Protein Shake, peach flavor, in 11 Fl. Oz. plastic bottles; 12 bottles per pack. Recall # F-1011-2012
CODE
1) Lot Code ASB11334BV 334 with Best By: 2012 Nov 30;
2) Lot Code ASB11335SB 335 with Best By: 2012 Dec 01;
3) Lot Code ASB11335MB with Best By: 2012 Dec 01;
4) Lot Code ASB11334MG with Best By: 2012 NOV 30;
5) Lot Code ASB11333PE with Best By: 2012 NOV 29
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mix 1 Corporate Office, Boulder, CO, by letter on February 21, 2012.
Manufacturer: Aseptic Solutions USA, LLC, Corona, CA. FDA initiated recall is ongoing.
REASON
Yeast and mold were found in the finished products.
VOLUME OF PRODUCT IN COMMERCE
Blueberry Vanilla - 5,005 12-packs; Strawberry Banana - 3,297 12-packs; Mix Berry - 4,626 12-packs; Mango - 3,940 12-packs; and Peach - 1,582 12-packs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Centrum Multivitamin/Multimineral Supplement --- 365 tablets --- UPC code 0005 4451 80. Recall# F-1012-2012
CODE
Lot F36903, Exp 05/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by letters on February 24, 2012. 
Manufacturer: Pfizer Inc., Pearl River, NY. Firm initiated recall is ongoing.
REASON
Pfizer Consumer Healthcare is recalling one lot of Centrum Tablets 365 CT because a portion of the lot may contain Centrum Silver tablets coated as Centrum tablets.
VOLUME OF PRODUCT IN COMMERCE
17,688 bottles
DISTRIBUTION
MD, NJ, TX, GA, FL, IL
___________________________________
PRODUCT
Cured Goat Cheese, 1 lb, packaged in plastic container. Recall # F-1036-2012
CODE
Lot code 15539427; Expiration Date 31-10-2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Triunfo Import & Export Corp., Newark, NJ, by telephone on September 15, 2011. 
Manufacturer: Queijos Tavares, SA, Seia, Portugal, New York Initiated recall is ongoing.
REASON
Imported cured goat cheese was found to contain less than 10 /g est E. coli and less than <1000 /g est for Staphylococcus aureus through NYSDAM sampling.
VOLUME OF PRODUCT IN COMMERCE
20 cases (8 1 lb packages per case)
DISTRIBUTION
NY and NJ
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
______________________________________
PRODUCT
Claravis ™ (Isotretinoin Capsules, USP) 40 mg, Carton containing 3 blister packs of 10 (30 capsules total), (NDC 0555-1057-86)
CODE
Lot #33800901A, exp 9/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc. Sellersville, PA
Manufacturer: Barr Laboratories Inc, Pomona, NY
REASON FOR RECALL
Stability data does not support expiration date: Due to the use of a packaging tool that created a slightly larger blister cavity.
______________________________________
PRODUCT
MethylPREDNISolone, Tablets, USP, 4 mg, 21 Count Blister Pack, (NDC 0603-4593-15)
CODE
Lot Number: S003M11, exp 9/13
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL
REASON FOR RECALL
Labeling: Label Mix-Up: label is rotated 180 degrees such that there is one tablet in the row for Day 1 that should be 6 tablets and 6 tablets in the row for Day 6 that should be 1 tablet.
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
NatureRelief instant wart and mole remover; Just One 15 Minute Application Removes All warts, Moles, Skin tags, And Genital Warts [HPV]; DERMATOLOGIST RECOMMENDED FORMULA FOR MEN & WOMEN; Ingredients; A natural proprietary blend of Garlic (Allum, Sativum), tomato (Lycopersium Esculenium), Calcium Oxide (Cao-Lime), & De-ionized Water. Recall # D-1313-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nature Relief, LLC, Miami Beach, FL, by press release on June 22, 2011 and email on July 7, 2011.
Manufacturer: Allium Corp., Artesia, CA. Firm initiated recall is ongoing.
REASON
Marketed Without an approved NDA/ANDA: Nature Relief, Lake Worth, FL is voluntarily recalling NatureRelief Instant Wart and Mole Remover because this product contains calcium oxide (Cao-Lime) which can cause cutaneous chemical burns to the skin. Nature Relief Instant Wart and Mole Remover was distributed in a kit with no NDC or lot control numbers on the packaging.
