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U.S. Department of Health and Human Services

Enforcement Report - Week of December 2, 2015

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Veterinary Purina Honor Show Chow ShowLamb Grower DX Medicated Feed, Type C. Item No. 0016970. Complete Feed for Starter - Grower - Finisher Sheep. Active Drug Ingredients: Decoquinate (0.0017%) For the prevention of coccidiosis in young sheep caused by Eimeria ovinoidalis, E. parva, E. bakuensis, and E. crandallis. UPC 83576-01157. Net Weight 50 lb (22.67 kg) Manufactured by Purina Animal Nutrition LLC, 1080 County Road F West, Shoreview, MN 55126 Lot No. 4MAR20LCW1 Class I One lot of Honor Show Chow Showlamb Grower DX feed product is being recalled because of the potential for an elevated copper level. Elevated copper can be harmful to sheep, and in some instances can result in mortality. Land O Lakes Purina LLC
Veterinary Purina Honor Show Chow ShowLamb Grower DX Medicated Feed, Type C. Item No. 0016970. Complete Feed for Starter - Grower - Finisher Sheep. Active Drug Ingredients: Decoquinate (0.0017%) For the prevention of coccidiosis in young sheep caused by Eimeria ovinoidalis, E. parva, E. bakuensis, and E. crandallis. UPC 83576-01157. Net Weight 50 lb (22.67 kg) Manufactured by Purina Animal Nutrition LLC, 1080 County Road F West, Shoreview, MN 55126 Lot No. 4MAR20LCW1 Class I One lot of Honor Show Chow Showlamb Grower DX feed product is being recalled because of the potential for an elevated copper level. Elevated copper can be harmful to sheep, and in some instances can result in mortality. Land O Lakes Purina LLC
Veterinary PURINA START & GROW SUNFRESH MP 0.0125% MEDICATED Packed in 50 LB paper bags; Formula No. 61V3; UPC Code:804273029559 Item Number: 0057262; Lot Numbers: 4APR07RIV3 and 4APR10RIV1. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary PURINA START & GROW SUNFRESH MP 0.0125% MEDICATED Packed in 50 LB paper bags; Formula No. 61V3; UPC Code:804273029559 Item Number: 0057262; Lot Numbers: 4APR07RIV3 and 4APR10RIV1. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary PURINA START & GROW SUNFRESH MP 0.0125% MEDICATED CRUMBLES packed in 25 LB paper bags. Formula No. 61Y3; UPC Code: 804273029573. Item Number: 0057265; Lot Number: 4APR08RIV2. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary PURINA START & GROW SUNFRESH MP 0.0125% MEDICATED CRUMBLES packed in 25 LB paper bags. Formula No. 61Y3; UPC Code: 804273029573. Item Number: 0057265; Lot Number: 4APR08RIV2. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary ALBERS CHICK STARTER/GROWER 18% AMP MEDICATED CRUMBLES packed in a 50 LB paper bag; Formula No.L55N; UPC Code: 883576003251. Item Number: 5052156; Lot Number: 4APR09RIV2. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary ALBERS CHICK STARTER/GROWER 18% AMP MEDICATED CRUMBLES packed in a 50 LB paper bag; Formula No.L55N; UPC Code: 883576003251. Item Number: 5052156; Lot Number: 4APR09RIV2. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary PURINA GAME BIRD STARTENA CRUMBLE packed in a 50 LB paper bag; Formula No.5419; UPC Code: 804273001876. Item Number:0001381 ; Lot Numbers 4APR08RIV3 and 4APR09RIV2. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary PURINA GAME BIRD STARTENA CRUMBLE packed in a 50 LB paper bag; Formula No.5419; UPC Code: 804273001876. Item Number:0001381 ; Lot Numbers 4APR08RIV3 and 4APR09RIV2. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary DEL' S POULTRY LAYER PELLET packed in a 50 LB paper bag; Formula No 510M.; UPC Code: 749394513269. Item Number 0010736 ; Lot Number 4APR09RIV3. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary DEL' S POULTRY LAYER PELLET packed in a 50 LB paper bag; Formula No 510M.; UPC Code: 749394513269. Item Number 0010736 ; Lot Number 4APR09RIV3. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary DEL'S LAYER CRUMBLE packed in a 50 LB paper bag; Formula No. 510T ; UPC Code: 749394513276. Item Number0010737; Lot Number 4APR08RIV1. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary DEL'S LAYER CRUMBLE packed in a 50 LB paper bag; Formula No. 510T ; UPC Code: 749394513276. Item Number0010737; Lot Number 4APR08RIV1. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary HOME GROWN LAYER 16% CRUMBLE packed in a 50 LB paper bag; Formula No. 6022 ; UPC Code: 883576010792. Item Number 0015219 ; Lot Number 4APR08RIV3. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary HOME GROWN LAYER 16% CRUMBLE packed in a 50 LB paper bag; Formula No. 6022 ; UPC Code: 883576010792. Item Number 0015219 ; Lot Number 4APR08RIV3. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary PURINA LAYENA SUNFRESH RECIPE PELLET packed in a 40 LB paper bag; Formula No 61R3; UPC Code: 804273038728. Item Number 0052070 ; Lot Number 4APR08RIV2. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary PURINA LAYENA SUNFRESH RECIPE PELLET packed in a 40 LB paper bag; Formula No 61R3; UPC Code: 804273038728. Item Number 0052070 ; Lot Number 4APR08RIV2. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary PURINA START & GROW SUNFRESH CRUMBLES packed in a 25 LB paper bag; Formula No 61X3; UPC Code: 804273029542. Item Number 0057261; Lot Number 4APR09RIV2. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary PURINA START & GROW SUNFRESH CRUMBLES packed in a 25 LB paper bag; Formula No 61X3; UPC Code: 804273029542. Item Number 0057261; Lot Number 4APR09RIV2. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary PURINA LAYENA SUNFRESH RECIPE PELLET packed in a 25 LB paper bag; Formula No 61Z3 ; UPC Code: 804273029634. Item Number 0057277; Lot Number 4APR10RIV1. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary PURINA LAYENA SUNFRESH RECIPE PELLET packed in a 25 LB paper bag; Formula No 61Z3 ; UPC Code: 804273029634. Item Number 0057277; Lot Number 4APR10RIV1. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary ALBERS BROILER STARTER/FINISHER CRUMBLES packed in a 50 LB paper bag; Formula No L55M ; UPC Code: 883576003237. Item Number 5052155; Lot Number 4APR09RIV1. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary ALBERS BROILER STARTER/FINISHER CRUMBLES packed in a 50 LB paper bag; Formula No L55M ; UPC Code: 883576003237. Item Number 5052155; Lot Number 4APR09RIV1. Class I The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. Purina Animal Nutrition LLC
