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U.S. Department of Health and Human Services

Safety

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Enforcement Report for May 16, 2012

 

May 16, 2012                                                                                             12-20
 
RECALLS AND FIELD CORRECTIONS: COSMETICS - CLASS III
___________________________________
PRODUCT
"***H***GENTLE***EYE MAKEUP***REMOVER***HYDRON***Detergent Free***Mineral Oil Free*** Fragrance Free***4 fl. oz., 118 ml***Bi-phase formula hydrates and conditions delicate skin and lashes***Mild cleansing agents dissolve even waterproof mascara***pH buffered to match tear fluid***Dermatologist and ophthalmologist tested. Safe for contact lens wearers***TO USE: Shake vigorously before application. Moisten cotton pad and wipe gently across eyelid. Rinse with plain water and pat dry.*** INGREDIENTS: Purified Water, Cyclomethicone, Isohexadecane, Hexylene Glycol, Polaxamer 184, Dipotassium Phosphate, Sodium Chloride, Benzyl Alcohol, Potassium Phosphate, Quaternium-15, Disodium EDTA, FD&C Green No .3***". Recall # F-1199-2012
CODE
Lot # BRX10D132
RECALLING FIRM/MANUFACTURER
Brand Builders Rx LLC, Saint Petersburg, FL, by letter dated June 10, 2010. FDA initiated recall is ongoing.
REASON
The FD&C Green #3 is prohibited for use on areas of the eye.
VOLUME OF PRODUCT IN COMMERCE
188
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Papayas Delicious Fruit, Produce of Mexico, approximately 15, 12, 9 or 8 per box, Papayas have a stick-on label: "PLU#3112". Recall #F-1197-2012
CODE
Lot # CH347, Codes: 6909014, 6909914, and 6909318
RECALLING FIRM/MANUFACTURER
Recalling Firm: Papayas & More LLC, Hidalgo, TX, by letter dated April 14, 2012. 
Manufacturer: Empaque de Frutas Chulavista S.A. de C.V., Tecoman, Mexico. Firm initiated recall is complete.
REASON                                                                                                                                                 
The papayas tested positive for Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,124 boxes
DISTRIBUTION
NY
___________________________________
PRODUCT
Recipe 216 Schwan's Caramel Peanut Chocolate Bar ice cream. 1.75 qts, bar. Recall # F-1198-2012
CODE
Code 517744, all product codes
RECALLING FIRM/MANUFACTURER
Schwan's Global Supply Chain Inc., Marshall, MN, by e-mail on January 31, 2009. FDA initiated recall is complete.
REASON                                                                                                                                                
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
7897 cases; 94,764 cartons; 199,004 lbs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
A Taste of the East maya (MAYA OVERSEAS FOOD INC.) brand Dry Fruit Kachori -- Net Wt. 8.75 oz (250 gms.) -- UPC 0 20843 16162 1 -- PRODUCT OF INDIA --- The product is packaged in a cardboard box. Recall # F-1215-2012
CODE
UPC only
RECALLING FIRM/MANUFACTURER
Maya Overseas Foods Inc., Maspeth, NY, by letter dated February 21, 2011. New York State initiated recall is complete.
REASON
The product was found to contain undeclared peanuts (11.0 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Deer brand RAISIN GOLDEN, Net Wt.: 14 oz. (400 G) -- UPC 7 14760 02926 2 -- PRODUCT OF INDIA -- There is no Nutrition Facts Panel to determine serving size and servings per package. The product is packaged in a sealed plastic bag. Recall # F-1216-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Best Cash and Carry, Maspeth, NY, by press release on September 7, 2011. New York initiated recall is complete.
REASON                                                                                                                                                 
The product was found to contain undeclared sulfites (276.7 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
1,180 units
DISTRIBUTION
NY, NJ, CT
___________________________________
PRODUCT
1) Crispy TWI Foods Almond Cake Rusk, Biscotte Croustillante Almande, Net Wt 750 g/26.4 oz., 14 packages per case; Product of Canada; UPC 6 27265 00217 6. Recall # F-1217-2012;
 
2) Crispy by TWI Foods Almond Cookies, Biscuit Almande, Net wt. 400 g/14.1 oz, 12 packages/case; Product of Canada; UPC 6 27265 00120 9. Recall # F-1218-2012;
 
3) Crispy by TWI Foods Coconut Cookies, Biscuit noix de coco, Net wt. 400 g/14.1 oz, 12 packages/case; Product of Canada; UPC 6 27265 00121 6. Recall # F-1219-2012;
 
4)Crispy by TWI Foods Pistachio Cookies, Biscuit pistache, Net wt. 400 g/14 oz, 12 packages/case; Product of Canada; UPC 6 27265 00601 3. Recall # F-1220-2012
CODE
All best before dates up to and including 29/MAR/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pita Plus Inc., Elk Grove Village, IL, by telephone on April 24-25, 2012 and either visited or by letters dated April 26, 2012.
Manufacturer: Twi Foods Inc., Mississauga, Ontario, Canada. FDA initiated recall is ongoing.
REASON                                                                                                                           
Product did not declare milk or almonds on the labeling.
VOLUME OF PRODUCT IN COMMERCE
345 cases
DISTRIBUTION
GA, IL, IN, IA, KY, MI, MN, MO, NB, OH, TN, WI
___________________________________
PRODUCT
1) Crispy TWI Foods Almond Cake Rusk, Biscotte Croustillante Almande, Net Wt 750 g, Product of Canada. UPC 6 27265 00217 6. Recall # F-1221-2012;
 
2) Crispy TWI Foods Almond Cookies, Biscuit, Net Wt 200 g, Product of Canada. UPC 6 27265 005221 6. Recall # F-1222-2012;
 
3) Crispy TWI Foods Pistachio Cookies, Biscuit, Net Wt 200 g, Product of Canada. UPC 6 27265 00161 2. Recall # F-1223-2012
CODE
All codes, best before March 27, 2013/ March 29, 2013.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shah Distributors, Tracy, CA, by telephone and/or visit on March 29, 2012. 
Manufacturer: Twi Foods Inc., Mississauga Ontario, Canada. FDA initiated recall is ongoing.
REASON
Products contain undeclared milk and/or almonds.
VOLUME OF PRODUCT IN COMMERCE
82 cases
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
1) Black Bean Ravioli packaged in 12 oz/341 g plastic containers (black bottom, clear lid). The UPC code is 000000154765. Recall# F-1201-2012;
 
2) Wild Mushroom Ravioli packaged in 12 oz/341 g plastic containers (black bottom, clear lid). The UPC code is 000000154772. Recall # F-1202-2012;
 
3) Mixed Vegetable Ravioli packaged in 12 oz/341 g plastic containers (black bottom, clear lid). The UPC code is 000000213646. Recall # F-1203-2012;
 
4) Cilantro Pesto Ravioli packaged in 12 oz/341 g plastic containers (black bottom, clear lid). The UPC code is 000000213639. Recall # F-1204-2012;
 
5) Spinach & Feta Ravioli packaged in 12 oz/341 g plastic containers (black bottom, clear lid). The UPC code is 000000213646. Recall # F-1205-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Holy Ravioli, Dallas, TX, by letter dated April 30, 2012. Firm initiated recall is ongoing.
REASON
Product fails to declare the wheat allergen on the label.
VOLUME OF PRODUCT IN COMMERCE
Approximately 40 each 12 oz/341 g containers
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Narala Bakery brand BUTTERFLY, Net Wt 10 oz --- INGREDIENTS: Enriched Flour (Bleached Flour, Malted Barley Flour, Niacin, Iron, Potassium Bromate Mononitrate, Riboflavn, Folic Acid), Vegetable Shortening (Partially Hydrogenated Soybean Oil and Partially Hydrogenated Palm Oil with Citric Acid Added as Preservative), Sugar, Salt, Baking Powder # 2419. Recall # F-1206-2012;
 
2) Narala Bakery brand Cake Rusk, Net Wt 12 oz --- INGREDIENTS: Enriched Flour (Bleached Flour, Malted Barley Flour, Niacin, Iron, Potassium Bromate Mononitrate, Riboflavn, Folic Acid), Vegetable Shortening (Partially Hydrogenated Soybean Oil and Partially Hydrogenated Palm Oil with Citric Acid Added as Preservative), Sugar, Salt, Baking Powder # 2419, Butter, Lemon Flavour (Water, Propylene Glycol, Xanthan Gum, Citric Acid, Sodium Benzoate), Whole Eggs. Recall # F-1207-2012;
 
3) Narala Bakery brand Fruit Cake, Net Wt 12 oz --- INGREDIENTS: Enriched Flour (Bleached Flour, Malted Rarley Flour, Niacin, Iron, Potassium Bromate Mononitrate, Riboflavn, Folic Acid), Soybean Oil, Sugar, Salt, Baking Powder # 2419, Butter, Lemon Flavour (Water, Propylene Glycol, Xanthan Gum, Citric Acid, Sodium Benzoate), Tuity Fruity (Orange Peel, Invert Syrup, Acidity Regulator, Citric Acid, Colours - FD&C YELLOW # 5, FD&C RED # 40, FD&C BLUE # 1), Whole Eggs. Recall # F-1208-2012;  
 
4) Narala Bakery brand Plain Bun --- INGREDIENTS: Enriched Flour (Bleached Flour, Malted Barley Flour, Niacin, Iron, Potassium Bromate Mononitrate, Riboflavn, Folic Acid), Soybean Oil, Salt, Sugar, Dry Yeast (Sorbitan Monostearate Ascordic Acid). Recall # F-1209-2012;
 
5) Narala Bakery brand Plain Cake, Net Wt 12 oz --- INGREDIENTS: Enriched Flour (Bleached Flour, Malted Rarley Flour, Niacin, Iron, Potassium Bromate Mononitrate, Riboflavn, Folic Acid), Soybean Oil, Sugar, Salt, Baking Powder # 2419, Butter, Lemon Flavour (Water, Propylene Glycol, Xanthan Gum, Citric Acid, Sodium Benzoate), Whole Eggs. Recall # F-1210-2012;
 
6) Narala Bakery brand Sheer Mall --- INGREDIENTS: Enriched Flour (Bleached Flour, Malted Rarley Flour, Niacin, Iron, Potassium Bromate Mononitrate, Riboflavn, Folic Acid), Soybean Oil, Salt, Sugar, Dry Yeast (Sorbitan Monostearate Ascordic Acid). Recall F-1211-2012;
 
7) Narala Bakery brand Tea Rusk, Net Wt 6 oz --- INGREDIENTS: Enriched Flour (Bleached Flour, Malted Rarley Flour, Niacin, Iron, Potassium Bromate Mononitrate, Riboflavin, Folic Acid), Soybean Oil, Salt, Sugar, Dry Yeast (Sorbitan Monostearate Ascorbic Acid). Recall # F-1212-2012;
 
8) Narala Bakery brand Zeera Cookies, Net Wt 8 oz --- INGREDIENTS: Enriched Flour (Bleached Flour, Malted Barley Flour, Niacin, Iron, Potassium, Bromate, Mononitrate, Riboflavin, Folic Acid), Vegetable Shortening, (Partially Hydrogenated Soybean Oil and Partially Hydrogenated Palm Oil with Citric Acid added as Preservative), Sugar, Salt, Baking Powder # 2419, Vanila Flavour Whole Zeera. Recall # F-1213-2012;
 
9) Narala Bakery brand Salted Tie, Net Wt 8 oz --- INGREDIENTS: Enriched Flour (Bleached Wheat Flour, Malted Barley Flour, Niacin, Iron, Potassium, Bromate, Thiamin Mononitrate, Riboflavin, Folic Acid), Vegetable Shortening, Butter, Sugar, Salt, Baking Powder # 2419, Vanila Flavour. Recall # F-1214-2012
CODE
No code
RECALLING FIRM/MANUFACTURER
Narala Bakery Inc., Brooklyn, NY, by visit in mid-September 2011 and during February 2012. FDA initiated recall is complete.
REASON                                                                                                                                                 
The product was manufactured using vegetable shortening which contains partially hydrogenated soybean oil and partially hydrogenated palm oil with citric acid added as a preservative, these sub-ingredients and the specific type of flour (wheat) was not listed on the ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY City
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
Haggen Brand No Salt Tomato Sauce, 8 oz (227g) can. Sodium content on No Salt Tomato Sauce: 20 mg for 1/4 cup serving Sodium content for Tomato Sauce: 260 mg for 1/4 cup serving. UPC 2698441033. Recall #F-1200-2012
CODE
Lot number 5T3 OK F287U
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pacific Coast Producers Inc., Lodi, CA, by letter on April 4, 2012.
Manufacturer: Pacific Coast Producers, Woodland, CA. Firm initiated recall is ongoing.
REASON
One lot of regular tomato sauce was labeled with "no salt" label.
VOLUME OF PRODUCT IN COMMERCE
24 cases
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Dried Vobla, uneviscerated fish. 20 lb boxes, not vacuum packed. Product sold in bulk without labeling. Recall # F-1224-2012;
 
2) Smoked Vobla, uneviscerated fish. 20 lb boxes, not vacuum packed. Product sold in bulk without labeling. Recall # F-1225-2012
CODE
No lot codes. No expiration dates.
RECALLING FIRM/MANUFACTURER
La Star Seafood Co Inc., Los Angeles, CA, by telephone on April 24, 2012 and by press release and letter on April 25, 2012. Firm Initiated recall is ongoing.
REASON                                                                                                                                                
The dry and smoked Vobla fish is uneviscerated and may be contaminated with Clostridium botulinum. 
VOLUME OF PRODUCT IN COMMERCE
521.72 lbs
DISTRIBUTION
UT, CA, CO, OR
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions toCDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
______________________________________
PRODUCT
 
None
 
RECALLS AND FIELD CORRECTIONS: DIETARY SUPPLEMENT - CLASS I
___________________________________
PRODUCT
1) Mince Belle Dietary Supplement, 30 Capsules. Recall # D-1347-2012;
 
2) Perfect Men Dietary Supplement, 10 Capsules. Recall # D-1348-2012;
 
3) EVERLAX Dietary Supplement, 30 capsules. Recall # D-1349-2012;
 
4) EVER Slim Dietary Supplement, 30 capsules. Recall # D-1350-2012;
 
5) Herbal Drink Acai-man mangosteen Dietary Supplement, Contents 16.6 fl oz. Recall # D-1351-2012;
 
