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U.S. Department of Health and Human Services

Safety

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Enforcement Report for August 11, 2010

 

August 11, 2010                                                                 10-31
 
RECALLS AND FIELD CORRECTIONS: COSMETICS - CLASS II
___________________________________
PRODUCT   
1) 100% Natural Perfecting Eye Cream. Made in U.S.A.; sold in the following sizes: a) 0.5 fl oz/15 mL plastic jar, 12 jars per case; sku 100-00254-000 (H70-129), UPC 7 64505 00254 8; b) 0.13 fl oz/4 mL plastic tube (sample), 350 tubes per case, sku 100-05254-000 (H69-069-H); The 0.5 fl oz. jars are also sold as a component of the following kits: a) Sea Pure Natural Skincare Collection, sku 100-09004-000, UPC 7 64505 09004 0; b) Sea Pure Tester Kit (Skincare - US - English), sku 100-09994-000, UPC 7 64505 09994 4; c) Sea Pure Tester Kit (Skincare - Canada - English), sku 100-09997-000, UPC 7 64505 09997 5; d) Sea Pure Tester Kit (Skincare - Canada - French), sku 100-09996-000, UPC 7 64505 09996 8; e) CVS Beauty 360 Sea Pure Tester Kit; sku 100-738892-000; The 0.13 fl oz plastic sample tubes are also sold as a component of the following kits: a) Sea Pure Training in A Box - US, sku 100-09009-000, UPC 7 64505 090009 5; b) Sea Pure Training in A Box - Canada, sku 300-09009-000, UPC 7 64505 090009 5; Recall # F-2625-2010;
 
2) 100% Natural Deep Moisture Cream. Made in U.S.A.; sold in the following sizes: a) 1.7 fl oz/50 mL plastic jar, 6 jars per case; sku 100-00257-000 (H70-132), UPC 7 64505 00257 9; b) 0.5 fl oz/15 mL plastic jar, sku 400-05257-005 (H70-132); c) 0.28 fl oz/8 mL plastic tube (sample), 350 tubes per case, sku 100-05535-000 (H69-070-H); The 0.5 fl oz. jars are sold as a component of the following kits: a) Sea Pure Natural Skincare Collection, sku 100-09004-000, UPC 7 64505 09004 0; b) Sea Pure Tester Kit (Skincare - US - English), sku 100-09994-000, UPC 7 64505 09994 4; c) Sea Pure Tester Kit (Skincare - Canada - English), sku 100-09997-000, UPC 7 64505 09997 5; d) Sea Pure Tester Kit (Skincare - Canada - French), sku 100-09996-000, UPC 7 64505 09996 8; e) CVS Beauty 360 Sea Pure Tester Kit; sku 100-738892-000; The 0.28 fl oz plastic sample tubes are also sold as a component of the following kits: a) Sea Pure Training in A Box - US, sku 100-09009-000, UPC 7 64505 090009 5; b) Sea Pure Training. Recall # F-2626-2010;
 
3) 100% Natural Gentle Refining Polish. Made in U.S.A.; sold in 2.5 fl oz/75 mL plastic tubes, 6 tubes per case, sku 100-00259-000 (H70-134), UPC 7 64505 00259 3; The 2.5 fl oz. tubes are also sold as a component of the following kits: a) Sea Pure Tester Kit (Skincare - US - English), sku 100-09994-000, UPC 7 64505 09994 4; b) Sea Pure Tester Kit (Skincare - Canada - English), sku 100-09997-000, UPC 7 64505 09997 5; c) Sea Pure Tester Kit (Skincare - Canada - French), sku 100-09996-000, UPC 7 64505 09996 8; d) CVS Beauty 360 Sea Pure Tester Kit; sku 100-738892-000. Recall # F-2627-2010;
 
4) 97% Natural Cleansing Body Oil; sold in 7 fl oz/210 mL plastic bottles, 6 bottles per case, sku 100-00434-000 (H70-136), UPC 7 64505 00434 4; The 7 fl oz. bottles are also sold as a component of the following kits: a) Sea Pure Tester Kit (Body - English), sku 100-09995-000, UPC 7 64505 09995 1; b) Sea Pure Tester Kit (Body - French), sku 100-09998-000, UPC 7 64505 09998 2; c) CVS Beauty 360 Sea Pure Tester Kit; sku 100-738892-000; 4.25 fl oz bottles were sold as a component of the following kit: a) Sea Pure Natural Bodycare Collection, sku 100-09000-000, UPC 7 64505 09000 2. Recall # F-2628-2010;
 
5) 100% Natural Replenishing Cream; sold in the following sizes: a) 6 fl oz/180 mL plastic tubes, 6 tubes per case, sku 100-00435-000 (H70-137), UPC 7 64505 00435 1; b) 2 fl oz/60 mL plastic sample tubes, 12 tubes per case, sku 100-06435-000 (H70-137); c) 4 fl oz / 118 mL plastic tubes, sku 100-04435-000; d) 1 fl oz / 30 mL plastic tubes, sku 400-10435-000;
The 6 fl oz. tubes are also sold as a component of the following kits: a) Sea Pure Tester Kit (Body - English), sku 100-09995-000, UPC 7 64505 09995 1; b) Sea Pure Tester Kit (Body - French), sku 100-09998-000, UPC 7 64505 09998 2; c) CVS Beauty 360 Sea Pure Tester Kit; sku 100-738892-000; The 4 fl oz/118 mL plastic tubes are sold as a component of the following kit: a) Sea Pure Natural Bodycare Collection, sku 100-09000-000, UPC 7 64505 09000 2; The 2 fl oz plastic sample tubes are also sold as a component of the following kits: a) Sea Pure Training in A Box - US, sku 100-09009-000, UPC 7 64505 090009 5; b) Sea Pure Training in A Box - Canada, sku 300-09009-000, UPC 7 64505 090009 5; The 1 fl oz/30 mL plastic tubes were included as a component of the following kits: a) Sea Pure Gift with Purchase, including Sea Pure Creamy Facial Cleanser, Replenishing Body Cream and Renewing Prep Tonic; sku 100-09007-000, UPC 7 64505 09007 1; b) Sea Pure Gift with Purchase - Canada, including Sea Pure Creamy Facial Cleanser, Replenishing Body Cream and Renewing Prep Tonic; sku 300-09007-000, UPC 7 64505 09007 1; c) Sea Pure Gift with Purchase including Sea Pure Purifying Body Mud, Replenishing Body Cream and Sheer Lotion SPF 15; sku 100-09008-000, UPC 7 64505 09008 8. Recall # F-2629-2010
CODE
1) sku 100-00254-000 (H70-129), lot 090817 A02; sku 100-05254-000 (H69-069-H), lot 090817 A02; sku 100-09004-000, lot 090828; sku 100-09994-000, lot 090911; sku 100-09997-000, lot 090911; sku 100-09996-000, lot 090911; sku 100-738892-000, lot 091104; sku 100-09009-000, lots 091016 and 091017; sku 300-09009-000, lot090916;
 
2) sku 100-00257-000 (H70-132), lot 090805 A02; sku 400-05257-005 (H70-132), lot 090805 A02; sku 100-05535-000 (H69-070-H), lot 090805 A02; sku 100-09004-000, lot 090828; sku 100-09994-000, lot 090911; sku 100-09997-000, lot 090911; sku 100-09996-000, lot 090911; sku 100-738892-000, lot 091104; sku 100-09009-000, lots 091016 and 091017; sku 300-09009-000, lot 090916;
 
3) sku 100-00259-000 (H70-134), lots 100114A03 and 090730A02 and 100114A03; sku 100-09994-000, lot 090911; sku 100-09997-000, lot 090911; sku 100-09996-000, lot 090911; sku 100-738892-000, lot 091104;
 
4) sku 100-00434-000 (H70-136), lots 090723A03 and 090724A04; sku 100-09995-000, lot 090911; sku 100-09998-000, lot 090910; sku 100-09000-000, lots 090824, 090825 and 090826; sku 100-738892-000, lot 091104;
 
5) sku 100-00435-000 (H70-137), lots 090810A03 and 090814A04; sku 100-06435-000 (H70-137), lots 090806A02 and 090810A03; sku 100-09995-000, lots 090910 and 090911; sku 100-09998-000, lot 090910; sku 100-738892-000, lot 091104; sku 100-09000-000, lots 090824, 090825 and 090826; sku 100-09009-000, lots 091016 and 091017; sku 300-09009-000, lot 090916; sku 100-09007-000, lots 090901 and 090902; sku 300-09007-000, lot 090902; sku 100-09008-000, lot 090903
RECALLING FIRM/MANUFACTURER
H2O Plus, L.P., Chicago, IL, by letters dated January 22, 2010. Firm initiated recall is ongoing.
REASON
The cosmetics have sporadic failure of the preservative system, which allows mold growth to occur.
VOLUME OF PRODUCT IN COMMERCE
17,816 jars, 49,399 tubes, 5,424 bottles, 26,248 kits
DISTRIBUTION
CA, FL, II, IA, MO, NY, RI, SC, TX, WA, WI, and Canada, Chile, Hong Kong, Malaysia, Mexico, Panama, Taiwan and Thailand
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Senor Mexicano Avocado Pulp (frozen), Net Wt: 32 oz (2 lb) plastic bags (6 per case), UPC Code: 7 503012 650001. Recall # F-2630-2010
CODE
Lot Number: A210410 (Code stickers on outside box also lists lot #A210412)
RECALLING FIRM/MANUFACTURER
Recalling Firm: J. Hellman Frozen Foods, Inc., Los Angeles, CA, by telephone on July 2, 2010.
Manufacturer: Huertas e Industrias Internacionales Pardo SA de CV, Michoacan, Mexico. FDA initiated recall is ongoing.
REASON
Avocado Pulp product has the potential to be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
992 cases
DISTRIBUTION
CA, HI
___________________________________
PRODUCT   
Mt. Vikos Brand Manouri Sheep & Goat's Milk Cheese, Net Wt. 4 oz, UPC# 6-65291-00201-2 Mt. Vikos Brand Manouri Sheep & Goat's Milk Cheese, Random Wt. logs (approximately 1 Kilogram). F-2631-2010
CODE
All best Buy Dates
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mt. Vikos, Inc., Marshfield, MA, by letter on May 6, 2010. 
Manufacturer: Roussas Dairy Sa, Almyros, Greece. Firm initiated recall is ongoing.
REASON
Product may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
288 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Roba Dolce Double Chocolate Chunk Gelato, 33.8 oz, plastic container. Recall # F-2645-2010
CODE
Enjoy by 12/10/10, Mfg with pride pl #44-50
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roba Dolce Inc., Warwick, RI, by telephone and website posting on June 25, 2010 and press release on July 1, 2010.
Manufacturer: Warwick Ice Cream Co., Warwick, RI. Firm initiated recall is ongoing.
REASON
Product contains undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
876 units
DISTRIBUTION
AZ, OH
___________________________________
PRODUCT   
Broccoli Raisin Salad sold per pound in the store deli. Recall # F-2646-2010
CODE
"Freeze or Use By" - July 12, 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kroger Co., Cincinnati, OH, by press release on July 10, 2010.  
Manufacturer: Quality Food Centers Inc., Seattle, WA.  Firm initiated recall is ongoing.
REASON
It was discovered that the product may contain walnuts and, if eaten, could result in an allergic reaction in persons sensitive to walnuts.
VOLUME OF PRODUCT IN COMMERCE
80 salad kits
DISTRIBUTION
OR & WA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT   
1) SeaSations Thai with Basil in 11.4 oz package. The product is frozen white whole fish fillet. The package includes two 5.7 oz fillets. The product is shipped 12 packages per case, UPC 80000 50007. Recall # F-2621-2010;
 
2)SeaSations Teriyaki Orange and Ginger in 11.4 oz package. The product is frozen white whole fish fillet. The package includes two 5.7 oz fillets. The product is shipped 12 packages per case, UPC 80000 50112. Recall # F-2622-2010
CODE
All dates codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: StarKist Co., Pittsburgh, PA, by press release and letter on April 16, 2010.
Manufacturer: Irvin and Johnson Limited, Cape Town 8000, South Africa. Firm initiated recall is ongoing.
REASON
Product contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
45,808 cases
DISTRIBUTION
AL, AR, CA, FL, MI, GA, IN, KY, LA, MS, OH, SC, TN, VA
___________________________________
PRODUCT   
Bausch & Lomb, PreserVision Eye Vitamin and Mineral Supplement, AREDS 2 Formula, with 10 mg Lutein & 1000 mg Omega-3 per day. The product is packaged in 60 count bottles and 2 count blister samples. Order number: AB62589 and AB53242. Recall # F-2642-2010
CODE
Lot numbers: 0923BK103, 0924BK103, 0924BK103A, 0925BK103A, 0926BK103A, 0927BK103A, 0928BK103A, 0929BK103A, 0929BK103A, 0929BK103B, 0930BK103A, 0930BK103B, 0931BK103A, 0931BK103B, 0932BK103A, 0932BK103B, 0933CK103A, 0934CK103A, 0935CK103A, 0935BK103B, 2899FK103
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb Inc., Greenville, SC, by press release on/about July 22, 2010.
Manufacturer: Nutra Manufacturing, Greenville, SC. Firm initiated recall is ongoing.
REASON
Reports of choking and other adverse events due to difficulties with swallowing dietary supplement gels (reported as being too large and hard).
VOLUME OF PRODUCT IN COMMERCE
6,582,240 Softgels
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
De Boles Kids Only! Gluten Free Tubettini Corn Pasta, Net wt 8.5 oz (240 g). Recall # F-2643-2010
CODE
Lot number: 30JUN11D1
RECALLING FIRM/MANUFACTURER
Deboles (Production), Shreveport, LA, by letters on July 21, 2010 and press release on July 22, 2010. FDA initiated recall is ongoing.
REASON
Corn pasta may contain undeclared whole wheat pasta.
VOLUME OF PRODUCT IN COMMERCE
1639 cases of 12 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
Fresh apple slices or wedges packaged in clear, perforated plastic bags in 2 oz and 3 lb sizes and labeled in part: "TREETOP***Apple Slices Net Wt 2 oz ***KEEP REFRIGERATED***INGREDIENTS: Fresh Apples, Calcium Ascorbate. The apple slices come in 2 oz and 3 lb bags; the apple wedges are in 3 lb bags only. Recall # F-2623-2010
CODE
a) 92590409019; b) 92590409014; c) 92590409018 code breakdown: YJJJPPLCPPP Y=year JJJ=julian date PPP=plant LC= line PPP=pallet number
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tree Top Inc - Selah Plant, Selah, WA, by telephone on September 17, 2009.
Manufacturer: Tree Top Ross Plant Fresh Facility, Selah, WA. Firm initiated recall is ongoing.
REASON
Finished product tests found high total coliform counts, however all were <10 Cfu/g for E. coli.
VOLUME OF PRODUCT IN COMMERCE
2 oz bags =100 cases, 300 lbs (gross wt.)///3lb bags of slices=90 cases, approx. 1080 lbs///3lb bags of wedges=12 cases, 156lbs
DISTRIBUTION
OR, ID
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
1) 72 HOURS [Proprietary Blend of White Willow Bark 25%, Bombyx Mori Ext., Ginger Root Powder, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry Powder, Rehmannia Root Powder, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, 1-count pouch and 10-count bottles, OTC. Recall # D-727-2010;
 