Veterinary RAW FOOD DIET BRAVO! BEEF BLEND FOR DOGS AND CATS (Made in New Zealand); 2 lb., 5 lb., and 10 lb. tubes. Product Numbers: 52-102, 52-105, 52-110 Best Used By Date: 10/10/15 or earlier Class I Potential for contamination with Listeria monocytogenes BRAVO! LLC
Veterinary RAW FOOD DIET BRAVO! BEEF BLEND FOR DOGS AND CATS (Made in New Zealand); 2 lb., 5 lb., and 10 lb. tubes. Product Numbers: 52-102, 52-105, 52-110 Best Used By Date: 10/10/15 or earlier Class I Potential for contamination with Listeria monocytogenes BRAVO! LLC
Veterinary BRAVO! BALANCE PREMIUM TURKEY FORMULA (Manufactured by: Bravo! Manchester, CT); 3 lb. box with (12) 4 oz. burgers. Product Number: 31-401 Best Used By Dates: 1/07/16 and 2/11/16 Class I Potential for contamination with Listeria monocytogenes BRAVO! LLC
Veterinary BRAVO! BALANCE PREMIUM TURKEY FORMULA (Manufactured by: Bravo! Manchester, CT); 3 lb. box with (12) 4 oz. burgers. Product Number: 31-401 Best Used By Dates: 1/07/16 and 2/11/16 Class I Potential for contamination with Listeria monocytogenes BRAVO! LLC
Veterinary RAW FOOD DIET BRAVO! LAMB BLEND FOR DOGS AND CATS (Made in New Zealand); All 2lb., 5 lb., and 10 lb. tubes; Product numbers 42-102, 42-105, 42-110 Best Used By Date: 10/10/15 or earlier Class I Potential for contamination with Listeria monocytogenes BRAVO! LLC
Veterinary RAW FOOD DIET BRAVO! LAMB BLEND FOR DOGS AND CATS (Made in New Zealand); All 2lb., 5 lb., and 10 lb. tubes; Product numbers 42-102, 42-105, 42-110 Best Used By Date: 10/10/15 or earlier Class I Potential for contamination with Listeria monocytogenes BRAVO! LLC
Veterinary RAW FOOD DIET BRAVO! LAMB BASIC FOR DOGS AND CATS (Made in New Zealand); 2 lb. tubes; Product numbers 42-202 Best Used By Date: 10/10/15 or earlier Class I Potential for contamination with Listeria monocytogenes BRAVO! LLC
Veterinary RAW FOOD DIET BRAVO! LAMB BASIC FOR DOGS AND CATS (Made in New Zealand); 2 lb. tubes; Product numbers 42-202 Best Used By Date: 10/10/15 or earlier Class I Potential for contamination with Listeria monocytogenes BRAVO! LLC
Veterinary RAW FOOD DIET BRAVO! BEEF & BEEF HEART FOR DOGS AND CATS (Made in New Zealand); 5 lb. tubes; Product numbers 53-130 Best Used By Date: 10/10/15 or earlier Class I Potential for contamination with Listeria monocytogenes BRAVO! LLC
Veterinary RAW FOOD DIET BRAVO! BEEF & BEEF HEART FOR DOGS AND CATS (Made in New Zealand); 5 lb. tubes; Product numbers 53-130 Best Used By Date: 10/10/15 or earlier Class I Potential for contamination with Listeria monocytogenes BRAVO! LLC
Veterinary RAW FOOD DIET BRAVO! 100% PURE & NATURAL PREMIUM GRASS-FED BUFFALO FOR DOGS AND CATS (Manufactured by: Bravo! Manchester, CT); NET WT 2LBS (32 OZ) .91KG (Tubes); Product Number: 72-222 Best Used By Date: 1/7/16 Class I Potential for contamination with Listeria monocytogenes BRAVO! LLC
Veterinary RAW FOOD DIET BRAVO! 100% PURE & NATURAL PREMIUM GRASS-FED BUFFALO FOR DOGS AND CATS (Manufactured by: Bravo! Manchester, CT); NET WT 2LBS (32 OZ) .91KG (Tubes); Product Number: 72-222 Best Used By Date: 1/7/16 Class I Potential for contamination with Listeria monocytogenes BRAVO! LLC
Veterinary BRAVO! TURKEY BALANCE FORMULA (Manufactured by: Bravo! Manchester, CT) NET WT 2 LBS (32 OZ) .09 KG, Chub (tube); Product Number: 31-402 and NET WT 5 LBS (80 OZ) 2.3KG, Chub (tube); Product Number: 31-405 Best Used By Dates: 1/7/16 and 2/11/16 Class I Potential for contamination with Listeria monocytogenes BRAVO! LLC
Veterinary BRAVO! TURKEY BALANCE FORMULA (Manufactured by: Bravo! Manchester, CT) NET WT 2 LBS (32 OZ) .09 KG, Chub (tube); Product Number: 31-402 and NET WT 5 LBS (80 OZ) 2.3KG, Chub (tube); Product Number: 31-405 Best Used By Dates: 1/7/16 and 2/11/16 Class I Potential for contamination with Listeria monocytogenes BRAVO! LLC
Veterinary RAW FOOD DIET BRAVO! LAMB BLEND FOR DOGS AND CATS (Manufactured by: Bravo! Manchester, CT); 5 LBS (80 OZ) 2.3KG, Chub (tube); Product Number: 42-105 Best Used By Date: 2/11/16 Class I Potential for contamination with Listeria monocytogenes BRAVO! LLC
Veterinary RAW FOOD DIET BRAVO! LAMB BLEND FOR DOGS AND CATS (Manufactured by: Bravo! Manchester, CT); 5 LBS (80 OZ) 2.3KG, Chub (tube); Product Number: 42-105 Best Used By Date: 2/11/16 Class I Potential for contamination with Listeria monocytogenes BRAVO! LLC
Veterinary PCI Brand Lamb Crunchys Dog Treats, 3 oz. Packaged in plastic bag/pouch with zip top. Product labeling in English and Spanish, reads in part:"***100% Natural Lamb Crunchys***PCI BRAND***MADE IN U.S.A NET WEIGHT 3 oz(85g)***PET CENTER, INC. 1-800-390-0575 www.petcenterinc.com***info@petcenterinc.com***". Item Number LAM-003. UPC# 727348200038). Date Code 122015 Class I Pet Center, Inc of Los Angeles, CA. is voluntarily recalling its 3 oz bag of Lamb Crunchys dog treats (LAM-003) (UPC# 727348200038) with date code 122015 product of USA, because it has the potential to be contaminated with Salmonella. Pet Center Inc
Veterinary PCI Brand Lamb Crunchys Dog Treats, 3 oz. Packaged in plastic bag/pouch with zip top. Product labeling in English and Spanish, reads in part:"***100% Natural Lamb Crunchys***PCI BRAND***MADE IN U.S.A NET WEIGHT 3 oz(85g)***PET CENTER, INC. 1-800-390-0575 www.petcenterinc.com***info@petcenterinc.com***". Item Number LAM-003. UPC# 727348200038). Date Code 122015 Class I Pet Center, Inc of Los Angeles, CA. is voluntarily recalling its 3 oz bag of Lamb Crunchys dog treats (LAM-003) (UPC# 727348200038) with date code 122015 product of USA, because it has the potential to be contaminated with Salmonella. Pet Center Inc