6) EVER SLIM Shake Mix Dietary Supplement Strawberry, Net Weight 17.6 oz. Recall # D-1352-2012;
 
7) EVER SLIM Shake Mix Dietary Supplement Chocolate, Net Weight 17.6 oz. Recall # D-1353-2012
CODE
1) Lot #: HPCMB/10-026, HPCMB/10-027, HPCMB/10-029, HPCMB/10-020, HPCMB/10-021, and HPCMB/10-016;
 
2) Lot #: HPCPM/002;
 
3) Lot #: HPCEX/074, HPCEX/076, HPCEX/072, and HPCEX/032;
 
4) Lot #: HPCES-079, HPCES-070, HPCES-071, and HPCES/038;
 
5) Lot #: HPJAC/004;
 
6) Lot #: HPESSF/168;
 
7) Lot #: HPESSC/061
RECALLING FIRM/MANUFACTURER
Recalling Firm: Healthy People, Irwindale, CA, by press release on February 3, 2012.
Manufacturer: Healthy Labs S. de R. L. de C. V., Irapuato, Mexico. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Marketed Without an Approved NDA/ANDA: FDA laboratory analyses found the products to contain Sibutramine, an appetite suppressant that was withdrawn from the market in October 2010 for safety reasons, making these products unapproved new drugs.
VOLUME OF PRODUCT IN COMMERCE
771 boxes (14,251 units)
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Kit for the Preparation of Technetium Tc99m Pyrophosphate Injection, a) 5-count multidose vials per box (NDC 45567-0060-1), b) 30-count multidose vials per box (NDC 45567-0060-2), Rx only. Recall # D-1342-2012
CODE
Lot #: 220053, Exp 06/12
RECALLING FIRM/MANUFACTURER
Pharmalucence, Inc., Bedford, MA, by telephone and/or letter dated May 2, 2012. Firm initiataed recall is ongoing.
REASON
Lack of assurance of sterility - Raw material used in the manufacture of the finished product did not meet specification for endotoxins.
VOLUME OF PRODUCT IN COMMERCE
19,140 vials
DISTRIBUTION
Nationwide, Puerto Rico, Australia, and Philippines
___________________________________
PRODUCT
1) SYMPT-X Glutamine Powder Regular Formula (glutamine), 480 gram jar, a) Product code 2L5100: cartons of 12 jars each; b) Product code 2L5011E: single jar cartons for direct consumers only; Rx only, Made in USA; NDC 0338-9170-91. Recall # D-1345-2012;
2) SYMPT-X Glutamine Powder Regular Formula (glutamine), 15 gram packets containing 10 grams Glutamine, 60-count packets per box, Rx only, Made in USA; NDC 0338-9177-91; Product code 2L5107. Recall # D-1346-2012
CODE
1) Lot #: 0061E9, Exp 01/12; 0093G9, Exp 03/12; 0175B0, Exp 10/12; 0123F0, Exp 01/13; 0284G0, Exp 02/13; 0197J0, Exp 05/13; 0449D1, Exp 11/13; and 0145F1, Exp 12/13;
 
2) Lot #: 0319G9, Exp 02/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated April 24, 2012.
Manufacturer: Garden State Nutritionals, Div. Vitaquest International, LLC, West Caldwell, NJ. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Labeling: Label w/Wrong or Incorrect EXP Date: The SYMPT-X Glutamine Powder is labeled with an incorrect expiry date, past the recommended shelf life from the date of manufacture.
VOLUME OF PRODUCT IN COMMERCE
21,870 jars, 1,613 boxes of packets
DISTRIBUTION
Nationwide, Canada, and Taiwan
___________________________________
PRODUCT
1) Topiramate Tablets, 100 mg, a) 60-count tablets per bottle (NDC 0093-7219-06, UPC 3 0093-7219-06 4), b) 1000-count tablets per bottle (NDC 0093-7219-10, UPC 3 0093-7219-10 1), Rx only. Recall # D-1339-2012;
 
2) Topiramate Tablets, 50 mg, 1000-count tablets per bottle, Rx only, NDC 0093-7540-10, UPC 3 0093-7540-10 6. Recall # D-1340-2013;
 
3) Topiramate Tablets, 200 mg, 1000-count tablets per bottle, Rx only, NDC 0093-7220-10, UPC 3 0093-7220-10 7. Recall # D-1341-2012
CODE
1) Lot #: a) 29T097, 29T098, Exp 08/13; b) 29T093, 29T094, 29T096, Exp 07/13; 29T099, Exp 08/13;
2) Lot #: 16T023, 16T024, and 16T026, Exp 03/12;
3) Lot #: 30T044, Exp 06/12; and 30T085, Exp 07/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on March 28, 2012.
Manufacturer: Teva Pharmaceutical Industries Ltd., Jerusalem, Israel. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: The specified lots may not meet the impurity specification through expiry.
VOLUME OF PRODUCT IN COMMERCE
12,467 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Ovcon 50 (norethindrone and ethinyl estradiol) tablets, USP, 1 mg/50 mcg, a) 3-count blister cards of 28 tablets each per carton (NDC 0430-0585-45, UPC 3 0430-0585-45 9), b) 6-count blister cards of 28 tablets each per Physician's Sample carton (NDC 0430-0585-95), Rx only. Recall # D-1344-2012
CODE
Lot #: a) 506964B, Exp 05/12; 509310A, Exp 09/12; 511071A, Exp 12/12; b) 506964C, Exp 05/12
RECALLING FIRM/MANUFACTURER
Warner Chilcott Company LLC, Fajardo, PR, by letter dated April 3, 2012. Firm initiated recall is ongoing
REASON
CGMP Deviations: This recall is being initiated as part of the commitments to the response to the FDA concerns on lack of full shelf-life stability data supporting 12-months expiry date.
VOLUME OF PRODUCT IN COMMERCE
a) 24,754 blister cards; b) 1,590 blister cards
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Advil Liqui-Gels 200 mg (ibuprofen), 40 count, 40+20 count and 240 count bottles. Recall # D-1337-2012
CODE
Lot # Exp Date: F48768 02/2013; F71099 03/2013; F74724 03/2013; 42281 03/2013; 42284 03/2013; 42285 03/2013; 42288 03/2013; 42291 03/2013; 1355CB 03/2013; 1712FR 03/2013;1412RR 03/2013 ; 1612RR 03/2013; 2010KA 03/2013 ; 1362KA 03/2013; 1361KA 03/2013 ; 1712AR 03/2013; 1612AR 03/2013 ; 1112CRA 03/2013; 1812AR 03/2013; 1212CR 03/2013; 1112CR 03/2013; 2005HA 03/2013; 2053DA 03/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by letter on March 16, 2012. 
Manufacturer: Catalent Argentina S.A.I.C., Villa Loma Hermosa, Argentina. Firm initiated recall is ongoing.
REASON
CGMP deviation; enzymatic hydrolysis time for the gelatin manufacturing process of these lots was increased which may have caused a stronger odor of the product.
VOLUME OF PRODUCT IN COMMERCE
653,162 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Levonorgestrel and Ethinyl Estradiol Tablets USP (0.1 mg/0.02 mg) and Ethinyl Estradiol Tablets USP (0.01 mg), Rx Only, 2 X 28 Tablets and 1 X 35 Tablets per Pouch, NDC 68180-848-11 (pouch), 68180-848-13 (carton). Recall # D-1338-2012
CODE
Lot #: 118901386, Exp. 9/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lupin Pharmaceuticals Inc., Baltimore, MD, by letters on March 30, 2012 with a follow-up telephone call.
Manufacturer: Lupin Pharmacare Ltd., Indore Madhya Pradesh, India. Firm initiated recall is ongoing.
REASON
Impurity/Degradation Products: This product is being recalled due to an out of specification test result for an individual unspecified impurity, identified as Bisphenol-A, during the 3 month long term stability testing.
VOLUME OF PRODUCT IN COMMERCE
5,400 cartons (10,800 pouches)
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Omnaris (ciclesonide) Nasal Spray 50 mcg, 7.1 g bottle, 60 metered actuations, Professional Sample, Rx only, NDC 63402-701-02, UPC 3 63402-702-02 0. Recall # D-1343-2012
CODE
Lot # 138122, Exp 08/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sunovion Pharmaceuticals Inc., Marlborough, MA, by letter dated May 3, 2012.
Manufacturer: Nycomed GmbH (frmly: Altana), Singen (hohentwiel), Germany. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Product Lacks Stability: Pinhole defects in the pouch surrounding the immediate container permit air ingress and results in a decrease of the preservative potassium sorbate and an increase in an associated impurity.
VOLUME OF PRODUCT IN COMMERCE
94,810 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Platelets Pheresis. Recall # B-1129-12
CODE
Unit: 32GP39713 (2 units)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by facsimile on April 11, 2006 and May 9, 2006. Firm initiated recall is complete.
REASON
Blood products, manufactured in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1161-12
CODE
Unit: W141608433142
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter dated September 16, 2008.
Manufacturer: Puget Sound Blood Center and Program, Lynnwood, WA. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1176-12;
2) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1177-12;
3) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1178-12;
4) Platelets Leukocytes Reduced. Recall # B-1179-12;
5) Plasma Frozen. Recall # B-1180-12;
6) Red Blood Cells Leukocytes Reduced Washed. Recall # B-1181-12;
7) Red Blood Cells Leukocytes Reduced. Recall # B-1183-12
CODE
1) Units: 017FK78101, 017FK77404, 017FK77409, 017FK77414, 017FK77426, 017KW95704, 017KW95710, 017KW95727, 017KW93789, 017KW93790, 017KW93793, 017KW93819, 017KW85374, 017KW85380, 017KW85389, 017KW85394, 017KW85402, 017KW85409, 017GS12625, 017GS12629, 017GS12631, 017GS12636, 017KW91004, 017KW91177, 017KW91206, 017KW91212, 017KW91214, 017FL75123, 017FL75138, 017FL75150, 017FK67558, 017FK67571, 017FK67618, 017KW88407, 017KW88421, 017KW88430;
 
2) Units: 017FS19823 (Parts 1 & 2), 017FS19824 (Parts 1 & 2), 017FS14751 (Parts 1 & 2), 017FS14760 (Parts 1 & 2), 017FS14732 (Parts 1 & 2), 017FS19694 (Parts 1 & 2), 017FS39723 (Parts 1 & 2), 017FS39724 (Parts 1 & 2), 017FS39725 (Parts 1 & 2), 017FS14701 (Parts 1 & 2), 017FS19622 (Parts 1 & 2), 017FS37892 (Parts 1 & 2), 017FS13952 (Parts 1 & 2), 017FS13953 (Parts 1 & 2), 017FS14649 (Parts 1 & 2), 017FS14596 (Parts 1 & 2), 017FS39828 (Parts 1 & 2), 017FS39855 (Parts 1 & 2), 017FS18861 (Parts 1 & 2), 017FS38063 (Parts 1 & 2), 017FS14532 (Parts 1 & 2);
 
3) Units: 017FK77929, 017GS08697, 017KV65104, 017KV65107, 017FK76119, 017KW87267, 017KW95842, 017FK72819, 017FK73016, 017FK73034, 017KW92820, 017KW93011, 017KW89928, 017KW89929, 017KW90009, 017GS10104, 017FK70199, 017FK70259, 017GS10336, 017GS10375, 017GS10379, 017KW89868, 017KW89883, 017KW89899;
 
4) Units: 017GR55392, 017GR55409, 017KV65228, 017KV65245, 017KV65249, 017KV65277, 017KV65283, 017GR54789, 017GR54803, 017GR54805, 017FK72862, 017FK72865, 017FK72870, 017FK72899, 017FK72902, 017GR53798, 017GR53810, 017GR53819, 017GR53836, 017FL74005, 017FL74020, 017FL74032, 017GR59308, 017GR56973;
 
5) 017FK78076, 017GS08693, 017FK77334, 017FJ79397, 017KV65228, 017FK64943, 017KW86138, 017FK72862, 017FK72865, 017FK72870, 017FK72899, 017FK73000, 017FK73013, 017FK73016, 017GR53798, 017GR53810, 017GR53819, 017KW93210, 017KW93273, 017KW92279, 017KW85709, 017GS12595, 017KW90924, 017FK70195, 017FK67308, 017KW88280, 017KW87988;
 
6) Unit: 017GX52397;
 