2) 72 HOURS [Proprietary Blend of White Willow Bark 25%, Bombyx Mori Ext., Ginger Root Powder, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry Powder, Rehmannia Root Powder, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 481.71 mg, 1-count pouch and 10-count bottle, OTC, UPC 8 55892 00326 0 and 8 51780 002018. Recall # D-728-2010;
 
3) AMOUR AGAIN [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, 2-count pouch and 10-count bottle. Recall # D-729-2010;
 
4) AROUSIN [Proprietary Blend of White Willow Bark 25%, Bombyx Mori Ext., Ginger Root Powder, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry Powder, Rehmannia Root Powder, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, 3-count pouch and 15-count bottle, OTC. Recall # D-730-2010;
 
5) Clyamax [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 375 mg, 4-count pouch and 16-count bottle, OTC. Recall # D-731-2010;
 
6) DEPTH CHARGE [Proprietary Blend of White Willow Bark 25%, Bombyx Mori Ext., Ginger Root Powder, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry Powder, Rehmannia Root Powder, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext., Eurycoma Longifolia Extract, Tribulus Terrestris Extract, L-Arginine] capsules, 380 mg, 2-count bottle, 8-count bottle, and 20-count bottle, OTC. Recall # D-732-201;
 
7) Enhancement [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, 16-count bottle, 32-count bottle, and 64-count bottle, OTC. Recall # D-733-2010;
 
8) ERECTZIA [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 375 mg, 2-count bottle, 4-count bottle, and 15-count bottle, OTC. Recall # D-734-2010;
 
9) EREXA [Proprietary Blend of White Willow Bark 25%, Bombyx Mori Ext., Ginger Root Powder, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry Powder, Rehmannia Root Powder, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, 2-count pouch, 4-count pouch, and 16-count bottle, OTC. Recall # D-735-2010;
 
10) ERE-XXX ELITE BODY [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 375 mg, 2-count pouch and 16-count bottle, OTC. Recall # D-736-2010;
 
11) ERE-XXX Maxi Elite [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed, Cordyceps Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, 16-count bottle, OTC. Recall # D-737-2010;
 
12) EROUSA [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps Ext. 7%, Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 489 mg, 1-count pouch and 12-count bottle, OTC. Recall # D-738-2010;
 
13) EZEREX [Proprietary Blend of White Willow Bark, Bombyx Mori ext., Cordyceps ext. 7%, Horny Goat Weed (Epimedium 10%), Ginger Root, Oyster ext., Charcoal, Green Coffee Bean ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Korean Ginseng, Wolfberry Ext.] 425mg; Vitamin B3 (Niacin) 0.02 mcg; capsules, 4-count bottle and 20-count bottle, OTC. Recall # D-739-2010;
 
14) Finally On DEMAND [Proprietary Blend of White Willow Bark, Bombyx Mori L, Ginger Root, Cordyceps Extract, Epimedium Extract, Oyster, Charcoal, Green Coffee Bean Extract, Vinpocentine, 2DG, Saffron Crocus, Wolfberry] capsules, 425mg, 8-count bottle, OTC, Item# FIN0D01A.  Recall # D-740-2010;
 
15) LIBIPLUS [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps Ext. 7%, Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425mg, 1-count blister, OTC, UPC 8 04879 13018 5. Recall # D-741-2010;
 
16) LOVE FUEL [Proprietary Blend of White Willow Bark, Bombyx Mori L, Ginger Root, Cordyceps Extract, Horny Goat Weed, Oyster Extract, Charcoal, Green Coffee Bean Extract, Vinpocentine, 2DG, Saffron Crocus, Wolfberry] capsules, 425mg, 4-count pouch (UPC 0 05643 89017 9) and 16-count bottle (UPC 0 00052 49739 1), OTC. Recall # D-742-2010;
 
17) RAINBOW ROCKET [Proprietary Blend of White Willow Bark, Bombyx Mori L, Ginger Root, Cordyceps Extract, Horny Goat Weed, Oyster Extract, Charcoal, Green Coffee Bean Extract, Vinpocentine, 2DG, Saffron Crocus, Wolfberry] capsules, 425mg, 4-count pouch (UPC 0 07642 17893 7) and 16-count bottle (UPC 0 01457 69031 8), OTC. Recall # D-743-2010;
 
18) RED HOT SEX [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps Ext. 7%, Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Ginger powder 5%, Wolfberry Ext.] capsules, 425mg, 1-count pouch and 10-count bottle, OTC. Recall # D-744-2010;
 
19) SEXUAL SURGE [Proprietary Blend of White Willow Bark 25%, Bombyx Mori Ext., Ginger Root Powder, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry Pwdr., Rehmannia Root Pwdr, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425mg, 16-count bottle, OTC, Barcode 2570001. Recall # D-745-2010;
 
20) STAMIN IT [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordycepts Ext. 7%, Oyster Ext., Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Yohimbe 10%, Wolfberry Ext.] capsules, 375 mg, 2-count pouch, OTC. Recall # D-746-2010;
 
21) STAMINIL [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps Ext. 7%, Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Yohimbe 10%, Wolfberry Ext.] capsules, 375 mg, 2-count pouch, 20-count pouch, and 20-count bottle, OTC. Proudly made in the U.S.A. Recall # D-747-2010;
 
22) TACKTOL [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed, Cordyceps Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext., Tongkat Ali, Tribulus Terrestris, 20-Beta-Hydroxyecdysterone] capsules, 426 mg, 2-count pouch (barcode 7350034170150) and 16-count bottle (barcode 7350034170143), OTC. Recall # D-748-2010;
 
23) TopViril [Proprietary Blend of White Willow Bark 25%, Bombyx Mori Ext., Ginger Root Powder, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry Pwdr., Rehmannia Root Pwdr, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, 20-count bottle, OTC, N*3734320. Recall # D-749-2010;
 
24) Vaxitrol [Proprietary Blend of Niacin, Horny Goat Weed (Epimedium extract 10%), Cordyceps extract 40%, Yohimbe 8%, Schizandra berry, Rehmannia Root, Korean Ginseng, Bombyx mori extract, Oyster extract and Ginger Root extract 5%)] capsules, 336.8 mg, 16-count bottle, OTC, UPC 7 2689091118 8. Recall # D-750-2010;
 
25) VIERECT [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps Ext. 7%, Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, OTC, 4-count bottle and 16-count bottle. Recall # D-751-2010;
 
26) VIGOR 100 [Proprietary Blend of White Willow Bark 25%, Bombyx Mori Ext., Ginger Root Powder, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry Powder, Rehmannia Root Powder, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, 1-count pouch, 2-count pouch, 3-count pouch, 10-count pouch, and 16-count bottle, OTC. Recall # D-752-2010;
 
27) WHATZ UP RX [Proprietary Blend of White Willow Bark, Bombyx Mori L, Ginger Root, Cordyceps Extract, Epimedium Extract, Oyster, Charcoal, Green Coffee Bean Extract, Vinpocentine, 2DG, Saffron Crocus, Wolfberry] capsules, 425 mg, 8-count bottle, OTC. Recall # D-753-2010;
 
28) XTREAMEXCITE [Proprietary Blend of White Willow Bark, Bombyx Mori L, Ginger Root, Cordyceps Extract, Epimedium Extract, Oyster, Green Coffee Bean Extract, Vinpocentine, 2DG, Saffron Crocus, Wolfberry] capsules, 375 mg, 8-count bottle, OTC. Recall # D-754-2010;
 
29) ZEN ERECT [Proprietary Blend of White Willow Bark, Bombyx Mori Extract, Cordyceps 7% Extract, Epimedium 10% Extract, Ginger Root Extract, Charcoal, Green Coffee Bean Extract, Vinpocentine, Cridium Monnier, L-Arginine Base, Tribulus Terrestris Extract, Schizandra Berry Powder, Rehmannia Root Powder, Niacin, Korean Ginseng] capsules, 425 mg, 16-count bottle, OTC.  Recall # D-755-2010
CODE
1) All lots that contain XXX-705-XX or XXX-706-XX, where X is any number;
 
2) All lots that contain XXX-705-XX, where X is any number;
 
3) All lots that contain XXX-705-XX, where X is any number;
4) All lots that contain XXX-705-XX, where X is any number;
 
5) All lots that contain XXX-705-XX, where X is any number;
 
6) All lots that contain XXX-807-XX or XX-807-XX, where X is any number;
 
7) All lots that contain XXX-705-XX or XXX-706-XX, where X is any number;
 
8) All lots that contain XXX-705-XX or XX-705-XX, where X is any number;
9) All lots that contain XXX-705-XX, where X is any number;
 
10) All lots that contain XXX-705-XX or XX-705-XX, where X is any number;
 
11) All lots that contain XXX-705-XX, where X is any number;
 
12) All lots that contain XXX-705-XX, where X is any number;
 
13) All lots that contain XXX-705-XX or XXX-706-XX, where X is any number;
 
14) All lots that contain XXX-706-XX, where X is any number;
 
15) All lots that contain XXX-705-XX, XXX-520A-XX, or XXX-520B-XX, where X is any number;
 
16) All lots that contain XXX-706-XX, XXX-520A-XX, or XXX-520B-XX, where X is any number;
 
17) All lots that contain XXX-706-XX, where X is any number;
 
18) All lots that contain XXX-705-XX, where X is any number;
 
19) All lots that contain XXX-705-XX, where X is any number;
 
20) All lots that contain XXX-705-XX, XXX-520A-XX, or XXX-520B-XX, where X is any number;
 
21) All lots that contain XXX-705-XX, XXX-520A-XX, or XXX-520B-XX, where X is any number;
 
22) All lots that contain XXX-705-XX, where X is any number;
 
23) All lots that contain XXX-705-XX, where X is any number;
 
24) All lots that contain XXX-520-XX, XXX-520A-XX, XXX-520B-XX, or XXX-520C-XX, where X is any number;
 
25) All lots that contain XXX-705-XX, where X is any number;
 
26) All lots that contain XXX-705-XX, where X is any number;
 
27) All lots that contain XXX-706-XX, where X is any number;
 
28) All lots that contain XXX-706-XX, where X is any number;
 
29) All lots that contain XXX-705-XX, or XXX-779-XX, where X is any number
RECALLING FIRM/MANUFACTURER
Atlas Operations, Inc., Pompano Beach, FL, by press release on December 11, 2009 and April 12, 2010, and letters dated December 22, 2009 and May 17, 2010. Firm initiated recall is ongoing.
REASON
Marketed Without An Approved NDA/ANDA: Atlas Operations is recalling 29 products sold as dietary supplements because FDA laboratory analysis revealed the presence of an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making these products an unapproved new drugs.
VOLUME OF PRODUCT IN COMMERCE
307,993 blisters, pouches, and bottles
DISTRIBUTION
Nationwide, UK, and Sweden
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
1) Oral Saline Laxative (Dibasic sodium phosphate 2.7g/Monobasic sodium phosphate 7.2 g) Ginger Lemon Flavor for relief of occasional constipation, Sugar Free, 1.5 Fl oz (45 mL) bottle, OTC; Product was distributed under the following labels: 1) Best Choice, UPC 0 70038 61131 8; 2) Western Family, UPC 0 15400 12193 4; 3) QC Quality Choice; (CDMA), UPC 6 35515 95528 8; 4) Rite Aid, UPC 0 11822 04105 8; 5) Safeway, UPC 3 21130 78218 6;  6) Select Brand, UPC 0 15127 01713 8; 7) Sunmark, UPC 0 10939 00744 5; 8) American Fare, UPC 0 72000 15068 9; 9) Kroger, UPC 0 41260 33384 2; 10) Major, UPC 3 09045 66675 3; 11) McKesson Medi-Pak Performance, NDC 68599-1051-1; 12) Meijer, UPC 7 19283 51548 3; 13) Premier Value, UPC 8 40986 02005 6; 14) Publix, UPC 0 41415 25073 4; 15) Healthy Accents, UPC 7 25439 93539 5; 16) Good Neighbor Pharmacy, UPC 0 87701 40136 7; 17) GoodSense, UPC 8 46036 00060 3; 18) Hannaford, UPC 0 41268 15052 6; 19) DR duane reade, UPC 6 39194 02335 1; 20) CVS Pharmacy, UPC 0 50428 08445 8; 21) Drug Mart, UPC 0 93351 12193 7; 22) Walgreens, UPC 3 11917 09279 9; 23) Longs, UPC 3 12333 00054 2; 24) The Medicine Shoppe, UPC 0 91899 18213 7; 25) LEADER, UPC 0 96295 11366 2; 26) Relieve, UPC 7 37513 30009 8; 27) TopCare: UPC 0 36800 08904 4; 28) equaline, UPC 0 41163 43255 0; 29) Today's Health, UPC 8 43072 00337 7. 30); CareOne, UPC 341520 31370 7. Recall # D-704-2010;
 