VOLUME OF PRODUCT IN COMMERCE
1,000 kits
DISTRIBUTION
Nationwide and Canada, Australia, Japan, United Kingdom and New Zealand.
___________________________________
PRODUCT
1) Polymyxin B for Injection Sterile, 500,000 Units per vial, 10 sterile vials, Rx only, NDC #55390-139-10. Recall # D-1314-2012;
 
2) Vecuronium Bromide for Injection, For IV use only, 10 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, NDC #55390-037-10. Recall # D-1315-2012;
 
3) Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 20mg Vials, lyophilized powder per carton, Rx Only, NDC #55390-039-10. Recall # D-1316-2012
CODE
1) Lot #0977-00-1942980, Exp Date 08/2013; Lot #0977-00-1895027, Exp Date 06/2013;
2) Lot #0905-04-1865067, Exp Date 05/2012;
3) Lot #0905-05-1865069, Exp Date 02/2012
RECALLING FIRM/MANUFACTURER
Ben Venue Laboratories Inc., Bedford, OH, by letters on August 2, 2011. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter: The potential for glass particulates in these lots of product cannot be eliminated.
VOLUME OF PRODUCT IN COMMERCE
23,151 cartons
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, 28-count tablets per blister card, packaged in 3 blister cards per carton, Rx only; NDC 68462-565-29. Recall # D-1317-2012
CODE
Lot #: 04110101, 04110106, 04110107, Exp 07/31/13; 04110114, 04110124, 04110129, Exp 08/31/2013; and 04110134, Exp 09/30/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Glenmark Generics Inc., USA, Mahwah, NJ, by press release and letters on February 24, 2012.
Manufacturer: Glenmark Generics Limited. Colvale Bardez, India. Firm initiated recall is ongoing.
REASON
Contraceptive Tablets Out of Sequence: Due to a packaging error, select blisters of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch.
VOLUME OF PRODUCT IN COMMERCE
92,952 cartons
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Midodrine Hydrochloride Tablets, 5 mg, 100-count tablets per bottle, Rx only, NDC 0185-0043-01, Recall # D-1312-2012
CODE
Lot number: BT0643, Exp 06/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz Inc., Princeton, NJ by letters and on/about February 21, 2012 and April 9, 2012 expanding the recall to the retail level.  
Manufactuer: Sandoz Inc., Wilson, NC
REASON
Tablet Thickness: This product is being recalled due to out of specification (above and below) results for tablet weight and above specification for tablet thickness.
VOLUME OF PRODUCT IN COMMERCE
7,088 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Pramipexole Dihydrochloride Tablets, 0.125 mg, 63-count tablets per bottle, Rx only; NDC 0555-0617-62. Recall # D-1321-2012
CODE
Lot #: 314467, 314642, 315467, 315468, Exp 03/12; 317085, 317086, 317218, Exp 08/12; 33800308A, Exp 04/13; 33800780A, 33800781A, Exp 06/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters and e-mail on March 22, 2012. 
Manufactuer: Barr Laboratories Inc., Pomona, NY. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products:Product may not meet the impurity specification through the 24-month shelf life.