7) Units: 017FK77834, 017FK77840, 017FK77843, 017FK77845, 017FK77913, 017FK77964, 017FK78008, 017FK78024, 017FK78032, 017FK78076, 017FK78115, 017FK78120, 017FK78128, 017FK78705, 017GS08621, 017GS08623, 017GS08630, 017GS08636, 017GS08643, 017GS08663, 017GS08674, 017GS08686, 017GS08694, 017GS08699, 017GS08703, 017GS08714, 017GS08725, 017KW87599, 017KW87624, 017KW87646, 017KW87659, 017KW87665, 017KW87668, 017KW87676, 017FK77316, 017FK77334, 017FK77381, 017FK77432, 017FK77466, 017FK77544, 017FK77548, 017FK77600, 017FK77606, 017FK77686, 017FK77749, 017FK77760, 017FK77764, 017FK77774, 017KW96126, 017KW96134, 017FJ79348, 017FJ79354, 017FJ79356, 017FJ79360, 017FJ79392, 017FJ79397, 017GR55370, 017GR55377, 017GR55389, 017GR55392, 017GR55399, 017GR55402, 017GR55409, 017KW87383, 017KW87391, 017KW87447, 017KW87451, 017KW87457, 017KW95378, 017KW95423, 017KW95429, 017KW95470, 017KW95472, 017KW95527, 017KW95538, 017KW95632, 017KW95647, 017KW95667, 017KV65025, 017KV65037, 017KV65050, 017KV65055, 017KV65097, 017KV65121, 017KV65127, 017KV65131, 017KV65170, 017KV65176, 017KV65209, 017KV65212, 017KV65228, 017KV65245, 017KV65249, 017KV65277, 017KV65283, 017KW87099, 017KW87106, 017FK76112, 017FK76150, 017FK76152, 017FK76189, 017FK76192, 017FK76210, 017FK76216, 017FK76248, 017FK76279, 017FR41392, 017FR41400, 017KW94994, 017KW95011, 017KW95016, 017KW95048, 017KW95102, 017KW95147, 017KW95361, 017KW95366, 017KW87246, 017KW87289, 017KW87295, 017KW87319, 017KW87329, 017KW87359, 017KW87363, 017KW87373, 017FK77226, 017FK77272, 017FK77279, 017KW95845, 017KW95849, 017KW95897, 017KW95905, 017KW95915, 017KW95918, 017KW95923, 017KW95927, 017KW95930, 017KW95990, 017KW96029, 017KW96033, 017GX53023, 017GX53032, 017GX53034, 017GX53051, 017GX53059, 017GX53100, 017GX53113, 017GX53118, 017GX53128, 017GX53133, 017GX53145, 017KW87065, 017KW94257, 017KW94262, 017KW94273, 017KW94277, 017KW94378, 017KW94381, 017KW94428, 017KW94529, 017KW94536, 017KW94574, 017KW94649, 017KW94662, 017KW94707, 017KW94723, 017KW94731, 017KW94745, 017KW94883, 017KW94958, 017KW94976, 017KW94993, 017GX53001, 017GX53011, 017FR34925, 017FR34932, 017FR34940, 017FR34946, 017FR34948, 017FR34953, 017FR34956, 017FR34958, 017FR34987, 017GR54765, 017GR54773, 017GR54789, 017GR54798, 017GR54803, 017GR54805, 017KS39490, 017FK74674, 017FK74725, 017FK74749, 017FK74770, 017FK74777, 017FK74784, 017FK74797, 017FK74862, 017FK74883, 017FK74924, 017KW94224, 017KW94229, 017KS39427, 017KS39430, 017KS39432, 017KS39448, 017KS39452, 017KS39457, 017KS39465, 017KS39479, 017KS39481, 017KW86299, 017KW86306, 017KW86312, 017KW86327, 017KW86329, 017KW86357, 017KW86374, 017KW86378, 017KW86402, 017KW86409, 017FK74537, 017FK74544, 017FK74549, 017FK74565, 017KW93733, 017KW93757, 017KW93876, 017KW93877, 017KW93901, 017KW93911, 017KW93933, 017KW93959, 017KW93961, 017KW93968, 017KW93992, 017KW93998, 017KW94079, 017KW84826, 017KW84837, 017KW84840, 017KW84852, 017KW84854, 017KW84875, 017KW84877, 017KW84897, 017KW84929, 017KW84934, 017KW84943, 017KW84954, 017KW84957, 017KW93439, 017KW93566, 017KW93579, 017KW93711, 017FK64929, 017FK64931, 017FK64943, 017FK64957, 017FK64991, 017GR53889, 017GR53895, 017GR53899, 017GR53903, 017KW86014, 017KW86016, 017KW86040, 017KW86043, 017KW86085, 017KW86094, 017KW86100, 017KW86101, 017KW86120, 017KW86123, 017KW86134, 017KW86138, 017KW86140, 017FK72792, 017FK72795, 017FK72812, 017FK72862, 017FK72865, 017FK72870, 017FK72899, 017FK72902, 017FK72920, 017FK72937, 017FK72978, 017FK72983, 017FK73000, 017FK73004, 017FK73013, 017KW92658, 017KW92676, 017KW92687, 017GX52334, 017GX52339, 017GX52357, 017GX52376, 017GX52379, 017GX52391, 017GR53798, 017GR53810, 017GR53819, 017GR53836, 017GR53862, 017GR53877, 017GR53882, 017KW85903, 017KW85914, 017KW85940, 017KW92824, 017KW92830, 017KW93008, 017KW93038, 017KW93064, 017KW93067, 017KW93082, 017KW93090, 017KW93128, 017KW93197, 017KW93204, 017KW93210, 017KW93230, 017KW93273, 017GR53474, 017GR53477, 017KW85721, 017KW85724, 017KW85728, 017KW85753, 017KW85778, 017KW85783, 017KW85791, 017KW85825, 017KW85834, 017KW85844, 017KW85867, 017KW92193, 017KW92229, 017KW92234, 017KW92258, 017KW92270, 017KW92279, 017KW92285, 017KW92289, 017KW92298, 017KW92303, 017KW92342, 017KW92348, 017KW92359, 017KW92363, 017KW92390, 017KW92431, 017KW92487, 017KW85416, 017KW85417, 017KW85421, 017KW85513, 017KW85532, 017KW85698, 017KW85704, 017KW85707, 017KW85709, 017FJ84259, 017FJ84316, 017FK71251, 017FK71256, 017FK71267, 017FK71281, 017FK71311, 017FK71318, 017FK71322, 017FK71335, 017FK71363, 017FK71376, 017KW91272, 017KW91275, 017KW91422, 017KW91448, 017KW91494, 017KZ72765, 017KZ72771, 017KZ72776, 017KZ72780, 017KZ72788, 017KZ72799, 017KZ72809, 017KZ72812, 017KW85216, 017KW85218, 017KW85224, 017KW85233, 017KW85239, 017KW85241, 017KW85272, 017KW85279, 017KW85313, 017KW85316, 017KW85326, 017KW85331, 017KW85334, 017KW85340, 017KW85346, 017GS12561, 017GS12592, 017GS12598, 017GS12601, 017GS12611, 017GS12615, 017GS12626, 017KW91656, 017KW91659, 017KW91663, 017KW91684, 017KW91709, 017KW92155, 017KZ72834, 017KZ72854, 017KW84973, 017KW84981, 017KW84985, 017KW84993, 017KW84996, 017KW85014, 017KW85027, 017KW85029, 017KW85034, 017KW85045, 017KW85051, 017KW85076, 017KW85095, 017KW85106, 017KW85124, 017KW85145, 017KW85183, 017KW91019, 017KW91088, 017KW91096, 017KW91099, 017KW91107, 017KW91116, 017KW91119, 017KW91132, 017KW91134, 017KW91143, 017KW91149, 017KW91258, 017KW91268, 017KW91269, 017KW90687, 017KW90702, 017KW90712, 017KW90742, 017KW90774, 017KW90780, 017KW90787, 017KW90789, 017KW90799, 017KW90804, 017KW90813, 017KW90814, 017KW90818, 017KW90835, 017KW90929, 017KW90950, 017GS11129, 017GS11136, 017GS11192, 017GS11216, 017GS11235, 017GS11247, 017GS11254, 017GS11271, 017GS11310, 017GS11311, 017KW89938, 017KW89942, 017KW89974, 017KW89979, 017KW89983, 017KW90049, 017GX55015, 017GX55026, 017GX55027, 017FL74005, 017FL74020, 017FL74032, 017FL74067, 017FL74071, 017FL75018, 017FL75035, 017GS10131, 017GS10145, 017GS10149, 017GS10216, 017GS10219, 017GS10226, 017GS10236, 017GS10252, 017GS10279, 017FK70147, 017FK70150, 017FK70155, 017FK70177, 017FK70194, 017FK70195, 017FK70240, 017FK70314, 017FK70337, 017GR59308, 017GR59319, 017KW90139, 017KW90177, 017KW90209, 017KW90245, 017KW90651, 017FK69123, 017GS10287, 017GS10407, 017KW89734, 017KW89759, 017KW89816, 017KW89860, 017KW89884, 017FK67272, 017FK67301, 017FK67308, 017FK67316, 017FK67321, 017FK67353, 017FK67365, 017FK67441, 017FK67479, 017FK67493, 017FK67519, 017FK67630, 017FK67633, 017FK67635, 017FK67642, 017FK67657, 017FK67660, 017KW88587, 017KW88596, 017GK18854, 017GK18857, 017GK18896, 017GK18903, 017GK18909, 017GK18910, 017GK18980, 017GK18988, 017GK19002, 017GK19018, 017KS42129, 017KS42151, 017KS42167, 017KS42236, 017KS42240, 017KS42289, 017KS42296, 017KS42300, 017GX54984, 017GX55005, 017GX55012, 017FR36619, 017FR36654, 017GR56963, 017GR56973, 017GR57000, 017GR57033, 017GR57035, 017GR57046, 017GR57055, 017GR57061, 017GR57066, 017GR57078, 017GR57089, 017GR57110, 017GX54529, 017GX54534, 017GX54556, 017GX54560, 017KW88445, 017KW88454, 017KW88462, 017KW88477, 017KW88503, 017KW88511, 017KW88518, 017KW88522, 017KW88535, 017KW88557, 017KW88560, 017KW88577, 017KW88582, 017KW88586, 017KW88589, 017KW88205, 017KW88219, 017KW88230, 017KW88235, 017KW88237, 017KW88250, 017KW88257, 017KW88262, 017KW88265, 017KW88275, 017KW88295, 017KW88315, 017KW88319, 017KW88326, 017KW88403, 017KW88418, 017KW88437, 017GS08748, 017GS08753, 017KW87988, 017KW87991, 017KW87993, 017KW88000, 017KW88013, 017KW88029, 017KW88032, 017KW88094, 017KW88112, 017KW88115, 017KW88121, 017KW88193, 017KW88196, 017KW88199
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by facsimile beginning July 28, 2006. Follow-up notifications were sent to non-responding consignees on September 5 and 6, 2006. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood products, collected from donors for whom donor suitability may not have been adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,478 units
DISTRIBUTION
Nationwide and Switzerland
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1184-12
CODE
Units: 12LP34829 (2 units), 12LP34776 (2 units), 12LP34806 (2 units), 12LY23506 (2 units), 12KK73414 (2 units), 12LY24545 (2 units), 12LY23376 (2 units), 12KK72453 (2 units), 12KK72508 (2 units), 12LY22874 (2 units), 12LP34638 (2 units), 12KK73129 (2 units), 12GJ16093 (2 units), 12KW21207 (2 units), 12KW21208 (2 units)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Carolinas Region, Winston Salem, NC, by letter dated January 14, 2009. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1189-12
CODE
Unit: W035812009163
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Mather, CA, by telephone on January 13, 2012. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood product, which did not meet the acceptable product specifications for release, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1190-12
CODE
Unit: W118811524281
RECALLING FIRM/MANUFACTURER
The Blood Alliance, Inc., Jacksonville, FL, by telephone on January 19, 2012. Firm initiated recall is complete.
REASON                                                                                                                           
Blood product, which was labeled as leukoreduced, but exceeded the White Blood Cell count limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1191-12
CODE
Units: 53KN62224 PART1; 53KN62224 PART2
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Reg., Baltimore, MD, by facsimile on January 4, 2012. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1193-12
CODE
Units: W043211074646; W043211073789
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by telephone and fax on February 16, 2012. 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
TN, IN, NY
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-1222-12;
2) Plasma Frozen. Recall # B-1223-12;
3) Red Blood Cells Leukocytes Reduced Recall # B-1224-12;
4) Fresh Frozen Plasma. Recall # B-1225-12;
5) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1226-12;
6) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1227-12;
7) Cryoprecipitated AHF Pooled. Recall # B-1228-12;
8) Plasma Cryoprecipitate Reduced. Recall # B-1229-12
CODE
1) Units: 03FQ65299, 03FJ02355, 03GP87191, 03GP87193, 03GZ89994, 03GZ89283, 03GZ89910; 
 
2) Units: 03FJ03311, 03FJ03323, 03FQ66207, 03GF34908, 03GZ90765, 03FQ65538, 03FQ65548, 03GZ90344, 03FQ65517, 03GN57779, 03GZ90362, 03GZ90370, 03GZ90774, 03GZ90778, 03GZ90782, 03FJ03303, 03FQ65558, 03FQ66186, 03FQ66196, 03GZ90387, 03FQ65530, 03FQ65536, 03GF34896, 03FQ65564, 03FQ65569, 03FJ03308, 03FQ66191, 03FQ66197, 03GS73945, 03GF34912, 03GS73952, 03GS73951, 03GZ90332, 03FG60617;
 
3) Units: 03FQ65233, 03FQ65569, 03FQ65833, 03FQ65872, 03GS73697, 03GZ90765, 03FJ02331, 03FX45038, 03GN57741, 03GZ90768, 03FQ65375, 03FQ66197, 03GP87184, 03GP87199, 03GZ90378, 03FQ66143, 03FJ03300, 03FQ65275, 03FQ65564, 03GS73691, 03GS73701, 03GS73705, 03GS73712, 03FQ65408, 03FQ66207, 03GZ90425, 03GZ90437, 03FQ65228, 03FQ65512, 03GN57729, 03GS73714, 03GS73951, 03GX38021, 03GX38037, 03FQ65254, 03FQ66397, 03FJ02325, 03FQ65542, 03GX38038, 03GX38254, 03GZ90771, 03GZ90778, 03GZ90782, 03FJ02347, 03FJ03279, 03FQ65255, 03FQ65419, 03FQ65456, 03FQ65484, 03FQ65527, 03FQ65530, 03GF34890, 03GP87191, 03GP87193, 03GS73716, 03GX38019, 03GZ89963, 03GZ89989, 03GZ91093, 03GZ91107, 03GZ90775, 03GZ90789, 03FQ65558, 03GZ90387, 03GN57801, 03FQ65261, 03FQ65287, 03FQ65802, 03FQ66167, 03GP87196, 03GS73933, 03GS73945, 03GS73952, 03GX38018, 03GX38256, 03GZ89999, 03GZ90362, 03GZ90370, 03GZ90375, 03GZ91137, 03GZ91144, 03FQ66098, 03FQ66572, 03GS73936, 03GX38026, 03GZ89947, 03FQ65222, 03FQ66381, 03FQ65388, 03FQ65548, 03FQ66172, 03GS73689, 03GZ90392, 03FQ66402, 03FQ66620, 03GF34874, 03FQ66615, 03FQ65226, 03FQ65299, 03FQ65306, 03FQ65531, 03FQ65536, 03FX44963, 03FX45013, 03GZ89924, 03GZ89994, 03GZ90332, 03GZ89957, 03GF34872, 03FQ65869, 03GF34896, 03FQ65842, 03GF34897, 03GZ90416, 03FQ65538, 03GF34868, 03GF34870, 03GF34873, 03GF34908, 03FQ66104, 03GZ90774, 03FQ65402, 03GF34912, 03GZ90393, 03GN57744, 03GS73700, 03GN57799, 03FQ66095, 03GS73710, 03FQ65800, 03GN57803, 03FJ02784, 03FQ65353, 03FQ65808, 03FX45051, 03FX45063, 03GZ89283, 03GZ89910, 03GZ90436, 03GZ90792, 03FQ65517, 03FQ65813, 03FQ65849, 03FQ65850, 03FQ65862, 03FQ66186, 03GZ89976, 03GZ90344, 03GZ90412, 03GZ90427, 03GN57809, 03GF34906, 03GN57732, 03GS73707, 03GN57798, 03FQ65366, 03FQ66137, 03FJ02343, 03FJ02344, 03FJ02355, 03FJ02360, 03GS73704, 03GZ89918, 03GZ90798, 03FQ66147, 03FQ66157, 03FQ66183, 03FQ66191, 03GF34879, 03GX38035, 03GN57725, 03GN57731, 03FJ03303, 03FQ65466, 03GZ89169, 03GN57745, 03GN57800, 03FJ02340, 03FG60617, 03FQ65831, 03FQ66153, 03GX38023, 03FQ66110, 03GN57795, 03GX38258, 03FQ65509, 03FQ65362, 03FQ66196, 03GN57728, 03FJ03305, 03FX45024, 03FQ66101, 03FQ65344, 03FJ02795, 03FQ65477, 03FJ03290, 03FX44992, 03GZ90009, 03FJ02322, 03FQ66135, 03FX45044, 03FQ66345, 03FQ65212, 03FQ65269, 03FQ65281, 03FQ65291, 03FQ65371, 03FQ66570, 03FQ66583, 03FQ65473, 03FJ03311, 03FJ03323, 03FQ66148, 03GZ90794, 03GF34893, 03FX44947, 03FX44985, 03FQ65840, 03GS73695;
 