2) Oral Saline Laxative (Dibasic sodium phosphate 2.7g/Monobasic sodium phosphate 7.2 g), Unflavored for relief of occasional constipation, Sugar Free, 1.5 Fl oz (45 mL) bottle, OTC; Product was distributed under the following labels: 1) QC Quality Choice; UPC 6 35515 95709 1. 2) Rite Aid; UPC 0 11822 06521 4. 3) Leader; UPC 0 96295 11444 7. Recall # D-705-2010;
 
3) Oral Saline Laxative (Dibasic sodium phosphate 2.7g and Monobasic sodium phosphate 7.2 g), Cherry Flavor for relief of occasional constipation, Sugar Free, 1.5 FL OZ (45 mL) bottle, OTC; Product was distributed under the following labels: 1) Premier Value; UPC 8 40986 02238 8. 2) Good Neighbor Pharmacy; UPC 0 87701 40293 7. 3) CVS pharmacy; UPC 0 50428 09254 5. 4) Drug mart; UPC 0 93351 12204 0. 5) Walgreens; UPC 3 11917 08498 5. D-706-2010;
 
4) Oral Saline Laxative (Monobasic Sodium Phosphate 2.4 g, Dibasic sodium Phosphate 0.9 g), Lemon Flavor for relief of occasional constipation, Sugar Free, Multi-Dose Container, 3 Fl oz (90 mL) bottle, OTC, Product was distributed under the following labels: 1) Walgreens, Wal-Phosphate, UPC 3 11917 05649 4; 2) Preferred plus Pharmacy; UPC 737513 00156 8. Recall # D-707-2010
CODE
1) Lot numbers: GL70001, GL70002, GL70003, GL70009, GL70010, GL70011, GL70016, GL70019, GL70023, GL70028, GL70030, GL70031, GL70032, GL70033, GL70038, GL70041, GL70042, GL70046, GL70052, GL70053, GL70054, GL70055, GL70058, GL70059, GL70062, GL70063, GL70064, GL70065, GL70066, GL70067, GL70070, GL70071, GL70072, GL70073, GL70074, GL70076, GL70077, GL70082, GL70083, GL70084, GL70092, GL70093, GL70094, GL70099, GL70100, GL70101, GL70102, GL70103, GL70104, GL70107, GL70108, GL70109, GL70110, GL70111, GL70112, GL70114 GL70115, GL70117, GL70118, GL70119, GL80001, GL80002, GL80003, GL80004, GL80005, GL80006, GL80007, GL80008, GL80012, GL80013, GL80014, GL80018, GL80019, GL80020, GL80021, GL80022, GL80023, GL80024, GL80026, GL80027, GL80028, GL80029, GL80030, GL80032, GL80033, GL80034, GL80035, GL80036, GL80037, GL80039, GL80042, GL80044, GL80045, GL80046, GL80048, GL80049 GL80050, GL80051, GL80052, GL80053, GL80055, GL80056, GL80058, GL80059 GL80061, GL80062, GL80063, GL80064, GL80065, GL80067, GL80068, GL80069 GL80070, GL80071, GL80072, GL80073;
 
2) Lot numbers: UF70015, UF70021, UF70022, UF70024, UF70025, UF70029, UF70034, UF70035, UF70047, UF70097, UF70113, UF80010, UF80040, UF80043, UF80060;
 
3) Lot numbers: CF70013, CF70036, CF70037, CF70045, CF70048, CF70060, CF70080, CF70086, CF70087, CF70091, CF70096, CF70105, CF80009, CF80011, CF80015, CF80016, CF80017, CF80025, CF80031, CF80038, CF80047, CF80054, CF80057, CF80066
 
4) Lot numbers: LE70012, LE70018, LE70026, LE70027, LE70039, LE70043, LE70049, LE70051, LE70056, LE70057, LE70061, LE70068, LE70069, LE70075, LE70079, LE70089, LE70090, LE70106
RECALLING FIRM/MANUFACTURER
Perrigo Florida Inc., Lake Worth, FL, by letter on January 7, 2009. Firm initiated recall is complete.
REASON
Label Mix-up: the product label insert mentions one of the uses as bowel cleansing, but products are not recommended for bowel cleansing.
VOLUME OF PRODUCT IN COMMERCE
103,811 Cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Dacarbazine for Injection, USP; 200 mg per 20 ml vial; 10 vials per package; Rx Only. NDC for individual vials is 0703-5075-01 and 0703-5075-03 for package of ten. Recall # D-709-2010
CODE
Lot numbers: 31310439B exp 12/12, 08A622 exp 1/11, 31301567B exp 4/11, 31310475B exp 12/12, 31310096B exp 11/12, 31305393D exp 1/12, and 31311155B exp 2/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter dated March 22, 2010.  
Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA. Firm initiated recall is ongoing.
REASON
Product may exhibit discoloration.
VOLUME OF PRODUCT IN COMMERCE
6700 vials
DISTRIBUTION
AL, CA, FL, GA, IL, PA, TN, and TX
___________________________________
PRODUCT
1) Methimazole USP; Tablets; 5 mg; 100 tablets: 10 blister cards of 10 tablets each packed in an outer carton; Rx Only; NDC #68084-275-01. Recall # D-711-2010;
 
2) Methimazole USP; Tablets; 10 mg; 100 tablets: 10 blister cards of 10 tablets each packed in an outer carton; NDC #68084-276-01. Recall # D-712-2010
CODE
1) Lot 082861, Exp. 12/09; Lot 090243, Exp. 07/10; Lot 084206, Exp. 07/10; and Lot 091657, Exp. 05/10;
 
2) Lot 082862, Exp. 12/09; Lot 090974, Exp. 04/10; and Lot 091270, Exp. 04/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, by letters on September 22, 2009.
Manufacturer: Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI. Firm initiated recall is ongoing.
REASON
Impurities/Degradation products. The product failed 18 month stability testing.
VOLUME OF PRODUCT IN COMMERCE
3,123 cartons of 100 tablets each
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Motrin IB (Ibuprofen) Tablets USP 200 mg, 100 count bottle, OTC, NDC 50580-109-04, UPC 3 0045 0463 04 3. Recall # D-715-2010;
 
2) Motrin IB (Ibuprofen) Caplets, USP 200 mg, a) 24 count bottle, NDC 50580-110-03, UPC 3 0045 0481 030; b) Bonus pack (50+ 25) count bottle, NDC 50580-110-76, UPC 3 0045 0481 764; OTC. Recall # D-716-2010;
 
3) Benadryl (Diphenhydramine HCl) Allergy tablets, 25 mg each, 100 Ultratab bottle, OTC, NDC 50580-226-10; UPC 3 12547 17033 8. Recall # D-717-2010;
 
4) Tylenol (Acetaminophen) Tablets, Extra Strength, 500 mg Each, Easy to Swallow EZ Tabs, a) 50 count bottle, NDC 50580-422-50, UPC 3 00450422507; b) 225 count NDC 50580-422-37, UPC 3 00450422378, OTC. Recall # D-718-2010;
 
5) Children's Tylenol (Acetaminophen) Tablets, Meltaways, Bubblegum Burst flavor, 80 mg, 30 count bottle, OTC, NDC 50580-519-30, UPC 3-0045-0519-306. Recall # D-719-2010;
 
6) Tylenol (Acetaminophen) Caplets, Extra Strength, 500 mg each a) 24 count bottle, NDC 50580-710-24, UPC 3 0045-0444-240, b) 24+12 count bottle, NDC 50580-449-31, UPC 3 0045-0444-318, c) 50 count bottle, NDC 50580-449-06, UPC 3 0045-0444-530, d) 50 count bottle, This Package for Households Without Young Children, NDC 50580-449-07, UPC 3 0045-0449-07 8, OTC. Recall # D-720-2010;
 
7) Tylenol (Acetaminophen) Capsules, Extra Strength, Rapid Release, 500 mg each, a) 225 count, NDC 50580-488-25, UPC 3 0045 0488 251, b) 24 count, NDC, 50580-488-24, UPC 3 0045 0488 244), OTC. Recall # D-721-2010;
 
8) Tylenol PM (Acetaminophen/Diphenhydramine HCl) Caplets, Extra Strength, 500mg/25 mg, a) 24 count bottle, NDC 50580-482-24, UPC 3 0045-0482-242, b) Day & Night Value Pack, 50 count bottle, NDC 50580-527-10, UPC 3 0045-0527-103, OTC. Recall # D-722-2010;
 
9) Tylenol PM (Acetaminophen/Diphenhydramine HCl) Geltab, Extra Strength, 500 mg/25 mg, 50 count bottle, OTC. Recall # D-723-2010;
 
10) Tylenol PM (Acetaminophen/Diphenhydramine HCl) Gelcaps, Extra Strength, Rapid Release, 500 mg/25 mg, 20 count, OTC, NDC 50580-244-20, UPC 3 0045-0244-208. Recall # D-724-2010
CODE
1) Lot Number: AFA060, Exp. Date: 4/30/2012;
 
2) a) Lot number: ACA003 Exp. Date: 11/30/2011 b) Lot number: ACA002 Exp. Date: 9/30/2011;
 
3) a) Lot number: ABA567 Exp. Date: 12/31/2010 b) Lot number: ABA574 Exp. Date: 10/31/2010;
 
4) a) Lot number: ABA005 Exp. Date: 11/30/2010 b) Lot number: ASA206 Exp. Date: 10/31/2011;
 
5) Lot number: ABA544, Exp. Date: 11/30/2010;
 
6) a) Lot number: ABA 566, Exp, Date: 11/30/2010, b) Lot number: ACA025, Exp. Date: 12/31/2012, c) Lot number: AFA018, Exp. Date: 4/30/2013, d) Lot number: ABA168, Exp. Date: 11/30/2012;
 
7) a) Lot number: AJA119, Exp, Date: 6/30/2011 b) Lot number: ACA024, Exp. Date: 12/31/2010;
 
8) Lot number: ACA005, Exp. Date: 1/31/2011, Lot number: ADA259, Exp. Date: 2/28/2011, Lot number: AEC005, Exp. Date: 1/31/2011, Lot number: AFC005, Exp. Date: 11/30/2010, Lot number: ADC002, Exp. Date: 10/31/2010;
 
9) Lot number: AFA100, Exp. Date: 4/30/2011;
 
10) Lot number: ACA004, Exp. Date: 12/31/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc., Fort Washington, PA, by Media, Internet, Fax & Mail beginning July 8, 2010.
Manufacturer: McNeil Healthcare, LLC, Las Piedras, PR. Firm initiated recall is ongoing.
REASON
Chemical Contamination: presence of a chemical called 2,4,6-tribromoanisole (TBA) in products.
VOLUME OF PRODUCT IN COMMERCE
2.468,496 bottles
DISTRIBUTION
Nationwide, Caribbean locations including Trinidad& Tobago, Dominican Republic, Jamaica, Fiji and Guatemal
___________________________________
PRODUCT
1) Benadryl (Diphenhydramine HCl) Allergy Ultratabs, 25 mg each, 100 Ultratab bottle, OTC. Recall # D-725-2010;
 
2) Tylenol Extra Strength Rapid Release Gels (Acetaminophen), 24 and 225 count bottles. Recall # D-726-2010
CODE
1) Lot # AJA008, ABA022, ABA264, ADA194;
2) Lot # ASA202 Expiration date 10/2011
RECALLING FIRM/MANUFACTURER
McNeil Consumer Products Co., Fort Washington, PA, by Media, Internet, Fax & Mail beginning June 8, 2010.
Manufacturer: McNeil Healthcare, LLC, Las Piedras, PR. Firm initiated recall is ongoing.
REASON
Chemical contamination: presence of a chemical called 2,4,6,-tribromoanisole.
VOLUME OF PRODUCT IN COMMERCE
1) 333,288 bottles; 2) 132,120 bottles
DISTRIBUTION
Nationwide, Bermuda, Trinidad and Tobago
___________________________________
PRODUCT
1) Methimazole, USP; 5 mg tablets; 100 or 1000 tablets per bottle (some bulk); Rx; NDC 57664-458-88 (100 count), NDC 57664-458-18 (1000 count). Recall # D-758-2010;
 
2) Methimazole, USP; 10 mg tablets; 100 or 1000 tablets per bottle (some bulk); Rx; NDC 57664-459-88 (100 count), NDC 57664-459-18 (1000 count). Recall # D-759-2010
CODE
1) All lots shipped prior to 6/24/09: 100 count lots: 80008A, 80009A, 81430B, 81431A, 81583B, 81584A, 82294A, 82295A, 82296B, 82297B, 82568A, 82569A, 82570A, 90311A, 90312A, 90313A, 90315A, 90656A, 90657A, 90658A, 90659A and 90660A. 1000 count lots: 80009B, 80010A, 80011A, 81093A, 82296A, 82297A, 82571B and 90314A;
 