VOLUME OF PRODUCT IN COMMERCE
424,675 bottles
DISTRIBUTION
Nationwide and Puerto Rico
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0989-12;
2) Fresh Frozen Plasma. Recall # B-0990-12
CODE
1) and 2) Unit: T32109
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter dated January 19, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the medication Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0991-12
CODE
Units: 0147504; 0147750; 0148226; 0148369; 0148870; FD0541495; FD0541930; FD0542653; FD0543030; FD0543498; FD0544080; FD0544442; FD0545121; FD0546173; FD0546320; FD0547239; FD0549228; FD0549491; FD0550272; FD0552330; FD0552660; FD0554249; FD0554900; FD0555389; FD0555958; FD0556249; FD0557506; FD0559767; FD0561594; FD0563252; FD0564032; FD0567091; FD0567688; FD0569886; FD0570318; FD0571808; FD0572177; FD0572912: FD0573309; FD0584198; FD0584685; FD0585541; FD0587168; FD0587783; FD0588557; FD0589463; FD0589876; FD0590796; FD0591152; FD0592138; FD0592679; FD0593651; FD0595403; FD0595851; FD0615624; FD0616158; FD0618986; FD0620774; FD0627467; FD0627890; FD0630621; FD0631097; FD0631953; FD0632456; FD0633462; FD0636105; FD0636863; FD0641223; FD0641588; FD0642206; FD0643814; FD0644156; FD0644844; FD0645419; FD0645841; FD0646443; FD0646751; FD0647403; FD0647853; FD0648432; FD0648779; FD0649411; FD0649889; FD0650511; FD0650946; FD0651696; FD0652020; FD0653016; FD0653349; FD0653975; FD0654379; FD0654995; FD0655378; FD0656003; FD0656445; FD0656901; FD0657340; FD0657915; FD0658257; FD0658848; FD0659222; FD0659808; FD0660875; FD0661260; FD0662015; FD0662622; FD0664031; FD0665084; FD0665462; FD0665911; FD0666192; FD0668065; FD0668327; FD0669830; FD0670107; FD0671041; FD0671310; FD0671811; FD0672126; FD0672546; FD0672920; FD0674513; FD0674683
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Farmington, NM, by electronic mail on September 28 and 29, 2011. Firm initiated recall is complete.
REASON
Blood products collected from a donor with a history of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
123 units
DISTRIBUTION
England, NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0992-12
CODE
Unit: W045011049548
RECALLING FIRM/MANUFACTURER
Community Blood Center Of Greater Kansas City, Kansas City, MO, by letter on December 22, 2011 and January 13, 2012. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MO
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0993-12
CODE
Unit: W037912888308
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, by facsimile on January 24, 2012. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-0995-12
CODE
Units: DU0443508, DU0443733, DU0443254, DU0444728
RECALLING FIRM/MANUFACTURER
DCI Plasma Center Of Duluth, LLC, Duluth, MN, by facsimile on December 23, 2011 and by e-mail on February 3, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0997-12;
2) Fresh Frozen Plasma. Recall # B-0998-12;
3) Red Blood Cells Leukocytes Reduced. Recall # B-0999-12
CODE
1) Units: LK28256, LK28256;
2) Unit: LV26057;
3) Units: LV26057, LK09552, LK02583
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on June 28, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who previously deferred for testing positive for hepatitis B surface antigen (HBsAg), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall #B-1000-12
CODE
Units: GJ13842 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on November 9, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Source Plasma. Recall # B-1002-12
CODE
Units: 04400584219, 04400578935, 04400485974, 04400569465, 04400477907, 04400471871, 04400549755, 04400544022, 04400530296, 04400518916, 04400514245, 04400503503, 04400497043, 04400466335, 04400461673, 04400448196, 04400441200, 04400344370, 04400337066, 04400328039, 04400321056, 04400301311, 04400297623, 04400274595, 04400272194, 04400261233, 04400250761, 04400246930, 04400232686, 04400230410, 04400220829, 04400219131, 04400216547, 04400179440, 04400177226, 04400185381, 04400163836, 04400158471, 04400134040, 04400130903, 04400027869, 04400038787, 04400034401, 04400013969, 04400010346, 04400070040, 04400047181, 04400043076, 04400055085, 04400050911
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Charleston, SC, by e-mail on February 16, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
50 units
DISTRIBUTION
IL, Germany, Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1003-12
CODE
Units: 01GQ00293, 01GQ00295, 01GQ00297, 01GQ00300, 01GQ00304
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, West Henrietta, NY, by facsimile and letter dated March 18, 2005.
Manufacturer: The American National Red Cross, Albany, NY. Firm initiated recall is complete.
REASON
Donor Screening/Donor record incomplete or incorrect.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NY
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall # B-1004-12;
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1005-12
CODE
1) and 2) Unit: 01LZ51080
RECALLING FIRM/MANUFACTURER
The American National Red Cross, West Henrietta, NY, by facsimile and letter dated July 1, 2005. Firm initiated recall is complete.
REASON
Blood products, did not meet specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1006-12
CODE
Units: W038111365927; W038111053159 Part 1; W038111053159 Part 2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers, Inc., Orlando, FL, by telephone on January 9, 2012 and letter on January 10, 2012.  