4) Units: 03FQ66101, 03FX45063, 03FQ65353, 03FQ65362, 03FX45044, 03GS73933, 03GS73936, 03GS73943, 03FQ65375, 03FX44985, 03FX45024, 03FQ65408, 03FQ65419, 03FX45013, 03FQ66095, 03FQ65371, 03FX44992;
 
5) Units: 03FQ65495, 03GZ91165, 03FQ66123, 03FQ65428, 03FQ66123, 03FQ65495, 03FQ66129, 03GP87197, 03GZ89946, 03GZ91165, 03GZ89946, 03FQ65236 (2 units), 03FQ65468 (2 units), 03FQ66129, 03GZ90367, 03FQ65416 (2 units), 03GZ90349, 03FQ65281, 03GP87197, 03GZ90349, 03FQ65428, 03GZ90367;
 
6) Units: 03FQ66333, 03FX44975, 03FQ66111, 03FJ02803, 03GP87185;
 
7) Units: 03FJ02343 (pool 789), 03FJ02344 (pool 777), 03FQ65306 (pool 783), 03FQ65802 (pool 813), 03FQ65813 (pool 814), 03FQ65822 (pool 819), 03FQ65831 (pool 813), 03FQ65849 (pool 818), 03FQ65850 (pool 829), 03FQ66345 (pool 827), 03GS73689 (pool 805), 03GS73691 (pool 806), 03GS73695 (pool 793), 03GS73701 (pool 810), 03GS73704 (pool 810), 03GS73705 (pool 808), 03GS73707 (pool 810), 03GS73712 (pool 803), 03GS73714 (pool 798), 03GS76367 (pool 797), 03GZ89947 (pool 800), 03GZ89989 (pool 795), 03FQ65833 (pool 811), 03FQ65840 (pool 824);
 