Veterinary Champion Lamb Texturized B30 6701LOT88022114M908840 (6701-product code, 88-plant code, 22114-date, M908840-batch code) Class I CHS Nutrition was informed that one lamb died from high copper in Champion Lamb Texturized B30. Analysis was performed on the feed and found to contain 54 ppm dry matter of copper. PGG/HSC Feed Co. LLC
Veterinary Champion Lamb Texturized B30 6701LOT88022114M908840 (6701-product code, 88-plant code, 22114-date, M908840-batch code) Class I CHS Nutrition was informed that one lamb died from high copper in Champion Lamb Texturized B30. Analysis was performed on the feed and found to contain 54 ppm dry matter of copper. PGG/HSC Feed Co. LLC
Veterinary Purina Accuration Cattle Limiter 2 Supplement Feed for Cattle on Pasture, Manufactured by Purina Animal Nutrition LLC, 1080 County Road F West, Shoreview, MN 55126 4APR11LUB1 Class I The feed has the potential to contain high protein/high urea cattle concentrate pellets. Land O Lakes Purina LLC
Veterinary Purina Accuration Cattle Limiter 2 Supplement Feed for Cattle on Pasture, Manufactured by Purina Animal Nutrition LLC, 1080 County Road F West, Shoreview, MN 55126 4APR11LUB1 Class I The feed has the potential to contain high protein/high urea cattle concentrate pellets. Land O Lakes Purina LLC
Veterinary Nutrena NatureWise Meatbird 22% Crumbles, 91585-40, packaged in 40 lb bag. UPC code 722304275754 Nutrena General Office, Minneapolis, MN. Lot # 5941181016 Class I The product is being recalled due to elevated levels of sodium ranging between 1.16% and 1.2%. Cargill, Inc Corporate Headquarters
Veterinary Nutrena NatureWise Meatbird 22% Crumbles, 91585-40, packaged in 40 lb bag. UPC code 722304275754 Nutrena General Office, Minneapolis, MN. Lot # 5941181016 Class I The product is being recalled due to elevated levels of sodium ranging between 1.16% and 1.2%. Cargill, Inc Corporate Headquarters
Devices Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system. Software versions R5.1.7 and R5.1.8 Class II When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView, the resultant image order is reversed. This occurs with software release R5.1.7/R5.1.8. Philips Medical Systems, Inc.
Devices Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system. Software versions R5.1.7 and R5.1.8 Class II When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView, the resultant image order is reversed. This occurs with software release R5.1.7/R5.1.8. Philips Medical Systems, Inc.
Veterinary LLOYD Thyro-Tabs Canine (levothyroxine sodium tablets, USP), 0.1 mg, packaged in 1,000-tablet bottles (NDC 11789-251-20), Rx, Lloyd, Inc., Shenandoah, IA. VKB12114, exp. 9/30/2016 Class II Super-potent product: product tested out of specification (high) for assay at the 6-month stability time point. Lloyd Inc. of Iowa
Veterinary LLOYD Thyro-Tabs Canine (levothyroxine sodium tablets, USP), 0.1 mg, packaged in 1,000-tablet bottles (NDC 11789-251-20), Rx, Lloyd, Inc., Shenandoah, IA. VKB12114, exp. 9/30/2016 Class II Super-potent product: product tested out of specification (high) for assay at the 6-month stability time point. Lloyd Inc. of Iowa
Veterinary Genesis Topical Spray, Solution of 0.015% Triamcinolone Acetonide, packaged in 8 oz and 16 oz spray bottles 140085, Exp Jan 2016 and 131154, Exp Sept 2015; Class III Stability testing of a sample was out of specification for potency at the 9 month time point. Virbac AH, Inc
Veterinary Genesis Topical Spray, Solution of 0.015% Triamcinolone Acetonide, packaged in 8 oz and 16 oz spray bottles 140085, Exp Jan 2016 and 131154, Exp Sept 2015; Class III Stability testing of a sample was out of specification for potency at the 9 month time point. Virbac AH, Inc
Veterinary Neomycin Oral Solution, Neomycin Sulfate Antibacterial, Contains per mL: neomycin sulfate 200 mg equivalent to 140 mg neomycin, For Animal Use Only, OTC, ANADA 200-379, Net Contents: 1 Gallon (3.785L) packaged in plastic jugs. The product is packaged under the following three labels: (1) Neovet Antibacterial - Neomycin Sulfate Oral Solution for Cattle, Swine, Sheep and Goats, UPC 0 99355 00533 4. Manufactured for: Aspen Veterinary Resources Ltd., Liberty, MO 64068; (2) Neomycin Oral Solution, NDC 57561-105-07, UPC 3 57561 01771 9. Manufactured for Agri Laboratories, Ltd., St. Joseph, MO 64503; (3) Neomycin Oral Solution Antibacterial, NDC 30798-340-35, UPC 7 45801 11313 8. Manufactured for Durvet, Inc., Blue Springs, MO 64014. lot 140071; expiration date 2/2016 Class III Product failed to meet 18-month stability specifications; subpotent preservatives. Sparhawk Laboratories Inc
Veterinary Neomycin Oral Solution, Neomycin Sulfate Antibacterial, Contains per mL: neomycin sulfate 200 mg equivalent to 140 mg neomycin, For Animal Use Only, OTC, ANADA 200-379, Net Contents: 1 Gallon (3.785L) packaged in plastic jugs. The product is packaged under the following three labels: (1) Neovet Antibacterial - Neomycin Sulfate Oral Solution for Cattle, Swine, Sheep and Goats, UPC 0 99355 00533 4. Manufactured for: Aspen Veterinary Resources Ltd., Liberty, MO 64068; (2) Neomycin Oral Solution, NDC 57561-105-07, UPC 3 57561 01771 9. Manufactured for Agri Laboratories, Ltd., St. Joseph, MO 64503; (3) Neomycin Oral Solution Antibacterial, NDC 30798-340-35, UPC 7 45801 11313 8. Manufactured for Durvet, Inc., Blue Springs, MO 64014. lot 140071; expiration date 2/2016 Class III Product failed to meet 18-month stability specifications; subpotent preservatives. Sparhawk Laboratories Inc
