Safety
Enforcement Report for March 16, 2011
March 16, 2011 11-11
RECALLS AND FIELD CORRECTIONS: COSMETICS - CLASS II
____________________________________
PRODUCT
Plus White 5 Minute Bleach Whitening Gel, Original Flavor, Net Wt. 3.0 oz/85 g; UPC 018515276162 ; Plus White 5 Minute Speed Whitening Gel, Net wt. 3.0 oz/85 g.
Product Item #27616A, UPC 0-18515-27616-0. Recall # F-0521-2011
CODE
Lot #: L008833B
RECALLING FIRM/MANUFACTURER
Recalling Firm: CCA Industries, Inc., E Rutherford, NJ, by letter, telephone and e-mail on January 17, 2011.
Manufacturer: Lornamead Brands, Inc., Tonawanda, NY. Firm initiated recall is ongoing.
REASON
One lot of Plus White 5 Minute Teeth Whitening Gel is being recalled due to a cosmetic defect.
VOLUME OF PRODUCT IN COMMERCE
29, 376 units
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
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PRODUCT
1) Bistro 28 Cranberry Mango Pico de Gallo, 34 oz, UPC: 7945388187. Recall # F-0494-2011;
2) CA Pizza Kitchen BBQ Chopped Chicken Salad, 36.5 oz, UPC: 7978185105. Recall # F-0495-2011;
3) Chef Solutions Mexican 5 Layer Dip 12 oz., UPC: 77509663208. Recall # F-0496-2011;
4) Fish House Foods Ceviche 5 lb., UPC: 1345435529. Recall # F-0497-2011;
5) Fish House Foods Fajita Chicken Salad Kit 1 lb., UPC: 1345435800. Recall # F-0498-2011;
6) Fry’s Krab Ceviche Fry 12 oz., UPC: 134543530. Recall # F-0499-2011;
7) Orval Kent Chipotle Chicken Pasta Kit, UPC: 1345435574. Recall # F-0500-2011;
8) Orval Kent Cilantro Pecan Dip 8 oz., UPC: 7945330215. Recall # F-0501-2011;
9) Trader Joe’s Cilantro Dressing 12 oz., UPC: 36420. Recall # F-0502-2011;
10) Trader Joe’s Spicy Peanut Vinaigrette 12 oz., UPC: 80947. Recall # F-0503-2011;
11) Trader Joe’s Cilantro Pecan Dip 7 oz., UPC: 76986. Recall # F-0504-2011;
12) Fish House Foods SW Fajita Bean Salad w/ Chicken, UPC: 1345437117. Recall # F-0505-2011;
13) Chef Solutions Spicy Green Chili Dip UPC: 7750963219. Recall # F-0506-2011;
14) Chef Solutions Cranberry Mango Salsa UPC: 7750963219. Recall # F-0507-2011;
15) HEB New Splash Peach Habanero UPC: 40000137549. Recall # F-0508-2011;
16) HEB TX Twist Chipotle Thousand Island UPC: 40000137492. Recall # F-0509-2011;
17) HEB TX Twist Cilantro Cotija UPC: 40000137493. Recall # F-0510-2011;
18) HEB TX Twist Poblano Ceaser UPC: 40000137490. Recall # F-0511-2011;
19) HEB Mexican Shrimp Cocktail UPC: 4122003261. Recall # F-0512-2011;
20) HEB Spicy Green Chile Dip UPC: 7750963219. Recall # F-0513-2011;
21) HEB 5 Layer Dip UPC: 4122017601. Recall # F-0514-2011;
22) HEB Roasted Salsa Ranch Dip UPC: 4122084246. Recall # F-0515-2011;
23) HEB TX Twist Creamy Avocado Dressing UPC: 40000137549. Recall # F-0516-2011
CODE
1) Lot Numbers: L552689 & L552677;
2) Lot Numbers: L548318,L548317, L548315, L548494, L548487 L548489, L549384, L548495, L548490, L550357, L550358, L550359, L550356, L551716, L551714, L551774, L551797, L551872, L551776, L551809, L551775, L551877 & L551826; Use By: 11/24/2010, 11/25/2010, 11/27/2010, 12/1/2010, 12/2/2010 & 12/2/2010;
3) Lot Numbers: L550065, L550073, L551349 & L551348;
4) Lot Numbers: L551131;
5) Lot Numbers: L550517, L552136;
6) Lot Number: L550572;
7) Lot Number: L550426;
8) Lot Number: L550587;
9) Lot Number: L550605, L550799, L550783, L550782, L550674, L550660, L550805, L550609, L550588, L550645, L550642, L550586, L550583 & L550582;
10) Lot Number: L550231, L550214, L550153, L550152, L550172, L550156, L550214, L549590 & L549580;
11) Lot Number: L550064, L551352;
12) Lot Number: L549791;
13) Lot Number: L550061, L550060, L551969 & L551984, Use By: 12/10/2010 &12/12/2010;
14) Lot Number: L550666, L550779, L550777 & L550665;
15) Lot Number: L548483;
16) Lot Number: L548584 Use by: 1/25/2011 & L551453 Use by: 2/1/2011;
17) Lot Number: L548623 Use by: 1/20/2011 & L551479 Use by: 1/27/2011;
18) Lot Number: L548499 Use by: 1/20/2011 & L551453 Use by: 1/27/2011;
19) Lot Number: L551085;
20) Lot Number: L551500;
21) Lot Number: L551294 exp.: 12/13/2010 & L548938 exp.: 12/5/2010;
22) Lot Number: L549024 & L548990;
23) Lot Number: L548772 Use by: 1/25/2010 & L2/1/2011
RECALLING FIRM/MANUFACTURER
Orval Kent Food Company, Inc., Vista, CA, by letter on November 5, 2010. Firm initiated recall is complete. 11/05/2010.
REASON
Products may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
4,630 cases
DISTRIBUTION
Nationwide
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PRODUCT
ST. JAMES SMOKEHOUSE***SCOTCH RESERVE***WHISKY AND HONEY***GENUINE PRODUCT OF SCOTLAND***SCOTTISH SMOKED SALMON***Net Wt 4 oz (114 G) ***KEEP UNDER REFRIGERATION AT 38 F (3 C) OR BELOW. ***STORAGE INSTRUCTIONS: Keep Refrigerated at 38 F (3 C) Use within 4 days of opening or until the sell by date. If unopened, product may be frozen for up to 3 months. Defrost and use within 1 day. PRODUCT OF SCOTLAND. Whisky & Honey Ingredients: Scottish Salmon (Farm raised with feed containing astaxanthin [A natural carotene found in salmon]), Salt, Sugar, Whisky Honey & Natural Oakwoods Smoke*** (Product of Scotland) *** 0.25 lb net Wt. Recall # F-0517-2011
CODE
Lot: 5797 batch: 4759
RECALLING FIRM/MANUFACTURER
Recalling Firm: St. James Smokehouse, Miami, FL, by telephone and press release on February 4, 2011.
Manufacturer: Caledonia Exports Ltd, Newton Stewart, UK. Florida initiated recall is ongoing.
REASON
Product tested positive for Listeria monocytogenes during routine sampling of product by the Florida Department of Agriculture Consumer Safety Services (FD ACS).
VOLUME OF PRODUCT IN COMMERCE
2,400 (4 oz) packs
DISTRIBUTION
Nationwide
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PRODUCT
Ground nutmeg packaged under the following labels: (1) Frontier Natural Products Co-op, packaged in 16-oz. foil bags, Item #165, UPC 0-89836-00165-8; and (2) Whole Foods 365, packaged in 1.92-oz. bottles, Item #W041931, UPC 0-99482-41931-8. Recall # F-0519-2011
CODE
1) Lot #0306; 2) Lot #3021. Best by Dec 2013 for both brands.
RECALLING FIRM/MANUFACTURER
Frontier Natural Products Co-op, Norway, IA, by press release and letters dated November30, 2010. Firm initiated recall is ongoing.
REASON
The product was manufactured using non-organic ground nutmeg recalled by Mincing Overseas Spice Company because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Approx. 1) 1,407/1-lb. foil bags and 2) 544/1.92-oz. bottles
DISTRIBUTION
Nationwide and Canada
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PRODUCT
Sonny’s Barbecue Deep Deveined Shrimp, Net Wt. 20 lbs. (9.07kg), Product Code 80692, Bar code 1 00 41322 80692, KEEP FROZEN. The product is packed in 2 pound cases which contain 10 - 2 lbs. bags. The inner bags are plain poly. Recall # F-0520-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rich Products Corp., Buffalo, NY, by press release on January 18, 2011.
Manufacturer: Rich Products Corp., Brownsville, TX. Firm initiated recall is ongoing.
REASON
Product was found to contain an undeclared milk ingredient (whey) in the coating of the shrimp.
VOLUME OF PRODUCT IN COMMERCE
560 cases
DISTRIBUTION
Southeastern United States
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PRODUCT
1) Potato chips - “Doraditas con chile”, in bags of Net Wt. 2.5 oz - UPC 7-90274 00011-9. Recall # F-0523-2011;
2) Corn churritos - “Chinacos con chile”, in bags of Net Wt. 4.0 oz - UPC: 7-90274 00121-5. Recall # F-0524-2011;
3) Wheat snack, Chicharrines Duranguenses Con Chile, in bags of Net Wt. 2.5 oz - UPC: 7-90274 00261-8. Recall # F-0525-2011;
4) Wheat snack - “Palitos Tapatios Con Chile”, in bags of Net Wt. 2.5 oz - UPC: 7-90274 00251-9. Recall # F-0526-2011;
5) Wheat snack, “Anillos Michoacanos Con Chile”, in bags of Net Wt. 2.5 oz - UPC: 7-90274 00351-6. Recall # F-0527-2011
CODE
All product manufactured and distributed between 11/16/2010 to 12/31/2010.
RECALLING FIRM/MANUFACTURER
La Placita Botanas Mexicanas Inc., South El Monte, CA, by telephone on January 6, 2011. FDA initiated recall is ongoing.
REASON
Chili powder used in the manufacture of several of the firms products is potentially contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Doraditas = 3178 bags; Chinacos = 5520 bags; Chicharrines = 2380 bags; Palitos = 625 bags; Anillos = 2478 bags
DISTRIBUTION
CA, AZ
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PRODUCT
1) Shurfine Breaded Okra Net Wt 16 oz 1 lb (454 g) Ingredients: Okra, Breading (Enriched Yellow Corn Meal, Enriched White Corn Meal, Enriched Wheat Flour, Salt, Enriched Yellow Corn Flour, Spices, Partially Hydrogenated Soybean Oil, Dextrose, Monoglycerides), Batter (Water, Enriched Yellow Corn Flour, Corn Starch Salt, Partially Hydrogenated Soybean Oil), Enriched With Niacin, Reduced Iron, Thiamin Mononitrate, Riboflavin, Folic Acid. Contains: Wheat. Recall # F-0547-2011;
2) Spartan grade A fancy breaded okra Ingredients: Okra, Breading (Enriched Yellow Corn Meal, Enriched White Corn Meal, Enriched Wheat Flour, Salt Enriched Yellow Corn Flour, Spices, Partially Hydrogenated Soy-Bean Oil, Dextrose, Monoglycerides), Batter (Water, Enriched Yellow Corn Flour, Corn Starch, Salt, Partially Hydrogenated Soybean Oil). Enriched With Niacin, Reduced Iron, Thiamin Mononitrate, Riboflavin, Folic Acid. Contains Wheat Ingredients. Recall # F-0548-2011;
3) Best Choice Breaded Cut Okra Fresh Frozen Grade A Fancy Net Wt 24 oz (1 lb 8 oz) 680g Keep Frozen. Ingredients: Okra, Bleached Wheat Flour, Water, Yellow Corn Flour, Modified Food Starch, Salt, Dextrose, Leavening (Sodium Acid Phosphate Sodium Bicarbonate), Monocalcium Phosphate, Partially Hydrogenated Soybean Oil, Extractives of Paprika. Keep Frozen DO NO REFREEZE. Recall # F-0549-2011;
4) a) H-E-B Southern Breaded Okra Net Wt 80 OZ (2.27 kg) Ingredients: Okra, Breading (Wheat Flour, Salt Dextrose, Partially Hydrogenated Soybean Oil, Caramel Color, Oleoresin Paprika), Water, Batter (Yellow Corn Flour, Corn Starch, Salt, Leavening [Sodium Acid Pyrophosphate, Sodium Bicarbonate, Monocalcium Phosphate]), Natural Flavor. Contains: Wheat, Soy. b) H-E-B Southern Breaded Okra Net Wt 24 OZ (680g) Ingredients: Okra, Breading (Wheat Flour, Salt, Dextrose, Partially Hydrogenated Soybean Oil, Caram. Recall # F-0550-2011
CODE
1) MV23510P1; 2) MV29110O1 Best By April 18, 2012;
3) MV28110O1, MV28110P1, MV28110Q1;
4) a) MV19410O1 Best By 01/2012, MV20310R1 Best By 01/2012, MV22210P1 Best By 02/2012, MV25610P1 Best By 03/2012, MV33310Q1 Best By 05/2012, MV33510Q1 Best By 06/2012, MV36510P1 Best By 06/2012, MV35510Q1 Best By 06/2012 b) MV18910O1 Best By 01/2012, MV19410O1 Best By 01/2012, MV19710Q1 Best By 01/2012, MV21610P1 Best By 02/2012, MV21610Q1 Best By 02/2012, MV22210O1 Best 02/2012
RECALLING FIRM/MANUFACTURER
Magic Valley Fresh Frozen, Inc., McAllen, TX, by press releases on January 31, 2011 and February 11, 2011. Firm initiated recall is ongoing.