8) Unit: 03GP87185
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by facsimile on December 28, 2006 and by letter dated January 12, 2007. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood products, collected from donors for whom donor suitability may not have been adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
332 units
DISTRIBUTION
GA, SC, NJ, NC
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall #B-1230-12;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1231-12
CODE
1) Units: W141608233064; W141608231525;
2) Unit: W141608232187
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter dated November 28, 2008.  
Manufacturer: Puget Sound Blood Center and Program, Vancouver, WA. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WA, Austria
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1232-12
2) Red Blood Cells. Recall # B-1233-12
CODE
1) Unit: W141608572362;
2) Unit: W141608570651
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by letter dated September 15, 2008.
Manufacturer: Puget Sound Blood Center and Program, Silverdale, WA. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA, CA, Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-1234-12
CODE
Units: 4080318805 4080318523 4080314902 4080313108 4080312438 4080311246 4080304499 4080299648 4080296783 4080295112 4080292009 4080291213 4080287831 4080286982 4080266531 4080259753 4080256404 4080255791 4080254281 4080253856 4080252281 4080251852 4080245962 4080244721 4080242262 4080240542 4080238093 4080236554 4080235779 4080233654
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Dayton, OH, by e-mail dated February 28, 2009. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood products, collected from a donor whose physical examination was improperly documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
IL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1238-12;
2) Fresh Frozen Plasma. Recall # B-1239-12
CODE
1) Units: GR83828; KC60611;
2) Unit: KC60611
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax and e-mail on September 11, 2007. Firm initiated recall is complete.
REASON                                                                                                                           
Blood products, collected from a donor who had previously tested reactive for Hepatitis B core antibody (HBcAb), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WI, NJ, Switzerland
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1240-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1241-12
CODE
1) and 2) Unit: LE95790
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on May 15, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1242-12;
2) Recovered Plasam. Recall # B-1243-12
CODE
1) and 2) Unit: GR60476
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax and e-mail on August 6, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had been deferred after testing reactive for Hepatitis C (HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI, Switzerland
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1244-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1245-12
CODE
1) and 2) Unit: KF33209
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on June 12, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had been deferred after testing reactive for Hepatitis C (HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1246-12
CODE
Unit: GN38235
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on August 4, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area that was potentially endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Source Plasma. Recall # B-1247-12
CODE
Units: 4030343099 4030341351 4030340532 4030338813 4030336665 4030335300 4030333557 4030331371 4030329597 4030328006 4030295677 4030294637 4030292892 4030291468 4030289339 4030287994 4030286256 4030284748 4030283343 4030280689 4030275864 4030274850 4030272154 4030271403 4030269568 4030267572 4030266814 4030265363 4030264604 4030263211 4030261789 4030260247 4030258718 4030257961 4030256477 4030255010 4030254439 4030252972 4030251478 4030250649 4030248302 4030246329 4030245080 4030242232 4030240540 4030239804
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Louisville, KY, by e-mail dated March 23, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
46 units
DISTRIBUTION
IL, Switzerland
___________________________________
PRODUCT
Source Plasma. Recall # B-1248-12
CODE
Unit: 06DTXB3402
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, LP, Denton, TX, by facsimile dated December 20, 2006. Firm initiated recall is complete.
REASON
Blood donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1249-12
CODE
Unit: 9234559; 6048636
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone dated July 1, 2008.
Manufacturer: Diablo Valley Center, Walnut Creek, 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) Recovered Plasma. Recall # B-1250-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1251-12
CODE
1) and 2) Unit: 6047379
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone dated April 24, 2008. 
Manufacturer: North Bay Center, Fairfield, CA. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1269-12
CODE
Unit: Q15798
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter dated November 15, 2006. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood product, collected from a donor with a history of hepatitis A, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1271-12
CODE
Unit: W088612300935
RECALLING FIRM/MANUFACTURER
Providence Health System Southern California, Burbank, CA, by telephone on February 28, 2012 and by letter on March 8, 2012. Firm initiated recall is complete.
REASON
Blood product, initially reactive for syphilis screening test, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1272-12
CODE
Units: W069109139247Part 1; W069108107502 Part 1; W069110126504; W069109154678; W069109109690 Part 1; W069109109690Part 2; W069108107502 Part 2; W069110103953; W069111105330; W069109123246; W069109139247 Part 2; W069111120981Part 1; W069111120981 Part 2
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services Inc., Flowood, MI, by fax on January 26, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from donors who had taken aspirin in the last 48 hours, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
MS
___________________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-1273-12
CODE
Unit: W036809376736
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Lauderhill, FL, by telephone on March 3, 2012. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland; FL
___________________________________
PRODUCT
1) Platelets Pooled Leukocytes Reduced. Recall # B-1275-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1277-12
CODE
1) Unit: W036811826255;
2) Unit: W036812320143
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Lauderhill, FL, by telephone and letter on March 3, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, MI, FL
___________________________________
PRODUCT
1) Platelets Pooled Leukocytes Reduced. Recall # B-1278-12;
2) Fresh Frozen Plasma. Recall # B-1279-12;
3) Red Blood Cells. Recall # B-1280-12
CODE
1) Unit: W036811802606;
2) and 3) Unit: W036811071447
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Miami, FL, by telephone and letter on February 28, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells. Recall #B-1284-12
CODE
Unit: W036811098449
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Lauderhill, FL, by letter on February 16, 2012. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland, FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1290-12
CODE
Unit: 5371028
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on April 14, 2008. 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
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1291-12
CODE
Unit: 5378850
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on April 18, 2008. 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
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1294-12
CODE
Unit: 1570876
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by electronic notification on June 27, 2008.
Manufacturer: Shasta Blood Center, Redding, CA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1295-12;
2) Platelets Pheresis Leukocytes Reduced. B-1296-12
CODE
1) Unit: 7365211;
2) Unit: 7355496
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on June 25, 2008.
Manufacturer: Marin Center, San Rafael, CA. Firm initiated recall is complete
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1298-12
CODE
Unit: 7361752
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on July 3, 2008 and by letter dated July 3, 2008.
Manufacturer: Marin Center, San Rafael, CA. 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
CA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1182-12
CODE
Units: K77834, 017FK77840, 017FK77843, 017FK77845, 017FK77913, 017FK77929, 017FK77964, 017FK78008, 017FK78024, 017FK78032, 017FK78101, 017FK78115, 017FK78120, 017FK78128, 017FK78705, 017GS08621, 017GS08623, 017GS08630, 017GS08636, 017GS08643, 017GS08663, 017GS08674, 017GS08686, 017GS08694, 017GS08697, 017GS08699, 017GS08703, 017GS08714, 017GS08725, 017KW87599, 017KW87624, 017KW87646, 017KW87659, 017KW87665, 017KW87668, 017KW87676, 017FK77316, 017FK77381, 017FK77404, 017FK77409, 017FK77414, 017FK77426, 017FK77432, 017FK77466, 017FK77544, 017FK77548, 017FK77600, 017FK77606, 017FK77686, 017FK77749, 017FK77760, 017FK77764, 017FK77774, 017KW96126, 017KW96134, 017FJ79348, 017FJ79354, 017FJ79356, 017FJ79360, 017FJ79392, 017GR55370, 017GR55377, 017GR55389, 017GR55392, 017GR55399, 017GR55402, 017GR55409, 017KW87383, 017KW87391, 017KW87447, 017KW87451, 017KW87457, 017KW95378, 017KW95423, 017KW95429, 017KW95470, 017KW95472, 017KW95527, 017KW95538, 017KW95632, 017KW95647, 017KW95667, 017KW95704, 017KW95710, 017KV65025, 017KV65037, 017KV65050, 017KV65055, 017KV65097, 017KV65104, 017KV65107, 017KV65121, 017KV65127, 017KV65131, 017KV65170, 017KV65176, 017KV65209, 017KV65212, 017KV65245, 017KV65249, 017KV65277, 017KV65283, 017KW87099, 017KW87106, 017FK76112, 017FK76119, 017FK76150, 017FK76152, 017FK76189, 017FK76192, 017FK76210, 017FK76216, 017FK76279, 017FR41392, 017FR41400, 017KW94994, 017KW95011, 017KW95016, 017KW95048, 017KW95102, 017KW95147, 017KW95361, 017KW95366, 017KW87246, 017KW87267, 017KW87289, 017KW87295, 017KW87319, 017KW87329, 017KW87359, 017KW87363, 017KW87373, 017FK77226, 017FK77272, 017FK77279, 017KW95727, 017KW95842, 017KW95845, 017KW95849, 017KW95897, 017KW95905, 017KW95915, 017KW95918, 017KW95923, 017KW95927, 017KW95930, 017KW95990, 017KW96029, 017KW96033, 017GX53023, 017GX53032, 017GX53034, 017GX53051, 017GX53059, 017GX53100, 017GX53113, 017GX53118, 017GX53128, 017GX53133, 017GX53145, 017KW87065, 017KW94529, 017KW94536, 017KW94574, 017KW94649, 017KW94662, 017KW94707, 017KW94723, 017KW94731, 017KW94745, 017KW94883, 017KW94958, 017KW94976, 017KW94993, 017GX53001, 017GX53011, 017FR34925, 017FR34932, 017FR34940, 017FR34946, 017FR34948, 017FR34953, 017FR34956, 017FR34958, 017FR34987, 017FR35004, 017GR54773, 017GR54789, 017GR54798, 017GR54803, 017GR54805, 017KS39490, 017FK74674, 017FK74725, 017FK74749, 017FK74763, 017FK74763, 017FK74770, 017FK74777, 017FK74784, 017FK74797, 017FK74862, 017FK74883, 017FK74924, 017KS39427, 017KS39430, 017KS39432, 017KS39448, 017KS39452, 017KS39457, 017KS39465, 017KS39479, 017KS39481, 017KW86299, 017KW86306, 017KW86312, 017KW86327, 017KW86329, 017KW86357, 017KW86374, 017KW86378, 017KW86402, 017KW86409, 017FK74537, 017FK74544, 017FK74549, 017FK74565, 017KW93733, 017KW93757, 017KW93789, 017KW93790, 017kw93793, 017KW93819, 017KW93876, 017KW93877, 017KW93901, 017KW93911, 017KW93933, 017KW93959, 017KW93961, 017KW93968, 017KW93992, 017KW93998, 017KW94079, 017KW84826, 017KW84837, 017KW84840, 017KW84852, 017KW84854, 017KW84875, 017KW84877, 017KW84897, 017KW84909, 017KW84909, 017KW84929, 017KW84934, 017KW84943, 017KW84954, 017KW84957, 017KW93439, 017KW93566, 017KW93579, 017KW93711, 017KW93719, 017KW93719, 017FK64929, 017FK64931, 017FK64957, 017FK64991, 017GR53889, 017GR53895, 017GR53899, 017GR53903, 017KW86014, 017KW86016, 017KW86040, 017KW86043, 017KW86085, 017KW86094, 