Manufacturer: Florida's Blood Centers, Inc., Leesburg, FL. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1007-12;
2) Recovered Plasma. Recall # B-1008-12
CODE
1) and 2) Unit: W036911447414
RECALLING FIRM/MANUFACTURER
Blood Bank Of Delmarva, Inc., Newark, DE, by telephone on January 13, 2012, letter on February 20, 2012 and by electronic mail on February 21, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from an indefinitely deferred donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland and District of Columbia
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1009-12
CODE
Unit: W036811208321
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South FL, Orlando, FL, by telephone and letter on January 25, 2012. 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 COMMERCEe.
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Platelets Pooled Leukocytes Reduced. Recall # B-1010-12;
2) Red Blood Cells. Recall #B-1011-12
CODE
1) Unit: W036811823246;
2) Unit: W036811311044
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Miami, FL, by telephone and letter on January 25, 2011. Firm initiated recall is complete.
REASON
Blood products, which were 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 Pooled Leukocytes Reduced. Recall # B-1014-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1015-12;
3) Fresh Frozen Plasma. Recall # B-1016-12
CODE
1) Unit: W036811823034;
2) and 3) Unit: W036811258218
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Hialeah, FL, by telephone and letter on January 20, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1017-12
CODE
Unit: 06FG51916
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by electronic mail on April 27, 2007 and letter on May 1, 2007. Firm initiated recall is complete.
REASON
Donor Screening/Donor record incomplete or incorrect.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1021-12
CODE
Unit: 2953321
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone dated September 12, 2006 and by follow-up letter dated September 13, 2006. Firm initiated recall initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1023-12
CODE
Units: 2940953; 2953756
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone dated October 2, 2006 and follow-up letter dated October 12, 2006. 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
CA
___________________________________
PRODUCT
PK 7300 Automated Microplate System, Part Number: MF0285. Recall # B-1024-12
CODE
Serial Number: 8090168, 8070159, 7110121, 8010132, 8020136, 7120126, 8010133, 8020135, 8030138, 8090166, 8040147, 8050148, 7120128, 7100115, 7100116, 7020100, 8050149, 8050151, 8050152, 7120127, 8020134, 7110120, 8020137
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on June 30, 3011.
Manufacturer: Beckman Coulter Mishima K K, Shizuoka, Japan. Firm initiated recall is ongoing.
REASON
Beckman Coulter's PK7300 Automated Microplate System, with out of specification load on the top cover struts potentially causing the cover to fall while in the open position, was distributed.
VOLUME OF PRODUCT IN COMMERCE
110 units total (27 units in US)
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0994-12
CODE
Unit: W038111404390
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on January 11, 2012 and by letter dated January 12, 2012. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving post donation information concerning an illness following donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced.  Recall # B-0996-12
CODE
Units: GS00220 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on September 27, 2007. Firm initiated recall is complete.
REASON
Blood products, which were not quarantined after receiving post donation information concerning an illness following donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1001-12
CODE
Units: KP26600, KP26473
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on May 23, 2007. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1018-12
CODE
Unit: 06FG51916
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by electronic mail on April 27, 2007 and letter on May 1, 2007. Firm initiated recall is complete.
REASON
Donor Screening/Donor record incomplete or incorrect.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Millipore Anti-A Murine IgM Monoclonal Blood Grouping Reagent -For Further Manufacturing Use. Recall # B-1020-12
CODE
Cell Line A3D3; Batch Number OWD1002
RECALLING FIRM/MANUFACTURER
Millipore (uk) Ltd., Livingston, United Kingdom, by telephone on April 13, 2011 and by letter on April 21, 2011. Firm initiated recall is complete.
REASON
Anti-A monoclonal murine IgM blood grouping reagent for further manufacturing use, with a failed 12 month stability point, was distributed.
VOLUME OF PRODUCT IN COMMERCE
12 Liters
DISTRIBUTION
NJ
___________________________________
PRODUCT
Cornea. Recall # B-1022-12
CODE
Units: OT20100631L, OT20100632R
RECALLING FIRM/MANUFACTURER
Lions Eye Bank of West Central Ohio, Dayton, OH, by letters on August 7, 2010. Firm initiated recall is complete.