REASON
The product label failed to declare whey as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
12,337 cases
DISTRIBUTION
CA and WI
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PRODUCT
English/French Label: ***Toffee Fudge Hot Chocolate Chocolat Chaud Caramel***Directions: Very carefully heat ¾ cup (6 ounces) of milk and gently stir in 2 heaping tablespoons (1 ounce) of the special Hot Chocolate Mix***Ingredients: Coco Mix: sugar, non-fat dry milk, whey powder, cocoa powder, artificial vanilla powder, salt, tricalcium phosphate. Dehydrated Marshmallows: sugar, corn syrup, modified corn starch, gelatin, sodium hexameta phosphate, natural and artificial flavors, artificial color (blue #1). Crush soft peppermint stick: sugar, invert sugar, pure peppermint oil, FD&C red #40, FD&C red #3. Semi-sweet Chocolate: sugar, chocolate liquor, cocoa butter, anyhydrous dextrose, soya lecithin (added as an emulsifier), vanillin (artificial flavor). Peppermint Stock: sugar, corn syrup, citric acid, natural and artificial flavors, artificial colors including blue #1, blue #2, red #40, red 40 lake, yellow #5, yellow #6, butterscotch, salt, partially hydrogenated vegetable oil.***ALLERGENS: SOY, MILK/ALLERGENES: SOJA, LAIT*** SKU #3295-9 UPC 0 34522 00993 1. Recall # F-0551-2011
CODE
Lot # 83053
RECALLING FIRM/MANUFACTURER
Pelican Bay Ltd, Inc., Dunedin, FL, by letter on January 21, 2011. FDA initiated recall is ongoing.
REASON
Product recalled due to presence of almonds not declared on the labeling.
VOLUME OF PRODUCT IN COMMERCE
3152 8 oz bags
DISTRIBUTION
Canada
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
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PRODUCT
Product is a powdered French Dip Au Jus Mix, packaged in a 1.1 oz size foil packet or in a 6 oz clear plastic bottle. The 1.1 oz. foil packet has a UPC 070381000685. The 6 oz clear plastic bottle has a UPC 07381800681. Labeling reads in part: “Johnny’s***French Dip (POWDERED) Au Jus Mix***Directions: Add contents of package to ***water, bring to a boil and serve. Ingredients: hydrolyzed vegetable protein ***yeast extract, salt. Contains: Soy, Wheat & Milk. Recall # F-0488-2011
CODE
Code date on the 6 oz jars is 0332. This code signifies the product will be expired on 33rd day of the year 2012. Code date on the 1.1 oz packets is 02212 and code date on the box is 220112. This code signifies the product will be expired on 22nd day of the year 2012.
RECALLING FIRM/MANUFACTURER
Johnny’s Fine Foods Inc., Tacoma, WA, by e-mail and press release on February 26, 2010. FDA initiated recall is ongoing.
REASON
The product was manufactured using Hydrolyzed Vegetable Protein (HVP) recalled by Basic Food Flavors, Inc because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
252 cases of 6 oz. and 291 cases of 1.1 oz
DISTRIBUTION
CA, IA, OR, UT, WA, and WI
________________________________________
PRODUCT
Green Chili and Cheese Tamale, 3.5 oz, 60 units/carton. Recall # F-0528-2011
CODE
Lot #s: 36401, 35601, 35001, and 34101
RECALLING FIRM/MANUFACTURER
B & S Food Products, Los Angeles, CA, by letter on February 2, 2011. Firm initiated recall is ongoing.
REASON
The product label listed cheese as an ingredient but failed to declare milk as required by FALCPA.
VOLUME OF PRODUCT IN COMMERCE
Approximately 35 cases
DISTRIBUTION
Southern CA
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PRODUCT
1) French Bread is packaged in plastic bag and weighs about 30 oz. There is no UPC on label. The product is labeled in parts: “French...Ingredients: Unbleached Flour, water, non-fat dry milk, salt, yeast, gluten flour...Harvest Mill Breadmakers...Net Wt. 30 oz. Recall # F-0529-2011;
2) Sourdough Bread is packaged in plastic bag and weighs about 30 oz. There is no UPC on label. The product is labeled in parts: “Sourdough...Ingredients: Unbleached flour, water, culture sour, non-fat dry milk, sugar, gluten flour, yeast... Harvest Mill Breadmakers...Net Wt. 30 oz. F-0530-2011;
3) Garlic Cheese Bread is packaged in plastic bag and weighs about 30 oz. There is no UPC on label. The product is labeled in parts: “Garlic Cheese...Ingredients: Unbleached flour, water, honey, onion, gluten flour, S-500 Red (Wheat flour, DATEM, Dextrose, Soybean Oil, Ascorbic Acid, L-Cysteine, Azodicarbonamide (ADA), Enzymes), yeast, salt, cheddar cheese, garlic, Prima Soft (Wheat Flour, Enzymes), parsley...Harvest Mill Breadmakers...Net Wt. 30 oz. Recall # F-0531-2011;
4) Orange Cake is packaged in the plastic tray and weighs about 1 lb. There is no UPC on label. The product is labeled in parts: “ORANGE CAKE...Sugar, Enriched Wheat Flour, Starch, Whey, Leavening, Wheat Gluten, Vegetable Oil, Eggs, Orange Juice, Orange Pulp, and Natural Orange Flavoring, Icing: Powdered Sugar, Cream Cheese and Natural Vanilla Flavoring. No preservatives... Harvest Mill Breadmakers...1 lb (454g). Recall # F-0532-2011;
5) Lemon Cake is packaged in the plastic tray and weighs about 1 lb. There is no UPC on label. The product is labeled in parts: “LEMON CAKE...Sugar, Enriched Wheat Flour, Starch, Whey, Leavening, Wheat Gluten, Vegetable Oil, Eggs, Lemon Juice, Lemon Pulp, and Natural Lemon Flavoring. Icing: Powdered Sugar, Cream Cheese and Natural Vanilla Flavoring. No preservatives... Harvest Mill Breadmakers ...1 lb (454g). Recall # F-0533-2011;
6) Cinnamon Rolls is packaged in the plastic tray and each package contains 4 pieces. There is no net weight. There is no UPC on label. The product is labeled in parts: “Cinnamon Rolls...Ingredients: Flour, Water, Powdered Sugar, Sugar, Brown Sugar, Butter, Eggs, Cinnamon, Vanilla, Salt, Nutmeg, Cloves, Yeast... Harvest Mill Breadmakers ...4-pack. Recall # F-0534-2011;
7) Cherry Cinnamon Rolls is packaged in the plastic tray and each package contains 4 pieces. There is no net weight. There is no UPC on label. The product is labeled in parts: “cherry Cinnamon Rolls...Ingredients: Flour, Water, cherry, Powdered Sugar, Sugar, Brown Sugar, Butter, Eggs, Cinnamon, Vanilla, Salt, Nutmeg, Cloves, Yeast... Harvest Mill Breadmakers ...4-pack. Recall # F-0535-2011;
8) Raspberry Cinnamon Rolls is packaged in the plastic tray and each package contains 4 pieces. There is no net weight. There is no UPC on label. The product is labeled in parts: “Raspberry Cinnamon Rolls...Ingredients: Flour, Water, Raspberries, Powdered Sugar, Sugar, Brown Sugar, Butter, Eggs, Cinnamon, Vanilla, Salt, Nutmeg, Cloves, Yeast... Harvest Mill Breadmakers...4-pack. Recall # F-0536-2011;
9) Garlic Cheese Rolls is packaged in the plastic tray and each package contains 6 pieces. There is no net weight. There is no UPC on label. The product is labeled in parts: “Garlic Cheese Rolls...Ingredients: Unbleached flour, water, cheddar cheese, honey, onion, gluten flour, salt, yeast, garlic, malt, parsley. Recall # F-0537-2011
CODE
Expiration date 02/07/11
RECALLING FIRM/MANUFACTURER
Harvest Mill Bread Works, Gresham, OR, by visit on February 2, 2011 and by letter on February 3, 2011. Firm initiated recall is ongoing.
REASON
Undeclared allergen. The product label did not list wheat as the source of flour as required by FALCPA.
VOLUME OF PRODUCT IN COMMERCE
45 units
DISTRIBUTION
OR, WA
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PRODUCT
1) DeBoles® All Natural Tomato & Basil Angel Hair, Net Wt 8 oz (226g). Recall # F-0552-2011;
2) DeBoles® ORGANIC Tomato & Basil Angel Hair, Net Wt 8 oz (226g). Recall # F-0553-2011;
3) DeBoles® ORGANIC Rotini, Net Wt 8 oz (226g). Recall # F-0554-2011;
4) DeBoles® ORGANIC Lasagna, Net Wt 10 oz (283g). Recall # F-0555-2011;
5) DeBoles® ORGANIC Shells, Net Wt 8 oz (226g). Recall # F-0556-2011;
6) DeBoles® ORGANIC Elbow Style Pasta, Net Wt 12 oz (340g). Recall # F-0557-2011;
7) DeBoles® ORGANIC Eggless Ribbon Style Pasta, Net Wt 8 oz (226g). Recall # F-0558-2011
CODE
All codes prior to 21 AUG 12
RECALLING FIRM/MANUFACTURER
Deboles Nutitional Foods Inc DBA Shreveport Macaroni Mfg Co., Shreveport, LA, by e-mail on February 24, 2011. Firm initiated recall is ongoing.
REASON
Undeclared wheat: ingredient statement read “durum semolina”
VOLUME OF PRODUCT IN COMMERCE
33,638 cases
DISTRIBUTION
Nationwide
_______________________________________
PRODUCT
1) Tropical Sunrise, Pina Colada A Real Mix Pina Colada. Recall # F-0559-2011;
2) Tropical Sunrise, Mango Daiquiri Concentrate for Blenders. Recall # F-0560-2011;
3) Tropical Sunrise, Banana Daiquiri Concentrate for Blenders. Recall # F-0561-2011;
4) Tropical Sunrise, Passion Fruit Mix Concentrate for Blenders. Recall # F-0562-2011
CODE
1) Lots 1932, 1933, 1937, 1941, 1942, 1943 and 1947;
2) Lot #: 1912;
3) Lot #: 1915;
4) Lot #: 1940
RECALLING FIRM/MANUFACTURER
Blends Maker Manufacturer, Inc., Comerio, PR, by visit or by telephone on November 15, 2010. Firm initiated recall is ongoing.
REASON
Yellow #5 not declared on the label, detected: during an FDA inspection.
VOLUME OF PRODUCT IN COMMERCE
4,284 containers of ½ gallon each (All Flavors)
DISTRIBUTION
PR
_________________________________________
PRODUCT
Black Pomfret Fish (frozen); Keshodwala (brand); 22.05 lbs (10 kg)/carton: White rectangular corrugated carton with clear polyethylene liner. Each fish is individually wrapped in unsealed polyethylene bag. Lot# 206241-2 is size 700/1000 grams (approximately 10-14 pieces per carton) and Lot # 26241-3 is size 1000/2000 grams (approximately 5-10 pieces per carton). Recall # F-0563-2011
CODE
Lot # 206241-2 & 206241-3
RECALLING FIRM/MANUFACTURER
Pacific American Fish Co Inc., Vernon, CA, by e-mails on February 7, 2011 and February 8, 2011.
Manufacturer: Keshodwala Foods, Veraval, India. FDA initiated recall is ongoing.
REASON
The affected frozen Pomfret fish has the potential to be contaminated with salmonella.
VOLUME OF PRODUCT IN COMMERCE
790 cartons
DISTRIBUTION
Southern CA and NV
_______________________________________
PRODUCT
Rouses Wild Caught Tuna, UPC beginning with 208732. Recall # F-0564-2011
CODE
Sell by dates: 12/01/2010 01/27/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rouse Supermarket, Thibodaux, LA, by press release on February 4, 2011.
Manufacturing Firm 1: Rouse Supermarket, Thibodaux, LA;
Manufacturing Firm 2: Miland Seafood, Inc., New Orleans, LA;
Manufacturing Firm 3: Jensen Tuna Inc., Houma, LA. FDA initiated recall is ongoing.
REASON
Possible elevated histamine level in tuna.
VOLUME OF PRODUCT IN COMMERCE
9,435 units
DISTRIBUTION
LA, MS
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
________________________________________
PRODUCT
Sunny Select Brand California Pitted Prunes, 24 oz. paper (wax lined) with metal bottom, UPC code 17544 11800 8. Recall # F-0522-2011
CODE
Lot Code: 0067V. exp. date 9/08/11
RECALLING FIRM/MANUFACTURER
Wilbur Packing Co., Yuba City, CA, by telephone on April 23, 2010. Firm initiated recall is complete.
REASON
Some cans of prunes were made with the wrong bottoms with insufficient coating, which may discolor due to the fruits’ acidity.