2) All lots shipped prior to 6/24/09: 100 count lots: 80012A, 80013A, 81717A, 81718B, 82070A, 82073A, 82566A, 82567A and 90385A. 1000 count lots: 80013B, 80014A, 82071A, 82072A and 90384A
RECALLING FIRM/MANUFACTURER
Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI, by letter dated August 18, 2009. Firm initiated recall is ongoing.
REASON
Impurities/Degradation products. The product failed 18 month stability testing.
VOLUME OF PRODUCT IN COMMERCE
89,032 5 mg bottles; 37,454 10 mg bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
VICKS Sinex (Phenylephrine HCl 0.5%) Spray, Nasal Decongestant, FL OZ (14.7 ml) bottle, OTC; The product was distributed under the following labels: 1) VICKS Sinex VapoSpray, 4 HOUR DECONGESTANT; NDC: 37000-684-01, UPC: 3 23900 00082 7. 2) VICKS Sinex NASAL SPRAY, For Sinus Relief, NDC: 37000-540-05, UPC: 3 23900 00082 7. 3) VICKS Sinex ULTRA FINE MIST, For Sinus Relief, NDC: 37000-541-05, UPC: 3 23900 00085 8. Recall # D-757-2010
CODE
Shipper Case code/ Bottle-Carton Code/ Expiration date: 01171720K1, 0117PR, Mar-13; 00601720K1, 0060PR, Jan-13; 00571720K1, 0057PR, Jan-13; 00511720K1, 0051PR, Jan-13; 00461720K1, 0046PR, Jan-13; 93271720K1, 9327PR, Oct-12; 93151720K1, 9315PR, Oct-12; 92921720K1, 9292PR, Sep-12; 92901720K1, 9290PR, Sep-12; 92721720K1, 9272PR, Aug-12; 92611720K1, 9261PR, Aug-12; 92601720K1, 9260PR, Aug-12; 92591720K1, 9259PR, Aug-12; 92311720K1, 9231PR, Jul-12; 92271720K1, 9227PR, Jul-12; 92261720K1, 9226PR, Jul-12; 92081720K1, 9208PR, Jun-12; 91821720K1, 9182PR, Jun-12; 91801720K1, 9180PR, May-12; 91601720K1, 9160PR, May-12; 91381720K1, 9138PR, Apr-12; 90781720K1, 9078PR, Feb-12; 90761720K1, 9076PR, Feb-12; 90491720K1, 9049PR, Jan-12;; 90481720K1, 9048PR, Jan-12; 90191720K1, 9019PR, Jan-12; 83241720K, 8324PR, Oct-11; 83231720K1, 8323PR, Oct-11; 83181720K1, 8318PR, Oct-11; 82941720K1, 8294PR, Sep-11; 82911720K1, 8291PR, Sep-11; 82521720K1, 8252PR, Aug-11; 82491720K1, 8249PR, Aug-11; 82481720K1, 8248PR, Aug-11; 82241720K1, 8224PR, Jul-11; 82011720K1, 8201PR, Jun-11; 82001720K1, 8200PR, Jun-11; 81991720K2, 8199PR, Jun-11; 81851720K2, 8185PR, Jun-11; 81851720K1, 8185PR, Jun-11; 81431720K1, 8143PR, Apr-11; 81421720K1, 8142PR, Apr-11; 80771720K1, 8077PR, Feb-11; 73371720K1, 7337PR, Nov-10; 73161720K1, 7316PR, Oct-10; 73061720K1, 7306PR, Oct-10; 72911720K1, 7291PR, Sep-10; 72841720K1, 7284PR, Sep-10; 72601720K1, 7260PR, Aug-10; 72561720K1, 7256PR, Aug-10; 72281720K2, 7228PR, Jul-10; 72231720K1, 7223PR, Jul-10; 72221720K1, 7222PR, Jul-10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Procter & Gamble Co, Mason, OH by press release and letter dated June 24, 2010 and letter dated June 24, 2010.
Manufacturer: Olay LLC, Cayey, PR. Firm initiated recall is ongoing.
REASON
Stability Data does not Support Expiration Date/Presence of Precipitate: The product formulation may not meet the expiration dates on the package and found evidence of a chlorhexidien precipitate.
VOLUME OF PRODUCT IN COMMERCE
3.09 million bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
ShopKo Cold/Flu Relief Multi Symptom Night Time Original (Acetaminophen 500mg, Dextromethorphan HBr 15mg, Doxylamine Succinate 6.25mg per 15mL tablespoon); liquid; 10 ounce bottle; UPC: 40064536093; Product Code 2415; OTC. Recall # D-708-2010
CODE
Lot # 4134
RECALLING FIRM/MANUFACTURER
IGI Inc., Buena, NJ, by letter on June 1, 2010. Firm initiated recall is ongoing.
REASON
Superpotency for Doxylamine Succinate during stability testing.
VOLUME OF PRODUCT IN COMMERCE
732 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ACUVAIL (Ketorolac tromethamine) 0.45% Ophthalmic solution, 0.4 mL Vial, Rx only, 1) 5 Single-Use Vials 0.4 mL Each, UPC 3 00233 50705 6; 2) 30 Single-Use Vials 0.4 mL Each, UPC 3 00233 50730 8, NDC 0023-3507-30. Recall # D-756-2010
CODE
Lot numbers 62348, 62377, 62385, 62386, 62391, 62438, 62815, 63191, 64040
RECALLING FIRM/MANUFACTURER
Recalling Firm: Allergan Inc., Irvine, CA, by letters dated July 19, 2010.
Manufacturer: Allergan Sales, LLC, Waco, TX. Firm initiated recall is ongoing.  
REASON
Failed PH Specifications: some lots found to be pH out of specification.
VOLUME OF PRODUCT IN COMMERCE
5,784,792 Unit Dose Vials
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Source Plasma. Recall # B-1497-10
CODE
Units: 3990019541, 3990018999, 3990018782, 3990018227, 3990017967, 3990025475, 3990029063, 3990029000, 3990028812, 3990028490, 3990027876, 3990027172, 3990024966, 3990024611, 3990020732, 3990020188, 3990019823
RECALLING FIRM/MANUFACTURER
International BioResources LLC, Columbus, OH, by facsimile on June 18, 2009 and July 31, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete physical exam prior to donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
NC
___________________________________
PRODUCT   
1) Fresh Frozen Plasma. Recall # B-1577-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1578-10
CODE
1) Unit: 2763721;
2) Units: 2914391, 2763721
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July 12, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was taking the medication Finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX, Austria
___________________________________
PRODUCT   
Red Blood Cells. Recall # B-1844-10
CODE
Unit: 17GC27244
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Saint Paul, MN, by telephone, fax and the LOGICS system on June 7, 2007.
Manufacturer: The American National Red Cross - North Central Region, Saint Paul, MN. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN, IL
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1847-10
CODE
Unit: 17GW07969
RECALLING FIRM/MANUFACTURER
The American National Red Cross – North Central Region, Saint Paul, MN, by telephone, fax and the LOGICS system on May 17, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN, IL   
___________________________________
PRODUCT   
1) Fresh Frozen Plasma. Recall # B-1849-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1850-10;
3) Platelets Leukocytes Reduced. Recall # B-1851-10
CODE
1), 2), and 3) Unit: 17FK88284
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Saint Paul, MN, by fax on May 29, 2007.
Manufacturer: The American National Red Cross – North Central Region, Saint Paul, MN. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
ME, MN
___________________________________
PRODUCT   
Red Blood Cells. Recall # B-1855-10
CODE
Units: 1525295; 1489750
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated February 22, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN, IL
___________________________________
PRODUCT   
Red Blood Cells. Recall # B-1857-10
CODE
Unit: 17KV73364
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Saint Paul, MN, by letter and e-mail on January 17, 2007.
Manufacturer: The American National Red Cross – North Central Region, Saint Paul, MN. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN, IL  
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1859-10
CODE
Units: 2988601; 2988602
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by fax on May 3, 2007 and May 11, 2007. Firm initiated recall is complete.
REASON
Blood products, processed from overweight units of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT   
Skin. Recall # B-1905-10
CODE
Units: 065836741001A, 065836741002A, 065836741003A, 065836741004A, 065836741005A, 065836741006A, 065836741007A, 065836741008A, 065836741009A
RECALLING FIRM/MANUFACTURER
Musculoskeletal Transplant Foundation, Edison, NJ, by letter dated May 24, 2010. Firm initiated recall is complete.
REASON
Skin tissue, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, was distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
PA, DC, CA, CT, MA, GA, DE, NJ
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1910-10
CODE
Unit: 2989641
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on August 29, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-1931-10;
2) Platelets Leukocytes Reduced. Recall # B-1932-10;
3) Fresh Frozen Plasma. Recall # B-1933-10
CODE
1) Units: 32FN05489, 32FN05491, 32FN05485, 32FN05275, 32FN05289, 32FN05357;
 
2) Units: 32FN05502, 32FN05489, 32FN05400, 32FN05443, 32FN05442, 32FN05444, 32FN05491, 32FN05506, 32FN05260, 32FN05275, 32FN05289, 32FN05356, 32FN05258, 32FN05359, 32FN05388, 32FN05394, 32FN05363;
 