REASON
Human corneas, recovered from a donor with a reactive screening test for evidence of relevant communicable diseases, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX, OH
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS I
___________________________________
PRODUCT
Salter Labs Bubble humidifier, with 6 PSI safety valve, 350cc, Latex Free; Single Patient use; used with supplemental oxygen therapy. Model Numbers 7600-0-50, E7600-0-50, NP7600-0-50 and special order patient kits that contain 7600 humidifiers. Patient kits have brand names of Salter Labs, AdvaCare; Allcare Medical; Memorial Home Services; Therapy Support Inc; Mendo-Lake Home Respiratory Services; MedAssurance Inc.; Abundant Home Care. Product Usage: Humidifier - single patient use. Used with supplemental oxygen therapy. Recall # Z-0803-2012
CODE
Humidifier lot numbers: 091911 and 092611
RECALLING FIRM/MANUFACTURER
Salter Labs, Arvin, CtelephoneA, by telephone on October 21, 2011. Firm initiataed recall is ongoing.
REASON
A manufacturing defect was discovered internally which indicates that in a small number of humidifier lids, the pop-off may not occur at the appropriate pressure and can result in a leak.
VOLUME OF PRODUCT IN COMMERCE
6,060 units
DISTRIBUTION
Nationwide and Italy
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code 708036 Product Usage: The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography. Recall # Z-0985-2012
CODE
Software Release: PBL 6.1.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated October 3, 2011.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
Incorrect Skin Dose calculation. AKR (Air Kerma Rate) displayed and stored in patient records is too low.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications. Recall # Z-1124-2012
CODE
Units: 2100, 3100, 4100, 2121, and 3131
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI, by letters beginning May 4, 2011. Firm initiated recall is ongoing.
REASON
It was discovered that when the Diamentor M4-KDK is installed on an Innova system the dose display is disabled on the certified Innova monitor and enabled on the Diamentor M4-KDK which is not certified as required by FDA regulation (Subpart J).
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Removal of Literature/Brochures for Antalgic-Trak. "***What is Antalgic-Trak?***Articulating Non-Surgical Spinal Decompression****Antalgic-Trak By Spinetronics***Note: "Decompression" as used herein refers to unloading due to distraction and positioning.***Antalgic-Trak is an improved form of non-surgical spinal decompression*. Recall # Z-1360-2012
CODE
NA
RECALLING FIRM/MANUFACTURER
Spinetronics, LLC, Coral Springs, FL, by letters on August 11, 2011. FDA initiated recall is ongoing. 
REASON
Product Brochures which contained language and/or claims that were not cleared under the original 510k, and represented a major change or modification in the intended use of the device.
VOLUME OF PRODUCT IN COMMERCE
1,600 units of literature
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy. Part number 101420-00, 10142100, 101422-00, 101424-00, 101425-00, 100430-00, 100431-00, 100432-00, 100434-00, 100435-00, 101420-98, 101421-98, 101422-98, 101424-98, 101425-98, and 10050000. Recall # Z-1376-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Animas Corp., West Chester, PA, by letters dated March 6, 2012. Firm initiated recall is ongoing.
REASON
There is an error in the pump software where the OneTouch(R) Ping(R) insulin pump did not allow the user to save changes to the time and date on the pump if those changes were made on February 29, 2012 (Leap Day). Users who did not attempt to change the time or date on their pump on February 29, 2012 are not affected by this issue.
DISTRIBUTION
Nationwide, Canada, Puerto Rico
___________________________________
PRODUCT
Siemens Axiom Luminos dRF solid state x-ray imager Solid state x-ray imager (flat panel/dig. imager). Model number 10094200. Recall # Z-1383-2012
CODE
Serial numbers 3019 and 1358
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on February 16, 2012. 
Manufacturer: Siemens AG, Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Firm became aware of a potential issue with torque wrenches - during a regular scheduled calibration of the wrench, it was discovered that the wrench was out of the specification. The wrench was over-torquing approximately 21% for low-end readings (50 ftlbs) and 9% for high-end readings (250 ftlbs).
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ACCU-CHEK Aviva Nano Blood Glucose Meter No product labeling, beyond the labels applied to the meter, was provided with the meter as these meters were never intended to be distributed. A representative copy of product labeling that would have been included in a finished device kit is attached. The Accu-Chek Aviva Nano Blood Glucose meter is intended to be used with Accu-Chek Aviva test strips for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The system is intended to be used by a single person and should not be shared. The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). 05075572002, 05075599002, 05075602002, 05075629002, Part numbers: 05180848002, 05075246002, 05075530002, 05075548002, 05075556002, 05075564002 these are not finished device part numbers and were not intended for use in the US. Recall # Z-1386-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter dated March 14, 2012. Firm initiated recall is ongoing.