VOLUME OF PRODUCT IN COMMERCE
620 cases
DISTRIBUTION
CA
___________________________________________
PRODUCT
1) 1) Item Code: 01955 85915 Name: Sausage, Egg & Pepper Jack Cheese Biscuit Brand: Lettieri’s, 5.06 lb case, 12 sandwiches per case Dates of mfr: 08-30-10, 09-20-10, 11-15-10, 12-13-10; 2) Item Code: 01955 85915 Name: Sausage, Egg & Pepper Jack Cheese Biscuit Brand: Lettieris, 5.06 lb case, 12 sandwiches per case Dates of mfr: 08-30-10, 09-20-10, 11-15-10, 12-13-10; 3) Item Code: 58955 85947 Name: Biscuit Sausage, Egg & Pepper Jack Cheese Brand: Cravins Market, 10.13 lb case, 24 sandwiches per case Dates of mfr: 10-08-10, 12-03-10, 01-06-11; 4) Item Code: 85435 Name: Sausage, Egg & Pepper Jack Cheese Biscuit Brand: Hot Stuff Foods, 10.13 lb case, 24 sandwiches per case Dates of mfr: 09-20-10, 11-15-10. Recall # F-0538-2011;
2) Item Code: 01957 85917 Name: Sausage, Egg, & Pepper Jack Cheese Bagel Brand: Lettieris, Unit size: 5.18 lb case Container description: Individual paper wrapped pieces in a cardboard master case. Total package size: 12 sandwiches per case Storage instructions: Keep Frozen Refrigerate up to 7 Days Date(s) of manufacture: 09-20-10, 11-19-10. Recall # F-0539-2011;
3) 1) Item Code: 01960 85919 Name: Sausage, Egg, & Cheese Biscuit Brand: Lettieris, 4.5 lb case, 12 sandwiches per case Dates of manufacture: 08-24-10, 08-30-10, 09-07-10, 10-11-10, 10-25-10, 11-01-10, 11-08-10, 11-22-10, 12-03-10, 12-28-10; 2) Item Code: 85437 Name: Sausage, Egg & Cheese Biscuit Brand: Hot Stuff Food, 9.0 lb case, 24 sandwiches per case Date(s) of manufacture: 10-18-10; 3) Item Code: 96960 85961 Name: Sausage, Egg & Cheese Biscuit Brand: Real Time Cafe, 4.5 lb case, 12 sandwiches per case Date(s) of manufacture: 08-30-10, 09-20-10, 10-04-10, 10-11-10, 10-25-10, 11-01-10, 11-15-10, 11-22-10, 12-06-10, 01-06-11; 4) Item Code: 58960 85949 Name: Biscuit Sausage, Egg & Cheese Brand: Cravins Market, 9.0 lb case, 24 sandwiches per case Date(s) of manufacture: 09-27-10, 10-11-10, 12-03-10, 01-06-11; 5) Item Code: 52960 85941 Name: Sausage, Egg, & Cheese Biscuit Brand: Wilson Farms, 9.0 lb case, 24 sandwiches per case Dates of mfr: 10-04-10, 10-22-10, 11-15-10, 12-13-10; 6) Item Code: 39960 85938 Name: Sausage, Egg & Cheese Biscuit Brand: Jacksons, 4.5 lb case, 12 sandwiches per case Dates of mfr: 08-24-10, 10-04-10, 10-18-10, 12-06-10. Recall # F-0540-2011;
4) 1) Item Code: 01964 85923 Name: Sausage Biscuit Brand: Lettieris, 3.08 lb case, 12 sandwiches per case Dates of mfr: 09-13-10, 10-11-10, 11-15-10, 11-22-10, 12-28-10, 01-06-11; 2) Item Code: 86128 Name: Sausage Biscuit Brand: Real Time Cafe, 3.08 lb case, 12 sandwiches per case Dates of mfr: 08-24-10, 09-22-10, 09-29-10, 10-04-10, 12-04-10, 01-06-11. Recall # F-0541-2011;
5) 1) Item Code: 01965 85924 Name: Egg, Sausage, & Cheese Croissant Brand: Lettieris, 3.87 lb case, 12 sandwiches per case Dates of mfr: 09-03-10, 09-15-10, 10-20-10, 10-27-20, 11-14-10, 11-17-10, 11-21-10, 12-14-10, 01-05-11. 2) Item Code: 86123 Name: Sausage, Egg & Cheese Croissant Brand: Real Time Cafe, 3.9 lb case, 12 sandwiches per case Dates of mfr: 09-03-10, 09-22-10, 10-08-10, 10-13-10, 10-20-10, 10-25-10, 11-03-10, 11-12-10, 11-21-10, 12-24-10, 12-27-10. Recall # F-0542-2011;
6) 1) Item Code: 01974 85929 Name: Sausage, Egg, & Cheese Bagel Brand: Lettieris, 4.61 lb case, 12 sandwiches per case Dates of mfr: 08-30-10, 09-20-10, 11-08-10, 12-13-10; 2) Item Code: 06974 85964 Name: Bagel Sausage, Egg and Cheese Brand: Blimpie, 4.62 lb case, 12 sandwiches per case Date(s) of manufacture: 09-20-10. Recall # F-0543-2011;
7) 1) Item Code: 86147 Name: Sausage, Egg, & Cheese Muffin Brand: Lettieris, 3.86 lb case, 12 sandwiches per case Dates of mfr: 09-03-10, 11-08-10, 11-28-10 2) Item Code: 86125 Name: Sausage, Egg & Cheese Muffin Brand: Real Time Cafe, 3.86 lb case, 12 sandwiches per case Dates of mfr: 10-05-10, 10-08-10, 10-12-10, 11-06-10, 11-12-10, 11-23-10. 3) Item Code: 58961 85950 Name: Muffin Sausage, Egg & Cheese Brand: Cravins Market, 7.73 lb case, 24 sandwiches per case Dates of mfr: 09-28-10, 10-12-10, 12-07-10. 4) Item Code: 52961 85942 Name: Sausage, Egg, & Cheese Muffin Brand: Wilson Farms, 7.73 lb case, 24 sandwiches per case Dates of mfr 09-28-10, 10-05-10, 10-22-10, 11-02-10, 11-23-10, 12-07-10. 5) Item Code: 39961 85939 Name: Sausage, Egg & Cheese Muffin Brand: Jacksons, 3.86 lb case, 12 sandwiches per case Dates of mfr: 08-31-10, 09-14-10, 10-19-10, 12-07-10. Recall # F-0544-2011;
8) Item Code: 18465 85967 Name: Sausage, Egg & Cheese Brand: Hotzi Unit size: 6.98 lb case Container description: Individual paper wrapped pieces in a cardboard master case. Total package size: 24 sandwiches per case Storage instructions: Keep Frozen Refrigerate up to 7 Days Date(s) of manufacture: 08-27-10, 09-03-10, 09-15-10, 09-22-10, 09-29-10, 09-30-10, 10-06-10, 10-13-10, 10-14-10, 10-20-10, 10-27-10, 10-30-10, 11-03-10, 11-06-10, 11-10-10, 11-14-10, 11-17-10, 11-21-10, 11-24-10, 12-01-10, 12-06-10, 12-08-10, 12-11-10, 12-13-10, 12-15-10, 12-17-10, 12-23-10, 12-27-10, 01-05-11. Recall # F-0545-2011;
9) Item Code: 86760 Name: Western Style Omelets with Sausage & Pepper Jack Cheese Bagel Brand: APlus Unit size: 5.1 lb case Container description: Individual paper wrapped pieces in a cardboard master case. Total package size: 12 sandwiches per case Storage instructions: Keep Frozen Refrigerate up to 7 Days Date(s) of manufacture: 11-19-10, 12-03-10. Recall # F-0546-2011
CODE
1) Date Codes: 1) 0242, 0263, 0319, 0347; 2) 0263. 0323; 3) 0281, 0337, 1006; 4) 09-20-10, 11-15-10;
2) Date Codes: 0263, 0323;
3) Date Codes: 1) 0226, 0236, 0240, 0243, 0250, 0284, 0292, 0298, 0305, 0312, 0314, 0320, 0326, 0337, 0341, 0362, 1004; 2) 10-18-10; 3) 0242, 0263, 0277, 0284, 0298, 0305, 0319, 0326, 0340, 1006; 4) 0270, 0284, 0337, 1006; 5) 0277, 0295, 0319, 0347; 6) 0236, 00277, 0291, 0340. F-0540-2011;
4) Date Codes: 1) 0256, 0284, 0319, 0326, 0362, 1006; 2) 0236, 0265, 0272, 0277, 0338, 1006;
5) Date Codes: 1) 0243, 0258, 0293, 0300, 0318, 0321, 0325, 0348, 1005. 2) 0246, 0265, 0281, 0286, 0293, 0298, 0307, 0316, 0325, 0348, 0361;
6) Date Codes: 1) 0236, 0277, 0291, 0340; 2) 0263;
7) Date Codes: 1) 0246, 0312, 0332; 2) 0278, 0281, 0285, 0310, 0316, 0327; 3) 0271, 0285, 0341; 4) 0271, 0278, 0295, 0306, 0327, 0341; 5) 0236, 00277, 0291, 0340;
8) Date Codes: 0239, 0246, 0258, 0265, 0272, 0273, 0279, 0286, 0287, 0293, 0300, 0303, 0307, 0310, 0314, 0318, 0321, 0325, 0328, 0335, 0340, 0342, 0345, 0347, 0349, 0351, 0357, 0361, 1005;
9) Date Codes: 11-19-10, 12-3-10
RECALLING FIRM/MANUFACTURER
Hot Stuff Foods, Inc., Shakopee, MN, by telephone, fax and letter dated January 11, 2011. Firm initiated recall is ongoing.
REASON
Products contain MSG (monosodium glutamate), which is not declared on the label. MSG is used as a flavor enhancer in a variety of foods prepared at home, in restaurants, and by food processors. Some persons who have eaten foods containing MSG have reported adverse reactions. To date, no illnesses or adverse reactions have been associated with any of these products.
VOLUME OF PRODUCT IN COMMERCE
802,947.66 lb or 141,866 cases
DISTRIBUTION
AZ, CA, CO, F;, GU, ID, IL, IN, IA, KS, LA, MD, MI, MN, MO, MT, NM, ND, OK, SD, TN, TX, WA,WV, WI
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I I
_________________________________________
PRODUCT
1) Apis Belladonna Mercurius. Recall # D-306-2011;
2) Apis regina Cerebri. Recall # D-307-2011;
3) Arnica Aurum 6/10 ampule. Recall # D-308-2011;
4) Arnica e pl. tota 6 ampule. Recall # D-309-2011;
5) Arnica Echinacea. Recall # D-310-2011;
6) Astragalus Formica. Recall # D-311-2011;
7) Aurum Stibium Hyoscyamus. Recall # D-312-2011;
8) Avena Valeriana. Recall # D-313-2011;
9) Belladonna ex herba 30. Recall # D-314-2011;
10) Berberis Oxalis. Recall # D-315-2011;
11) Betula Spiraea. Recall # D-316-2011;
12) Cerebellum Thalamus A Aurum. Recall # D-317-2011;
13) Cerebellum Thalamus B Aurum ampule. Recall # D-318-2011;
14) Chamomilla e rad. 20 ampule. Recall # D-319-2011;
15) Citrus Cydonia 3% ampule. Recall # D-320-2011;
16) Citrus Quartz. Recall # D-321-2011;
17) Colon 6 ampules. Recall # D-322-2011;
18) Cuprum aceticum Nicotiana. Recall # D-323-2011;
19) Epiphysis 8 ampules. Recall # D-324-2011;
20) Formica Arnica. Recall # D-325-2011;
21) Gelsemium Bryonia. Recall # D-326-2011;
22) Ginko 10 ampule Special Order. Recall # D-327-2011;
23) Glandulae suprarenales 4. Recall # D-328-2011;
24) Helleborus e pl. tota 2 ampule & 4 ampule; Recall # D-329-2011;
25) Lien Plumbum. Recall # D-330-2011;
26) Lobelia Quercus. Recall # D-331-2011;
27) Lycopodium Berberis. Recall # D-332-2011;
28) Magne site Viscum. Recall # D-333-2011;
29) Mandragora Arnica. Recall # D-334-2011;
30) Medulla ossium 8. Recall # D-335-2011;
31) Mercurius auratus Pulmo. Recall # D-336-2011;
32) Mercurius vivus 8. Recall # D-337-2011;
33) Opal 30. Recall # D-338-2011;
34) Periodontium Hypophysis. Recall # D-339-2011;
35) Phosphorus comp. Recall # D-340-2011;
36) Pulmo Bryonia Recall # D-341-2011;
37) Pulmo Ferrum. Recall # D-342-2011;
38) Rhus tox e fol. 4. Recall # D-343-2011;
39) Robinia Nicotiana. Recall # D-344-2011;
40) Sabal Populus. Recall # D-345-2011;
41) Secale Betula ampule Special Order. Recall # D-346-2011;
42) Silicea Belladonna. Recall # D-347-2011;
43) Ureter 8 ampule Special Order. Recall # D-348-2011;
44) Veratrum Chamomilla. Recall # D-349-2011;
45) Vertebrae lumbalis 6. Recall # D-350-2011;
46) Viscum Mali e pl. tota 30. Recall # D-351-2011;
47) a) Viscum Quercus D, G ampule; b) Viscum Quercus E ampule. Recall # D-352-2011
CODE
1) ampule 100915;
2) ampule 101001;
3) ampule 101004;
4) ampule 100923;
5) ampule 100902;
6) ampule 100927;
7) ampule 101004;
8) ampule 101013;
9) ampule 100902;
10) ampule 100914;
11) ampule 101012;
12) and 13) ampule 100928;
14) ampule 101004;
15) ampule 100927;
16) ampule 100917;
17) ampule 101013;
18) ampule 100923;
19) and 20) ampule 100913;
21) ampule 10101;
22) ampule Special Order 101006;
23) ampule 100913;
24) 2 ampule & 4 ampule 100922;
25) ampule 100916;
26) ampule 101008;
27) ampule 101006;
28) ampule 100920;
29) and 30) ampule 101014;
31) ampule 100902;
32) ampule 100916;
33) ampule 101008;
34) ampule 100927;
35) ampule 100928;
36) ampule 100902;
37) ampule 101013;
38) ampule 101011;
39) ampule 100930;
40) ampule 100922;
41) ampule Special Order 100921;
42) ampule 101006;
43) ampule Special Order 100910;
44) ampule 100922;
45) ampule 101011;
46) ampule: 100921;
47) a) ampule: 101011, b) 101012
RECALLING FIRM/MANUFACTURER
Uriel Pharmacy, Inc., East Troy, WI, by telephone on October 21, 2010 and by letters on November 4, 2010. Firm initiated recall is ongoing.
REASON
Uriel Pharmacy is recalling specific ampules due to presence of foreign substances. Glass particles were found in some ampules which were manufactured from September 1 through October 15, 2010.
VOLUME OF PRODUCT IN COMMERCE
367 boxes (10 ampules/box)
DISTRIBUTION
Nationwide, UK, Canada, Japan
_________________________________
PRODUCT
Invega Sustenna (paliperdione palmitate) extended-release injectable suspension, 234 mg, 1.5 mL prefilled syringe and 2 needles per kit, a) (trade) NDC 50458-564-01, b) (samples not for sale) NDC 50458-564-03, Rx only. Recall # D-354-2011
CODE
a) Lot # 9IBK000, 9IBK002, Exp 09/11; 9IBK001, 9IBK003, Exp 12/11; 9IBK004, 02/12; 9JBK000, 9IBK005, Exp 05/12;
b) Lot # 9IBK000, 12/11; 9JBK000, 9JBK001, 08/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ, by letters on February 11, 2011 and February 16, 2011.