3) Units: 32FN05289, 32FN05356
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by telephone or facsimile on December 15, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom the arm scrub was performed incorrectly, were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
IL, PR, WI
___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced. Recall # B-1937-10
CODE
Unit: W065610024459
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by telephone on April 27, 2010 and by facsimile on April 28, 2010. Firm initiated recall is complete.
REASON
Blood product, which tested positive for Hepatitis B surface antigen (HBsAg), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT   
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1942-10
CODE
Unit: W044209529276
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by letter dated March 26, 2010. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as leukoreduced, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT   
Source Plasma. Recall # B-1976-10
CODE
Units: 0690099331, 0690099865
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Lincoln, NB, by letter dated March 18, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Spain
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1977-10
CODE
Unit: 20LH42556
RECALLING FIRM/MANUFACTURER
American National Red Cross, Boise, ID, by letter dated March 15, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, AZ   
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1979-10
CODE
Unit: 0263348
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC, by telephone and facsimile on May 4, 2010 and by telephone on May 5, 2010, May 19, 2010, and June 1, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT   
1) Plasma Frozen within 24 hours (FP24). Recall # B-1980-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1981-10
CODE
1) and 2) 29KT12976
RECALLING FIRM/MANUFACTURER
American National Red Cross – Mid Atlantic Region, Norfolk, VA, by telephone and facsimile on April 5, 2010, and by letter dated May 24, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC, MD
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1982-10
CODE
Unit: W036309249603
RECALLING FIRM/MANUFACTURER
BloodCenter Of Wisconsin, Inc., Milwaukee, WI, by facsimile on March 30, 2010. 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
WI
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-1983-10;
2) Plasma Frozen. Recall # B-1984-10
CODE
1) and 2) Unit: 011FJ27415
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by facsimile on April 27, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MO
___________________________________
PRODUCT   
Fresh Frozen Plasma. Recall # B-1985-10
CODE
Unit: W037709092267
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by telephone on January 26, 2010. 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
OH
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-1986-10;
2) Fresh Frozen Plasma. Recall # B-1987-10
CODE
1) Unit: W037710007892;
2) Units: W037710007869, W037710007872, W037710007886, W037710007888, W037710007891, W037710007890
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by telephone on February 4, 2010. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
OH
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1994-10
CODE
Unit: 012FX26710
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC, by fax on April 29, 2010 and May 3, 2010 and by letter on April 29, 2010. 
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, NC      
___________________________________
PRODUCT   
Source Plasma. Recall # B-1996-10
CODE
Unit: HS0232610
RECALLING FIRM/MANUFACTURER
DCI Biologicals Hot Springs, Inc., Hot Springs National Park, AR, by fax on March 4, 2010 and email on May 6, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a tattoo within 12 months of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
UK
___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced. Recall # B-1997-10
CODE
Unit: 72N686026
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers - Montgomery Region, Montgomery, AL, by fax on May 06, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT   
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2008-10
CODE
Unit: 7179875
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on February 5, 2010. 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
TX
___________________________________
PRODUCT   
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2009-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-2010-10;
3) Fresh Frozen Plasma. Recall # B-2011-10
CODE
1) Unit: 6378948;
2) and 3) Unit: 6390691
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by telephone on February 2, 2010 and by facsimile on February 3, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-2012-10
CODE
Unit: W333410006874
RECALLING FIRM/MANUFACTURER
Mississippi Valley Regional Building Center, Davenport, IA, by telephone and facsimile on April 19, 2010. Firm initiated recall is complete.
REASON
Blood product, which tested positive for Hepatitis B surface antigen (HBsAg), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT   
1) Plasma Frozen. Recall # B-2013-10;
2) Platelets Leukocytes Reduced. Recall # B-2014-10;
3) Red Blood Cells Leukocytes Reduced. Recall # B-2015-10
CODE
1), 2) and 3) Unit: 19GP53171
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services – Tennessee Valley Region, Nashville, TN, by telephone and facsimile on April 8, 2010 and by letter dated April 8, 2010. 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
3 units
DISTRIBUTION
TN, KY
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-2017-10
CODE
Unit: 0262261
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC, by telephone on May 5, 2010 and by letter dated May 5, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC
___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced. Recall # B-2018-10
CODE
Unit: 9082632
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC, by telephone and facsimile on May 5, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-2019-10;
2)Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-2020-10
CODE
1) Unit: 19LJ38828;
2) Unit: 19LS70629
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by facsimile on April 14, 2010 and by letter dated April 14, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN, CA   
___________________________________
PRODUCT   
Source Plasma. Recall # B-2023-10
CODE
Units: GN0260551, GN0260913
RECALLING FIRM/MANUFACTURER
DCI Biologicals, Orlando LLC, Gainesville, FL, by facsimile on April 21, 2010 and by e-mail on May 17, 2010. Firm initiated recall is complete.
REASON
Blood products, which were not quarantined after receiving post donation information concerning receipt of a piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY
___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced. Recall # B-2024-10
CODE
Unit: 72N752600
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on May 19, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced. Recall # B-2025-10
CODE
Unit: 72N238266
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on May 25, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-2028-10
CODE
Unit: W047009306531
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Long Island City, NY, by fax on April 13, 2010 and by letter on May 10, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT   
Source Plasma. Recall # B-2031-10
CODE
Unit: 4180383409
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Charlotte, NC, by e-mail on April 5, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who may have received a tattoo and/or piercing within 12 months of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT   
Source Plasma, For Manufacturing Use Only. Recall # B-2050-10
CODE
Units: FD0352541, FD0353287, FD0353501, FD0354000, FD0354230, FD0354726, FD0354938, FD0356975, FD0357302, FD0360235, FD0362117, FD0362267, FD0362670, FD0362917, FD0363328, FD0363526, FD0363892, FD0364098, FD0364535, FD0364753, FD0365175, FD0378255, FD0378534, FD0379225, FD0379524
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Farmington, NM, by fax dated August 10, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
NC, NY
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-2052-10
CODE
Unit: 2978311
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on March 21, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-2053-10;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-2054-10
CODE
1) Unit: 2955703;
2) Unit: 7120242
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on April 18, 2007. 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
TX
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-1579-10
CODE
Unit: 2914391
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July 12, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was taking the medication Finasteride, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX, Austria
___________________________________
PRODUCT   
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1810-10
CODE
Units: 17FS25729 Part 1, 17FS25729 Part 2
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by fax on May 28, 2007. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA, MN
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-1845-10
CODE
Unit: 17GC27244
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Saint Paul, MN, by telephone, fax and the LOGICS system on June 7, 2007.
Manufacturer: The American National Red Cross - North Central Region, Saint Paul, MN. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL, MN
___________________________________
PRODUCT   
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1846-10
CODE
Units: LJ60103; LJ60103; LJ60131; LJ60131; LJ60142; LJ60142; LJ60147; LJ60147; LJ60154; LJ60154; LJ60171; LJ60171; LJ60193; LJ60199; LJ60214; LJ60214; LJ60242; LJ60242; LJ60147; LJ60208; LJ60208; LJ60229; LJ60229; LJ60241; LJ60241; LJ60261; LJ60261; LJ60263; LJ60263; LJ60285; LJ60290; LJ60290; LJ60298; LJ60298; LJ60307; LJ60307; LJ60330; LJ60330; LJ60345; LJ60345; LJ60370; LJ60370; LJ60407; LJ60407; LJ60480; LJ60480; LJ60528; LJ60528; LJ60559; LJ60559; LJ60991; LJ60991; LJ60903; LJ60903
RECALLING FIRM/MANUFACTURER
Recalling Firm: BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax starting on November 16, 2006.
Manufacturer: BloodCenter of Wisconsin, Inc., Greendale, WI. Firm initiated recall is complete.
REASON
Blood products, collected using equipment that did not undergo performance qualification following repair, were distributed.
VOLUME OF PRODUCT IN COMMERCE
54 units
DISTRIBUTION
WI
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-1848-10
CODE
Unit: 17GW07969
RECALLING FIRM/MANUFACTURER
The American National Red Cross – North Central Region, Saint Paul, MN, by telephone, fax and the LOGICS system on May 17, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN, IL
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1852-10
CODE
Unit: 300574060
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on August 9, 2007.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood product, which contained anti-Fya but which was labeled negative for unexpected antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-1858-10
CODE
Unit: 17KV73364
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Saint Paul, MN, by letter and e-mail on January 17, 2007.
Manufacturer: The American National Red Cross – North Central Region, Saint Paul, MN. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN, IL
___________________________________
PRODUCT   
Source Plasma. Recall # B-1975-10
CODE
Units: 0180238183, 0180233182, 0180239845, 0180240172, 0180233411, 0180234286, 0180234813, 0180235603, 0180236492, 0180237023, 0180237675
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Las Vegas, NV, by letter dated February 22, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for testing positive for hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Spain
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-1978-10
CODE
Unit: 20LH42556
RECALLING FIRM/MANUFACTURER
American National Red Cross, Boise, ID, by letter dated March 15, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, AZ
___________________________________
PRODUCT   
Source Leukocytes. Recall # B-1992-10
CODE
Unit: W066209034696
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by fax on January 23, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1993-10
CODE
Units: 21LG90903, 21LG90917
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by fax on April 12, 2010 and by telephone on April 15, 2010. Firm initiated recall is complete.
REASON
Blood products, collected using a scale that had unacceptable quality control results documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OR
___________________________________
PRODUCT   
Plasma Frozen within 24 hours (FP24). Recall # B-1995-10
CODE
Unit: 012FX26710
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC, by fax on April 29, 2010 and May 3, 2010 and by letter on April 29, 2010. 
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, NC
___________________________________
PRODUCT   
Source Leukocytes. Recall # B-2016-10
CODE
Unit: W066210014554
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by facsimile on May 10, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-2021-10
CODE
Units: 19LJ38828, 19LS70629
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by facsimile on April 14, 2010 and by letter dated April 14, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN, CA
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-2022-10
CODE
Unit: 038KV02948
RECALLING FIRM/MANUFACTURER
American National Red Cross Indiana-Ohio Region, Fort Wayne, IN, by telephone and e-mail on March 16, 2010 and by letter dated March 21, 2010. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving post donation information concerning an illness following donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-2026-10;
2) Recovered Plasma. Recall # B-2027-10
CODE
1) and 2) Unit: W117010164957
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by facsimile and telephone on May 4, 2010. 
Manufacturer: Blood Centers of the Pacific- Peninsula Center, Millbrae, CA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom documentation of an arm check was omitted, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, CA
___________________________________
PRODUCT   
Source Leukocytes. Recall # B-2029-10
CODE
Unit: W066210003459
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by fax on February 8, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT   
Source Leukocytes. Recall # B-2030-10
CODE
Unit: W066210008367
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by fax on March 23, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT   
Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient protocols. Product part numbers: V15-2-000xxxxxx.  Recall # Z-1410-2010
CODE
Serial Numbers: various, non-contiguous as follows: Device Serial Numbers: 37799911, 37799913, 37799914, 37799915, 37800767, 37800768, 37800769, 37800771, 37803641, 37803642, 37803643, 37803644, 37803645, 37803646, 37803647, 37803648, 37803650, 37803651, 37804604, 37804605, 37804606, 37804607, 37804615, 37805136, 37805137, 37805138, 37805139, 37805140, 37805141, 37805142, 37805143, 37805144, 37805145, 37805146, 37805147, 37805148, 37805149, 37805150, 37805151, 37805152, 37805153, 37805154, 37805155, 37805156, 37805157, 37805158, 37805159, 37805160, 37805161, 37805162, 37805163, 37805164, 37805165, 37805166, 37805167, 37805168, 37805169, 37805170, 37805171, 37805172, 37805173, 37805174, 37805182, 37805183, 37805184, 37805185, 37805186, 37805187, 37805188, 37805189, 37805190, 37805191, 37805192, 37805193, 37805194, 37805195, 37805196, 37805197, 37805198, 37805199, 37805201, 37805202, 37808586, 37808587, 37808588, 37808589, 37808590, 37808591, 37808592, 37808593, 37808595, 37808596, 37808597, 37808598, 37808599, 37808600, 37810775, 37810776, 37810777, 37810778, 37810779, 37810780, 37810781, 37810782, 37810783, 37810784, 37810785, 37810786, 37810787, 37810788, 37810789, 37810819, 37810820, 37810821, 37810823, 37811957, 37811958, 37811959, 37811960, 37811961, 37811962, 37811963, 37811964, 37811966, 37811967, 37811969, 37811970, 37811971, 37811972, 37812496, 37812497, 37812498, 37812499, 37812500, 37812501, 37812502, 37812503, 37812504, 37812505, 37812506, 37812507, 37812508, 37812509, 37812510, 37869570, 37869571, 37869572, 37869574, 37869575, 37869576, 37869578, 37869580, 37869582, 37869583, 37869784, 37869785, 37869786, 37869787, 37869788, 37869789, 37869790, 37869791, 37869792, 37869793, 37869800, 37869801, 37869808, 37869809, 37869810, 37869811, 37869812, 37869814, 37869815, 37869816, 37869817, 37869818, 37869820, 37869821, 37869822, 37869823, 37869824, 37869825, 37869826, 37869827, 37869828, 37869829, 37870210, 37870211, 37870212, 37870213, 37870214, 37870215, 37870216, 37870217, 37870218, 37870219, 37870220, 37870221, 37870222, 37870223, 37870224, 37870225, 37870226, 37870228, 37870229, 37870236, 37870245, 37870247, 37870249, 37870250, 37870252, 37870254, 37870255, 37870258, 37870259, 37870260, 37900478, 37900488, 37900602, 37900603, 37900604, 37900608, 37900610, 37900612, 37900615, 37900616, 37900617, 37900623, 37900624, 37900625, 37900626, 37900628, 37900629, 37900630, 37900631, 37900632, 37900633, 37923078, 37923087, 37923100, 37923112, 37923125, 37923155, 37923156, 37923162, 37923201, 37923203, 37923204, 37923205, 37923206, 37923207, 37923208, 37923210, 37923211, 37923213, 37923214, 37924152, 37924153, 37924154, 37924155, 37924156, 37924160, 37924163, 37924164, 37924165, 37928454, 37928455, 37928456, 37928457, 37928458, 37928459, 37928460, 37928461, 37928462, 37928463, 37928790, 37928791, 37928792, 37928793, 37928794, 37928958, 37928960, 37928961, 37928964, 37928967, 37928968, 