Food Refine 3-Day Cleanse, a juice kit that contains Lean Green, 16 oz (6 bottles), Beet It, 16 oz (6 bottles), Almond Milk, 8 oz (3 bottles) and Wheat grass juice, 8 oz (2 bottles) None Class I Unpasteurized juice product with elevated pH levels and unlabeled almond milk were distributed. TN Juice Bar
Food Refine 3-Day Cleanse, a juice kit that contains Lean Green, 16 oz (6 bottles), Beet It, 16 oz (6 bottles), Almond Milk, 8 oz (3 bottles) and Wheat grass juice, 8 oz (2 bottles) None Class I Unpasteurized juice product with elevated pH levels and unlabeled almond milk were distributed. TN Juice Bar
Food M&M Old Fashioned Gourmet Cookie Dough NET WT. 3 lb. (48 oz.) Distributed By: Tower Cafe, Okarche, OK 73762 packaged in plastic tub. Product does not contain lot codes or best by dates. Recall applies to all product on the market. UPC: 025405737764 Class I Undeclared milk, soy, wheat, and yellow #5 in frozen cookie dough. Tower Cafe Inc. DBA Okarche Bakery
Food M&M Old Fashioned Gourmet Cookie Dough NET WT. 3 lb. (48 oz.) Distributed By: Tower Cafe, Okarche, OK 73762 packaged in plastic tub. Product does not contain lot codes or best by dates. Recall applies to all product on the market. UPC: 025405737764 Class I Undeclared milk, soy, wheat, and yellow #5 in frozen cookie dough. Tower Cafe Inc. DBA Okarche Bakery
Food Chocolate Chip Old Fashioned Gourmet Cookie Dough NET WT. 3 lb. (48 oz.) Distributed By: Tower Cafe, Okarche, OK 73762 packaged in plastic tub. Product does not contain lot codes or best by dates. Recall applies to all product on the market. UPC: 025405737726 Class I Undeclared milk, soy, and wheat in frozen cookie dough. Tower Cafe Inc. DBA Okarche Bakery
Food Chocolate Chip Old Fashioned Gourmet Cookie Dough NET WT. 3 lb. (48 oz.) Distributed By: Tower Cafe, Okarche, OK 73762 packaged in plastic tub. Product does not contain lot codes or best by dates. Recall applies to all product on the market. UPC: 025405737726 Class I Undeclared milk, soy, and wheat in frozen cookie dough. Tower Cafe Inc. DBA Okarche Bakery
Food Sugar Old Fashioned Gourmet Cookie Dough NET WT. 3 lb. (48 oz.) Distributed By: Tower Cafe, Okarche, OK 73762 packaged in plastic tub. Product does not contain lot codes or best by dates. Recall applies to all product on the market. UPC: 025405737733 Class II Undeclared soy and wheat in frozen cookie dough. Tower Cafe Inc. DBA Okarche Bakery
Food Sugar Old Fashioned Gourmet Cookie Dough NET WT. 3 lb. (48 oz.) Distributed By: Tower Cafe, Okarche, OK 73762 packaged in plastic tub. Product does not contain lot codes or best by dates. Recall applies to all product on the market. UPC: 025405737733 Class II Undeclared soy and wheat in frozen cookie dough. Tower Cafe Inc. DBA Okarche Bakery
Food Oatmeal Raisin Old Fashioned Gourmet Cookie Dough NET WT. 3 lb. (48 oz.) Distributed By: Tower Cafe, Okarche, OK 73762 packaged in plastic tub. Product does not contain lot codes or best by dates. Recall applies to all product on the market. UPC: 0254057337740 Class II Undeclared soy and wheat in frozen cookie dough. Tower Cafe Inc. DBA Okarche Bakery
Food Oatmeal Raisin Old Fashioned Gourmet Cookie Dough NET WT. 3 lb. (48 oz.) Distributed By: Tower Cafe, Okarche, OK 73762 packaged in plastic tub. Product does not contain lot codes or best by dates. Recall applies to all product on the market. UPC: 0254057337740 Class II Undeclared soy and wheat in frozen cookie dough. Tower Cafe Inc. DBA Okarche Bakery
Devices CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices. Lot/Codes: KN165 (exp. 2017-09), KN169 (exp. 2017-10), KN171 (exp. 2017-11) and KN177 (exp. 2018-02) Class III CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert. Biochemical Diagnostics Inc
Devices CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices. Lot/Codes: KN165 (exp. 2017-09), KN169 (exp. 2017-10), KN171 (exp. 2017-11) and KN177 (exp. 2018-02) Class III CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert. Biochemical Diagnostics Inc
Food Curley Parsley 4/5 lb packaged in cardboard box, UPC code 740695801109 -0915, 09-15, 0915- Class III Product tested positive for the pesticides propanocarb and trifloxystrobin. MR Cuta dba Riley's
Food Curley Parsley 4/5 lb packaged in cardboard box, UPC code 740695801109 -0915, 09-15, 0915- Class III Product tested positive for the pesticides propanocarb and trifloxystrobin. MR Cuta dba Riley's
Food Daily Chef Peanut Butter Bars, Net Wt. 27 oz (1 lb 11 oz) 765g, Made in Canada, Manufactured for: CSM Bakery Products NA, Inc., Tucker, GA 30084 UPC Code: 78742 11172, Lot: TFF 15 237, Shipper Best By Code: Aug 25, 2016; Lot: TFF  ...
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Class II Foreign matter (rigid plastic pieces) found in peanut butter bars. CSM Bakery Products NA
Food Daily Chef Peanut Butter Bars, Net Wt. 27 oz (1 lb 11 oz) 765g, Made in Canada, Manufactured for: CSM Bakery Products NA, Inc., Tucker, GA 30084 UPC Code: 78742 11172, Lot: TFF 15 237, Shipper Best By Code: Aug 25, 2016; Lot: TFF  ...
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Class II Foreign matter (rigid plastic pieces) found in peanut butter bars. CSM Bakery Products NA
Devices Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections. CD10-270-CE-S (0.1 ml) 6033086 (U.S. Distribution) expire 06/2016, 6032390 expires 04/2016, 6033622 expires 07/2016. CD10-270-CE (1ml) 6032742 (U.S. Distribution) expires 11/2017. Class II These Lot numbers are not stable up to the expiry date on the product labeling. Leica Microsystems, Inc.
Devices Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections. CD10-270-CE-S (0.1 ml) 6033086 (U.S. Distribution) expire 06/2016, 6032390 expires 04/2016, 6033622 expires 07/2016. CD10-270-CE (1ml) 6032742 (U.S. Distribution) expires 11/2017. Class II These Lot numbers are not stable up to the expiry date on the product labeling. Leica Microsystems, Inc.