Manufacturer: Janssen Pharmaceutica N.V., Beerse, Belgium. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: Invega Sustenna Extended-Release Injectable Suspension 234 mg strength is being recalled after detection that some of the pre-filled syringes of the 234 mg strength can contain a crack in the syringe barrel.
VOLUME OF PRODUCT IN COMMERCE
71,238 kits
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
1) Caziant Tablets, 0.1/0.025mg, 0.125/0.025mg, 0.15/0.025mg; NDC Number: 52544-0959-31, Boxes of 3 tablet dispensers, 28 tablets each. Recall # D-355-2011;
2) Caziant Tablets, 0.1/0.025mg, 0.125/0.025mg, 0.15/0.025mg; NDC Number: 52544-0959-28, Single dispenser of 28 tablets. Recall # D-356-2011
CODE
1) and 2) Lot Number: 228088A; Expiration Date: 01/31/2011
RECALLING FIRM/MANUFACTURER
Watson Laboratories Inc., Corona, CA, by letter on November 11, 2010. Firm initiated recall is ongoing.
REASON
Firm is recalling product due to impurities/degradation products. The firm found out-of-specification result for the 3-keto Desogestrel degradant at the 12-month stability time point.
VOLUME OF PRODUCT IN COMMERCE
19,268 boxes
DISTRIBUTION
Nationwide
______________________________________
PRODUCT
1) Enbrel (etanercept) 50 mg/mL (0.98mL), Single-use prefilled syringes, 4 syringes/ carton, Rx only, NDC 58406-435-04. Recall # D-357-2011;
2) Enbrel (etanercept) 25 mg/mL (0.51mL), Single-use prefilled syringes, 4 syringes/carton, NDC 58406-455-04. Recall # D-358-2011
CODE
1) Lot #: 1018839 Exp 03/2013, Lot # 1018840, Exp Date 03/2013, Lot # 1019849, Exp Date 04//2013, and Lot # 1019850, Exp Date 04/2013
2) Lot #: 1020189 Exp 04/2013
RECALLING FIRM/MANUFACTURER
Amgen Manufacturing, Limited, Juncos, PR, by letters on October 25, 2010. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility; Potential syringe breakage.
VOLUME OF PRODUCT IN COMMERCE
338,948 each (All Lots)
DISTRIBUTION
Nationwide, Puerto Rico and Canada. Embrel is distributed in the European Union, Australia, and New Zealand
______________________________________
PRODUCT
PLAVIX� (clopidogrel bisulfate) Tablets, 75 mg Bottles of 30 Count, List 1171-60 NDC 63653-1171-6. Recall # D-359-2011
CODE
Lot # 0G56655, Exp JUL 2013; Lot # 0H49877, Exp AUG 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bristol-Myers Squibb Co., New Brunswick, NJ, by letters on/about January 11, 2011.
Manufacturer: Bristol Myers Squibb Manufacturing Co., Humacao, PR. Firm initiated recall is ongoing.
REASON
Firm is recalling product because of chemical contamination. The odor was confirmed for returned complaint samples received and was determined to be due to the presence of 2,4,6-tribromoanisole (TBA) found at very low levels in the bottles and caps for the recalled lots. The source of TBA has been determined to be associated with the use of the chemical wood preservative 2,4,6-tribromophenol (TBP) on wood sourced to manufacture wood pallets.
VOLUME OF PRODUCT IN COMMERCE
210916 bottles (all lots)
DISTRIBUTION
Nationwide
_________________________________________
PRODUCT
1) Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1) 100 tablets count bottle, NDC: 0781-5180-01; 2) 1000 tablets count bottle, NDC: 0781-5180-10, Rx only. Recall # D-366-2011;
2) Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 1) 100 tablets count bottle, NDC: 0781-5181-01; 2) 1000 tablets count bottle, NDC: 0781-5181-10, Rx only. Recall # D-367-2011
CODE
1) Lot number: 09T11370, Exp: 03/11; Lot number: 09T11380, Exp: 03/11; Lot number: 10T0990, Exp: 04/11; Lot number: 10T1000, Exp: 04/11; Lot number: 10T0980, Exp: 04/11; Lot number: 09T11390, Exp: 03/11;
2) Lot number: 09T11270, Exp: 03/11; Lot number: 10T1010, Exp: 04/11; Lot number: 09T11280, Exp: 03/11; Lot number: 09T11290, Exp: 03/11; Lot number: 10T1020, Exp: 04/11; Lot number: 10T1170, Exp: 04/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alara Pharmaceutical Co., San Juan, PR, by letter on December 3, 2010.
Manufacturer: Patheon Puerto Rico Inc., Caguas, PR. Firm initiated recall is ongoing.
REASON
Subpotent (Single Ingredient Drug): Out of specification result in an assay test for the Levothyroxine Sodium Tablets.
VOLUME OF PRODUCT IN COMMERCE
72,500 bottles total
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
Little Fevers by Little Remedies --- Children’s Fever/Pain Reliever --- Acetaminophen --- 4 fl. oz. (118 mL) --- OTC --- Primary package consists of 4 fl. oz. round, white HDPE bottle 4.7 inches tall with a 24 mm neck size. 4 fl. oz. in a bottle/24 packages in each case. UPC code 756184101247, Product Code 10756184101244. Recall # D-369-2011
CODE
Lot # 5741799, exp. 9/2012; Lot # 5741800, exp.09/2012; Lot # 5741815, exp. 09/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Prestige Brands, Inc., Irvington, NY, by letters on December 23, 2010.
Manufacturer: Guardian Drug Co. Inc., Dayton, NJ. Firm initiated recall is complete.
REASON
Labeling defect; Upon peeling back the label, the copy from the back side of the label may transfer onto the bottle surface rendering it illegible to the consumer.
VOLUME OF PRODUCT IN COMMERCE
34,488 units (4 fl. oz.)
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
1) Sodium Bicarbonate Injection, USP 7.5%, 3.75 grams (44.6 mEq)/50 mL, 50 mL Single Dose Vial, Rx only, NDC 0517-0639-25. Recall # D-370-2011;
2) Sodium Bicarbonate Injection, USP 8.4%, 4.2 grams (50 mEq)/50 mL, 50 mL Single Dose Vial, Rx only, NDC 0517-1550-25. Recall # D-371-2011
CODE
1) Lot #s: 8833, Exp. 12/10; 9130, Exp. 02/11; 9342, Exp. 05/11; 9543, Exp 08/11; 9702, Exp. 10/11; 0068, Exp. 02/12; 0276, Exp. 04/12; 0581, Exp. 08/12; 0745, Exp 11/12;
2) Lot #s: 8845, Exp. 12/10; 9062, Exp. 01/11; 9058, 9111, 9128, Exp. 02/11; 9158, 9180, 9212, Exp. 03/11; 9262, 9271, 9292, Exp. 04/11; 9346, 9346A, 9360, 9374, Exp. 05/11; 9396, 9412, 9438, Exp. 06/11; 9720, Exp. 10/11; 9801, 9821, Exp. 11/11; 0054, Exp. 01/12; 0115, Exp. 02/12; 0162, 0172, Exp. 03/12; 0237, Exp. 04/12; 0427, Exp. 06/12; 0528, Exp. 08/12; 0597, 0649, Exp. 09/12
RECALLING FIRM/MANUFACTURER
Luitpold Pharmaceuticals, Inc., Shirley, NY, by press release and letter dated December 23, 2010. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter: Recall was initiated because particulates were noted during the inspection of the retain samples.
VOLUME OF PRODUCT IN COMMERCE
4,818,850 vials
DISTRIBUTION
Nationwide and Puerto Rico
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
_________________________________________
PRODUCT
Claravis (Isotretinoin Capsules, USP), 40 mg, Rx only, 1) 3 Blister Packs of 10 capsules (NDC 0555-1057-86), 2) 10 Blister Packs of 10 capsules (NDC 0555-1057-56). Recall # D-361-2011
CODE
1) Lot #’s: 309683, 309684, 309965, 309966, 309967, 309968, 701980, 309969, 310357, 310358, 310359 - Exp. 1/31/2011; 310472, 310498, 310499, 310500, 310834, 310835, 310897 - Exp. 2/28/2011; 310991, 310992, 310993, 701981, 310994, 311220, 311221, 311222, 311223, Exp. 3/31/2011; 311457, 311479, 311458, 701982, 311481, 311482, 311480, Exp. 4/30/2011; 311483, 701881, 311823, 701983, 311824, 312016, 312015, Exp. 5/31/2011; 312079, 311966, 311967, 311968, Exp. 6/30/2011; 312733, 312734, 702109, 702144, 702110, 702145, Exp. 7/31/2011; 702199, 702246, 702195, 702196, 702198, 702197, 702265, Exp. 8/31/2011; 702264, 702279, 702282, 702352, 702281, 702280 702283, 702379, 702380, 702491, Exp. 9/30/2011; 702492, 702493, 702494, 702538, 702509, 702510, 702511, Exp. 10/31/2011; 702648, 702649, 702650, 702669, 702670, 702671, 702768, Exp. 11/30/2011; and 702825, Exp. 12/31/2011;
2) Lot #’s: 309530, 309970, Exp. 1/31/2011 310360, 310494, 310804, Exp. 2/28/2011; 310998, 310989, Exp. 3/31/2011; 311556, 311555, Exp. 4/30/2011; 311775, 311889, 311891, 5/31/2011; 312194, Exp. 6/30/2011; 702247, 702104, Exp. 8/31/2011; 702284, 702285, 702378, Exp. 9/30/2011; 702606, 702607, 702605, Exp. 10/31/2011; 702608, Exp. 11/30/2011; 702823, 702824, Exp. 12/31/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on December 3, 2010.
Manufacturer: Barr Laboratories, Inc., Pomona, NY. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements: Lots may deliver a reduced dose of available active drug.
VOLUME OF PRODUCT IN COMMERCE
744,400 units
DISTRIBUTION
Nationwide
_________________________________________
PRODUCT
1) Lisinopril Tablets, USP, 10 mg, a) 100 count bottle, NDC 0172-3759-60, b) 500 count bottle, NDC 0172-3759-70, c) 1000 count bottle, NDC 0172-3759-80, Rx only. Recall # D-362-2011;
2) Lisinopril Tablets USP, 20 mg, a) 100 count bottles, NDC 0172-3760-60; b) 500 count bottles, NDC 0172-3760-70; c) 1000 count bottles, NDC 0172-3760-80, Rx only. Recall # D-363-2011;
3) Lisinopril Tablets USP, 30 mg, a) 100 count bottles (NDC 0172-3762-60), b) 500 count bottles (NDC 0172-3762-70), Rx only. Recall # D-364-2011;
4) Lisinopril Tablets USP, 40 mg, 500 count bottles, Rx only. Recall # D-365-2011
CODE
1) Lot #s: a) TE03026A, Exp 03/12; TE03152A, Exp 03/12; b) TE03026B, Exp 03/12; TE03152B, Exp 03/12; TE03160B, Exp 03/12; c) TE03026C, Exp 03/12; TE03152C, Exp 03/12; TE03160C, Exp 03/12; TE05086, Exp 05/12; TE05136, Exp 05/12; TE05137, Exp 05/12; TE05194, Exp 06/12;
2) Lot #s: a) Lot # TE03271B, Exp 04/12; TE05028B, Exp 05/12; TE05119B, Exp 05/12; b) Lot #: TE03271C, Exp 04/12; TE05028C, Exp 05/12; TE05119C, Exp 05/12; c) Lot #: TE03271A, Exp 04/12; TE05028A, Exp 05/1212; TE05119A, Exp 05/12; TE07250, Exp 07/12; TE07285, Exp 08/12; TE08140, Exp08/12; TE08187, Exp 08/12; TE09081, Exp 09/12;
3) Lot #s: a) Lot # TE02124A, Exp 02/12; b) Lot # TE02124B, Exp 02/12; TE04169B, Exp 05/12; TE04170B, Exp 06/12;
4) Lot #s: TE06073, Exp 06/12; TE06085, Exp 06/12; TE06226, Exp 07/12; TE07018, Exp 07/12; TE07106, Exp 07/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on December 21, 2010.
Manufacturer: Emcure Pharmaceuticals Limited, Pune, Maharashtra, India. Firm initiated recall is ongoing.
REASON
Discoloration: Some tablets may exhibit areas of blue discoloration.
VOLUME OF PRODUCT IN COMMERCE
153,508 bottles
DISTRIBUTION
Nationwide
____________________________________________
PRODUCT
ProAir HFA (albuterol sulfate), Inhalation Aerosol, 90 mcg, 200 metered actuations, Rx only, NDC 59310-579-20. Recall # D-368-2011
CODE
Lot Numbers: AEC84B, Exp. 1/2011; AEC84C, Exp. 1/2011; AEC75B, Exp. 12/2010; AEC75C, Exp. 12/2010; AEC59B, Exp. 12/2010; AEC59C, Exp. 12/2010; AEC57B, Exp. 11/2010; and AEC57C, Exp. 11/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on January 11, 2011.
Manufacturer: Teva Pharmaceuticals Limited, Waterford, Ireland. Firm initiated recall is ongoing.
REASON
Failed USP Content Uniformity Requirements: May not meet dose content uniformity specification.
VOLUME OF PRODUCT IN COMMERCE
1,475,456 inhalers
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
Delsym Night-Time Cough & Cold Liquid, 4 fl. oz, UPC 3-63824-18264-3. Recall # D-372-2011
CODE
Lot number: 0G231, Exp: 07/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Reckitt Benckiser, Inc., Fort Worth, TX, by letter on February 3, 2011.
Manufacturer: H & P Industries, Inc., Hartland, WI. Firm initiated recall is ongoing.
REASON
Subpotent (Multiple Ingredient Drug): Product contains below the minimum specification limit.