37930940, 37930942, 37930944, 37930946, 37930948, 37930953, 37930960, 37930962, 37930964, 37930966, 37930968, 37930970, 37930972, 37930974, 37930976, 37930977, 37930979, 37930982, 37930983, 37930984, 37930986, 37930987, 37930988, 37930989, 37930990, 37930991, 37930992, 37930993, 37930994, 37930995, 37930996, 37930997, 37931000, 37931001, 37931003, 37931004, 37931005, 37933237, 37933238, 37933240, 37933241, 37933242, 37933243, 37933244, 37933245, 37933246, 37933247, 37933248, 37933249, 37933250, 37933251, 37933252, 37933253, 37933254, 37933256, 37933257, 37933259, 37933260, 37933261, 37933262, 37933263, 37933264, 37933265, 37933266, 37933267, 37933268, 37933269, 37933271, 37933273, 37933275, 37933276, 37933277, 37933278, 37933279, 37933280, 37937842, 37937843, 37937844, 37937845, 37937846, 37937847, 37937848, 37937849, 37937850, 37937851, 37937852, 37937854, 37937855, 37937856, 37937862, 37937863, 37937864, 37937865, 37937866, 37937867, 37937868, 37937869, 37937870, 37937871, 37937872, 37937873, 37937874, 37937881, 37937883, 37937884, 37937885, 37937886, 37937887, 37937889, 37937890, 37937891, 37937892, 37937893, 37937894, 37937895, 37937896, 37949523, 37949524, 37949525, 37949526, 37949527, 37949528, 37949529, 37949530, 37949531, 37949532, 37949533, 37949534, 37949535, 37949536, 37949537, 37949538, 37949539, 37949540, 37949541, 37949542, 37949543, 37949544, 37949545, 37949546, 37949547, 37949548, 37949549, 37949550, 37949551, 37949552, 37949554, 37949558, 37949559, 37949560, 37949561, 37949562, 37949563, 37949564, 37949565, 37949566, 37952557, 37952558, 37952559, 37952560, 37952561, 37952563, 37952564, 37952565, 37952566, 37952567, 37952568, 37952569, 37952570, 37952571, 37952572, 37952573, 37952574, 37952576, 37952580, 37952581, 37952582, 37952583, 37952584, 37952585, 37952586, 37952587, 37952588, 37952589, 37952590, 37952591, 37952592, 37952593, 37952594, 37952595, 37955465, 37955466, 37955467, 37955468, 37955469, 37955470, 37955471, 37955472, 37955474, 37955475, 37955476, 37955477, 37955478, 37955479, 37955483, 37955491, 37955492, 37955493, 37955494, 37955495, 37955497, 37955499, 37955500, 37955501, 37955502, 37955508, 37955509, 37955510, 37955512, 37955513, 37955514, 37955516, 37955517, 37955518, 37955519, 37955521, 37955523, 37963250, 37963292, 37963295, 37963300, 37963302, 37963303, 37963322, 37963323, 37963324, 37963325, 37963327, 37963328, 37963329, 37963923, 37963926, 37963927, 37963928, 37963929, 37963930, 37963931, 37963932, 37963935, 37964552, 37964554, 37964557, 37964559, 37964560, 37964561, 37964564, 37964565, 37964567, 37964569, 37964575, 37964585, 37964587, 37964588, 37964589, 37964591, 37964594, 37964596, 37964599, 37964600, 37964601, 37964607, 37964608, 37964609, 37964610, 37964613, 37964614, 37964615, 37964617, 37964618, 37964621, 37964622, 37964623, 37964626, 37964628, 37964629, 37964630, 37968304, 37968306, 37968321, 37968323, 37968326, 37968422, 37968424, 37968425, 37968427, 37968429, 37968715, 37968716, 37968717, 37968718, 37968721, 37968722, 37968724, 37976542, 37976544, 37976545, 37976551, 37977472, 37977473, 37977475, 37977476, 37977477, 37977478, 38006814, 38006832, 38006833, 38006834, 38006836, 38006837, 38006838, 38006839, 38006841, 38046540, 38046542, 38046543, 38046544, 38046546, 38046548, 38046549, 38046550, 38046552, 38046553, 38046555, 38046556, 38046557, 38046558, 38046559, 38046561, 38046563, 38046564, 38046565, 38046566, 38046568, 38046569, 38046571, 38046572, 38046573, 38051946, 38051949, 38051950, 38051951, 38051952, 38051954, 38051955, 38051956, 38051957, 38051958, 38051960, 38051961, 38051962, 38051963, 38051964, 38051965, 38051967, 38051969, 38051970, 38051971, 38051972, 38051973, 38051974, 38051975, 38051977, 38051979, 38051980, 38051983, 38051990, 38051992, 38051993, 38051994, 38051995, 38051996, 38052002, 38052003, 38052004, 38052006, 38052008, 38052009, 38052012, 38052014, 38053197, 38053198, 38053199, 38053200, 38053201, 38053203, 38053204, 38053209, 38053210, 38053211, 38053213, 38053215, 38053216, 38053217, 38053218, 38053219, 38053220, 38053221, 38053224, 38053225, 38053229, 38053230, 38053231, 38053233, 38053234, 38053236, 38053237, 38053239, 38053241, 38053246, 38053247, 38053248, 38059562, 38059568, 38059570, 38059571, 38059573, 38059574, 38059575, 38059576, 38059578, 38059582, 38059588, 38059589, 38059591, 38059593, 38059595, 38059596, 38059598, 38059600, 38059602, 38059603, 38059604, 38059605, 38059606, 38059607, 38059608, 38062627, 38062630, 38069610, 38120768, 38120769, 38120770, 38120771, 38120772, 38120773, 38120774, 38120775, 38120776, 38120777, 38120779, 38120780, 38120781, 38120782, 38120783, 38120784, 38120785, 38120786, 38120787, 38120788, 38120789, 38120790, 38120791, 38124016, 38124017, 38124018, 38124019, 38124020, 38124022, 38124027, 38124028, 38124029, 38124030, 38124031, 38124032, 38124033, 38124034, 38124035, 38124036, 38124041, 38124042, 38124043, 38124044, 38124046, 38124047, 38124048, 38124049, 38125969, 38125970, 38125971, 38125972, 38125973, 38125974, 38125975, 38125976, 38125977, 38125978, 38125979, 38125980, 38125981, 38125982, 38125983, 38125984, 38125985, 38125986, 38125987, 38125988, 38125989, 38125990, 38125991, 38125994, 38126252, 38126253, 38126254, 38126255, 38126256, 38126257, 38126258, 38126259, 38126260, 38126261, 38126262, 38126263, 38126265, 38126267, 38126268, 38126269, 38126270, 38126271, 38126272, 38126273, 38126274, 38126276, 38126277, 38127128, 38127130, 38127131, 38127132, 38127133, 38127134, 38127135, 38127136, 38127137, 38127138, 38127139, 38127140, 38127141, 38127143, 38127144, 38127145, 38127146, 38127147, 38129758, 38130272, 38130273, 38130275, 38130276, 38130277, 38130278, 38130279, 38130280, 38130281, 38130282, 38130283, 38130284, 38130285, 38130286, 38130287, 38131588, 38131589, 38131591, 38131592, 38131597, 38131598, 38131599, 38131600, 38131602, 38131603, 38131605, 38131606, 38131607, 38131608, 38131756, 38131757, 38131758, 38131759, 38131760, 38131761, 38131762, 38131763, 38131764, 38131765, 38131767, 38131768, 38131769, 38131770, 38131772, 38131773, 38131774, 38131775, 38131776, 38131777, 38131779, 38131781, 38131782, 38131842, 38131843, 38131844, 38131845, 38131937, 38132365, 38132366, 38132368, 38132370, 38132371, 38132653, 38132947, 38132948, 38132950, 38132951, 38132953, 38132954, 38133884, 38133885, 38133886, 38133887, 38133888, 38134508, 38134510, 38134511, 38134512, 38134515, 38134516, 38134517, 38134518, 38134520, 38134521, 38134522, 38134523, 38134524, 38134525, 38135120, 38135127, 38135171, 38135181, 38135186, 38135198, 38135205, 38135210, 38135211, 38135212, 38135213, 38135214, 38135215, 38135216, 38135217, 38135218, 38135219, 38135220, 38135221, 38136504, 38136505, 38136506, 38136507, 38136508, 38136509, 38136510, 38136512, 38136513, 38136514, 38136515, 38136516, 38136517, 38136518, 38136519, 38136520, 38136522, 38136523, 38137115, 38137116, 38137122, 38137134, 38137136, 38137137, 38137138, 38137143, 38137149, 38137155, 38137156, 38137161, 38137168, 38137174, 38137178, 38138844, 38138845, 38138846, 38141001, 38141002, 38141003, 38141004, 38141005, 38141006, 38141007, 38141008, 38141009, 38141010, 38141012, 38141014, 38141015, 38141016, 38141017, 38141018, 38141020, 38141023, 38141025, 38141027, 38141028, 38142062, 38142064, 38142065, 38142067, 38142068, 38142070, 38142071, 38142073, 38142077, 38142079, 38142559, 38142564, 38142565, 38142566, 38142567, 38142568, 38142569, 38142574, 38142575, 38142741, 38142742, 38142743, 38142941, 38142943, 38142944, 38142945, 38142946, 38142947, 38142948, 38142949, 38142950, 38142951, 38142952, 38143265, 38143266, 38143268, 38143269, 38143270, 38143272, 38143274, 38143275, 38143276, 38143277, 38143279, 38143280, 38143282, 38143288, 38143289, 38143290, 38143291, 38143292, 38143294, 38143296, 38143297, 38143298, 38143299, 38143300, 38143301, 38143302, 38143843, 38143844, 38143845, 38145711, 38145723, 38145724, 38147665, 38147670, 38147673, 38147680, 38147681, 38147682, 38147683, 38147684, 38147687, 38147688, 38147689, 38148017, 38148019, 38148020, 38148021, 38148026, 38148028, 38148031, 38148032, 38148033, 38148034, 38148035, 38148040, 38148041, 38148043, 38148045, 38148047, 38148048, 38148050, 38148051, 38148053, 38148054, 38148056, 38148057, 38148059, 38148060, 38148061, 38148062, 38148063, 38148065, 38148066, 38148067, 38148068, 38148069, 38148070, 38148072, 38148073, 38148074, 38148076, 38148079, 38148080, 38148081, 38148082, 38148083, 38148084, 38148085, 38148086, 38148088, 38150685, 38150687, 38150688, 38150691, 38150692, 38150693, 38150694, 38150695, 38150696, 38150697, 38150700, 38150701, 38150704, 38150705, 38150706, 38150707, 38150708, 38150709, 38150710, 38151892, 38151893, 38151894, 38151895, 38151896, 38151897, 38151898, 38151899, 38153123, 38153124, 38153126, 38153127, 38153128, 38153130, 38153131, 38153132, 38153133, 38153134, 38153135, 38153136, 38153138, 38153140, 38153141, 38153142, 38153143, 38153864, 38153865, 38153866, 38153867, 38153870, 38153871, 38153876, 38153877, 38153878, 38153879, 38153880, 38153881, 38153884, 38153888, 38153889, 38153890, 38153891, 38153892, 38154511, 38154513, 38154514, 38154515, 38154516, 38154517, 38154518, 38154519, 38154520, 38154521, 38154522, 38154523, 38154524, 38154525, 38155371, 38155372, 38155376, 38155378, 38155379, 38155380, 38155381, 38155382, 38155850, 38155851, 38155856, 38155857, 38155864, 38155865, 38155882, 38155889, 38155900, 38155905, 38155906, 38155907, 38155911, 38155912, 38155913, 38155914, 38155918, 38155919, 38155920, 38155924, 38156569, 38156570, 38156571, 38156573, 38156574, 38156575, 38157896, 38157897, 38157899, 38157900, 38157901, 38157903, 38157904, 38157905, 38157906, 38157907, 38157908, 38157909, 38157910, 38157911, 38157912, 38157913, 38157914, 38157915, 38157916, 38157917, 38158071, 38158072, 38158074, 38158075, 38158076, 38158078, 38158079, 38158080, 38158081, 38158082, 38158083, 38158084, 38158085, 38158086, 38158087, 38158088, 38158089, 38158090, 38158091, 38159137, 38159138, 38159139, 38159141, 38159142, 38159144, 38159145, 38159151, 38159152, 38159153, 38159156, 38159157, 38159158, 38159159, 38159160, 38159162, 38159163, 38159165, 38159167, 38159169, 38159170, 38159171, 38159172, 38159174, 38159180, 38159181, 38159182, 38159183, 38159185, 38159187, 38159188, 38159190, 38159192, 38159195, 38159197, 38159200, 38159201, 38160075, 38160078, 38161892, 38161893, 38161894, 38161895, 38161896, 38161897, 38161898, 38161899, 38161900, 38161901, 38161902, 38161903, 38161904, 38161905, 38161906, 38161907, 38161908, 38161909, 38161910, 38161911, 38161912, 38161913, 38161915, 38161917, 38162528, 38162531, 38162535, 38162538, 38162541, 38162543, 38162545, 38162548, 38162551, 38162553, 38162557, 38162559, 38162561, 38162562, 38162565, 38162565, 38162566, 38162567, 38162573, 38162574, 38162576, 38162578, 38162580, 38162581, 38162583, 38162584, 38162586, 38162588, 38162589, 38162591, 38162592, 38162594, 38162595, 38162597, 38162598, 38162599, 38162602, 38162604, 38162605, 38162606, 38162609, 38162610, 38164390, 38164391, 38164393, 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RECALLING FIRM/MANUFACTURER
Physio Control, Inc., Redmond, WA, by letter dated March 2010. Firm initiated recall is ongoing.
REASON
Potential for the device to power off then on by itself, or to power off by itself and requiring the operator to turn it back on, or the device doesn't turn off.
VOLUME OF PRODUCT IN COMMERCE
3,609 (1,242 Nationwide and 2,159 Internationally)
DISTRIBUTION
Nationwide, Netherlands, Germany, Canada, Australia, and Hong Kong
___________________________________
PRODUCT   
Cardiac Science, Automated External Defibrillator (AED) under the following brand names (with respective model numbers): Powerheart AED G3: 9300A, 9300C, 9300D, 9300E, 9300P, 9390A/E; CardioVive: 92532 and 92533; Nihon Kohden: 9200G, and 9231; and Responder: 2019198 and 2023440. Indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. The affected devices were manufactured between October 29, 2003 and February 10, 2009. Recall # Z-1424-2010
CODE
Serial Numbers: 331104, 331604, 337397, 337878, 339693, 340376, 341871, 342086, 344846, 345416, 345909, 346118, 352290, 355192, 358479, 361455, 361573, 362241, 363055, 363268, 363491, 363662, 364586, 370323, 371556, 378795, 387103, 390455, 902084, 4001786, 4002442, 4006599, 4006773, 4008380, 4009395, 4017448, 4029897, 4030020, 4031719, 4035141, 4037678, 4038609, 4038631, 4039224, 4039431, 4039467, 4039645, 4039672, 4039807, 4040185, 4040577, 4040749, 4040833, 4041493, 4041535, 4041684, 4042176, 4042279, 4042808, 4043020, 4043292, 4044056, 4044528, 4044602, 4044862, 4045071, 4045087, 4045252, 4045536, 4045614, 4046271, 4046456, 4046647, 4047057, 4047176, 4047282, 4047283, 4047743, 4048352, 4048662, 4048730, 4048741, 4048941, 4100095, 4101486, 4102240, 4102554, 4102687, 4102872, 4103794, 4104098, 4104101, 4104118, 4104164, 4104492, 4104507, 4104622, 4104660, 4104970, 4105065, 4105091, 4105230, 4105549, 4105836, 4106271, 4106382, 4106588, 4106694, 4106729, 4107001, 4107262, 4107491, 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4185007, 4185021, 4185204, 4186135, 4186565, 4186914, 4187049, 4187425, 4187429, 4187442, 4187456, 4187505, 4187528, 4187699, 4187823, 4187862, 4188125, 4188285, 4188348, 4188396, 4188550, 4188929, 4189057, 4189408, 4189417, 4189423, 4189872, 4189940, 4190140, 4190185, 4190222, 4190348, 4190743, 4190784, 4191191, 4191485, 4191805, 4191927, 4192037, 4192125, 4192270, 4192605, 4192665, 4192708, 4192754, 4193111, 4193204, 4193306, 4193951, 4193975, 4194236, 4194389, 4194403, 4194409, 4194422, 4194480, 4194993, 4195072, 4195100, 4195137, 4195348, 4195760, 4196115, 4196640, 4196734, 4197173, 4197390, 4197707, 4198049, 4198465, 4198497, 4198643, 4198796, 4198883, 4199702, 4199781, 4200226, 4200491, 4200501, 4200531, 4200671, 4200811, 4200823, 4200910, 4200911, 4201196, 4201278, 4201628, 4201855, 4201922, 4201983, 4202009, 4202083, 4202138, 4202517, 4202720, 4203084, 4203375, 4203777, 4203804, 4203846, 4204264, 4204368, 4204523, 4204589, 4204992, 4205228, 4205458, 4205479, 4205683, 4205796, 4205809, 4206165, 4206321, 4206486, 4206559, 4207016, 4207047, 4207127, 4207335, 4207903, 4207930, 4208070, 4208076, 4208318, 4208415, 4208552, 4208881, 4209024, 4209178, 4209366, 4209440, 4210123, 4210136, 4210315, 4210586, 4210625, 4210649, 4210761, 4210916, 4210953, 4210968, 4211043, 4211083, 4211281, 4211379, 4211508, 4211692, 4211712, 4211795, 4211832, 4211968, 4212149, 4212194, 4212391, 4212412, 4212886, 4212956, 4213501, 4213588, 4213700, 4213736, 4213743, 4213866, 4213901, 4213961, 4214229, 4214256, 4214552, 4214950, 4214976, 4215024, 4215031, 4215063, 4215297, 4215407, 4215416, 4215455, 4215599, 4215870, 4215961, 4216011, 4216284, 4216336, 4216371, 4216467, 4216503, 4216610, 4216671, 4216767, 4216841, 4216946, 4216980, 4217166, 4217217, 4217372, 4217505, 4217591, 4217625, 4217651, 4217652, 4217861, 4217904, 4217914, 4218050, 4218317, 4218318, 4218324, 4218331, 4218441, 4218629, 4218666, 4218932, 4218968, 4219107, 4219148, 4219155, 4219381, 4219954, 4220334, 4220423, 4220715, 4220743, 4221053, 4221202, 4221522, 4221644, 4221934, 4221996, 4222205, 4222411, 4222554, 4222581, 4222582, 4222681, 4222883, 4222950, 4222963, 4223039, 4223054, 4223107, 4223664, 4223848, 4224027, 4224121, 4224152, 4224686, 4225092, 4225353, 4225545, 4225622, 4226025, 4226061, 4226121, 4226256, 4226310, 4226324, 4226462, 4226652, 4226719, 4226895, 4227193, 4227213, 4227469, 4227526, 4227549, 4227660, 4227769, 4227823, 4227824, 4227863, 4227903, 4228076, 4228113, 4228391, 4228656, 4228830, 4228862, 4228875, 4228892, 4229027, 4229070, 4229208, 4229485, 4229512, 4229529, 4229589, 4229648, 4229820, 4229939, 4230005, 4230129, 4230770, 4230985, 4231016, 4231074, 4231217, 4231627, 4231728, 4231793, 4231810, 4231875, 4231918, 4232144, 4232345, 4232426, 4232464, 4232517, 4232538, 4232558, 4232670, 4232671, 4232806, 4232914, 4232944, 4233153, 4233607, 4234032, 4234432, 4234739, 4234787, 4234800, 4236149, 4236181, 4236259, 4236319, 4236567, 4236753, 4236759, 4236805, 4236883, 4237341, 4237486, 4237490, 4237582, 4237595, 4237672, 4237714, 4237859, 4237983, 4240118, 4240204, 4240544, 4240707, 4242546, 4242592, 4243602, 4243627, 4244211, 4244258, 4244262, 4244279, 4244303, 4244432, 4244538, 4244746, 4244817, 4245198, 4245301, 4245487, 4245607, 4246012, 4246013, 4246030, 4246096, 4246395, 4246529, 4246533, 4246573, 4246620, 4246896, 4247013, 4247029, 4247036, 4247205, 4247256, 4247399, 4247461, 4247607, 4247679, 4247681, 4247687, 4247933, 4248178, 4248570, 4248629, 4248996, 4249504, 4249511, 4249535, 4250443, 4250521, 4250550, 4250919, 4250937, 4250983, 4251443, 4252619, 4252668, 4253145, 4211109ppc, 4221006ppc, 4221940ppc, 4227360ppc, 4227446ppc, 4230124ppc, 4230260ppc, 4238396ppc, 4239157ppc, and 4243424ppc
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardiac Science Corp., Bothell, WA, by letters dated October 2009. 
Manufacturer: Cardiac Science Corp., Deerfield, WI. Firm initiated recall is ongoing.
REASON
Certain models of Powerheart G3 AEDs may not have received adequate electrical safety testing prior to being shipped from the factory.
VOLUME OF PRODUCT IN COMMERCE
1171 (Nationwide 569; Internationally 602)
DISTRIBUTION
Nationwide, Australia, Belgium, Canada, Chile, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Marshall Islands, Nigeria, Norway, Philippines, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, and the United Kingdom
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT   
1) AC power cords manufactured by Electri-Cord with tall bridge design. Used across all Philips product lines, as well as Respironics/Philips products, Dixtel owned products and Dixtal (formerly Novametrix or Respironics/Novametrix products. Philips HeartStart MRx Defibrillator/Monitor model number M3535A. For use for the termination of ventricular tachycardia and ventricular fibrillation. Recall # Z-1257-2010;
 