017KW86100, 017KW86101, 017KW86120, 017KW86123, 017KW86134, 017KW86140, 017FK72781, 017FK72781, 017FK72792, 017FK72795, 017FK72812, 017FK72819, 017FK72838, 017FK72838, 017FK72902, 017FK72920, 017FK72937, 017FK72978, 017FK72983, 017FK73004, 017FK73034, 017KW92658, 017KW92676, 017KW92687, 017GX52334, 017GX52339, 017GX52374, 017GX52376, 017GX52379, 017GX52391, 017GX52397, 017GR53836, 017GR53862, 017GR53877, 017GR53882, 017KW85903, 017KW85914, 017KW85940, 017KW93008, 017KW93011, 017KW93038, 017KW93064, 017KW93067, 017KW93082, 017KW93090, 017KW93128, 017KW93197, 017KW93204, 017KW93230, 017GR53474, 017GR53477, 017KW85721, 017KW85728, 017KW85753, 017KW85778, 017KW85783, 017KW85791, 017KW85803, 017KW85825, 017KW85834, 017KW85844, 017KW85867, 017KW92180, 017KW92180, 017KW92190, 017KW92190, 017KW92193, 017KW92229, 017KW92234, 017KW92258, 017KW92270, 017KW92285, 017KW92289, 017KW92298, 017KW92303, 017KW92307, 017KW92307, 017KW92332, 017KW92332, 017KW92342, 017KW92348, 017KW92359, 017KW92363, 017KW92390, 017KW92431, 017KW92487, 017KW85374, 017KW85380, 017KW85389, 017KW85394, 017KW85402, 017KW85409, 017KW85416, 017KW85417, 017KW85421, 017KW85513, 017KW85521, 017KW85532, 017KW85698, 017KW85704, 017KW85707, 017FJ84259, 017FJ84316, 017FK71251, 017FK71256, 017FK71267, 017FK71281, 017FK71311, 017FK71318, 017FK71322, 017FK71329, 017FK71329, 017FK71335, 017FK71363, 017FK71376, 017KW91272, 017KW91275, 017KW91411, 017KW91422, 017KW91448, 017KW91494, 017KZ72765, 017KZ72771, 017KZ72776, 017KZ72780, 017KZ72799, 017KZ72809, 017KZ72812, 017KW85216, 017KW85218, 017KW85224, 017KW85233, 017KW85239, 017KW85241, 017KW85249, 017KW85253, 017KW85253, 017KW85272, 017KW85279, 017KW85313, 017KW85316, 017KW85326, 017KW85331, 017KW85334, 017KW85340, 017KW85346, 017GS12561, 017GS12592, 017GS12595, 017GS12598, 017GS12601, 017GS12611, 017GS12615, 017GS12625, 017GS12626, 017GS12629, 017GS12631, 017GS12636, 017KW91656, 017KW91659, 017KW91663, 017KW91675, 017KW91684, 017KW91709, 017KW92155, 017KZ72834, 017KZ72854, 017KW84973, 017KW84981, 017KW84985, 017KW84993, 017KW84996, 017KW85014, 017KW85027, 017KW85029, 017KW85034, 017KW85045, 017KW85051, 017KW85076, 017KW85095, 017KW85106, 017KW85124, 017KW85145, 017KW85183, 017KW91004, 017KW91019, 017KW91084, 017KW91084, 017KW91088, 017KW91096, 017KW91099, 017KW91107, 017KW91116, 017KW91119, 017KW91132, 017KW91134, 017KW91143, 017KW91149, 017KW91154, 017KW91177, 017KW91206, 017KW91212, 017KW91214, 017KW91240, 017KW91240, 017KW91258, 017KW91268, 017KW91269, 017KW90687, 017KW90702, 017KW90712, 017KW90742, 017KW90774, 017KW90780, 017KW90787, 017KW90789, 017KW90799, 017KW90804, 017KW90813, 017KW90814, 017KW90818, 017KW90822, 017KW90822, 017KW90835, 017KW90913, 017KW90913, 017KW90919, 017KW90919, 017KW90924, 017KW90929, 017KW90950, 017GS11129, 017GS11136, 017GS11192, 017GS11216, 017GS11235, 017GS11247, 017GS11254, 017GS11271, 017GS11310, 017GS11311, 017KW89928, 017KW89929, 017KW89938, 017KW89942, 017KW89974, 017KW89979, 017KW89983, 017KW90009, 017KW90049, 017GX55015, 017GX55026, 017GX55027, 017FL74005, 017FL74020, 017FL74032, 017FL74067, 017FL74071, 017FL75018, 017FL75035, 017FL75123, 017FL75138, 017FL75150, 017GS10104, 017GS10131, 017GS10145, 017GS10149, 017GS10216, 017GS10219, 017GS10226, 017GS10236, 017GS10252, 017GS10279, 017FK70147, 017FK70150, 017FK70155, 017FK70177, 017FK70194, 017FK70199, 017FK70240, 017FK70256, 017FK70259, 017FK70314, 017FK70337, 017GR59308, 017GR59319, 017KW90139, 017KW90177, 017KW90209, 017KW90245, 017KW90651, 017FK69123, 017GS10287, 017GS10336, 017GS10375, 017GS10379, 017GS10407, 017KW89734, 017KW89759, 017KW89816, 017KW89860, 017KW89868, 017KW89883, 017KW89884, 017KW89899, 017FK67272, 017FK67301, 017FK67316, 017FK67321, 017FK67353, 017FK67365, 017FK67441, 017FK67479, 017FK67493, 017FK67519, 017FK67558, 017FK67571, 017FK67618, 017FK67630, 017FK67633, 017FK67635, 017FK67642, 017FK67657, 017FK67660, 017KW88587, 017KW88596, 017GK18854, 017GK18857, 017GK18896, 017GK18903, 017GK18909, 017GK18910, 017GK18980, 017GK18988, 017GK19002, 017GK19018, 017KS42129, 017KS42151, 017KS42167, 017KS42236, 017KS42240, 017KS42289, 017KS42296, 017KS42300, 017GX54984, 017GX55005, 017GX55012, 017FR36619, 017FR36654, 017GR56963, 017GR56973, 017GR57000, 017GR57033, 017GR57035, 017GR57046, 017GR57055, 017GR57061, 017GR57066, 017GR57078, 017GR57089, 017GR57110, 017GX54529, 017GX54534, 017GX54556, 017GX54560, 017KW88445, 017KW88454, 017KW88462, 017KW88477, 017KW88503, 017KW88511, 017KW88518, 017KW88522, 017KW88535, 017KW88557, 017KW88560, 017KW88577, 017KW88582, 017KW88586, 017KW88589, 017KW88203, 017KW88205, 017KW88230, 017KW88235, 017KW88237, 017KW88250, 017KW88257, 017KW88262, 017KW88265, 017KW88275, 017KW88295, 017KW88315, 017KW88319, 017KW88326, 017KW88403, 017KW88407, 017KW88418, 017KW88421, 017KW88430, 017KW88437, 017GS08748, 017GS08753, 017KW87991, 017KW87993, 017KW88000, 017KW88013, 017KW88029, 017KW88032, 017KW88094, 017KW88112, 017KW88115, 017KW88121, 017KW88193, 017KW88196, 017KW88199
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by facsimile beginning July 28, 2006. Follow-up notifications were sent to non-responding consignees on September 5 and 6, 2006. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood products, collected from donors for whom donor suitability may not have been adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,478 units
DISTRIBUTION
Nationwide and Switzerland
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1192-12
CODE
Units: W043211074646; W043211073789
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by telephone and fax on February 16, 2012. 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
TN, IN, NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1194-12
CODE
Unit: W036812346070
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Lauderhill, FL, by telephone and letter on January 9, 2012. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood product, that was irradiated twice, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Plasma Frozen. Recall # B-1201-12
CODE
Unit: 084KM40015
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by telephone dated May 27, 2005. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood product, for which during the collection process the coagulation factors may have been compromised, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1267-12;
2) Recovered Plasma. Recall # B-1268-12
CODE
1) and 2) Unit: V63210
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter on February 2, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received human tissue transplant within one year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1270-12
CODE
Unit: Q15798
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter dated November 15, 2006. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood product, collected from a donor with a history of hepatitis A, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1274-12
CODE
Unit: W036809376736
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Lauderhill, FL, by telephone on March 3, 2012. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland; FL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1276-12
CODE
Unit: W036812320143
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Lauderhill, FL, by telephone and letter on March 3, 2012. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland, MI, FL
___________________________________
PRODUCT
Source Leukocytes. Recall # B-1281-12
CODE
Unit: W035212074872R
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by email on March 6, 2012. Firm initiated recall is complete.
REASON                                                                                                                            
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. B-1282-12
CODE
Unit: W069111126523
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services Inc., Flowood, MS, by letter on January 19, 2012. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was temporarily deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1283-12
CODE
Unit: W036811098449
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Lauderhill, FL, by letter on February 16, 2012. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland, FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1288-12
CODE
Unit: K07725
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter on December 22, 2006. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood product, which was labeled as leukoreduced, but did not meet the requirements for a leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1289-12
CODE
Units: 06DTXA0744, 06DTXA1248, 06DTXA1981, 06DTXA2385, 06DTXA6728, 06DTXA6943, 06DTXA7510, 06DTXA7758, 06DTXA3551
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services L.P., Deerfield, IL, by facsimile on December 20, 2006. 
Manufacturer: BioLife Plasma Services, LP, Denton, TX. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1292-12;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1293-12
CODE
1) Units: 7355829, 7355627 (2 units), 7352251, 1573575, 7352256 (2 units);
2) Units: 7352227, 7355829, 7352251, 7352240 (2 units), 7354599
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Fairfield, CA, by telephone on April 18, 2008 and May 22, 2008. Firm initiated recall is complete.
REASON
Blood products, which were stored at unacceptable storage temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647; Disposable laryngoscope blades. Recall # Z-3213-2011
CODE
All lots with expiration dates between August 2010 and July 2015.
RECALLING FIRM/MANUFACTURER
Penlon, Ltd. (Fmly East Healthcare), Abingdon, United Kingdom, by letter dated March 7, 2011. Firm initiated recall is complete.Firm initiated recall is complete.
REASON
Disposable laryngoscope blades incorrectly labeled with wrong size.
VOLUME OF PRODUCT IN COMMERCE
5 cartons (20 blades each)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Selex M2A Magnum Modular Head, Ref, S331140, 40 mm head diameter plus 3 mm neck, 1 Taper, Sterile, Product Usage: Intended for use in non-cemented primary and revision hip joint replacement. Recall # Z-1449-2012
CODE
Lot #: 446970
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by telephone on September 13, 2011 by letter on March 23, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification.
VOLUME OF PRODUCT IN COMMERCE
5 devices
DISTRIBUTION
MI, NC., OK and WI
___________________________________
PRODUCT
MEDITECH Anatomical Pathology Software Client Releases- Client Service Releases 5.6, 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1, 6.12 and 6.13 Product Usage: Meditech Anatomical Pathology Software records, stores, codes, searches and provides reports for pathology cases. It enables pathology staff and other personnel to access related findings in real time. Recall # Z-1465-2012
CODE
Client Service Releases 5.6, 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1, 6.12 and 6.13
RECALLING FIRM/MANUFACTURER
Medical Information Technology, Inc., Westwood, MA, by e-mail beginning on January 19, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Meditech Anatomical Pathology software is being recalled because data on a pathology specimen may be inadvertently deleted.
VOLUME OF PRODUCT IN COMMERCE
280 units
DISTRIBUTION
Nationwide, Bahamas, Canada and United Kingdom
___________________________________
PRODUCT
1) VITROS 3600 Immunodiagnostic System Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. Recall # Z-1468-2012; 
 
2) VITROS 4600 Chemistry System, Product Code: 6802445 Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.) Recall # Z-1469-2012;
 
3) VITROS 5600 Chemistry System, Product Code: 6802413 Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Recall # Z-1470-2012;
 
4) VITROS 5,1 FS System, Product Codes: 6801375 & 6801890 Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Recall # Z-1471-2012;
 
5) VITROS 5,1 FS Refurbished System, Product Codes: 6801375 & 6801890 Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Recall # Z-1472-2012
CODE
1) Serial number range: 36000467 – 36000639;
 
2) Serial number range: 46000108 – 46000157;
 
3) Serial number range: 56001033 – 56001449;
 
4) Serial number range: 34002115 – 34002243;
 