VOLUME OF PRODUCT IN COMMERCE
1,368 cases (32,832 bottles)
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
_______________________________________
PRODUCT
1) Platelets. Recall # B-0912-11;
2) Fresh Frozen Plasma. Recall # B-0913-11;
3) Red Blood Cells. Recall # B-0914-11
CODE
1), 2), and 3) Unit: W088410046375
RECALLING FIRM/MANUFACTURER
Blood Bank Of Hawaii, Honolulu, HI, by facsimile on December 14, 2010 and by letter dated December 16, 2010. 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
3 units
DISTRIBUTION
HI
________________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0951-11
CODE
Units: W117010189683 Part 1; W117010189683 Part 2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by telephone on December 20, 2010 and follow-up letter on December 29, 2010.
Manufacturer: Blood Centers of the Pacific - Cupertino Center, Cupertino, CA. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
________________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-0954-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0955-11
CODE
1) and 2) Unit: 12FG43045
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by facsimile and letter dated January 12, 2011.
Manufacturer: American Red Cross Blood Services, Durham, NC. 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
NC
_________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0956-11
CODE
Unit: W087908304577
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Lancaster County Medical Society, Lincoln, NB, by facsimile and letter dated January 28, 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
NY
_________________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0960-11
CODE
Unit: J01317
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone on May 25, 2005. 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
Red Blood Cells Leukocytes Reduced. Recall # B-0961-11
CODE
Unit: LJ68589
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by telephone and letter dated on September 20, 2005. 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
CA
________________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0962-11;
2) Recovered Plasma. Recall # B-0963-11
CODE
1) and 2) Unit: LJ66247
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by electronic mail and letter on August 30, 2005. 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 and Switzerland
________________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0964-11;
2) Fresh Frozen Plasma. Recall # B-0965-11
CODE
1) and 2) Unit: P56392
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone on October 17, 2005 and by letter on November 18, 2005. 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
Red Blood Cells Leukocytes Reduced. Recall # B-0968-11
CODE
Unit: W115910220321
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by facsimile on December 9, 2010 and December 27, 2010. 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
CA
________________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0969-11
CODE
Units: W227010007603; W227010015710; W227010007603; W227010029496; W227010022269; W227010022269; W227010041480; W227010041480; W227010032886; W227010032886; W227010029496
RECALLING FIRM/MANUFACTURER
Community Blood Center of Carolinas, Charlotte, NC, by facsimile and telephone on December 23, 2010. 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
11 units
DISTRIBUTION
NC
________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0970-11
CODE
Unit: W089809011504
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Inova Blood Donor Services, Sterling, VA, by letter on November 24, 2010. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0971-11
CODE
Unit: W089810401989
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Inova Blood Donor Services, Sterling, VA, by letter dated November 24, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0972-11
CODE
Unit: W045110143445
RECALLING FIRM/MANUFACTURER
Community Blood Center of the Ozarks, Springfield, MO, by letter dated December 6, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AR
______________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0974-11
CODE
Unit: W037710026548
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by telephone on March 30, 2010. 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
OH
________________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0980-11
CODE
Units: 7242640- part 1; 7242640- part 2
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center,inc-cellular Therapy Laboratory, New York, NY, by telephone on September 2, 2007 and facsimile on September 5, 2007.
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood products, with positive bacterial detection testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0981-11
CODE
Unit: 7004487-part 1; 7004487-part 2
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center,inc-cellular Therapy Laboratory, New York , NY, by facsimile on April 4, 2007.
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete.
REASON
Blood products, with positive bacterial detection testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
________________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # Recall # B-0982-11
CODE
Unit: 7578525
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center,inc-cellular Therapy Laboratory, New York, NY, by facsimile on November 14, 2007.
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood product, with positive bacterial detection testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
________________________________________
PRODUCT
Source Plasma Recall # B-0983-11
CODE
Units: 0650349469;0650307549;0650306818;0650305794; 0650305086;0650304826;0650304257;0650303694; 0650303465;0650302542;0650302263
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Boca Raton, FL. by facsimile on May 11, 2007.
Manufacturer: CSL Plasma, Inc., Racine, WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received body piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
NC
_______________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0984-11;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0985-11
CODE
1) Units: 7583973(BAG1);7583973(BAG2);
2) Units: 7562886(BAG1); 7562886(BAG2); 7576941(BAG1); 7576941(BAG2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center,inc-cellular Therapy Laboratory, New York, NY, by telephone on December 4, 2007 and by FAX notification on December 4, 2007 and December 11, 2007.
Manufacturer: New York Blood Center, Inc., Westbury, NY. 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
6 units
DISTRIBUTION
NY
________________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0987-11
CODE
Units: 6483464- part 1; 6483464- part 2
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center,inc-cellular Therapy Laboratory, New York, NY, by telephone on December 19, 2006 and facsimile on January 03, 2007. A second notification was sent on January 10, 2007.
Manufacturer: New York Blood Center, Inc., Long Island City NY. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications for release, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
________________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0990-11
CODE
Units: W03551091604300 and W03551091604300
RECALLING FIRM/MANUFACTURER
BloodNetUSA, Inc., Lakeland, FL, by facsimile on December 16, 2010. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may compromise the sterility of the product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0992-11
CODE
Unit: W115111037075S
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers - Montgomery Region, Montgomery, AL, by facsimile on January 11, 2011. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
_________________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0993-11;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0994-11
CODE
1) Units: 017FE63193; 017FE63205; 017FE63205;
2) Units: 017FE63222; 017FE63222; 017FE63173; 017FE63193
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by letter and telephone on December 14, 2010 and December 15, 2010. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
WI, MN
_________________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0995-11;
2) Recovered Plasma. Recall # B-0996-11
CODE
1) and 2) Units: W038110343911 and W038110222572
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by facsimile and letter on December 21, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo applied within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
France, Austria, and FL
_________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1009-11
CODE
Units: 18GX23433; 18FS98797
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on October 13, 2010 and follow up letter dated November 11, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for positive HIV test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI, CA
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1018-11
CODE
Unit: W043810021135
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter dated January 31, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________________
PRODUCT
Source Plasma. Recall # B-1021-11
CODE
Unit: 4650141516
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., San Diego, CA, by e-mail on February 4, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a complete physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0821-11
CODE
Units: 001Q35750, 001LP04986, 001LP04983, 001LH00108, 001GL53602, 001H31375, 001KX33381, 001KY04878, 001Q35742, 001LN66520, 001LF63712, 001C15671, 001LT79417, 001G12633, 001KM63641, 001GS60481, 001GS60485, 001KQ12232, 001Q35787, 001KY04876, 001LH00105, 001C15669, 001LV03255, 001LF63711, 001Q35744
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Tulsa, OK, by telephone on February 12, 2010 and by facsimile on February 19, 2010.
Manufacturer: The American National Red Cross, Dallas, TX. Firm initiated recall is complete.
REASON
Blood products, which remained out of controlled storage for greater than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
TX
________________________________________
PRODUCT
Red Blood Cells. Recall # B-0919-11
CODE
Unit: W038110352356
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter dated December 2, 2010. 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
FL
___________________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0952-11
CODE
Unit: W038611328571 Part 2
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by telephone on January 24, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
_______________________________________
PRODUCT
Recovered Plasma. Recall # B-0953-11
CODE
Unit: 12FG43045
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by facsimile and letter dated January 12, 2011.
Manufacturer: American Red Cross Blood Services, Durham, NC. 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
NC
________________________________________
PRODUCT
Platelets Leukocytes Reduced. Recall # B-0957-11
CODE
Units: W041010216039C; W041010216022U
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc dba United Blood Services, Scottsdale, AZ, by telephone and fax on December 20, 2010. Firm initiated recall is complete.
REASON
Blood products, which were exposed to unacceptable temperature during storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
________________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated. Recall # B-0973-11
CODE
Unit: W280310101127
RECALLING FIRM/MANUFACTURER
Upstate New York Transplant Services, Inc., Buffalo, NY, by facsimile on December 21, 2010 and January 11, 2011. Firm initiated recall is complete.
REASON
Blood product, labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
__________________________________________
PRODUCT
Source Plasma. Recall # B-0986-11
CODE
Unit: 0650295880
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Services, Boca Raton, FL, by email on April 28, 2008.
Manufacturer: CSL Plasma, Inc., Racine, WI. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
________________________________________
PRODUCT
Recovered Plasma. Recall # B-1010-11
CODE
Unit: 18GX23433
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on October 13, 2010 and follow up letter dated November 11, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred for positive HIV test results, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI, CA
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
__________________________________________
PRODUCT