REASON
Accu-Chek Aviva Nano Blood Glucose meters that were manufactured for the purpose of validating a manufacturing process for product to be distributed outside the US were distributed in the US through eBay by an unauthorized third party. These meters were not intended for distribution, were not verified to meet final product specifications and were not distributed to customers with the necessary product labeling (i.e. instructions for use).
VOLUME OF PRODUCT IN COMMERCE
82 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Pharmacy compounding system. It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities. Product Usage: Pharmacy compounding System for parenteral macro and micro ingredients. 2 model numbers 2400 D and 2400 M. Recall # Z-1389-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Baxa Corp., Englewood, CO, by letter dated March 23, 2009. Firm iInitiated recall is ongoing.
REASON
Software issue with compounding pump resulting in over delivery of component ingredients during routine operations.
VOLUME OF PRODUCT IN COMMERCE
1,322 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test kit 04610049(10309078)- 50 Test kit 04611509 (1 0335503)- 250 REF Test kit ADVIA Centaur Systems Cortisol: For in vitro diagnostic use in the quantitative determination of cortisol in serum or urine using the ADVIA Centaur and ADVIA Centaur XP systems. Recall # 1390-2012
CODE
Cortisol reagent kit lots from the reagent lots ending with the following three digits: 254, 255, 256, 257. Kit Lot# 50 Test 70078254 70860254 72058254 73346254 74543254 75397254 76332255 77366255 78595255 79146255 80596255 81274255 82938256 83522256 84771256 86150257 250 Test 69991254 70470254 73049254 74027254 76202255 78071255 80179255 81497255 82689256 83316256 86138257 250 Test 73880254 77890255 80812255 83456256 86151257 Not Applicable. Expiry Date 23 May 2012 23 May 2012 23 May 2012 23 May 2012 23 May 2012 23 May 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 15 Feb 2013 15 Feb 2013 15 Feb 2013 09 May 2013 23 May 2012 23 May 2012 23 May 2012 23 May 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 15 Feb 2013 15 Feb 2013 09 May 2013 05 May 2012 07 Oct 2012 07 Oct 2012 15 Feb 2013 09 May
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., East Walpole, MA, by e-mail on March 6, 2012. Firm initiated recall is ongoing.
REASON
Cortisol Assay reagent kit lots do not meet onboard stability and calibration interval claims
VOLUME OF PRODUCT IN COMMERCE
40,023 Test Kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System. The EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostics devices. The EasyLink(TM) is included with the Dimension Vista(R) System, and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks. Catalog number 1000034805. Recall # Z-1391-2012
CODE
Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4.
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated December 2011. Firm initiated recall is ongoing.
REASON
QC results may be unexpectedly associated with a Pending Control. When this situation occurs, Pending QC Controls maybe be created or reused.
VOLUME OF PRODUCT IN COMMERCE
787
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber EVA Halobag, and Baxa Calibration Bags. Model 137, Size 250 ml, Cat. No. H938 137 3; Model 138, Size 500 ml, Cat No. H938 138 3; Model 139, Size 1000 ml, Cat No. H938 139 3; Model 140, Size 2000 ml, Cat. No. H938 140 3; Model 141, Size 3000 ml, Cat. No. H938 141 3; Model 142, Size 4000 ml, Cat. No. H938 142 3; Model 143, Size 5000 ml, Cat. No. H938 143 3; Model 341, Size 500/3000 ml, Cat No. H938 341 3. Recall # Z-1420-2012
CODE
No lot numbers
RECALLING FIRM/MANUFACTURER
Baxa Corp., Englewood, CO, by letter dated May 8, 2009. Firm initiated recall is ongoing.
REASON
Spike port flor EVA TPN Bags contains low levels of DEHP which could leach out.
VOLUME OF PRODUCT IN COMMERCE
347,494 cases @ 50 bags case
DISTRIBUTION
Nationwide and Internationally
 
END OF ENFORCEMENT REPORT FOR APRIL 18, 2012
 
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