5) Serial numbers: 34002115 - 34002243: 34000193; 34000318; 34000360; 34000420; 34000451; 34000478; 34000495; 34000497; 34000529; 34000538; 34000552; 34000596; 34000761; 34000799; 34000833; 34000947; 34001218; 34001243; 34001422; 34001504; 34001569; 34001572; 34001633; 34001633; 34001875
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letter dated March 15, 2012. Firm initiated recall is ongoing.
REASON
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.
VOLUME OF PRODUCT IN COMMERCE
776 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product Usage: The Philips eCareManager System software is intended for use in data collection, storage, and clinical information management with independent bedside devices and ancillary systems that are connected either directly or through networks. The eCareManager system provides patient information and surveillance of monitored patients at the point of care location and at a remote, supplementary care location through wide area networking technology and dedicated phone lines and is solely intended for use in a hospital environment. It is not intended to be used in a home environment. Recall # Z-1474-2012
CODE
v3.7, v3.7.1, v3.8
RECALLING FIRM/MANUFACTURER
Visicu, Inc., Baltimore, MD, by letter dated February 22, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Three versions of software for the eCareManager failed to display anticoagulants on the medications screen. The problem arose due to an unexpected change in the National Drug Data File.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Micro-Tech Informer Plus Silver Monitor, Model 81830. Product Usage: The system is a bed exit system designed to indicate, by alarm or signal, when someone attempts to leave the bed. The system consists of a control unit that is mounted on the bed and a pressure sensitive bed sensor pad that is placed across the width of the bed under the mattress or just beneath the sheets and overlays. The control unit is powered by means of a plug-in type power supply and an alarm cord is used to interface the control unit with the nurse call system. Recall # Z-1476-2012
CODE
Serial numbers: 071100025 through 111100306
RECALLING FIRM/MANUFACTURER
Stanley Security Solutions, Inc., Lincoln, NB, by telephone and email on December 13, 2011, and by letter on December 14, 2011 and December 16, 2011. Firm initiated recall is ongoing.
REASON                                                                                                                           
Connection between the call cord and the receptacle may not make a correct connection resulting in a continuous or intermittent (false) signal to the nurse call system.
VOLUME OF PRODUCT IN COMMERCE
824 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Troch Nail, REF 28234, Long 11MM, Right 34 CM Peritrochanteric Nail System, Rx Sterile Rod, Fixation, Intramedullary and Accessories Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromiummolybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. Recall # Z-1478-2012
CODE
Lot 486130
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated April 18, 2012. Firm initiated recall is complete.
REASON
The Trochanteric Nail, Lot 486130, was mislabeled as a right nail orientation but the contents are actually a left nail orientation.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Smith & Nephew 560P High Definition Camera Control Unit Catalog Number: 7220191. The 560P camera system is configured to be connected as a stand-alone system on an endoscopic cart or tower. It is designed for use with the Smith & Nephew 560H 3-CCD High Definition Camera Head (560H camera head). The 560P camera system is designed to be used in conjunction with various peripheral devices, including the 560H camera head, Smith & Nephews 300 watt xenon light source, various flat panel displays, image capture devices, and print and video recording devices. Recall # Z-1479-2012
CODE
Serial Numbers: BBS0835 BBS0869 BBS0973 BBS1096 BBS1100 BBS1103 BBS1105 BBS1106 BBS1109 BBS1114 BBS1115 BBS1120 BBS1124 BBS1125 BBS1133 BBS1135 BBS1138 BBS1139 BBS1140 BBS1141 BBS1142 BBS1143 BBS1144 BBS1151 BBS1153 BBS1158 BBS1178 BBS1187 BBS1190 BBS1191 BBS1192 BBS1194 BBS1198 BBS1202 BBS1203 BBS1206 BBS1214 BBS1218 BBS1223 BBS1230 BBS1232 BBS1236 BBS1237 BBS1239 BBS1240 BBS1241 BBS1242 BBS1243 BBS1245 BBS1246 BBS1247 BBS1248 BBS1249 BBS1250 BBS1251 BBS1252 BBS1253 BBS1254 BBS1255 BBS1256 BBS1258 BBS1259 BBS1261 BBS1262 BBS1265 BBS1267 BBS1268 BBS1269 BBS1270 BBS1271 BBS1273 BBS1275 BBS1277 BBS1278 BBS1280 BBS1281 BBS1284 BBS1285 BBS1299 BBS1303 BBS1304 BBS1305 BBS1306 BBS1307 BBS1308 BBS1310 BBS1311 BBS1314 BBS1316 BBS1321 BBS1322 BBS1323 BBS1324 BBS1325 BBS1326 BBS1329 BBS1330 BBS1334 BBS1335 BBS1336 BBS1345 BBS1348 BBS1349 BBS1351 BBS1352 BBS1354 BBS1355 BBS1356 BBS1357 BBS1358 BBS1359 BBS1360 BBS1364 BBS1370 BBS1371 BBS1372 BBS1373 BBS1374 BBS1375 BBS1376 BBS1377 BBS1378 BBS1380 BBS1381 BBS1382 BBS1383 BBS1385 BBS1386 BBS1388 BBS1389 BBS1390 BBS1391 BBS1396 BBS1398 BBS1399 BBS1401 BBS1402 BBS1403 BBS1404 BBS1405 BBS1408 BBS1410 BBS1411 BBS1412 BBS1414 BBS1416 BBS1417 BBS1418 BBS1419 BBS1420 BBS1421 BBS1422 BBS1423 BBS1424 BBS1426 BBS1427 BBS1429 BBS1430 BBS1432 BBS1433 BBS1434 BBS1436 BBS1439 BBS1440 BBS1441 BBS1442 BBS1443 BBS1445 BBS1447 BBS1450 BBS1451 BBS1452 BBS1453 BBS1455 BBS1456 BBS1457 BBS1458 BBS1459 BBS1460 BBS1462 BBS1464 BBS1465 BBS1466 BBS1468 BBS1469 BBS1471 BBS1472 BBS1473 BBS1474 BBS1475 BBS1476 BBS1477 BBS1479 BBS1480 BBS1481 BBS1482 BBS1483 BBS1484 BBS1485 BBS1487 BBS1488 BBS1490 BBS1491 BBS1492 BBS1493 BBS1494 BBS1495 BBS1496 BBS1497 BBS1498 BBS1499 BBS1500 BBS1501 BBS1502 BBS1503 BBS1504 BBS1505 BBS1506 BBS1508 BBS1509 BBS1515 BBS1519 BBS1531 BBS1533 BBS1537 BBS1538 BBS1539 BBS1548 BBS1567 BBS1571 BBS1591 BBS1592 BBS1657 BBS1658 BBS1671 BBS1673 BBS1697 BBS1724 BBS2133
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc. Endoscopy Division, Andover, MA, by letter on March 29, 2012.
Manufacturer: Smith & Nephew, Inc Endoscopy Division, Oklahoma City, OK.  Firm initiated recall is ongoing.
REASON
May experience intermittent loss of video due to a defective board component.
VOLUME OF PRODUCT IN COMMERCE
239 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Churchill Medical Systems Winged Infusion Set, 22Ga, 1", Latex-Free Winged Infusion Set Product Code: MBS-2210 Huber type needle set used for the infusion of medical fluids into implantable ports. Recall # Z-1480-2012
CODE
Lot Number: 1202077
RECALLING FIRM/MANUFACTURER
Churchill Medical Systems, Inc., Dover, NH, by letter dated April 16, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Mislabeled: MBS-2210 code on case label -22Ga Winged Infusion Set, however, the product label states 20Ga MBS-2010 code listed on device label.
VOLUME OF PRODUCT IN COMMERCE
522 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) VALOR(R), TARGETING GUIDE, REF 4150011000. The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcots Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis. Recall # Z-1484-2012;
 
2) VALOR(TM) TTC FUSION, INSTRUMENT KIT, REF 4150-KIT1. The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcots Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis. Recall # Z-1485-2012
CODE
All lots distributed until 03/9/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wright Medical Technology Inc., Arlington, TN, by letter dated April 2, 2012.
Manufacturers: Wright Medical Technology Inc., Arlington, TN;
Quintus Inc., Camp Verde, AZ. Firm initiated recall is ongoing.
REASON
The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.
VOLUME OF PRODUCT IN COMMERCE
133 devices
DISTRIBUTION
Nationwide and Australia
___________________________________
PRODUCT
Siemens-branded linear accelerator with a 550 TxT Treatment Table with a. Siemens brand ARTISTE, ONCOR and PRIMUS Linear Accelerator systems include the 550 TxT" Treatment Table. System IVK no. Component IVK Ser # ARTISTE MV system 8139789 550 TxT table 7346534 d1894 ONCOR Expression 7360717 550 TxT table 7346534 d1894 ONCOR Impression 5857912 550 TxT table 7346534 d1894 Plus ONCOR Impression 5857920 550 TxT table 7346534 d1894 ONCOR Avant Garde 5863472 550 TxT table 7346534 d1894 PRIMUS HI 4504200 550 TxT table 7346534 d1894 PRIMUS Mid-Energy 1940035 550 TxT table 7346534 d1894. Product Usage: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Recall # Z-1486-2012
CODE
Serial number d 1894
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letters beginning April 3, 2012. 
Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.
REASON
SIEMENS has received reports where a dropping down of the 550 TxT" Treatment Table was observed while the table was being moved downwards during operation by means of the hand control.
VOLUME OF PRODUCT IN COMMERCE
624 active devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Alere Triage CardioProfiler Panel, PN 97100CP. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart failure, and as an aid in the risk stratification of patients with acute coronary syndromes. Recall # Z-1466-2012;
 
2) Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation of thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes. Recall # Z-1467-2012
CODE
1) Lot #: W49569; 2) Lot #: W48990
RECALLING FIRM/MANUFACTURER
Alere San Diego, Inc., San Diego, CA, by letter on March 15, 2012, Firm initiated recall is ongoing.
REASON
These lots have an increased frequency of Troponin I results>0.05ng/mL for samples which are found to be below 0.05ng/mL upon additional testing.
VOLUME OF PRODUCT IN COMMERCE
1,284 kits
DISTRIBUTION
Nationwide, Brazil, China, India and Kuwait
___________________________________
PRODUCT
EG-3870UTK, Pentax Ultrasound Video Gastroscope. The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization via a video monitor of, ultrasonic visualization of, and therapeutic access to the Upper Gastrointestinal Tract, including, but restricted to the organs, tissues, and sub-systems; Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the need for procedure are observed in adult and pediatric patient populations. Recall # Z-1489-2012
CODE
Marketing Status of Device a. Class : 2 b. PMN : K090197 c. LST : D076884 EG-3870UTK A110013 EG-3870UTK A110014 EG-3870UTK A110015 EG-3870UTK A110016 EG-3870UTK A110018 EG-3870UTK A110021 EG-3870UTK A110022 EG-3870UTK A110023 EG-3870UTK A110024 EG-3870UTK A110025 EG-3870UTK A110026 EG-3870UTK A110028 EG-3870UTK A110029 EG-3870UTK A110030 EG-3870UTK A110031 EG-3870UTK A110033 EG-3870UTK A110034 EG-3870UTK A110035 EG-3870UTK A110038 EG-3870UTK A110040 EG-3870UTK A110041 EG-3870UTK A110042 EG-3870UTK A110044 EG-3870UTK A110045 EG-3870UTK A110046 EG-3870UTK A110047 EG-3870UTK A110048 EG-3870UTK A110050 EG-3870UTK A110051 EG-3870UTK A110052 EG-3870UTK A110053 EG-3870UTK A110054 EG-3870UTK A110055 EG-3870UTK A110056 EG-3870UTK A110057 EG-3870UTK A110058 EG-3870UTK A110059 EG-3870UTK A110060 EG-3870UTK A110061 EG-3870UTK A110062 EG-3870UTK A110063 EG-3870UTK A110064 EG-3870UTK A110065 EG-3870UTK A110066 EG-3870UTK A110067 EG-3870UTK A110068 EG-3870UTK A110069 EG-3870UTK A110070 EG-3870UTK A110071 EG-3870UTK A110075 2008/2/22 EG-3870UTK A110076 2008/2/26 EG-3870UTK A110078 2008/2/28 EG-3870UTK A110080 2008/3/19 EG-3870UTK A110081 2008/3/28 EG-3870UTK A110082 2008/3/28 EG-3870UTK A110083 2008/4/17 EG-3870UTK A110084 2008/5/16 EG-3870UTK A110085 2008/5/16 EG-3870UTK A110086 2008/5/16 EG-3870UTK A110087 2008/5/16 EG-3870UTK A110088 2008/5/21 EG-3870UTK A110090 2008/6/16 EG-3870UTK A110093 2008/8/18 EG-3870UTK A110094 2008/8/18 EG-3870UTK A110095 2008/8/18 EG-3870UTK A110096 2008/8/27 EG-3870UTK A110098 2008/9/5 EG-3870UTK A110099 2008/9/18 EG-3870UTK A110100 2008/9/30 EG-3870UTK A110101 2008/9/29 EG-3870UTK A110104 2008/10/2 EG-3870UTK A110105 2008/10/7 EG-3870UTK A110106 2008/11/11 EG-3870UTK A110107 2008/11/10 EG-3870UTK A110108 2008/11/11 EG-3870UTK A110109 2009/1/13 EG-3870UTK A110110 2008/11/7 EG-3870UTK A110111 2008/11/25 EG-3870UTK A110112 2008/12/8 EG-3870UTK A110113 2008/12/8 EG-3870UTK A110114 2008/12/24 EG-3870UTK A110115 2009/1/30 EG-3870UTK A110116 2009/2/10 EG-3870UTK A110117 2009/2/24 EG-3870UTK A110118 2009/4/21 EG-3870UTK A110119 2009/5/7 EG-3870UTK A110120 2009/4/16 EG-3870UTK A110121 2009/4/28 EG-3870UTK A110122 2009/5/27 EG-3870UTK A110123 2009/6/18 EG-3870UTK A110124 2009/7/25 EG-3870UTK A110125 2009/8/10 EG-3870UTK A110126 2009/8/19 EG-3870UTK A110127 2009/8/5 EG-3870UTK A110128 2009/8/11 EG-3870UTK A110129 2009/9/10 EG-3870UTK A110130 2009/8/11 EG-3870UTK A110131 2009/10/8 EG-3870UTK A110133 2009/8/19 EG-3870UTK A110134 2009/8/25 EG-3870UTK A110135 2009/8/25 EG-3870UTK A110136 2009/8/27 EG-3870UTK A110137 2009/8/28 EG-3870UTK A110138 2009/9/3 EG-3870UTK A110139 2009/9/17 EG-3870UTK A110140 2009/9/17 EG-3870UTK A110141 2009/10/2 EG-3870UTK A110142 2009/10/6 EG-3870UTK A110143 2009/10/15 EG-3870UTK A110144 2009/10/23 EG-3870UTK A110145 2009/11/4 EG-3870UTK A110146 2009/11/10 EG-3870UTK A110147 2009/12/19 EG-3870UTK A110148 2009/12/26 EG-3870UTK A110149 2010/2/26 EG-3870UTK A110150 2010/1/25 EG-3870UTK A110151 2010/1/25 EG-3870UTK A110152 2010/2/2 EG-3870UTK A110153 2010/2/8 EG-3870UTK A110154 2010/2/12 EG-3870UTK A110155 2010/2/19 EG-3870UTK A110156 2010/2/19 EG-3870UTK A110161 2010/3/8 EG-3870UTK A110162 2010/3/8 EG-3870UTK A110163 2010/3/18 EG-3870UTK A110164 2010/4/14 EG-3870UTK A110165 2010/4/16 EG-3870UTK A110166 2010/4/20 EG-3870UTK A110167 2010/4/20 EG-3870UTK A110168 2010/4/21 EG-3870UTK A110169 2010/4/22 EG-3870UTK A110170 2010/4/23 EG-3870UTK A110172 2010/4/28 EG-3870UTK A110173 2010/5/8 EG-3870UTK A110174 2010/5/8 EG-3870UTK A110175 2010/5/10 EG-3870UTK A110177 2010/5/14 EG-3870UTK A110178 2010/5/21 EG-3870UTK A110179 2010/5/26 EG-3870UTK A110180 2010/6/1 EG-3870UTK A110181 2010/6/1 EG-3870UTK A110182 2010/6/8 EG-3870UTK A110183 2010/6/8 EG-3870UTK A110184 2010/6/15 EG-3870UTK A110186 2010/6/22 EG-3870UTK A110192 2010/7/8 EG-3870UTK A110193 2010/7/12 EG-3870UTK A110194 2010/7/13 EG-3870UTK A110195 2010/7/22 EG-3870UTK A110196 2010/7/26 EG-3870UTK A110199 2010/7/29 EG-3870UTK A110200 2010/7/27 EG-3870UTK A110203 2010/8/2 EG-3870UTK A110205 2010/8/6 EG-3870UTK A110206 2010/8/9 EG-3870UTK A110208 2010/9/28 EG-3870UTK A110210 2010/8/30 EG-3870UTK A110211 2010/8/31 EG-3870UTK A110213 2010/11/16 EG-3870UTK A110214 2010/10/12 EG-3870UTK A110215 2010/10/1 EG-3870UTK A110216 2010/10/1 EG-3870UTK A110217 2010/10/12 EG-3870UTK A110218 2010/10/13 EG-3870UTK A110219 2010/10/18 EG-3870UTK A110221 2010/10/22 EG-3870UTK A110222 2010/11/17 EG-3870UTK A110224 2010/11/22 EG-3870UTK A110225 2010/12/27 EG-3870UTK A110226 2010/11/29 EG-3870UTK A110227 2010/12/27 EG-3870UTK A110228 2010/12/15 EG-3870UTK A110229 2010/12/16 EG-3870UTK A110230 2011/1/21 EG-3870UTK A110231 2011/1/21 EG-3870UTK A110232 2011/1/28 EG-3870UTK A110233 2011/1/28 EG-3870UTK A110234 2011/2/4 EG-3870UTK A110235 2011/4/4 EG-3870UTK A110236 2011/2/16 EG-3870UTK A110237 2011/2/15 EG-3870UTK A110239 2011/4/4 EG-3870UTK A110240 2011/4/11 EG-3870UTK A110241 2011/5/12 EG-3870UTK A110242 2011/5/19 EG-3870UTK A110243 2011/5/19 EG-3870UTK A110244 2011/5/26 EG-3870UTK A110245 2011/5/24 EG-3870UTK A110249 2011/6/8 EG-3870UTK A110250 2011/6/8 EG-3870UTK A110253 2011/6/29 EG-3870UTK A110254 2011/6/14 EG-3870UTK A110255 2011/6/15 EG-3870UTK A110256 2011/6/29 EG-3870UTK A110257 2011/6/29 EG-3870UTK A110258 2011/6/29
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pentax Medical, Co., Montvale, NJ, by letter on March 14, 2012.
Manufacturer: Hoya Corp., Pentax Life Care Division, Miyagi Factory, Miyagi,   
Japan. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Endoscope ultrasound balloon evacuation tube may become clogged with patient body fluid if users fail to properly follow instructions for pre-procedure check, operating the suction valve during procedure and pre-cleaning procedure.
VOLUME OF PRODUCT IN COMMERCE
194 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx device; Made in Costa Rica; product 120300412, list number 12030-12. Product Usage: For administration of I.V. fluids. Recall # Z-1491-2012
CODE
Lot number 89-029-5H; expiration date 01 JUN 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letter dated April 25, 2012. Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia,
Costa Rica. Firm initiated recall is ongoing.
REASON                                                                                                                                                
The Lifeshield Primary Plumsets may cause a cassette test failure alarm when the set is loaded onto the infusion pump. A set which results in a cassette test failure alarm may result in delay in therapy, requiring medical intervention.
VOLUME OF PRODUCT IN COMMERCE
145,875 sets
DISTRIBUTION
Nationwide and Australia
___________________________________
PRODUCT
GE Healthcare, Optima MR450W with GEM. Product Usage - The GEM Option for 1 .5T MRI systems is a set of receive-only RF surface coils designed for use with 1 .5T MRI systems manufactured by GE Healthcare. The GEM Option for 1 .5T MRI systems is indicated for use for: head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone imaging. The nucleus detected is hydrogen. Recall # Z-1492-2012
CODE
Units: HM0227 HM0243 HM0245 HM0255 HM0290 HM0292 HM0296 HM0301 HM0315 HM0316 HM0321 HM0343 HM0271 HM0339 HMO293 HM0287 HM0263 HM0236 312 HM0322 HM0331 HM0332 357 HM0247 HM0250 HM0253 HM0261 HM0326 HMO300 HM0242 HM0249 HM0251 HM0254 HM0309 HM0310 HM0334 HM0338 HM0344 HM0347 HM0262 HM0323
RECALLING FIRM/MANUFACTURER
GE Medical Systems, LLC, Waukesha, WI, by visit beginning April 12, 2012.
REASON                                                                                                                                                 
GE Healthcare is conducting a recall on Optima MR450W with GEM. During scanning of a patient, if an improperly torqued gradient connection exists, it may cause the gradient lead to produce excessive heat. If a second and compounding issue of improperly routed Rear Pedestal Air Supply Hose is also present, routed in such a way to cause the hose to come in contact with the overheated gradient lead cable, then the hose may generate smoke.
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: ARTISTE MV System; ONCOR Avant Garde ONCOR Impression ONCOR Impression Plus ONCOR Expression. ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Product Model with Part Number: ARTISTE MV System, 8139789; ONCOR Avant Garde, 5863472; ONCOR Impression, 5857920; ONCOR Impression, Plus 5857912; ONCOR Expression, 7360204; ONCOR Expression, 7360717. ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Recall # Z-1493-2012
CODE
No serial numbers or lot numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on April 3, 2012.
Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.
REASON
Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one segment (issue 1). Additionally, there may be a potential for collision if the operator does not ensure clearance of the extended flat panel positioner for all gantry rotation angles (issue 2).
VOLUME OF PRODUCT IN COMMERCE
290 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Sickle Heme, Hemoglobin S Solubility For Qualitative Determination of Hemoglobin S Test; 100 Test Kit Product, No MCA 100, Contents: Two bottles of Sickle Cell Buffer, Two Bottles of Sickle Cell Powder; One Line Scale Two Dispensing Closures; For Invitor Diagnostics Use, Store at Room Temperature. For the qualitative determination of positive or negative Sickle Cell Anemia present in Hemoglobin , for in vitro diagnostic use only. Recall # Z-1501-2012;
 