1) TotalCare beds P1900 with P500 Microclimate Management Surface Hill Rom, Batesville, IN. The TotalCare� Bed Systems is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare� Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare� Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. Recall # Z-1563-2011;
2) VersaCare beds P3200 and P3201 with P500 Microclimate Management Surface. The VersaCare� Bed System is intended to provide a patient support suited to be used in healthcare environments. The VersaCare� Bed may be used in such settings as acute care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). Recall # Z-1564-2011;
3) VersaCare P500 Microclimate Management Surface Upgrade Kits P3218A and P3219A Hill-rom Batesville, IN. The TotalCare Bed Systems is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. Recall # Z-1565-2011
CODE
1) Units: J212AM8818, K202AM4400, L196AM9109, L200AM9139, L200AM9142, L200AM9145, L200AM9148, L209AM9299, L209AM9302, L209AM9314, L217AM9487, L218AM9499, L218AM9502, L218AM9524, L221AM9579, L222AM9584, L222AM9588, L222AM9596, L222AM9601, L222AM9610, L223AM9611, L223AM9614, L223AM9617, L223AM9620, L223AM9624, L223AM9630, L224AM9647, L224AM9650, L224AM9653, L224AM9656, L224AM9662, L225AM9666, L225AM9680, L225AM9684, L225AM9689, L226AM9693, L226AM9697, L226AM9700, L228AM9716, L228AM9720, L228AM9724, L228AM9728, L228AM9732, L231AM9812, L235AM9942, L235AM9945, L235AM9948, L235AM9952, L235AM9957, L236AM9960, L236AM9983, L236AM9988, L236AM9995, L237AM0026, L237AM0030, L250AM0297, L250AM0303, L250AM0306, L250AM0309, L250AM0312, L250AM0324, L250AM0327, L250AM0330, L251AM0333, L251AM0337, L251AM0342, L251AM0345, L251AM0348, L251AM0351, L251AM0354, L251AM0357, L251AM0361, L252AM0370, L252AM0377, L252AM0402, L256AM0522, L257AM0541, L257AM0548, L258AM0566, L258AM0570, L258AM0576, L258AM0596, L258AM0603, L270AM0920, L271AM0923, L271AM0928, L271AM0931, L271AM0932, L271AM0936, L271AM0939, L272AM0954, L273AM0971, L273AM0973, L273AM0979, L273AM0981, L274AM1000, L285AM1143, L286AM1140, L286AM1163, L287AM1184, L288AM1206, L291AM1235, L301AM1396, L301AM1400, L301AM1403, L302AM1423, L306AM1473, L306AM1476, L307AM1479, L307AM1482, L323AM1757 and L326AM1762;
2) Units: K356AD0067, K356AD0071, K356AD0107, K356AD0108, L005AD0273, L088AD4924, L089AD5029, L089AD5045, L089AD5047, L131AD6851, L132AD6912, L138AD7208, L138AD7209, L138AD7211, L138AD7212, L138AD7214, L138AD7215, L138AD7217, L138AD7218, L138AD7238, L138AD7239, L144AD7506, L145AD7520, L145AD7522, L145AD7525, L145AD7528, L145AD7531, L145AD7533, L145AD7543, L145AD7549, L145AD7552, L158AD8221, L176AD9387, L176AD9399, L182AD9683, L182AD9695, L182AD9696, L182AD9704, L182AD9714, L182AD9724, L182AD9728, L183AD9733, L183AD9734, L183AD9735, L183AD9738, L183AD9739, L183AD9742, L183AD9743, L183AD9744, L183AD9753, L183AD9786, L183AD9793, L183AD9800, L193AD9807, L193AD9809, L193AD9811, L193AD9813, L193AD9815, L193AD9817, L193AD9819, L193AD9820, L193AD9824, L193AD9826, L193AD9830, L193AD9835, L193AD9840, L193AD9843, L193AD9847, L193AD9852, L193AD9855, L194AD9876, L194AD9886, L194AD9889, L194AD9891, L194AD9895, L194AD9898, L194AD9902, L194AD9908, L194AD9910, L195AD9933, L195AD9940, L196AD0034, L200AD0169, L200AD0170, L200AD0172, L200AD0173, L200AD0175, L200AD0176, L200AD0177, L200AD0180, L200AD0181, L200AD0182, L200AD0184, L200AD0185, L200AD0186, L200AD0188, L200AD0189, L200AD0191, L200AD0193, L200AD0194, L200AD0195, L200AD0197, L200AD0198, L200AD0199, L200AD0201, L200AD0204, L200AD0205, L200AD0207, L200AD0208, L200AD0209, L200AD0211, L203AD0384, L203AD0386, L203AD0436, L203AD0438, L203AD0439, L203AD0440, L203AD0441, L203AD0443, L204AD0446, L204AD0448, L204AD0449, L204AD0451, L204AD0456, L204AD0457, L204AD0461, L204AD0464, L204AD0468, L204AD0471, L204AD0474, L204AD0479, L204AD0480, L204AD0482, L204AD0483, L204AD0485, L204AD0488, L204AD0489, L204AD0492, L204AD0505, L204AD0506, L207AD0603, L207AD0605, L207AD0608, L207AD0610, L207AD0612, L207AD0614, L207AD0616, L207AD0618, L207AD0619, L207AD0622, L207AD0624, L207AD0626, L207AD0629, L207AD0630, L207AD0632, L207AD0634, L207AD0636, L207AD0638, L207AD0640, L208AD0642, L208AD0644, L208AD0646, L208AD0648, L208AD0650, L208AD0652, L208AD0654, L208AD0656, L208AD0658, L208AD0660, L208AD0663, L208AD0667, L208AD0670, L208AD0671, L208AD0673, L208AD0676, L208AD0679, L208AD0681, L208AD0683, L208AD0685, L208AD0690, L208AD0692, L208AD0694, L208AD0696, L208AD0697, L209AD0738, L209AD0739, L209AD0745, L209AD0755, L209AD0760, L209AD0783, L209AD0803, L209AD0805, L209AD0807, L209AD0809, L209AD0812, L210AD0815, L214AD1035, L216AD1216, L216AD1219, L216AD1222, L216AD1225, L216AD1232, L216AD1235, L216AD1238, L217AD1265, L217AD1268, L217AD1273, L217AD1274, L217AD1286, L217AD1288, L217AD1292, L217AD1295, L217AD1301, L217AD1302, L218AD1356, L218AD1357, L218AD1359, L218AD1360, L218AD1362, L218AD1369, L218AD1370, L218AD1372, L218AD1373, L218AD1375, L218AD1376, L218AD1378, L218AD1379, L218AD1381, L218AD1383, L218AD1385, L218AD1387, L218AD1389, L219AD1461, L219AD1463, L219AD1464, L221AD1472, L221AD1479, L221AD1481, L221AD1482, L221AD1485, L221AD1487, L221AD1488, L221AD1492, L221AD1507, L221AD1509, L221AD1516, L221AD1518, L221AD1520, L221AD1542, L222AD1570, L222AD1574, L222AD1576, L222AD1578, L222AD1580, L222AD1584, L222AD1586, L222AD1588, L222AD1590, L222AD1594, L222AD1596, L222AD1599, L222AD1601, L222AD1605, L222AD1609, L222AD1611, L222AD1612, L222AD1617, L222AD1619, L222AD1621, L224AD1798, L224AD1799, L224AD1802, L224AD1803, L224AD1806, L224AD1807, L224AD1810, L224AD1811, L224AD1814, L224AD1815, L224AD1822, L224AD1823, L224AD1826, L224AD1830, L224AD1838, L224AD1839, L224AD1843, L224AD1859, L224AD1863, L229AD2072, L229AD2074, L230AD2096, L230AD2098, L230AD2100, L230AD2101, L230AD2105, L230AD2109, L230AD2111, L230AD2113, L230AD2116, L230AD2117, L235AD2395, L235AD2453, L235AD2459, L235AD2461, L235AD2463, L235AD2467, L235AD2470, L235AD2474, L235AD2477, L235AD2480, L235AD2483, L236AD2501, L236AD2507, L236AD2512, L236AD2518, L236AD2524, L236AD2529, L236AD2532, L236AD2537, L236AD2572, L236AD2581, L236AD2588, L237AD2624, L238AD2850, L238AD2851, L238AD2853, L238AD2854, L238AD2856, L239AD2859, L239AD2860, L239AD2863, L239AD2865, L239AD2866, L239AD2868, L239AD2869, L239AD2871, L239AD2874, L239AD2875, L239AD2878, L239AD2880, L239AD2881, L239AD2883, L240AD2989, L243AD3152, L243AD3153, L243AD3161, L243AD3162, L243AD3164, L243AD3167, L243AD3168, L243AD3170, L243AD3172, L243AD3174, L243AD3177, L243AD3179, L243AD3181, L243AD3183, L243AD3186, L243AD3188, L243AD3191, L243AD3193, L243AD3195, L243AD3209, L243AD3211, L243AD3213, L243AD3215, L243AD3217, L243AD3219, L243AD3220, L244AD3222, L244AD3223, L244AD3231, L244AD3232, L244AD3234, L244AD3236, L244AD3238, L244AD3240, L244AD3242, L244AD3244, L244AD3246, L244AD3250, L244AD3252, L244AD3254, L244AD3256, L244AD3258, L244AD3260, L244AD3262, L244AD3264, L244AD3266, L244AD3268, L244AD3270, L244AD3272, L244AD3273, L244AD3274, L244AD3276, L244AD3278, L244AD3280, L244AD3282, L244AD3290, L244AD3292, L244AD3297, L244AD3303, L244AD3305, L244AD3312, L244AD3316, L244AD3317, L245AD3321, L245AD3324, L245AD3325, L245AD3340, L245AD3341, L245AD3348, L245AD3349, L245AD3384, L245AD3391, L245AD3392, L245AD3394, L245AD3395, L245AD3399, L245AD3401, L245AD3403, L245AD3405, L245AD3407, L245AD3409, L245AD3411, L245AD3412, L246AD3426, L246AD3427, L246AD3430, L246AD3431, L246AD3434, L246AD3435, L246AD3438, L246AD3439, L246AD3442, L246AD3443, L246AD3447, L246AD3448, L246AD3450, L246AD3451, L246AD3454, L246AD3455, L246AD3459, L246AD3460, L246AD3463, L246AD3464, L246AD3467, L246AD3468, L246AD3471, L246AD3472, L246AD3475, L246AD3476, L246AD3479, L246AD3480, L246AD3483, L246AD3484, L246AD3487, L246AD3488, L246AD3491, L246AD3492, L246AD3495, L246AD3496, L246AD3499, L246AD3500, L246AD3503, L246AD3504, L246AD3507, L246AD3508, L246AD3510, L246AD3511, L250AD3515, L250AD3516, L250AD3518, L250AD3520, L250AD3522, L250AD3523, L250AD3524, L250AD3525, L250AD3527, L250AD3528, L250AD3530, L250AD3531, L250AD3534, L250AD3535, L250AD3538, L250AD3539, L250AD3542, L250AD3543, L250AD3552, L250AD3553, L250AD3556, L250AD3557, L250AD3559, L250AD3562, L250AD3563, L250AD3566, L250AD3568, L250AD3570, L250AD3572, L250AD3574, L250AD3575, L250AD3577, L250AD3579, L250AD3580, L250AD3583, L250AD3584, L250AD3587, L250AD3588, L250AD3591, L250AD3592, L250AD3595, L250AD3596, L250AD3599, L250AD3600, L250AD3603, L250AD3604, L250AD3607, L250AD3608, L251AD3624, L251AD3626, L251AD3628, L251AD3633, L251AD3637, L251AD3639, L251AD3641, L251AD3643, L251AD3645, L251AD3648, L251AD3649, L251AD3653, L251AD3655, L251AD3657, L251AD3660, L251AD3661, L251AD3663, L251AD3665, L251AD3667, L251AD3669, L251AD3671, L251AD3673, L251AD3677, L251AD3678, L251AD3679, L251AD3681, L251AD3683, L251AD3685, L251AD3687, L251AD3688, L251AD3690, L251AD3691, L251AD3693, L251AD3694, L251AD3696, L251AD3697, L251AD3700, L252AD3718, L252AD3758, L252AD3761, L252AD3770, L252AD3776, L253AD3826, L253AD3828, L253AD3835, L253AD3842, L253AD3844, L253AD3854, L253AD3856, L253AD3859, L253AD3866, L253AD3868, L253AD3872, L253AD3874, L253AD3880, L253AD3882, L253AD3885, L253AD3887, L253AD3888, L253AD3889, L253AD3895, L253AD3897, L253AD3898, L253AD3899, L253AD3905, L253AD3907, L253AD3908, L256AD3909, L256AD3911, L256AD3913, L256AD3915, L256AD3916, L256AD3919, L256AD3921, L256AD3923, L256AD3925, L256AD3927, L256AD3929, L256AD3930, L256AD3932, L256AD3933, L256AD3935, L256AD3936, L256AD3938, L256AD3939, L256AD3941, L256AD3942, L256AD3944, L256AD3945, L256AD3947, L256AD3948, L256AD3950, L256AD3952, L256AD3953, L256AD3955, L256AD3956, L256AD3958, L256AD3959, L256AD3961, L256AD3962, L256AD3964, L256AD3965, L256AD3967, L256AD3968, L256AD3970, L256AD3971, L256AD3973, L256AD3974, L256AD3976, L256AD3977, L256AD3979, L256AD3981, L256AD3983, L256AD3985, L256AD3987, L256AD3989, L256AD3990, L256AD3992, L256AD3993, L258AD4164, L258AD4171, L258AD4249, L258AD4250, L258AD4252, L258AD4259, L258AD4260, L258AD4265, L258AD4266, L259AD4271, L259AD4272, L259AD4273, L259AD4274, L259AD4278, L259AD4279, L259AD4282, L259AD4283, L259AD4286, L259AD4289, L259AD4294, L259AD4295, L259AD4297, L259AD4298, L259AD4300, L259AD4301, L259AD4303, L259AD4304, L259AD4306, L259AD4307, L259AD4312, L259AD4318, L259AD4321, L259AD4322, L259AD4329, L259AD4330, L259AD4332, L259AD4333, L259AD4340, L259AD4341, L259AD4343, L259AD4344, L259AD4347, L259AD4348, L259AD4350, L259AD4357, L259AD4358, L259AD4360, L259AD4361, L259AD4363, L259AD4364, L259AD4366, L259AD4367, L259AD4369, L259AD4370, L259AD4372, L259AD4373, L259AD4375, L259AD4376, L259AD4378, L259AD4379, L259AD4381, L259AD4382, L260AD4384, L260AD4386, L260AD4388, L260AD4389, L260AD4391, L260AD4392, L260AD4393, L260AD4395, L260AD4396, L260AD4407, L260AD4412, L260AD4413, L260AD4435, L260AD4436, L260AD4438, L260AD4439, L260AD4441, L260AD4442, L260AD4444, L260AD4445, L260AD4447, L260AD4448, L260AD4454, L260AD4455, L260AD4458, L260AD4459, L260AD4462, L260AD4463, L260AD4467, L260AD4468, L260AD4473, L260AD4474, L260AD4476, L260AD4478, L260AD4479, L260AD4486, L260AD4487, L260AD4490, L260AD4491, L260AD4494, L260AD4495, L261AD4498, L261AD4499, L261AD4506, L261AD4507, L261AD4514, L261AD4517, L261AD4518, L261AD4520, L261AD4521, L261AD4523, L261AD4524, L261AD4527, L261AD4528, L261AD4531, L261AD4535, L261AD4537, L261AD4539, L261AD4541, L261AD4543, L261AD4545, L261AD4547, L261AD4549, L261AD4551, L261AD4553, L261AD4562, L261AD4563, L261AD4566, L261AD4567, L261AD4570, L261AD4572, L261AD4574, L261AD4577, L261AD4581, L261AD4587, L261AD4589, L263AD4603, L263AD4604, L263AD4606, L263AD4620, L263AD4635, L263AD4654, L263AD4677, L263AD4690, L263AD4692, L264AD4703, L264AD4707, L264AD4726, L264AD4734, L264AD4738, L264AD4749, L264AD4750, L264AD4769, L264AD4775, L264AD4777, L265AD4810, L265AD4824, L265AD4828, L265AD4830, L265AD4839, L265AD4841, L265AD4860, L265AD4882, L265AD4898, L266AD4900, L266AD4907, L266AD4908, L266AD4910, L267AD5014, L267AD5027, L267AD5059, L267AD5069, L267AD5071, L267AD5101, L267AD5106, L270AD5111, L270AD5113, L270AD5119, L270AD5121, L270AD5122, L270AD5123, L270AD5125, L270AD5126, L270AD5133, L270AD5134, L270AD5137, L270AD5142, L271AD5175, L271AD5177, L272AD5322, L272AD5325, L273AD5328, L273AD5331, L273AD5333, L273AD5336, L273AD5339, L273AD5355, L273AD5357, L273AD5359, L273AD5360, L273AD5362, L273AD5363, L273AD5365, L273AD5366, L273AD5368, L273AD5369, L273AD5371, L273AD5372, L273AD5374, L273AD5375, L273AD5377, L273AD5378, L273AD5380, L273AD5381, L273AD5383, L273AD5384, L273AD5386, L273AD5387, L273AD5388, L273AD5390, L273AD5391, L273AD5392, L273AD5394, L273AD5395, L273AD5396, L274AD5398, L274AD5399, L274AD5400, L274AD5402, L274AD5403, L274AD5406, L274AD5407, L274AD5409, L274AD5410, L274AD5424, L278AD5560, L278AD5561, L278AD5563, L278AD5566, L278AD5568, L278AD5569, L278AD5571, L278AD5573, L278AD5580, L278AD5582, L278AD5583, L278AD5585, L278AD5588, L278AD5590, L278AD5591, L278AD5593, L278AD5596, L278AD5598, L278AD5604, L278AD5606, L278AD5608, L278AD5610, L278AD5612, L278AD5614, L278AD5616, L278AD5618, L278AD5620, L279AD5661, L279AD5665, L279AD5667, L279AD5670, L279AD5672, L279AD5673, L279AD5675, L279AD5677, L279AD5680, L279AD5682, L279AD5684, L279AD5688, L279AD5690, L280AD5694, L281AD5774, L281AD5775, L284AD5884, L284AD5885, L284AD5887, L284AD5888, L284AD5890, L284AD5891, L284AD5893, L284AD5894, L284AD5896, L284AD5897, L284AD5899, L284AD5900, L284AD5903, L284AD5905, L284AD5906, L284AD5908, L284AD5909, L284AD5911, L284AD5912, L284AD5914, L284AD5915, L284AD5916, L285AD5918, L285AD5919, L285AD5921, L285AD5924, L287AD6127, L287AD6128, L287AD6130, L287AD6131, L287AD6133, L287AD6134, L287AD6136, L287AD6137, L287AD6139, L287AD6140, L288AD6142, L288AD6143, L288AD6145, L288AD6146, L288AD6148, L288AD6149, L288AD6151, L288AD6152, L288AD6154, L288AD6155, L288AD6157, L288AD6159, L288AD6161, L288AD6162, L288AD6207, L288AD6208, L291AD6234, L291AD6235, L291AD6237, L291AD6238, L291AD6240, L291AD6241, L291AD6247, L291AD6250, L291AD6254, L298AD6587, L298AD6591, L298AD6595, L298AD6599, L298AD6603, L298AD6625, L298AD6629, L298AD6634, L298AD6638, L298AD6642, L298AD6646, L299AD6650, L299AD6655, L299AD6658, L299AD6661, L299AD6666, L299AD6676, L299AD6685, L299AD6693, L299AD6697, L299AD6701, L299AD6705, L299AD6709, L299AD6713, L299AD6717, L300AD6725, L300AD6726, L300AD6727, L300AD6729, L300AD6734, L300AD6738, L300AD6740, L300AD6742, L300AD6746, L300AD6750, L300AD6752, L300AD6764, L300AD6775, L300AD6783, L300AD6786, L300AD6789, L301AD6814, L301AD6817, L301AD6819, L301AD6820, L301AD6844, L301AD6847, L301AD6850, L301AD6853, L301AD6856, L301AD6860, L301AD6863, L301AD6866, L301AD6869, L301AD6870, L302AD6873, L302AD6875, L302AD6876, L302AD6878, L302AD6880, L302AD6883, L302AD6885, L302AD6887, L302AD6922, L302AD6928, L302AD6930, L302AD6933, L302AD6945, L302AD6959, L305AD6980, L306AD7072, L306AD7073, L306AD7074, L306AD7078, L306AD7080, L306AD7082, L306AD7083, L307AD7151, L307AD7153, L307AD7154, L307AD7156, L307AD7157, L307AD7159, L314AD7498, L314AD7499, L314AD7501, L314AD7502, L314AD7504, L314AD7506, L314AD7508, L315AD7582, L315AD7583, L315AD7585, L315AD7586, L315AD7588, L315AD7589, L315AD7591, L315AD7592, L315AD7595, L315AD7596, L315AD7599, L315AD7600, L315AD7602, L315AD7603, L315AD7604, L315AD7606, L315AD7607, L315AD7609, L315AD7610, L315AD7611, L315AD7614, L315AD7618, L316AD7667, L316AD7670, L316AD7673, L319AD7730, L319AD7732, L319AD7734, L319AD7736, L319AD7738, L319AD7740, L319AD7742, L319AD7744, L322AD8012, L322AD8014, L322AD8016, L322AD8018, L322AD8022, L322AD8032, L323AD8096, L323AD8098, L323AD8102, L323AD8104, L323AD8106, L323AD8108, L323AD8110, L323AD8111, L323AD8113, L323AD8116, L326AD8121, L326AD8123, L326AD8125, L326AD8128, L326AD8133, L326AD8135, L326AD8138, L326AD8152, L326AD8157, L326AD8162, L326AD8176, L326AD8181, L326AD8183, L327AD8187, L327AD8192, L327AD8197, L327AD8235, L327AD8241, L327AD8246, L328AD8251, L328AD8256, L328AD8261, L328AD8266, L328AD8271, L328AD8276, L328AD8305, L328AD8310, L328AD8317, L333AD8336, L333AD8341, L333AD8346, L333AD8351, L333AD8356, L333AD8361, L334AD8415, L335AD8481, L335AD8484, L335AD8487, L335AD8544, L335AD8545, L336AD8547, L336AD8548, L336AD8550, L336AD8552, L336AD8554, L342AD9053, L342AD9060, L342AD9071, L342AD9073, L342AD9087, L342AD9091, L343AD9175, L343AD9178, L343AD9181, L343AD9184, L343AD9191, L343AD9194, L343AD9197, L343AD9200, L343AD9203, L343AD9208, L343AD9211, L343AD9214, L343AD9217, L343AD9221, L343AD9222, L343AD9227, L343AD9233, L343AD9253, L344AD9340, L344AD9346, L344AD9395, L345AD9536, L345AD9539, L345AD9542, L345AD9545, L345AD9548, L345AD9551, L345AD9554, L345AD9557, L345AD9560, L345AD9566, L345AD9570, L345AD9573, L345AD9578, L345AD9579, L345AD9583, L345AD9595, L345AD9598, L345AD9601, L345AD9608, L345AD9614, L345AD9616, L345AD9618, L347AD9641, L347AD9646, L347AD9654, L347AD9656, L347AD9658, L347AD9660, L347AD9662, L347AD9668, L347AD9672, L347AD9676, L347AD9680, L347AD9682, L347AD9686, L347AD9688, L347AD9691, L347AD9695, L347AD9699, L347AD9701, L347AD9703, L347AD9705, L347AD9707, L347AD9709, L348AD9712, L348AD9713, L348AD9719, L348AD9751, L348AD9753, L348AD9755, L348AD9757, L348AD9759, L348AD9761, L348AD9763, L348AD9765, L348AD9767, L348AD9769, L349AD9862, L349AD9864, L349AD9867, L349AD9868, L349AD9869, L349AD9871, L349AD9873, L349AD9875, L350AD9877, L350AD9879, L350AD9881, L350AD9883, L350AD9885, L350AD9887, L350AD9889, L350AD9891, L350AD9893, L350AD9895, L350AD9897, L350AD9899, L350AD9901, L350AD9903, L350AD9905, L350AD9907, L350AD9909, L350AD9911, L350AD9913, L350AD9915, L350AD9917, L350AD9919, L350AD9922, L350AD9924, L350AD9926, L350AD9928, L350AD9930, L350AD9931, L350AD9932, L350AD9934, L350AD9935, L350AD9937, L350AD9938, L350AD9939, L350AD9941, L350AD9942, L350AD9944, L350AD9946, L350AD9948, L350AD9950, L350AD9952, L350AD9954, L350AD9955, L350AD9956, L350AD9958, L350AD9959, L350AD9960, L351AD0000, L351AD0003, L351AD0007, L351AD9962, L351AD9963, L351AD9964, L351AD9966, L351AD9967, L351AD9968, L351AD9970, L351AD9971, L351AD9972, L351AD9974, L351AD9975, L351AD9976, L351AD9978, L351AD9979, L351AD9980, L351AD9982, L351AD9983, L351AD9984, L351AD9986, L351AD9987, L351AD9988, L351AD9990, L351AD9991, L351AD9993, L351AD9996, L355AD0209, L355AD0211, L355AD0213, L355AD0215, L355AD0217, L355AD0219, L356AD0222, L356AD0224, L356AD0226, L356AD0228, L356AD0249, L356AD0251, L356AD0252, L356AD0254, L357AD0333, L357AD0342, L357AD0344, L357AD0347, L357AD0351, L357AD0352, L357AD0355, L357AD0356, L357AD0358, L357AD0367, L357AD0369, L357AD0370, M003AD0384, M003AD0387, M003AD0390, M003AD0393, M003AD0396, M003AD0399, M003AD0405, M003AD0408, M003AD0411, M003AD0412, M003AD0415, M003AD0433, M003AD0435, M004AD0468, M004AD0469, M004AD0481, M005AD0543, M005AD0545, M005AD0547, M005AD0550, M005AD0554, M005AD0558, M005AD0560, M005AD0562, M005AD0564, M005AD0565, M005AD0566, M005AD0568, M005AD0570, M005AD0572, M005AD0574, M006AD0615, M006AD0621, M006AD0622, M006AD0623, M006AD0625, M006AD0627, M006AD0631, M006AD0632, M006AD0634, M006AD0637, M006AD0638, M006AD0656, M006AD0660, M006AD0668, M006AD0670, M006AD0672, M006AD0673, M006AD0676, M006AD0679, M006AD0682, M006AD0685, M006AD0694, M006AD0698, M006AD0702, M006AD0709, M006AD0713, M007AD0718, M007AD0719, M007AD0723, M007AD0740, M007AD0741, M007AD0749, M007AD0750, M007AD0753, M007AD0762, M007AD0763, M007AD0766, M007AD0767, M007AD0769, M007AD0770, M007AD0771, M007AD0778, M007AD0780, M010AD0790, M010AD0793, M010AD0796, M010AD0800, M010AD0801, M010AD0802, M010AD0805, M010AD0808, M010AD0821, M010AD0824, M010AD0828, M011AD0884, M011AD0904, M011AD0907, M011AD0908, M011AD0911, M011AD0913, M011AD0915, M011AD0916, M011AD0918, M011AD0922, M011AD0924, M011AD0926, M011AD0928, M011AD0930, M011AD0932, M011AD0935, M011AD0937, M011AD0940, M011AD0944, M011AD0946, M011AD0948, M011AD0950, M011AD0951, M012AD0959, M012AD0960, M012AD0963, M012AD0964, M012AD0967, M012AD0969, M012AD0973, M012AD0975, M012AD0976, M012AD0977, M012AD0979, M012AD0980, M012AD0982, M012AD0983, M012AD0985, M012AD0990, M012AD0993, M012AD0998, M012AD0999, M012AD1000, M012AD1001, M012AD1002, M012AD1003, M012AD1004, M012AD1005, M012AD1006, M012AD1007, M012AD1008, M012AD1009, M012AD1010, M012AD1011, M012AD1012, M012AD1013, M012AD1014, M012AD1015, M012AD1016, M012AD1017, M012AD1019, M012AD1021, M013AD1024, M013AD1025, M013AD1027, M013AD1029, M013AD1030, M013AD1033, M013AD1035, M013AD1037, M013AD1039, M013AD1043, M013AD1044, M013AD1045, M013AD1047, M013AD1048, M013AD1050, M013AD1051, M013AD1052, M013AD1054, M013AD1055, M013AD1060, M013AD1062, M013AD1064, M013AD1070, M013AD1072, M013AD1073, M013AD1074, M013AD1076, M013AD1077, M013AD1078, M013AD1080, M013AD1081, M013AD1083, M013AD1084, M013AD1086, M013AD1087, M013AD1088, M013AD1109, M017AD1298, M017AD1299, M017AD1300, M017AD1301, M017AD1302, M017AD1303, M018AD1310, M018AD1311, M018AD1312, M018AD1313, M018AD1317, M018AD1321, M018AD1325, M018AD1331, M018AD1334, M018AD1336, M018AD1343, M018AD1349, M018AD1369, M019AD1397, M019AD1470, M019AD1471, M020AD1482, M020AD1484, M020AD1488, M020AD1489, M020AD1491, M020AD1493, M020AD1495, M020AD1498, M020AD1501, M020AD1502, M020AD1504, M020AD1508, M020AD1509, M020AD1510, M020AD1512, M020AD1513, M020AD1515, M020AD1516, M020AD1517, M020AD1521, M020AD1522, M020AD1523, M020AD1525, M020AD1528, M020AD1530, M020AD1532, M020AD1534, M027AD1921, M028AD3004, M028AD3005, M029AD3084, M029AD3092, M029AD3096, M029AD3098, M029AD3100, M029AD3102, M031AD3156, M031AD3159, M031AD3162, M031AD3166, M031AD3172, M031AD3175, M034AD3206, M034AD3238, M034AD3240, M034AD3244, M034AD3246, M035AD3291 and M035AD3305;
3) No code
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated February 21, 2011, Firm initiated recall is ongoing.
REASON
Hill-Rom has become aware of a potential issue with some TotalCare and VersaCare beds equipped with the integrated P500 Microclimate Management (MCM) therapy surface, and with the VersaCare P500 MCM surface upgrade. Because of an unauthorized vendor part modification, it is possible that the MCM blower may not perform as originally designed. Given this modification, the MCM blower may experience the following: delayed start, slow running, or failure to operate. Patients may experience some reduced efficacy with managing skin temperature and moisture due to the reduced operation of the MCM blower. Please note that the mattress will continue to provide pressure redistribution to the patient, as the pump supplying air to the mattress bladders will continue to operate.
VOLUME OF PRODUCT IN COMMERCE
2,475 units
DISTRIBUTION
Nationwide, Aruba, Austria, Canada, France, Germany, Lebanon, Portugal and Saudi Arabia
____________________________________________
PRODUCT
1) Terumo Advanced Perfusion System 1, 100/120V System 1 Base, REF 801763, Terumo Cardiovascular Systems Corp., Ann Arbor, MI. The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Recall # Z-1566-2011;
2) Terumo Advanced Perfusion System 1, 220/240V System 1 Base, REF 801764, (not sold in the USA) The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Recall # Z-1567-2011
CODE
1) Serial numbers: 0011-0610, 1001-1182;
2) Serial numbers: 006-0322, 1001-1173
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems, Corp., Ann Arbor, MI, by letter dated February 14, 2011. Firm initiated recall is ongoing.
REASON
Terumo Cardiovascular Systems (CVS) has received 19 reports of a circuit breaker for the Terumo Advanced Perfusion System 1 tripping and causing the system to switch to battery back-up power. In two cases, the incident was caused when the circuit breaker came into incidental contact with the base of an IV pole; in others there was no known cause. Terumo CVS' investigation has determined that the location and design of the circuit breakers (near the floor on the back of the base) contribute to the likelihood that a breaker can be inadvertently tripped by incidental contact with other equipment in close proximity.
VOLUME OF PRODUCT IN COMMERCE
1,113
DISTRIBUTION
Nationwide and Internationally
__________________________________________
PRODUCT
Polycarbonate prescription single vision lenses for use in sport goggles. To be worn by a customer in a sport goggle frame to provide corrective refraction in accordance with the customer's prescription. Per the customer's request, some of the devices may also provide protection from bright sunlight. In the U.S., the Liberty Sport frame models and the corresponding SKU numbers into which the lenses at issue were inserted are: MaxMorpheus - 3703097, 3703105, 3703121, 3703139, 3703154, 3703162; Slam - 4286102, 4286103; Rec Spec Maxx - 1292931, 2102549, 2102549, 2102556, 2102564, 2102606, 2621068, 2621076, 2621084, 3300266, 3300274, 3300282, 3300332, 3300340, 3300357; Rec Spec Zone - 2102622, 3300407; Rec Spec Fusion - 2102655, 2102663, 3300373; Rec Spec Matrix - 1270439, 1278090, 1278089; Rec Spec HS2C - 1260789; Rec Spec 2003 - 1278092; Rec Spec Soft Touch - 1260791 In Canada, the Liberty Sport frame models and the corresponding SKU numbers into which the lenses at issue were inserted are: MaxMorpheus - 3703097, 3703162; Rec Spec Maxx - 2102549, 2102556, 2621068, 2621076, 3300381. Recall # Z-1568-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Luxottica Optical Manufacturing, Mason, OH, by letters on June 30, 2010.