Devices Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation. Devices manufactured prior to June 4, 2015. Affected serial numbers range from US00100100 - US00587045. Class II The following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the automated Ready-For-Use (RFU) test in an abnormal state when the device is turned off. Philips Electronics North America Corporation
Devices Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation. Devices manufactured prior to June 4, 2015. Affected serial numbers range from US00100100 - US00587045. Class II The following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the automated Ready-For-Use (RFU) test in an abnormal state when the device is turned off. Philips Electronics North America Corporation
Devices Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction. 12156526 12156527 12156528 12156529 12156530 12156531 12158162 12158163 12158164 12158165 12158166 12161289 12161290 12161291 12161292 12161293 12161294 12161295 12161296 12161297 12161298 12161299 12165173 12165174 12165175 12165176 12165179 12165187 12165188 12165192 12165193 12199362 12199363 12199365 12199367 12205570 12205881 12205882 12205883 12205884 12205885 12205886 12205887 12205888 12205889 12205890 12205891 12208850 12208851 12208852  ...
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Class I Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL. Alcon Research, Ltd.
Devices Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction. 12156526 12156527 12156528 12156529 12156530 12156531 12158162 12158163 12158164 12158165 12158166 12161289 12161290 12161291 12161292 12161293 12161294 12161295 12161296 12161297 12161298 12161299 12165173 12165174 12165175 12165176 12165179 12165187 12165188 12165192 12165193 12199362 12199363 12199365 12199367 12205570 12205881 12205882 12205883 12205884 12205885 12205886 12205887 12205888 12205889 12205890 12205891 12208850 12208851 12208852  ...
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Class I Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL. Alcon Research, Ltd.
Devices ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems. 10379673 (160 tests kit), 10485591 (800 tests kit) Lot 230 (SMN 10485591 and 10379673) and lot 231(SMN 10485591) Class II Reagent in these lots may demonstrate an increased occurrence of high %HbA1c bias, a positive bias averaging 0.6% HbA1c units, ranging from -0.1% to 1.1% HbA1c units. The maximum bias was observed at higher %HbA1c concentrations. QC samples may exhibit a similar bias. Siemens Healthcare Diagnostics, Inc.
Devices ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems. 10379673 (160 tests kit), 10485591 (800 tests kit) Lot 230 (SMN 10485591 and 10379673) and lot 231(SMN 10485591) Class II Reagent in these lots may demonstrate an increased occurrence of high %HbA1c bias, a positive bias averaging 0.6% HbA1c units, ranging from -0.1% to 1.1% HbA1c units. The maximum bias was observed at higher %HbA1c concentrations. QC samples may exhibit a similar bias. Siemens Healthcare Diagnostics, Inc.
Devices Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System. Lot Number 15063BA Class II Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. The under-recovery ranged from -0.3 mg/dL [0.12 mmol/L] to -1.6 mg/dL [0.66 mmol/L]; equivalent to a maximum negative bias of -88%. Siemens Healthcare Diagnostics, Inc.
Devices Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System. Lot Number 15063BA Class II Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. The under-recovery ranged from -0.3 mg/dL [0.12 mmol/L] to -1.6 mg/dL [0.66 mmol/L]; equivalent to a maximum negative bias of -88%. Siemens Healthcare Diagnostics, Inc.
Drugs Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01), 15 mg (NDC 69761-015-01),18 mg (NDC 69761-018-01),20 mg (NDC 69761-020-01), 22 mg (NDC 69761-022-01), 25 mg (NDC 69761-025-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013 Lots: A002 Exp.: 10/23/2015; A003 Exp.: 10/25/2015; A009  ...
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Class II Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance. Qualgen
Drugs Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01), 15 mg (NDC 69761-015-01),18 mg (NDC 69761-018-01),20 mg (NDC 69761-020-01), 22 mg (NDC 69761-022-01), 25 mg (NDC 69761-025-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013 Lots: A002 Exp.: 10/23/2015; A003 Exp.: 10/25/2015; A009  ...
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Class II Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance. Qualgen
Drugs Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01), 50 mg (NDC 69761-150-01), 87.5 mg (NDC: 69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013 Lots: A005 Ex.: 10/30/2015; A008 Ex.: 11/01/2015; A010  ...
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Class II Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance. Qualgen
Drugs Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01), 50 mg (NDC 69761-150-01), 87.5 mg (NDC: 69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013 Lots: A005 Ex.: 10/30/2015; A008 Ex.: 11/01/2015; A010  ...
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Class II Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance. Qualgen
Food Meijer Caramel Corn, packed in 10 oz. bags, ( 283 g), 12 bags per case Code dates: 8/23/2015 8/23/2015 10/10/2015 10/28/2015 11/19/2015 11/21/2015 11/21/2015 11/27/2015 11/27/2015 12/5/2015 11/27/2015 12/5/2015 12/12/2015 12/25/2015 12/30/2015 1/25/2016 2/29/2016 2/29/2016 3/18/2016 3/19/2016 3/28/2016 3/28/2016 Class II Product labeling declared butter as an ingredient, but did not specify that the allergen milk is present in the product. Meijer Distribution, Inc
Food Meijer Caramel Corn, packed in 10 oz. bags, ( 283 g), 12 bags per case Code dates: 8/23/2015 8/23/2015 10/10/2015 10/28/2015 11/19/2015 11/21/2015 11/21/2015 11/27/2015 11/27/2015 12/5/2015 11/27/2015 12/5/2015 12/12/2015 12/25/2015 12/30/2015 1/25/2016 2/29/2016 2/29/2016 3/18/2016 3/19/2016 3/28/2016 3/28/2016 Class II Product labeling declared butter as an ingredient, but did not specify that the allergen milk is present in the product. Meijer Distribution, Inc