2) BioTron Sickle Cell Reagent Set, Catalog No.25100, Screening test for the Presence of Hemoglobin S 2 x 100 ml Sickle Cell Buffer, 2 vials sickle Cell Reagent, Size 100 tests, Store 2-8 C. For the qualitative determination of positive or negative Sickle Cell Anemia present in Hemoglobin , for in vitro diagnostic use only. Recall # Z-1502-2012;
 
3) Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the Determination of Hemoglobin S Two bottles Sickle Cell Solubility Buffer, 100 ml , 2 vials Sickle Cell Solubility Powder, Size 100 tests, Store 20-30 C. For the qualitative determination Hemoglobin S, for in vitro diagnostic use only. Recall # Z-1503-2012
CODE
1), 2) and 3) Lot# 1187, expiration date: 7/13, Powder Lot # 1171 (part of kit)
RECALLING FIRM/MANUFACTURER
MichClone Associates, Inc., Madison Heights, MI, by letter dated March 15, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Two complaints received concerning the powder vial included in the 100 test kit observed producing pressure while sealed. When the powders are opened, the pressure from within the vial releases a small amount of powder into the air. This powder, if released near the face and inhaled can cause minor irritation resulting in sneezing and nasal congestion. Investigation found no affect on the performance of the Sickle Cell test kit.
VOLUME OF PRODUCT IN COMMERCE
400 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
DISPOSA-SHIELD. The Disposable Curing Shield For Your Curing Light. The disposable Disposa-Shield is sold in different sizes from 6 mm, 8 mm, 9 mm, 11 mm and 13 mm. The devices are Intended to be place over the tip of a dental curing light wand to protect the doctor's and patient's vision from exposure to high intensity light; soften contact of curing light against the teeth, and keep light guide cleaner, therefore maintaining good levels of light intensity for proper and fast curing The label of the O'Ryan Disposa-Shield listed the following: -Protect Doctor's And Patient's Vision From Exposure To High Intensity Light. -Soften Contact Of Light Guide Against Teeth. -Keep Light Guide Cleaner, Therefore, Maintaining Good Levels Of Light Intensity For Proper And Faster Curing. There are 25 devices per clear plastic bag when distributed in bulk and two devices per clear plastic zip lock type bag when distributed with curing lights. The "Sterilize Before Use" label is placed on a clear plastic bag containing 25 pieces of Disposa-Shield units distributed with all shipment of bulk Disposa-Shield. The "Sterilize Before Use" label is NOT placed on plastic zip lock type bag when distributed with two Disposa-Shield with curing lights. The product is labeled in parts: "***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***STERILIZE BEFORE USE***O'RYAN INDUSTRIES***INSTRUCTIONS FOR INSTALLING DISPOSA-SHIELD***1. Remove and dispose of old DISPOSA-SHIELD***2. Sterilize wand tip***3. Simply stretch new DISPOSA-SHIELD over tip of wand***'. The private label is labeled in parts: "***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***STERILIZE BEFORE USE***". Recall # Z-1505-2012
CODE
None
RECALLING FIRM/MANUFACTURER
O'Ryan Industries Inc., Vancouver, WA, by telephone and email on April 25, 2012, and by letter dated May 7, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Product is recalled due to lacking 510K, PM or IDE, and inadequate quality system.
VOLUME OF PRODUCT IN COMMERCE
454 Bags (25 Disposa Shield per bag) and 11 Bags (2 Disposa Shield units with Curing Lights per bag)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Plastic Panels, Item 690-7604-000. Made in China. LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Walnut Panels, Item 690-7004-000; Made in China. Therapeutic bed intended for home use. Recall # Z-1536-2012
CODE
Lot #'s: A0309, A0501, A0609, B0309, B0501, B0609, C0309,C0501 , D0309,E0309, F0309 Lot/serial number: A0309: 6970400900001 6970400900002 6970400900003 6970400900004 6970400900005 6970400900006 6970400900007 6970400900008 6970400900009 6970400900010 6970400900011 6970400900012 6970400900013 6970400900014 6970400900015 6970400900016 6970400900017 6970400900018 6970400900019 6970400900020 6970400900021 6970400900022 6970400900023 6970400900024 6970400900025 6970400900026 6970400900027 6970400900028 6970400900029 6970400900030 6970400900031 6970400900032 6970400900033 6970400900034 6970400900035 6970400900036 6970400900037 6970400900038 6970400900039 6970400900040 6970400900041 6970400900042 6970400900043 6970400900044 6970400900045 6970400900046 6970400900047 6970400900048 6970400900049 6970400900050 6970400900051 6970400900052 6970400900053 6970400900054 6970400900055 6970400900056 6970400900057 6970400900058 6970400900059 6970400900060 6970400900061 6970400900062 6970400900063 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6976040901449 B0309: 6970400900151 6970400900152 6970400900153 6970400900154 6970400900155 6970400900156 6970400900157 6970400900158 6970400900159 6970400900160 6970400900161 6970400900162 6970400900163 6970400900164 6970400900165 6970400900168 6970400900169 6970400900170 6970400900171 6970400900172 6970400900173 6970400900174 6970400900175 6970400900176 6970400900177 6970400900178 6970400900179 6970400900180 6970400900182 6970400900183 6970400900184 6970400900185 6970400900186 6970400900187 6970400900188 6970400900189 6970400900190 6970400900192 6970400900193 6970400900194 6970400900195 6970400900196 6970400900197 6970400900198 6970400900199 6970400900200 6970400900201 6970400900202 6970400900205 6970400900206 6970400900208 6970400900210 6970400900211 6970400900212 6970400900213 6970400900214 6970400900215 6970400900216 6970400900217 6970400900218 6970400900219 6970400900220 6970400900221 6970400900222 6970400900225 6970400900226 6970400900228 6970400900229 6970400900230 6970400900231 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6970400900536 6970400900537 6970400900538 6970400900539 6970400900540 6970400900541 6970400900542 6970400900543 6970400900544 6970400900545 6970400900546 6970400900547 6970400900548 6970400900549 6970400900550 6976040900352 6976040900355 6976040900356 6976040900358 6976040900359 6976040900360 6976040900362 6976040900363 6976040900364 6976040900365 6976040900366 6976040900367 6976040900368 6976040900369 6976040900373 6976040900374 6976040900375 6976040900376 6976040900378 6976040900381 6976040900384 6976040900385 6976040900386 6976040900387 6976040900388 6976040900399 6976040900400 6976040900401 6976040900402 6976040900403 6976040900404 6976040900405 6976040900406 6976040900407 6976040900420 6976040900431 6976040900438 6976040900441 6976040900442 6976040900443 6976040900444 6976040900445 6976040900446 6976040900447 6976040900448 6976040900449 6976040900450 6976040900451 6976040900452 6976040900453 6976040900454 6976040900455 6976040900456 6976040900457 6976040900458 6976040900459 6976040900460 6976040900466 6976040900467 6976040900468 6976040900470 6976040900475 6976040900477 6976040900478 6976040900479 6976040900485 6976040900491 6976040900512 6976040900513 6976040900518 6976040900519 6976040900520 6976040900521 6976040900522 6976040900525 6976040900529 6976040900530 6976040900531 6976040900532 6976040900536 6976040900537 6976040900540 6976040900541 6976040900542 6976040900543 6976040900545 6976040900546 6976040900547 6976040900548 6976040900549 6976040900550 C0501: 6970400901296 6970400901297 6970400901298 6970400901301 6970400901302 6970400901304 6970400901305 6970400901306 6970400901307 6970400901308 6970400901309 6970400901310 6970400901312 6970400901313 6970400901314 6970400901315 6970400901316 6970400901317 6970400901318 6970400901319 6970400901320 6970400901321 6970400901322 6970400901323 6970400901324 6970400901325 6970400901326 6970400901327 6970400901328 6970400901329 6970400901330 6970400901331 6970400901332 6970400901333 6970400901334 6970400901335 6970400901336 6970400901337 6970400901338 6970400901339 6970400901340 6970400901341 6970400901342 6970400901343 6970400901344 6970400901345 6970400901346 6970400901347 6970400901348 6970400901349 6970400901350 6970400901351 6970400901352 6970400901353 6970400901355 6970400901356 6970400901357 6970400901358 6970400901359 6970400901360 6970400901361 6970400901362 6970400901363 6970400901364 6970400901365 6970400901366 6970400901367 6970400901368 6970400901369 6970400901370 6970400901371 6970400901372 6970400901373 6970400901374 6970400901375 6970400901376 6970400901377 6970400901378 6970400901379 6970400901380 6970400901381 6970400901382 6970400901383 6970400901384 6970400901385 6970400901387 6970400901388 6970400901389 6970400901390 6970400901391 6970400901393 6970400901395 6970400901396 6970400901397 6970400901398 6970400901399 6970400901400 6970400901401 6970400901402 6970400901403 6970400901404 6970400901405 6970400901406 6970400901407 6970400901408 6970400901409 6970400901410 6970400901411 6970400901412 6970400901413 6970400901414 6970400901415 6970400901416 6970400901417 6970400901418 6970400901419 6970400901421 6970400901422 6970400901426 6970400901428 6970400901429 6970400901430 6970400901431 6970400901432 6970400901433 6970400901434 6970400901435 6970400901436 6970400901437 6970400901438 6970400901439 6970400901440 6970400901441 6970400901442 6970400901445 6976040901300 6976040901308 6976040901310 6976040901322 6976040901324 6976040901327 6976040901328 6976040901329 6976040901330 6976040901331 6976040901332 6976040901333 6976040901334 6976040901335 6976040901336 6976040901361 6976040901362 6976040901369 6976040901377 6976040901378 6976040901379 6976040901380 6976040901381 6976040901382 6976040901383 6976040901386 6976040901396 6976040901397 6976040901398 6976040901399 6976040901400 6976040901401 6976040901402 6976040901403 6976040901404 6976040901405 6976040901406 6976040901407 6976040901408 6976040901409 6976040901410 6976040901411 6976040901412 6976040901413 6976040901414 6976040901415 6976040901416 D0309: 6970400900551 6970400900552 6970400900553 6970400900554 6970400900555 6970400900556 6970400900557 6970400900558 6970400900559 6970400900560 6970400900561 6970400900562 6970400900563 6970400900564 6970400900565 6970400900567 6970400900568 6970400900570 6970400900571 6970400900572 6970400900573 6970400900574 6970400900576 6970400900577 6970400900578 6970400900579 6970400900580 6970400900582 6970400900583 6970400900585 6970400900586 6970400900587 6970400900588 6970400900589 6970400900590 6970400900591 6970400900592 6970400900593 6970400900594 6970400900595 6970400900596 6970400900597 6970400900598 6970400900599 6970400900600 6970400900601 6970400900602 6970400900604 6970400900606 6970400900607 6970400900608 6970400900609 6970400900610 6970400900611 6970400900612 6970400900613 6970400900614 6970400900615 6970400900616 6970400900617 6970400900618 6970400900620 6970400900621 6970400900622 6970400900623 6970400900624 6970400900625 6970400900626 6970400900627 6970400900629 6970400900630 6970400900631 6970400900632 6970400900633 6970400900634 6970400900635 6970400900636 6970400900637 6970400900638 6970400900639 6970400900640 6970400900641 6970400900642 6970400900643 6970400900644 6970400900645 6970400900646 6970400900648 6970400900649 6970400900650 6970400900651 6970400900652 6970400900653 6970400900654 6970400900655 6970400900656 6970400900657 6970400900658 6970400900659 6970400900660 6970400900661 6970400900662 6970400900663 6970400900664 6970400900665 6970400900666 6970400900667 6970400900668 6970400900669 6970400900670 6970400900671 6970400900672 6970400900673 6970400900674 6970400900675 6970400900676 6970400900677 6970400900678 6970400900679 6970400900680 6970400900681 6970400900682 6970400900683 6970400900684 6970400900685 6970400900686 6970400900687 6970400900688 6970400900689 6970400900690 6970400900691 6970400900692 6970400900693 6970400900694 6970400900695 6970400900696 6970400900697 6970400900698 6970400900700 6970400900701 6970400900702 6970400900703 6970400900704 6970400900705 6970400900706 6970400900707 6970400900708 6970400900709 6970400900711 6970400900712 6970400900713 6970400900714 6970400900715 6970400900716 6970400900717 6970400900718 6970400900719 6970400900720 6970400900721 6970400900722 6970400900723 6970400900724 6970400900725 6970400900726 6970400900727 6970400900728 6970400900729 6970400900730 6970400900732 6970400900733 6970400900734 6970400900735 6970400900737 6970400900738 6970400900739 6970400900740 6970400900741 6970400900743 6970400900744 6970400900746 6970400900747 6970400900748 6970400900749 6976040900551 6976040900553 6976040900554 6976040900555 6976040900556 6976040900557 6976040900559 6976040900560 6976040900561 6976040900562 6976040900563 6976040900564 6976040900565 6976040900566 6976040900567 6976040900568 6976040900570 6976040900591 6976040900592 6976040900593 6976040900594 6976040900595 6976040900596 6976040900598 6976040900599 6976040900600 6976040900601 6976040900602 6976040900603 6976040900604 6976040900605 6976040900606 6976040900607 6976040900608 6976040900609 6976040900610 6976040900633 6976040900634 6976040900635 6976040900636 6976040900637 6976040900638 6976040900639 6976040900640 6976040900641 6976040900642 6976040900643 6976040900644 6976040900645 6976040900646 6976040900647 6976040900648 6976040900649 6976040900650 6976040900652 6976040900653 6976040900654 6976040900655 6976040900656 6976040900657 6976040900658 6976040900659 6976040900660 6976040900682 6976040900688 6976040900690 6976040900703 6976040900704 6976040900705 6976040900706 6976040900709 6976040900710 6976040900711 6976040900712 6976040900713 6976040900714 6976040900715 6976040900716 6976040900717 6976040900718 6976040900719 6976040900720 6976040900721 6976040900722 6976040900723 6976040900724 6976040900725 6976040900726 6976040900727 6976040900728 6976040900728 6976040900729 6976040900730 6976040900748 6976040900749 6976040900750 E0309: 6970400900751 6970400900752 6970400900753 6970400900756 6970400900757 6970400900758 6970400900759 6970400900760 6970400900761 6970400900762 6970400900764 6970400900765 6970400900767 6970400900769 6970400900770 6970400900773 6970400900774 6970400900775 6970400900776 6970400900778 6970400900779 6970400900780 6970400900785 6970400900786 6970400900787 6970400900788 6970400900789 6970400900791 6970400900792 6970400900793 6970400900794 6970400900796 6970400900797 6970400900801 6970400900802 6970400900803 6970400900806 6970400900807 6970400900808 6970400900809 6970400900810 6970400900811 6970400900812 6970400900814 6970400900815 6970400900816 6970400900818 6970400900819 6970400900820 6970400900821 6970400900822 6970400900823 6970400900824 6970400900826 6970400900827 6970400900828 6970400900829 6970400900832 6970400900833 6970400900834 6970400900835 6970400900836 6970400900837 6970400900838 6970400900839 6970400900840 6970400900841 6970400900842 6970400900843 6970400900844 6970400900845 6970400900846 6970400900847 6970400900848 6970400900849 6970400900850 6970400900851 6970400900852 6970400900853 6970400900855 6970400900856 6970400900857 6970400900858 6970400900859 6970400900860 6970400900861 6970400900862 6970400900863 6970400900864 6970400900865 6970400900866 6970400900869 6970400900870 6970400900871 6970400900872 6970400900873 6970400900876 6970400900877 6970400900878 6970400900879 6970400900880 6970400900881 6970400900882 6970400900883 6970400900884 6970400900885 6970400900886 6970400900887 6970400900888 6970400900889 6970400900890 6970400900891 6970400900892 6970400900893 6970400900894 6970400900895 6970400900896 6970400900897 6970400900898 6970400900899 6970400900900 6970400900901 6970400900904 6970400900905 6970400900906 6970400900907 6970400900908 6970400900909 6970400900910 6970400900912 6970400900913 6970400900915 6970400900916 6970400900917 6970400900919 6970400900920 6970400900923 6970400900924 6970400900925 6970400900927 6970400900928 6970400900929 6970400900930 6970400900933 6970400900934 6970400900935 6970400900936 6970400900937 6970400900938 6970400900939 6970400900940 6970400900945 6970400900948 6970400900949 6976040900781 6976040900786 6976040900788 6976040900790 6976040900791 6976040900792 6976040900793 6976040900794 6976040900795 6976040900796 6976040900797 6976040900798 6976040900801 6976040900802 6976040900803 6976040900804 6976040900805 6976040900806 6976040900807 6976040900808 6976040900809 6976040900810 6976040900811 6976040900812 6976040900813 6976040900814 6976040900815 6976040900818 6976040900819 6976040900820 6976040900821 6976040900822 6976040900823 6976040900826 6976040900827 6976040900828 6976040900829 6976040900830 6976040900831 6976040900832 6976040900833 6976040900834 6976040900835 6976040900836 6976040900837 6976040900838 6976040900839 6976040900840 6976040900841 6976040900842 6976040900843 6976040900844 6976040900845 6976040900846 6976040900847 6976040900848 6976040900849 6976040900850 6976040900851 6976040900852 6976040900853 6976040900855 6976040900856 6976040900857 6976040900859 6976040900860 6976040900861 6976040900862 6976040900863 6976040900867 6976040900869 6976040900870 6976040900873 6976040900874 6976040900880 6976040900883 6976040900884 6976040900885 6976040900887 6976040900889 6976040900890 6976040900891 6976040900892 6976040900893 6976040900894 6976040900895 6976040900897 6976040900900 6976040900901 6976040900902 6976040900904 6976040900908 6976040900909 6976040900911 6976040900912 6976040900914 6976040900915 6976040900916 6976040900917 6976040900918 6976040900919 6976040900920 6976040900924 6976040900925 6976040900928 6976040900929 6976040900930 6976040900931 6976040900933 6976040900935 6976040900938 6976040900941 6976040900942 6976040900943 6976040900945 6976040900948 F0309: 6970400900951 6970400900952 6970400900953 6970400900954 6970400900955 6970400900956 6970400900957 6970400900958 6970400900959 6970400900960 6970400900961 6970400900962 6970400900963 6970400900964 6970400900965 6970400900966 6970400900967 6970400900968 6970400900969 6970400900970 6970400900971 6970400900972 6970400900973 6970400900974 6970400900975 6970400900976 6970400900977 6970400900978 6970400900979 6970400900980 6970400900981 6970400900982 6970400900983 6970400900984 6970400900985 6970400900986 6970400900987 6970400900988 6970400900989 6970400900990 6970400900991 6970400900992 6970400900993 6970400900994 6970400900995 6970400900996 6970400900997 6970400900998 6970400900999 6970400901000 6970400901001 6970400901002 6970400901003 6970400901004 6970400901005 6970400901006 6970400901007 6970400901008 6970400901009 6970400901010 6970400901011 6970400901012 6970400901013 6970400901014 6970400901015 6970400901016 6970400901017 6970400901018 6970400901019 6970400901020 6976040900951 6976040900952 6976040900953 6976040900954 6976040900955 6976040900956 6976040900957 6976040900958 6976040900959 6976040900960 6976040900961 6976040900962 6976040900963 6976040900964 6976040900965 6976040900966 6976040900967 6976040900968 6976040900969 6976040900970 6976040900971 6976040900972 6976040900973 6976040900974 6976040900975 6976040900976 6976040900978 6976040900979 6976040900980 6976040900981 6976040900982 6976040900983 6976040900984 6976040900985 6976040900986 6976040900987 6976040900988 6976040900989 6976040900990 6976040900991 Serial Number: 6970400900184 6970400900595 6970400900764 6970400900934 6970400901036 6976040900150 6976040900211 6976040900298 6976040900368 6976040900832 6976040901037 6976040901062 6976040901097 6976040901191 6976040901400 6976040901536 6976040900001 6976040900008
RECALLING FIRM/MANUFACTURER
Recalling Firm: GF Health Products, Inc./d.b.a.Basic American Metal Products, Fond Du Lac, WI, by letter dated April 17, 2012.
Manufacturers: Apex Health Care Mfg., Inc., Min Hsiung, Chia Yi, Taiwan.
GF Health Products, Inc./d.b.a.Basic American Metal Products, Fond Du Lac, WI. Firm initiated recall is ongoing.
REASON
The supplier deviated from the print specifications of a machined pin to a sheared pin. This deviation has the potential to provide room for the pin to move during use. If failure were to occur, the bed could descend rapidly causing non-typical patient movement and could pose a risk of injury to the patient and others.
VOLUME OF PRODUCT IN COMMERCE
2,719 pairs of bed ends
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures. Recall # Z-1539-2012
CODE
Serial Numbers - 18 total: 70952; 70972; 71002; 71012; 71022; 71032; 71042; 71052; 71062; 71082; 71102; 71112; 71122; 71142; 81162; 81172; 81182; 81192
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mitaka USA, Inc., Park City, UT, by letter on February 27, 2009. 
Manufacturer: Mitaka Kohki Co Ltd., Tokyo, Japan. Firm initiated recall is ongoing.
REASON
Use of a potentially weaker spring in the device than required to meet specifications to hold the Point Setter ARM in place during surgery.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
Nationwide and Canada
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS III
___________________________________
PRODUCT
AtheNA Multi-Lyte MMV Test System- A93111G A microparticle-based immunoassay intended for the qualitative presumptive detection of IgG class antibody to the Mumps virus in human serum using the AtheNA Multi-Lyte Test System. The test system is intended to be used for determination of a previous infection with the Mumps virus. Recall # Z-1500-2012
CODE
Units: 11120087 and 11120165
RECALLING FIRM/MANUFACTURER
Zeus Scientific, Inc., Branchburg, NJ, by letter dated March 8, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                           
Select lots of AtheNA Multi-Lyte MMV Test System have lost reactivity and may produce false positive results in seronegative patients who have not been previously affected with or vaccinated against Mumps.
VOLUME OF PRODUCT IN COMMERCE
327 kits
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS III
___________________________________
PRODUCT
VET one Hydrogen Peroxide 3% Topical, containing a 3% aqueous solution of Hydrogen Peroxide USP, packaged in 1-gal. jugs. Recall # V-066-2012
CODE
Lot #s: 251002 and 251003
RECALLING FIRM/MANUFACTURER
Centaur Inc., Olathe, KS, by e-mail on January 16, 2011 and by letter, via FedEx, on January 20, 2012. Firm initiated recall is ongoing.
REASON
Product failed room temperature stability testing at 6 and 9 month testing intervals (low).
VOLUME OF PRODUCT IN COMMERCE
2,752 gallons
DISTRIBUTION
KS
 
END OF ENFORCEMENT REPORT FOR MAY 16, 2012
 
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