Manufacturers: Luxottica Optical Manufacturing, Dallas, TX;
Luxottica, Memphis, TN;
Luxottica Optical, Knoxville, TN;
Luxottica Retail, Lockbourne, OH;
Luxottica North America D LLC; Winnipeg Manitoba, Canada.
Firm initiated recall is ongoing.
REASON
The polycarbonate prescription lenses may not meet the frame manufacturer's minimum lens thickness specification of 2.0 millimeters. LNAD made the decision to remove these sport goggles from the market because of the potential risk that the lenses could break or disengage from the frame in the event of an impact.
VOLUME OF PRODUCT IN COMMERCE
U.S., 1,443 sport goggles and in Canada, 15 sport goggles
DISTRIBUTION
Nationwide and Canada
_______________________________________
PRODUCT
1) MONOJECT Blood Collection Tubes containing heparin 13x100 sodium heparin trace element Item Code 8881307014. Recall # Z-1569-2011;
2) MONOJECT Blood Collection Tubes containing heparin 10x50 Sodium Heparin Item code 8881320157. Recall # Z-1570-2011;
3) MONOJECT Blood Collection Tubes containing heparin 10x64 Sodium Heparin Item code 8881320256. Recall # Z-1571-2011
CODE
1) Lot # 910905;
2) Lot # 918210;
3) Lot # 914803, Lot # 920402
RECALLING FIRM/MANUFACTURER
Recalling Firm: Covidien LP, Mansfield, MA, by letter dated November 12, 2010.
Manufacturer: Covidien, LP, Norfolk, NB. FDA initiated recall is ongoing.
REASON
The heparin sodium USP used to manufacture blood collection tubes was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.
VOLUME OF PRODUCT IN COMMERCE
176,100 units
DISTRIBUTION
Nationwide and Canada
________________________________________
PRODUCT
1) Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-14010MLL, 14ga (2.1mm) x 10cm (10). Recall # Z-1573-2011;
2) Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820MLL, 18ga (1.3mm) x 20cm (10). Recall # Z-1574-2011;
3) Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825MLL, 18ga (1.3mm) x 25cm (10). Recall # Z-1575-2011;
4) Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820M, 18ga (1.3mm) x 20cm (10). Recall # Z-1576-2011;
5) Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825M, 18ga (1.3mm) x 25cm (10). Recall # Z-1577-2011
CODE
1) Lot number: 083384;
2) Lot numbers: 090162 090289, 905416, 090684, 090758 and 090862;
3) Lot numbers: 083383 and 090582;
4) Lot numbers: 090212, 091351 and 093136;
5) Lot numbers: 092453, 092743, 092956 and 100646
RECALLING FIRM/MANUFACTURER
Remington Medical Inc., Alpharetta, GA, by facsimile, email and certified mail starting February 7, 2011. Firm initiated recall is ongoing..
REASON
There is a potential for the needle hubs to break during use.
VOLUME OF PRODUCT IN COMMERCE
46,878 units
DISTRIBUTION
Nationwide
_________________________________________
PRODUCT
1) Biomet Innervue Disposable Scope Kit, 1.2MM, Part Number: 922140, Sterile. Recall # Z-1588-2011;
2) Biomet Innervue Disposable Scope Kit, 1.2MM with Cannula set. Part Number: 922141, Sterile. Recall # Z-1589-2011
CODE
1) Lot Numbers: 337350, 381090, 381110, 337340, 751560, 751550, 707500, 707520, 707480, 073120, 073140;
2) Lot Numbers: 649680, 818630, 390060, 968890, 783990, 784000
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letters on February 10, 2011. Firm initiated recall is ongoing.
REASON
The cannula could not be connected to the scope and scopes disengage during use. The outer hub of Innervue scopes may become detached from the inner hub of the scopes during assembly of the scope to the Innervue hand piece. This condition may prevent the Innervue scope from being securely attached to the Innervue hand piece.
VOLUME OF PRODUCT IN COMMERCE
532 units
DISTRIBUTION
Nationwide, the Netherlands
______________________________________
PRODUCT
Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0.2.10. Recall # Z-1592-2011
CODE
Article Number Description Version 019.0333 Offline Upgrade CDX Station 7 EN (6+) 7.0.2.10 019.0334 Offline Upgrade CDX PPP 7 EN 7.0.2.10 019.0343 coDiagnostiX Station V 7.0 EN 7.0.2.10 019.0344 coDiagnostiX PPP V 7.0 EN 7.0.2.10 019.0345 coDiagnostiX coDoctor V 7.0 EN 7.0.2.10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Straumann Manufacturing Inc., Andover, MA, by letter dated September 30, 2010.
Manufacturer: Instituit Strauman, Basel, Switzerland. Firm initiated recall is ongoing.
REASON
Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
Nationwide
_________________________________________
PRODUCT
ARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF 31-301850. The torque limiting T-handle is used with attachments and hex drivers for preparation of the femur and for locking screw insertion at specified torque limit in Arcos hip procedures. Recall # Z-1594-2011
CODE
Units: 419402, 419403, 419404 and 419405
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomet, Inc., Warsaw, IN, by telephone on January 28, 2011 and letter dated February 21, 2011.
Manufacturer: Symmetry Medical USA, Inc, Warsaw, IN. Firm initiated recall is ongoing.
REASON
The firm received two complaints of the tabs on the Torque Limiting T-Handle fracturing during surgery. The firm performed internal testing and found that the tabs may fracture when used in the “OFF” or “locked” setting for hand-reaming the femoral canal.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
CA, NY, FL, VA, UT, IL, MI, KY, OH, MA, PA, SD, MO, TX, NV, Puerto Rico, and the countries of Australia, New Zealand, Canada
________________________________________
PRODUCT
AMPLATZER Sizing Balloon II, REF 9-SB-034, Sterile EO, AGA Medical Corporation, 5050 Nathan Lane North, Plymouth, MN 55442. The AMPLATZER Sizing Balloon II is intended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device. Z-1595-2011
CODE
Lot # 10004282114
RECALLING FIRM/MANUFACTURER
AGA Medical Corp., Plymouth, MN, by letter, dated December 17, 2010. Firm initiated recall is ongoing.
REASON
Mislabeled AMPLATZER Sizing Balloon II. AGA Medical received 2 reports from customers who received sizing balloons that were labeled as 34 mm; however, the package contained 24 mm devices. The proper sizing (24 mm) was printed on the device hub visible through the product package.
VOLUME OF PRODUCT IN COMMERCE
54 Units
DISTRIBUTION
Argentina, Germany, Greece, Netherlands, Peru, Poland, Portugal, Slovakia, United Kingdom
______________________________________
PRODUCT
Hospira Power cord use on Symbiq One-Channel infuser and Symbiq Two-Channel infuser. Power cord part number: HSP3306-E07. Used on List No. 16026 - Symbiq One Channel infuser; List No. 16027 - Symbiq Two-Channel infuser. Recall # Z-1596-2011
CODE
Power cord part number: HSP3306-E07. Used on List No. 16026 - Symbiq One Channel infuser; List No. 16027 - Symbiq Two-Channel infuser List number configurations: 16026-04-01/03/04, 51/52,. 53/54, 79/80, 81/82, 83/84/ 87/88; 16027-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88; 16026-13-25/26, 53/54; 16027-13-25/26, 53/54.
RECALLING FIRM/MANUFACTURER
Hospira Inc., Morgan Hill, CA, letters on November 1, 2010. Firm initiated recall is ongoing.
REASON
Complaints of broken, bent or missing prongs, charring, sparks, visible smoke, burnt smell have been reported on Symbiq AC Power cords.
VOLUME OF PRODUCT IN COMMERCE
32,376 cords
DISTRIBUTION
Nationwide, Australia, Canada, and Malaysia
________________________________________
PRODUCT
1) Hospira Plum XL Infusion Pump, Single Channel; list number 11555. Recall # Z-1597-2011;
2) Hospira Plum XL Micro/Macro Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list number 11846. Recall # Z-1598-2011;
3) Hospira Plum XL Micro/Macro with DataPort Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list number 11859. Recall # Z-1599-2011;
4) Hospira Plum XL3 Infusion Pump, Triple Channel; list number 11781. Recall # Z-1600-2011;
5) Hospira Plum XL3 Micro/Macro Infusion Pump, Triple Channel, with a 0.1-999 mL/hr flow rate range; list number 11845. Recall # Z-1601-2011;
6) Hospira Plum XL3 Micro/Macro with DataPort Infusion Pump, Triple Channel, with a 0.1-999 mL/hr flow rate range; list number 11855. Recall # Z-1602-2011
CODE
1) Serial numbers 0011200063 through 0097280149;
2) Serial numbers: 0012200009 through 0097830800;
3) Serial numbers: 0012520001 through 0099936319;
4) Serial numbers: 0011600016 through 0011604705;
5) Serial numbers: 0012100010 through 0097951146;
6) Serial numbers: 0012620007 through 0012621660
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letters dated February 14, 2011.
Manufacturers: Hospira Inc., Morgan Hill, CA;
Hospira Holdings de, Costa Rica Ltd., Real Cariari, Zona Franca Global, La Aurora de Heredia, Costa Rica. FDA initiated recall is ongoing.
REASON
Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low audio level setting.
VOLUME OF PRODUCT IN COMMERCE
205,689 pumps
DISTRIBUTION
Nationwide and Internationally
______________________________________
PRODUCT
MMP 200 Articulating Booms, Catalog Number 0682-000-604SX, Product Number 0682-001-060C. Used for operating room equipment. Recall # Z-1611-2011
CODE
Serial numbers: 02074510100008 and 0207451010000
RECALLING FIRM/MANUFACTURER
Stryker Communications Corp., Flower Mound, TX, by telephone on January 28, 2011 and by letter dated February 11, 2011. Firm initiated recall is complete.
REASON
Utilization of incorrect screws resulted in inadequate thread engagement reducing the load bearing capability of the product.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MA, CO
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS III
_____________________________________
PRODUCT
VCare Vaginal-Cervical Ahluwalias Retractor-Elevator devices. The VCare IFU is packaged one per carton of eight VCare Pouched Devices. The Instructions for Use is an 8.5” x 12” 12-page booklet and is packed loose in the carton. Only the carton will have to be opened to replace the old IFU; there is no need to open the sterile packaging of the individual VCare pouches. The ConMed VCARE Retractor/Elevator is indicated for manipulation of the uterus and injection of fluids or gases during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the vagina once colpotomy is performed. VCare Standard Cervical Cup (Catalog# 60-6085-100), VCare Small Cervical Cup (Catalog# 60-6085-101) and VCare Large Cervical Cup (Catalog# 60-6085-102). Recall # Z-1520-2011
CODE
Lot codes for product manufactured between January 20, 2009 (Lot 090120X) and through July 31, 2009 (Lot 090731X). Lot Code Key = YYMMDDX, where X = manufacturing shift (e.g. 1, 2 or 3)
RECALLING FIRM/MANUFACTURER
ConMed Corp., Utica, NY, by letter on February 2, 2011. Firm initiated recall is ongoing.
REASON
Product manufactured after April 11, 2008, but before August 1, 2009, contains the earlier Instructions For Use, IFU (PN 17416, Rev. D) which does not contain the revisions on the addition of Warning Notes 10 and 11 and the expansion of Warning Note 6 to the VCare� Instructions for Use. The reason for the field correction is to provide a copy of the revised IFU to all customers who may have unexpired Vcare� devices in their possession that were made prior to August 1, 2009.
VOLUME OF PRODUCT IN COMMERCE
31,028 units
DISTRIBUTION
Nationwide and the countries of Austria, Jordan, Turkey, China, Portugal, Chile, Belgium, Ecuador, Brazil, Romania, Japan, Malaysia, India Switzerland, Colombia, Netherlands, Spain, Saudi Arabia, France, and Canada
___________________________________
PRODUCT
MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests. MESOMARK is an enzyme linked immunosorbent assay (ELISA) for the quantitative measurement of Soluble mesothelin Related Peptides (SMRP) in human serum. Measurement of SMRP may aid in the monitoring of patients diagnosed with epithelioid or biphasic mesothelioma. MESOMARK values must be interpreted in conjunction with all other available clinical and laboratory data. Item # 801-905. Recall # Z-1606-2011
CODE
Lot: 57K04510, Expiration Date: December 14, 2010 and Lot: 57K04409, Expiration Date: June 15, 2010
RECALLING FIRM/MANUFACTURER
Fujirebio Diagnostics, Inc., Malvern, PA, by letter dated July 7, 2010. Firm initiated recall is complete.
REASON
Presence of material attached to the bottom of some wells in places visible to the naked eye, which caused an overestimation of the sample.
VOLUME OF PRODUCT IN COMMERCE
42 kits
DISTRIBUTION
Nationwide
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PRODUCT
Natura Durahesive ConvaTec Moldable Technology Post-Operative/Surgical System (57mm), 2 ¼ inch This kit is comprised of a pouch, wafer, and related accessories (low pressure adaptor, measuring guide, insert and other packaging components); required for application to a patient immediately after ostomy surgery. Product Code # 416921. Recall # Z-1610-2011
CODE
Lot # 0J00814
RECALLING FIRM/MANUFACTURER
Recalling Firm: Convatec Inc., Skillman, NJ, by letter dated February 1, 2011.
Manufacturer: Nypro Dominican Republic, Inc., San Cristobal, Dominican Republic. Firm initiated recall is ongoing.
REASON
Natura Durahesive ConvaTec Moldable Technology Post Operative/Surgical System (57mm) units may contain pouches with 45 mm Natura flanges, therefore the pouch, low pressure adapter and barrier would not fit together.
VOLUME OF PRODUCT IN COMMERCE
77 market units
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR MARCH 16, 2011
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