Food ALBACORE TUNA, sold under brand The Garibaldi Cannery, metal can, net weight 8 oz. (227 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned Albacore tuna product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food ALBACORE TUNA, sold under brand The Garibaldi Cannery, metal can, net weight 8 oz. (227 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned Albacore tuna product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food ALBACORE TUNA BELLIES, sold under brand The Garibaldi Cannery, Net weight 8 oz. (227 gram). The word "Bellies" is written on top of can. No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned Albacore tuna bellies product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food ALBACORE TUNA BELLIES, sold under brand The Garibaldi Cannery, Net weight 8 oz. (227 gram). The word "Bellies" is written on top of can. No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned Albacore tuna bellies product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food ALBACORE TUNA NO SALT, sold under brand The Garibaldi Cannery, metal cans, net weight 8 oz. (227 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned Albacore tuna no salt product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food ALBACORE TUNA NO SALT, sold under brand The Garibaldi Cannery, metal cans, net weight 8 oz. (227 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned Albacore tuna no salt product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food JALAPEÑO ALBACORE TUNA , sold under brand The Garibaldi Cannery, metal can, net weight 8 oz. (227 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned jalapeno Albacore tuna product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food JALAPEÑO ALBACORE TUNA , sold under brand The Garibaldi Cannery, metal can, net weight 8 oz. (227 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned jalapeno Albacore tuna product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food SMOKED ALBACORE TUNA, sold under brand The Garibaldi Cannery, metal can, net weight 8 oz. (227 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned smoked Albacore tuna product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food SMOKED ALBACORE TUNA, sold under brand The Garibaldi Cannery, metal can, net weight 8 oz. (227 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned smoked Albacore tuna product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food GARLIC ALBACORE TUNA, sold under brand The Garibaldi Cannery, metal can, net weight 8 oz. (227 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned garlic Albacore tuna product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food GARLIC ALBACORE TUNA, sold under brand The Garibaldi Cannery, metal can, net weight 8 oz. (227 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned garlic Albacore tuna product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food PACIFIC SALMON, sold under brand The Garibaldi Cannery, Net weight 6 oz. (170 gram). No UPC Any codes starting with OC. Last date of distribution of recalled product was September 2015. Class I The canned Pacific Salmon product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food PACIFIC SALMON, sold under brand The Garibaldi Cannery, Net weight 6 oz. (170 gram). No UPC Any codes starting with OC. Last date of distribution of recalled product was September 2015. Class I The canned Pacific Salmon product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food SMOKED PACIFIC SALMON, sold under brand The Garibaldi Net weight 6 oz. (170 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned smoked Pacific salmon product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food SMOKED PACIFIC SALMON, sold under brand The Garibaldi Net weight 6 oz. (170 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned smoked Pacific salmon product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food SILVER SALMON, sold under brand The Garibaldi Cannery, Net weight 6 oz. (170 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned Silver salmon product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food SILVER SALMON, sold under brand The Garibaldi Cannery, Net weight 6 oz. (170 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned Silver salmon product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food CHINOOK SALMON, sold under brand The Garibaldi Cannery, Net weight 6 oz. (170 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned Chinook salmon product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food CHINOOK SALMON, sold under brand The Garibaldi Cannery, Net weight 6 oz. (170 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class I The canned Chinook salmon product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Devices Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion. Lot Numbers: 1503500094, 1431900098, 1435800009 Class II Incorrectly packaged with a 90 degree bend at the distal tip Covidien LLC
Devices Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion. Lot Numbers: 1503500094, 1431900098, 1435800009 Class II Incorrectly packaged with a 90 degree bend at the distal tip Covidien LLC
Devices Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion. Lot Numbers: 1500600182 ,1423000104 Class II Incorrectly packaged with a 90 degree bend at the distal tip Covidien LLC
Devices Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion. Lot Numbers: 1500600182 ,1423000104 Class II Incorrectly packaged with a 90 degree bend at the distal tip Covidien LLC
Devices Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion. Lot Numbers: 1504700102, 1516900090, 1425000091 Class II Incorrectly packaged with a 90 degree bend at the distal tip Covidien LLC
Devices Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion. Lot Numbers: 1504700102, 1516900090, 1425000091 Class II Incorrectly packaged with a 90 degree bend at the distal tip Covidien LLC
Devices Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145046C The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion. Lot Numbers: 1506100125 Class II Incorrectly packaged with a 90 degree bend at the distal tip Covidien LLC
Devices Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145046C The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion. Lot Numbers: 1506100125 Class II Incorrectly packaged with a 90 degree bend at the distal tip Covidien LLC
Devices Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion. Lot Numbers: 1425000092 Class II Incorrectly packaged with a 90 degree bend at the distal tip Covidien LLC
Devices Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion. Lot Numbers: 1425000092 Class II Incorrectly packaged with a 90 degree bend at the distal tip Covidien LLC
Food Cranberry Chipotle Spread, 10.5 oz, packed in glass jar with metal lid, inside a cardboard box Manufactured: October 28/2013 to July 8/2015 10C3283 10C3304 10C4013 10C5016 10C5197 (10=10.5oz, C=cranberry Chipotle, 5=2015, Julian date) Class III Something Special Deli Foods LTD initiated a voluntary on 10/15/2015 of the Cranberry Chipotle Spread due to the potential for mold. Something Special Deli-Foods Ltd.
Food Cranberry Chipotle Spread, 10.5 oz, packed in glass jar with metal lid, inside a cardboard box Manufactured: October 28/2013 to July 8/2015 10C3283 10C3304 10C4013 10C5016 10C5197 (10=10.5oz, C=cranberry Chipotle, 5=2015, Julian date) Class III Something Special Deli Foods LTD initiated a voluntary on 10/15/2015 of the Cranberry Chipotle Spread due to the potential for mold. Something Special Deli-Foods Ltd.