2) HeartStart MRx Defibrillator/Monitor. For use for the termination of ventricular tachycardia and ventricular fibrillation. Recall # Z-1258-2010;
 
3) HeartStart MRx- AC power module kit. For use for the termination of ventricular tachycardia and ventricular fibrillation. Model # M3539A. Recall # Z-1259-2010;
 
4) DeviceLink Connectivity Hardware. Supports Philips specified manufacturers' devices including urimeters, ventilators, oximeters, patient monitors, infusion pumps and anesthesia machines. Recall # Z-1260-2010;
 
5) Evaluation Kit, Capnostat 5, Respironics/Philips Product. Intended use of the Capnostat 5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system. Recall # Z-1261-2010;
 
6) NICO2, Model 7600 Respironics/Philips Product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation. Recall # Z-1262-2010;
 
7) Sharn TidalGuard SP 710V, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care. Recall # Z-1263-2010;
 
8) C5 LOFLO Evaluation Kit, Respironics/Philips product. Intended use of the LoFlo C5 CO2 sensor is to provide carbon dioxide monitoring. Recall # Z-1264-2010;
 
9) Evaluation Kit, LOFLO Engine, Respironics/Philips product. Intended use of the LoFlo C5 CO2 sensor is to provide carbon dioxide monitoring. Recall # Z-1265-2010;
 
10) 100-120V Capnogard 1265, Respironics/Philips product. Intended to be used for monitoring end tidal CO2 and respiration rate in all critical monitoring environments. Recall # Z-1266-2010;
11) Spanish Capnogard 1265, Respironics/Philips product. Intended to be used for monitoring end tidal CO2 and respiration rate in all critical monitoring environments. Recall # Z-1267-2010;
 
12) Cosmo - Model 7100 SP02 & ETC02 Monitor, Respironics./Philips product. Intended to be used for monitoring end tidal CO2, respiration rate, oxygen saturation and pulse rate in critical monitoring environments. Recall # Z-1268-2010;
 
13) Spanish 100-120V Cosmo - 7100 Capnograp, Respironics/Philips products. Intended to be used for monitoring end tidal CO2, respiration rate, oxygen saturation and pulse rate in critical monitoring environments. Recall # Z-1269-2010;
 
14) Transcutaneous C02 & O2 Monitor - 860, Respironics/Philips product. Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 measurements. Recall # Z-1270-2010;
 
15) French 100-120V 860 TC C02 & 02 Monitor, Respironics/Philips product. Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 measurements. Recall # Z-1271-201;
 
16) Spanish 100-120V TCOM-860, Respironics/Philips product. Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 measurements. Recall # Z-1272-2010;
 
17) Tidal wave, Model 610, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care. Recall # Z-1273-2010;
 
18) Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product. Used to provide spirometric, carbon dioxide and pulse oximetry monitoring. Recall # Z-1274-2010;
 
19) Spanish 100-120V Cosmo Plus 8100, Respironics/Philips product. Used to provide spirometric, carbon dioxide and pulse oximetry monitoring. Recall # Z-1275-2010;
 
20) TidalWave SP 710, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care. Recall # Z-1276-2010;
 
21) Japanese TidalWave SP 710, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care. Recall # Z-1277-2010;
 
22) Tidal Wave Sp Model 715, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care. Recall # Z-1278-2010
 
23) Japanese TidalWave SP 715, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care. Recall # Z-1279-201;
 
24) 100-120V NICO, 7300 Cardio Mgt system, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU; spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department. Recall # Z-1280-2010;
 
25) French 100-120V NICO 7300, Respironics/Philips product. Intended use is: cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU ; spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department. Recall # Z-1281-2010;
 
26) Spanish 100-120V NICO 7300, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU; spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department. Recall # Z-1282-2010;
 
27) Tidal Wave Model 615, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care. Recall # Z-1283-2010;
 
28) NIC02 Model 7600 Demo Unit, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU;spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department. Recall # Z-1284-2010
 
29) NIC02 Model 7600 Refurbished, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU; spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department. Recall # Z-1285-2010;
 
30) 100-120V Capnogard 1265, Refurbished, Respironics/Philips product. Intended to be used for monitoring end tidal CO2 and respiration rate in all critical monitoring environments in ventilator support, patient support and anesthesia. Recall # Z-1286-2010;
 
31) Cosmo Model 7100 SP02 & ETC02 Monitor, Refurbished, Respironics/Philips product. Intended to be used for monitoring end tidal CO2, respiration rate, oxygen saturation and pulse rate in critical monitoring environments including ventilator support and anesthesia. Recall # Z-1287-2010;
 
32) Transcutaneous C02 & 02 Monitor - 860, Refurbished, Respironics/Philips product. Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 measurements. Recall # Z-1288-2010;
 
33) Tidal Wave 610, Refurbished, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care. Recall # Z-1289-2010;
 
34) Resp Profile Monitor, 8100 Cosmo+, Refurbished, Respironics/Philips product. Used to provide spirometric, carbon dioxide and pulse oximetry monitoring during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Recall # Z-1290-2010;
 
35) Refurbished Tidal Wave SP 710, Refurbished, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care. Recall # Z-1291-2010
 
36) Refurbished Tidal Wave SP 715, Refurbished, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care. Recall # Z-1292-2010;
 
37) 100-200V NICO, 7300 Cardio Mgt System, Refurbished, Respironics/Philips product. The intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU; spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the ICU and emergency department. Recall # Z-1293-2010;
 
38) Tidal Wave - 615, Refurbished, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care. Recall # Z-1294-2010;
 
39) 100-120V Oxypleth - 520A Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Recall # Z-1295-2010;
 
40) Japanese 100-120V Oxypleth - 520A Pulse Oximeter- Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Recall # Z-1296-2010;
 
41) Span 100-120V 520A - OxyPleth Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Recall # Z-1297-2010;
 
42) 515B Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Recall Z-1298-2010;
 
43) French 100-120V 515B Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Recall Z-1299-2010;
 
44) 100-120V 515B with RS-232 Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Recall # Z-1300-2010;
 
45) Spanish 100-120V 515B Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Recall # Z-1301-2010;
 
46) 100-120V 2001 Pulse Oximeter with Mars - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Recall # Z-1302-2010;
 
47) 100-120V 2001 Pulse Oximeter with Mars Nurse Call - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Recall # Z-1303-2010;
 
48) Spanish 100-120V 2001 Pulse Oximeter WI - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Recall # Z-1304-2010;
 
49) 100-120V Oxypleth - 520A Pulse Oximeter, Refurbished - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Recall # Z-1305-2010;
 
50) 515B Pulse Oximeter, Refurbished - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Recall # Z-1306-2010;
 
51) 515B Pulse Oximeter, RS232, Refurbished - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Recall # Z-1307-2010;
 
52) 100-120V 2001 Pulse Oximeter with Mars, Refurbished - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Recall # Z-1308-2010;
 
53) 100-120V 2001 Pulse Oximeter with Mars Nurse Call, Refurbished - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Recall # Z-1309-2010
CODE
1) ID # 861288;
2) ID # 861289;
3) ID # 861287;
4) ID # 865123
5) ID # 1021948;
6) ID # 1024839;
7) ID #1027703;
8) ID # 1040075;
9) ID # 1043294;
10) ID # 5555-00
11) Model/ID # 5555-SPA;
12) Model/ID # 5758-00;
13) Model/ID # 5758-SPA;
14) Model/ID # 6590-00;
15) Model/ID # 6590-FRE;
16) Model/ID # 6590SPA;
17) Model/ID # 6700-00;
18) Model/ID # 6758-00;
19) Model/ID # 6758-SPA;
20) Model/ID # 9110-00;
21) Model/ID # 9110-JPN;
22) Model/ID # 9146-00;
23) Model/ID # 9146-JPN;
24) Model/ID 9226-00;
25) Model/ID 9226-FRE;
26) Model/ID 9226-SPA;
27) Model/ID 9425-00;
28) Model/ID DU1024839;
29) Model/ID U1024839;
30) Model/ID U5555-00;
31) Model/ID U5785-00;
32) Model/ID U6590-00;
33) Model/ID U6700-00.
34) Model/ID U6758-00;
35) Model/ID U9110-00;
36) Model/ID U9146-00;
37) Model/ID U9226-00;
38) Model/ID U9425-00;
39) Model/ID 5693-00;
40) Model/ID 5693-JPN;
41) Model/ID 5693-SPA;
42) Model/ID 6500-00;
43) Model/ID 6500-FRE;
44) Model/ID 6500R-00;
45) Model/ID 6500-SPA;
46) Model/ID 9400-00;
47) Model/ID 9400N-00;
48) Model/ID 9400-SPA;
49) Model/ID U5693-00;
50) Model/ID U6500-00;
51) Model/ID # U6500R-00;
52) Model/ID # U9400-00;
53) Model/ID U9400N-00
RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA, by telephone beginning November 20, 2009. Firm initiated recall is ongoing.
REASON
Power cords’ prongs may crack or fail – Philips was notified that FDA is investigating whether certain types of Electric-Cord Manufacturing Co power cords used with medical devices may be defective in that the power cord’s prongs may crack and fail at/or inside the plug. Potential for burns or electrical shock.
VOLUME OF PRODUCT IN COMMERCE
37,997 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT   
1) GE Centricity PACS-IW software. Device that receives stores and communicates medical images and data from various imaging sources. Recall # Z-1402-2010
 