Food Canned albacore tuna, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans. No UPC. Production codes starting with OC. The last date of distribution of recalled products is September 2015. Class I Canned albacore tuna, Dungeness Seaworks brand, with any code starting with "OC" was recalled because it has the potential to be contaminated with Clostridium botulinum. Dungeness Seaworks
Food Canned albacore tuna, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans. No UPC. Production codes starting with OC. The last date of distribution of recalled products is September 2015. Class I Canned albacore tuna, Dungeness Seaworks brand, with any code starting with "OC" was recalled because it has the potential to be contaminated with Clostridium botulinum. Dungeness Seaworks
Food Albacore Tuna Garlic, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans. No UPC. Production codes starting with OC. The last date of distribution of recalled products is September 2015. Class I Canned Albacore Tuna Garlic, Dungeness Seaworks brand, with any code starting with "OC" was recalled because it has the potential to be contaminated with Clostridium botulinum. Dungeness Seaworks
Food Albacore Tuna Garlic, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans. No UPC. Production codes starting with OC. The last date of distribution of recalled products is September 2015. Class I Canned Albacore Tuna Garlic, Dungeness Seaworks brand, with any code starting with "OC" was recalled because it has the potential to be contaminated with Clostridium botulinum. Dungeness Seaworks
Food Albacore Tuna Jalepeno, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans. No UPC. Production codes starting with OC. The last date of distribution of recalled products is September 2015. Class I Canned Albacore Tuna Jalepeno, Dungeness Seaworks brand, with any code starting with "OC" was recalled because it has the potential to be contaminated with Clostridium botulinum. Dungeness Seaworks
Food Albacore Tuna Jalepeno, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans. No UPC. Production codes starting with OC. The last date of distribution of recalled products is September 2015. Class I Canned Albacore Tuna Jalepeno, Dungeness Seaworks brand, with any code starting with "OC" was recalled because it has the potential to be contaminated with Clostridium botulinum. Dungeness Seaworks
Food Albacore Tuna Olive Oil, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans. No UPC. Production codes starting with OC. The last date of distribution of recalled products is September 2015. Class I Canned Albacore Tuna Olive Oil, Dungeness Seaworks brand, with any code starting with "OC" was recalled because it has the potential to be contaminated with Clostridium botulinum. Dungeness Seaworks
Food Albacore Tuna Olive Oil, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans. No UPC. Production codes starting with OC. The last date of distribution of recalled products is September 2015. Class I Canned Albacore Tuna Olive Oil, Dungeness Seaworks brand, with any code starting with "OC" was recalled because it has the potential to be contaminated with Clostridium botulinum. Dungeness Seaworks
Food Albacore Tuna Hickory Smoke, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans. No UPC. Production codes starting with OC. The last date of distribution of recalled products is September 2015. Class I Canned Albacore Tuna Hickory Smoke, Dungeness Seaworks brand, with any code starting with "OC" was recalled because it has the potential to be contaminated with Clostridium botulinum. Dungeness Seaworks
Food Albacore Tuna Hickory Smoke, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans. No UPC. Production codes starting with OC. The last date of distribution of recalled products is September 2015. Class I Canned Albacore Tuna Hickory Smoke, Dungeness Seaworks brand, with any code starting with "OC" was recalled because it has the potential to be contaminated with Clostridium botulinum. Dungeness Seaworks
Food Skippy Creamy 25% Less Fat Reduced Fat Peanut Butter Spread Net Wt. 16.3 OZ (1 lb 0.3 OZ) 462g in plastic jars, UPC: 037600105002 Best IF Used By DEC1416LR1 Class II Potential metal shavings in jars of peanut butter. Hormel Foods Corporation
Food Skippy Creamy 25% Less Fat Reduced Fat Peanut Butter Spread Net Wt. 16.3 OZ (1 lb 0.3 OZ) 462g in plastic jars, UPC: 037600105002 Best IF Used By DEC1416LR1 Class II Potential metal shavings in jars of peanut butter. Hormel Foods Corporation
Devices SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic. Part Number: SCF-MLD265; LOT#: 130703-01 Part Number: SCF-MLD273; LOT#: 130703-02 Class II SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw. Pega Medical Inc.
Devices SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic. Part Number: SCF-MLD265; LOT#: 130703-01 Part Number: SCF-MLD273; LOT#: 130703-02 Class II SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw. Pega Medical Inc.
Devices Thermo Scientific p21 WAF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds to cyclin/CDK complexes and inhibits their kinase activity thereby stopping cell cycle progression. It also binds to PCNA (proliferating cell nuclear antigen) and blocks DNA replication but not the DNA repair process. Product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy. Product code: MS-230-P; lot 230P1409A, Expiry 9-2016; Product code: MS-230-P0; lot 230P1409C, Expiry 9-2016. Class III It was discovered that the labeling of MS-230 antibody incorrectly describes the concentration - label reads 0.2mg/ml but it is actually 0.4 mg/ml. Lab Vision Corporation
Devices Thermo Scientific p21 WAF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds to cyclin/CDK complexes and inhibits their kinase activity thereby stopping cell cycle progression. It also binds to PCNA (proliferating cell nuclear antigen) and blocks DNA replication but not the DNA repair process. Product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy. Product code: MS-230-P; lot 230P1409A, Expiry 9-2016; Product code: MS-230-P0; lot 230P1409C, Expiry 9-2016. Class III It was discovered that the labeling of MS-230 antibody incorrectly describes the concentration - label reads 0.2mg/ml but it is actually 0.4 mg/ml. Lab Vision Corporation
Devices Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes. Catalog Number: 16TA24, Lot Number: 0006936810 Class II The wire pass hole is not present on the tools. Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Devices Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes. Catalog Number: 16TA24, Lot Number: 0006936810 Class II The wire pass hole is not present on the tools. Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Devices NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5 Software versions 4.9 and 4.10 Class II Ultrafiltration (UF) Volume software error inaccurate fluid removal NxStage Medical, Inc.
Devices NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5 Software versions 4.9 and 4.10 Class II Ultrafiltration (UF) Volume software error inaccurate fluid removal NxStage Medical, Inc.
Devices NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A Software versions 4.9 and 4.10 Class II Ultrafiltration (UF) Volume software error inaccurate fluid removal NxStage Medical, Inc.
Devices NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A Software versions 4.9 and 4.10 Class II Ultrafiltration (UF) Volume software error inaccurate fluid removal NxStage Medical, Inc.
Food Natures Promise Organic Shelled Edamame, 16 oz., UPC 68826712764. Product is frozen. All lots Class I Product contains undeclared soy. Green Organic Vegetables Incorporated
Food Natures Promise Organic Shelled Edamame, 16 oz., UPC 68826712764. Product is frozen. All lots Class I Product contains undeclared soy. Green Organic Vegetables Incorporated
Food Natures Promise Organic Edamame in Pod, 16 oz., UPC 68826702124. Product is frozen. All lots Class I Product contains undeclared soy. Green Organic Vegetables Incorporated
Food Natures Promise Organic Edamame in Pod, 16 oz., UPC 68826702124. Product is frozen. All lots Class I Product contains undeclared soy. Green Organic Vegetables Incorporated