2)GE Centricity Web Diagnostic (WebDX) software; Device that receives stores and communicates medical images and data from various imaging sources. Recall # Z-1403-2010
CODE
1) Software version 3.7.3;
2) Software version 1.0.0.2
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare It, Barrington, IL, by letter dated February 11, 2010.  
Manufacturer: Dynamic Imaging, LLC, Allendale, NJ. Firm initiated recall is ongoing.
REASON
There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software when dragging-and-dropping images from the Navigator causing flipping of the images that may impact patient safety.
VOLUME OF PRODUCT IN COMMERCE
42 units
DISTRIBUTION
CA, IL, IN, MN, NV, NY, WI, Austria, Canada, Finland, France, Germany, Ireland, Lebanon, Japan, Philippines, Saudi Arabia, Singapore, Switzerland, Turkey, United Arab Emirates and the United Kingdom
___________________________________
PRODUCT   
Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2.  Intended for use as a radiation therapy treatment of malignant neo-plastic diseases, as determined by a licensed medical practitioner. Recall # Z-1405-2010
CODE
Serial Numbers: 151008, 151024, 151025, 151033, 151038, 151051, 151053, 151055, 151059, 151073, 151074, 151076, 151080, 151084, 151093, 151104, 151110, 151130, 151134, 151141, 151143, 151151, 151154, 151155, 151156, 151157, 151160, 151167, 151168, 151173, 151176, 151178, 151216, 151228, 151229, 151238, 151245, 151250, 151253, 151256, 151259, 151260, 151266, 151267, 151269, 151298, 151301, 151305, 151309, 151317, 151325, 151326, 151327, 151328, 151340, 151352, 151359, 151360, 151362, 151363, 151369, 151371, 151387, 151394, 151398, 151411, 151416, 151421, 151422, 151423, 151430, 151433, 151435, 151441, 151446 and 151479
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated December 12, 2008. 
Manufacturer: Elekta Oncology Systems (Fmrl Philipps), West Sussex, United Kingdom. Firm initiated recall is ongoing.
REASON
It is possible that two (or more) CT reference data sets are necessary for one patient, for example, if you have to scan a patient during breath hold and then again during free breathing.
VOLUME OF PRODUCT IN COMMERCE
76 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO. Designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Recall # Z-1731-2010
CODE
Lot number: G775032
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merit Medical Systems, Inc., South Jordan, UT, by telephone beginning May 5, 2010.
Manufacturer: Merit Medical Systems, Inc., Angleton, TX. Firm initiated recall is complete.
REASON
Marker bands on angiographic catheters may not be properly attached, allowing movement of the bands.
VOLUME OF PRODUCT IN COMMERCE
96 units
DISTRIBUTION
GA, IL, MO, NY, PA and WI
___________________________________
PRODUCT   
Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. a) Includes models Amber, Amethyst, Blueberry Crush, BumbleBee Yellow, Denim Blue, Envious Green, Honey, Pebble Gray, Marble Swirl, Royal Blue, Ultraviolet, HA11, HA12, HA13, HA14, HA16, HL21, HL22, HL23, HL24, HL26, Fierce Fandango and Holiday Green; b) inlcudes models Copper, Gotham Gray, HJ31, HW21, HW22, Jade and Natural Hazel; c) includes models Aquamist, Artic Blue, Deep Ocean Blue, HJ35, HJ36 and HW26; d) includes models HJ33, HJ34, HW23, HW24, Lavender, Lazer Green, Sour Apple Green and Vibrant Violet; and e) includes models 011, 015, 024, 029, 032, 033, 035, 043-1, 044, 046, 047, 049, 055, 063-1, 064, 071, 079, 085 and 088. Recall # Z-1756-2010
CODE
a) Lot Number D01704; b) Lot Number D01711; c) Lot Number D01712; d) Lot Number D01713; e) Lot (unidentified)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kim's Trading Inc., Bethlehem, PA, by telephone on May 12, 2010.
Manufacturer: Dreamcon Co., Yangsan City, Republic Of (South), Korea. Firm initiated recall is ongoing.
REASON
Recall is being conducted because the recalled color cosmetic contact lenses are unapproved medical devices.
VOLUME OF PRODUCT IN COMMERCE
300 units (one pair/unit)
DISTRIBUTION
PA
___________________________________
PRODUCT   
Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial and neonate whole blood. Recall # Z-1783-2010
CODE
Lot Number: 0309019249, Expiration Date: 1/31/2011
RECALLING FIRM/MANUFACTURER
Nova Biomedical Corp., Waltham, MA, by telephone and follow up by email and/or fax dated February 12, 2010. Firm initiated recall is ongoing.
REASON
Glucose strips report low glucose results.
VOLUME OF PRODUCT IN COMMERCE
392 Cases (1800 Test Strips per Case)
DISTRIBUTION
CO, MA, MN, RI, United Kingdom, Germany, France and Italy
___________________________________
PRODUCT   
Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. Intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing. Recall # Z-1784-2010
CODE
Lot number: 0964081
RECALLING FIRM/MANUFACTURER
Recalling Firm: Orthohelix Surgical Designs Inc., Medina, OH, by letter  dated March 23, 2010.
Manufacturer: 3d-Machining, Riviera Beach, FL. Firm initiated recall is ongoing.
REASON
The recalling firm packaged MFT-021-35-24 Screws from lot 0964092 as MFT-021-35-22 lot 0964081.
VOLUME OF PRODUCT IN COMMERCE
62 pieces
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Passport V Monitor: Mindray, North America. Mindray DS USA. Intended for intra hospital use under the direct supervision of a healthcare practitioner for the monitoring of various human physiological parameters. Part Number 6100F. Recall # Z-1785-2010
CODE
Domestic Serial Numbers: PV 02018-K9, PV02024-K9, PV02039-K9, PV01999-K9, PV02004-K9, PV02017-K9, PV02020-K9, PV01687-I9, PV01694-I9, PV01702-I9, PV02325-K9, PV02043-K9, PV01403-I9, PV01509-I9, PV01675-I9, PV02229-K9, PV02011-K9, PV02045-K9, PV02044-K9, PV02037-K9, PV02300-K9, PV01412-I9, PV01411-I9 and PV01695-I9; and Foreign Serial Numbers: PV01470-I9, PV01924-J9, PV0926-J9, PV01989-K9, PV01994-K9, PV01997-K9, PV02330-K9, PV02332-K9, PV02744-A0, PV03005-A0, PV03006-A0, PV03007-A0, PV01965-K9, PV01970-K9, PV01971-K9, PV02056-K9 and PV02057-K9
RECALLING FIRM/MANUFACTURER
Mindray DS USA, Inc., dba Datascope Patient Monitoring, Mahwah, NJ, by letters beginning April 28, 2010. Firm initiated recall is ongoing.
REASON
An issue with the Passport V Monitor has been identified where the Arrhythmia Analysis, ST Analysis and Invasive Blood Pressure functions are not operational.
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
OH, TX, AZ, NY, MO, IL, FL, TN, Spain, Indonesia, Brazil, Italy, Columbia and British West Indies
___________________________________
PRODUCT   
Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Designed for single use acute and chronic hemodialysis. Recall # Z-1951-2010
CODE
Lot Number: 10AU04011, Exp 01/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresenius Medical Care North America, Waltham, MA, by telephone script beginning May 14, 2010 and follow up letter.
Manufacturer: Fresenius Medical Care North America, Ogden, UT. Firm initiated recall is ongoing.
REASON
Hemodialyzer may leak at the header/end cap.
VOLUME OF PRODUCT IN COMMERCE
34,152 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Microtek Medical, Inc, Stackhouse Laser Resistant Suction Probe, Size: 1/4" x 9" (0.64cm x 22.9cm), REF 24014, qty 10 ea, Sterile EO, 2015-05. Manufactured in the U.S.A. Suction probe for a smoke evacuation device. Recall # Z-2109-2010
CODE
Lot number: C10133
RECALLING FIRM/MANUFACTURER
Microtek Medical, Inc., Columbus, MS, by telephone on May 25, 2010 followed with a letter dated June 3, 2010. Firm initiated recall is complete.
REASON
Product labeled as sterile was distributed with sterilization.
VOLUME OF PRODUCT IN COMMERCE
2 cases of 10 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Medfusion Syringe Infusion Pumps, Models 3010 and 3010a with Software Versions 2.0.2, 2.0.3, AND 2.0.4 Medfusion Syringe Infusion Pumps are designed for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. Recall # Z-2121-2010
CODE
All Models 3010 and 3010a, with Software Versions 2.0.2, 2.0.3. or 2.0.4
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Saint Paul, MN, by letter dated June 11, 2010. Firm initiated recall is ongoing.
REASON
Smiths Medical has found that pumps with obsolete software may continue to run past the set volume limit. This can result in an over-delivery if the syringe is over-filled. Smiths Medical has received no reports of serious patient injury or death related to this issue.
VOLUME OF PRODUCT IN COMMERCE
4,816 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT   
Claw Hex Screw Charlotte " F&A System Contents: 1 each Foot and Ankle Screw ... Implant Material: Stainless Steel Ref: 4013-3520 ... Size 3.5MM, Length 20 MM, Use with Clava 3.5MM - Non-Sterile. Implantation: used in Food and Ankle surgeries. Item # 40133520. Recall # Z-2188-2010
CODE
Lot # 0501148499
RECALLING FIRM/MANUFACTURER
Wright Medical Technology Inc., Arlington, TN via telephone on June 7, 2010 and followed with a letter dated June 15, 2010 and June 29, 2010. Firm initiated recall is ongoing.
REASON
One lot of CLAW Hex Foot and Ankle Screws was incorrectly packaged containing Multi-use Compression Screws.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
FL, PA, KS, IN, MO, CA
___________________________________
PRODUCT   
Ascent Healthcare Solutions. Reprocessed Femoral Compression Device, Model 11165. Recall # Z-2196-2010
CODE
Lot numbers: 869509, 878402, 878439, 879762, 879990, 880274
RECALLING FIRM/MANUFACTURER
Ascent Healthcare Solutions, Inc., Lakeland, FL, by letter on June 25, 2010. Firm initiated recall is ongoing.
REASON
The FemoStop Devices may fail to inflate or hold pressure. A separation between the dome and arch base prevents the device from maintaining pressure when inflated.
VOLUME OF PRODUCT IN COMMERCE
175 devices
DISTRIBUTION
VA, CA, FL, MI, WA
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT   
BD Visitec EdgeAhead MVR Knife. Intended for use in cataract surgery to create self-sealing stab incisions through the cornea or sclera. Also used in retinal surgery for sclerotomy incisions. Model # 585230. Recall # Z-1597-2010
CODE
Lot number: 9202221
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson and Co, Waltham, MA, by letter dated April 6, 2010.
Manufacturer: Becton Dickinson Ophthalmic Systems, Warwickshire, UK. Firm initiated recall is ongoing.
REASON
A field action was initiated due to a recent customer complaint from Japan there is a labeling mixup and that some of the BD Visitec EdgeAhead MVR Knife 0.90mm (20G), REF 585230, shelf packs may contain BD Visitec EdgeAhead Slit Knife 2.3mm (40 degree), REF 8009918.
VOLUME OF PRODUCT IN COMMERCE
1170 (Nationwide 810, Internationally 360)
DISTRIBUTION
Nationwide, Canada and Japan
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS III
___________________________________
PRODUCT   
Atgard C (dichlorvos) Swine Wormer, Type A Medicated Article, packaged in 8-lb. pails, containing 9.6% dichlorvos by weight, NADA 040-848. Recall # V-190-2010
CODE
Lot 079AP54, Exp. 7/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boehringer Ingelheim Vetmedica Inc., Saint Joseph, MO, by e-mail notification on April 30, 2010.
Manufacturer: Boehringer Ingelheim Vetmedica, Inc., Elwood, KS. Firm initiated recall is complete.
REASON
The firm had been averaging nonconforming sample results during their OOS  investigations.
VOLUME OF PRODUCT IN COMMERCE
198/8-lb. pails
DISTRIBUTION
MN, WI, NE, SD, IA, KS, IL, and TX
___________________________________
PRODUCT   
ATOPICA (Cyclosporine Capsules USP), Modified, 50 mg or 100 mg/Net contents 15 capsules in blister packs, Made in Germany. Recall # V-191-2010
CODE
Lot #S0090C, Expiration: 09.2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Animal Health US Inc., Greensboro, NC, by letter on/about June 14, 2010. 
Manufacturer: R.P. Scherer GmbH, Eberbach, Germany. Firm initiated recall is ongoing.
REASON
Outer carton labeled Atopica 100 mg may contain 50 mg capsules.
VOLUME OF PRODUCT IN COMMERCE
3,978 units
DISTRIBUTION
ID, MA, MD, NE, OH, OR and TX
___________________________________
PRODUCT   
Medfusion Syringe Infusion Pump, Models 3010 and 3010a with Software Versions 2.0.2, 2.0.3, and 2.0.4. Recall # V-192-2010
CODE
Software Versions 2.0.2, 2.0.3. or 2.0.4
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Saint Paul, MN, by letter on June 22, 2010. Firm initiated recall is ongoing.
REASON
Smiths Medical is conducting a correction of Medfusion Syringe Infusion Pumps, Models 3010 and 3010a, with obsolete software versions 2.0.2, 2.0.3, and 2.0.4. Smiths Medical has found that pumps with obsolete software may continue to run past the set volume limit. This can result in an over-delivery if the syringe is over-filled. Smiths Medical has received no reports of serious patient injury or death related to this issue.
VOLUME OF PRODUCT IN COMMERCE
5 units out of 4816 distributed for veterinary use.
DISTRIBUTION
FL, NY, VA
 
END OF ENFORCEMENT REPORT FOR AUGUST 11, 2010
 
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