Devices BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern. Model 657701; Lot No. 4344945, 5037611, both with expiry date of 31 DEC 2015; and 5063945 with expiry date of 29 FEB 2016. Class II Three lots of CD64 (MD22) are contaminated with CD4 antibody. Becton, Dickinson and Company, BD Biosciences
Devices BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern. Model 657701; Lot No. 4344945, 5037611, both with expiry date of 31 DEC 2015; and 5063945 with expiry date of 29 FEB 2016. Class II Three lots of CD64 (MD22) are contaminated with CD4 antibody. Becton, Dickinson and Company, BD Biosciences
Cosmetics Diptyque 75ml Shower Gel Lot 1509; Batch #s: 1525811231, 1526514019 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015  September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Diptyque 75ml Shower Gel Lot 1509; Batch #s: 1525811231, 1526514019 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015  September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Neil George 100ml Shampoo Item #: B2800SH100ML; Lot 1509; Batch #: 1521611140 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Neil George 100ml Shampoo Item #: B2800SH100ML; Lot 1509; Batch #: 1521611140 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Hyatt Regency 1oz Shampoo Item #: B230SH30ML; Lot 1509; Batch #s: 1516624083 1521121109 1525514144 1525514105 1525514144; Lot # 1506, Batch #s: 1515321093 1516221033 1516221144 1516224021 1514722696 1516224082 1516224083 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Hyatt Regency 1oz Shampoo Item #: B230SH30ML; Lot 1509; Batch #s: 1516624083 1521121109 1525514144 1525514105 1525514144; Lot # 1506, Batch #s: 1515321093 1516221033 1516221144 1516224021 1514722696 1516224082 1516224083 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Verde Collection 1oz Conditioner Item #: B300CD010; Lot 1509; Batch #s: 1526401438 & 1526401841 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Verde Collection 1oz Conditioner Item #: B300CD010; Lot 1509; Batch #s: 1526401438 & 1526401841 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics EE Spa 1oz Shampoo D25 Tube Item #: B151SH30ML; Lot 1509; Batch #s: 1517524028, 1524012152, 1524012068 & Lot #s: 1506, Batch #s: 1515511218 1516711206 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics EE Spa 1oz Shampoo D25 Tube Item #: B151SH30ML; Lot 1509; Batch #s: 1517524028, 1524012152, 1524012068 & Lot #s: 1506, Batch #s: 1515511218 1516711206 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Mohonk 40ml Shampoo Item #: B1107SH40ML; Lot 1509; Batch #s: 1521123153 & 1523223592 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Mohonk 40ml Shampoo Item #: B1107SH40ML; Lot 1509; Batch #s: 1521123153 & 1523223592 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Neil George 50ml Body Wash Item #: B2800BW50MLA; Lot 1508; Batch #s: 1515241431& 1515241819 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Neil George 50ml Body Wash Item #: B2800BW50MLA; Lot 1508; Batch #s: 1515241431& 1515241819 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Pelican Hill 100ml Bath Gel Item #: B6782BG100ML; Lot 1509; Batch #s: 1506807073, 1525112402, 1525112301 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Pelican Hill 100ml Bath Gel Item #: B6782BG100ML; Lot 1509; Batch #s: 1506807073, 1525112402, 1525112301 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Morongo Casino 40ml Body Wash Item #: B5188BW40ML; Lot 1508; Batch #s: 1523114130 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Morongo Casino 40ml Body Wash Item #: B5188BW40ML; Lot 1508; Batch #s: 1523114130 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Beekind 30ml Body Lotion Tube Item #: B950BL30ML; Lot 1508; Batch #s: 1523633343 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Beekind 30ml Body Lotion Tube Item #: B950BL30ML; Lot 1508; Batch #s: 1523633343 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Gaylord 37ml Shower Gel Item #: B1221SG37ML; Lot 1508; Batch #s: 1523422311, 1523421011, 1523421124, 1523421080, 1523422651 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Gaylord 37ml Shower Gel Item #: B1221SG37ML; Lot 1508; Batch #s: 1523422311, 1523421011, 1523421124, 1523421080, 1523422651 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Temple Spa 30ml Shower Gel - Tube Item #: B9800SG30ML; Lot 1508; Batch #s: 1521514014 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Temple Spa 30ml Shower Gel - Tube Item #: B9800SG30ML; Lot 1508; Batch #s: 1521514014 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Temple Spa 30ml Shampoo - Tube Item #: B9800SH30ML; Lot 1508; Batch #s: 1521514143 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Temple Spa 30ml Shampoo - Tube Item #: B9800SH30ML; Lot 1508; Batch #s: 1521514143 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Spa Therapy Conditioning Shampoo 1oz Item #: B128CS010; Lot 1506; Batch #s: 1514912109 & 1506209563 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Spa Therapy Conditioning Shampoo 1oz Item #: B128CS010; Lot 1506; Batch #s: 1514912109 & 1506209563 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Temple Spa 25ml Shampoo Item #: B9800SH25ML; Lot 1508; Batch #s: 1523115449, 1522924011, 1523115702, 1522924120, 1523712150, 1521514014, 1521514060, 1521514143, 1522411033, 1522411058, 1522411014; Lot # 1507, Batch #s: 1517613449, 1520926119, 1511310301, 1511310655, 1511309401, 1511309709, 1511310878, 1511309479; Lot #: 1506, Batch #s: 1511034814, 1514821065, 1516024059, 1516024060, 1516824149, 1511034463 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Temple Spa 25ml Shampoo Item #: B9800SH25ML; Lot 1508; Batch #s: 1523115449, 1522924011, 1523115702, 1522924120, 1523712150, 1521514014, 1521514060, 1521514143, 1522411033, 1522411058, 1522411014; Lot # 1507, Batch #s: 1517613449, 1520926119, 1511310301, 1511310655, 1511309401, 1511309709, 1511310878, 1511309479; Lot #: 1506, Batch #s: 1511034814, 1514821065, 1516024059, 1516024060, 1516824149, 1511034463 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Hyatt Place 1oz Shampoo Item #: B630SH30ML; Lot 1508; Batch #s: 1522511472, 1522511410, 1523022056, 1523121007, 1523121096, 1523022058, 1522211932; Lot #: 1506, Batch #s: 1514923100, 1515321112, 1515321075, 1514923034, 1514923145, 1515321093 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Hyatt Place 1oz Shampoo Item #: B630SH30ML; Lot 1508; Batch #s: 1522511472, 1522511410, 1523022056, 1523121007, 1523121096, 1523022058, 1522211932; Lot #: 1506, Batch #s: 1514923100, 1515321112, 1515321075, 1514923034, 1514923145, 1515321093 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Temple Spa 25ml Shower Gel Item #: B9800SG25ML; Lot 1508; Batch #s:1522411058, 1522924062, 1522924120 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Temple Spa 25ml Shower Gel Item #: B9800SG25ML; Lot 1508; Batch #s:1522411058, 1522924062, 1522924120 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Antica Farmacista 3oz Shower Gel Item #: B6800SG030; Lot 1508; Batch #s:1515422722 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Antica Farmacista 3oz Shower Gel Item #: B6800SG030; Lot 1508; Batch #s:1515422722 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Hyatt Place 1oz Conditioner Item #: B630CD30ML; Lot 1506; Batch #s:1516602993, 1516331616, 1516202358, 1516602540, 1516602510 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Hyatt Place 1oz Conditioner Item #: B630CD30ML; Lot 1506; Batch #s:1516602993, 1516331616, 1516202358, 1516602540, 1516602510 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Antica Farmacista 1.5oz Shower Gel Item #: B6800SG015; Lot 1506; Batch #s:1515422823, 1515422722, 1515422288, 1516613121 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Antica Farmacista 1.5oz Shower Gel Item #: B6800SG015; Lot 1506; Batch #s:1515422823, 1515422722, 1515422288, 1516613121 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics EE Spa 1oz Conditioning Shampoo D25 Tube Item #: B151CS30ML; Lot 1506; Batch #s:1502710044 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics EE Spa 1oz Conditioning Shampoo D25 Tube Item #: B151CS30ML; Lot 1506; Batch #s:1502710044 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Spa Therapy Shampoo 1oz Item #: B128SH010; Lot 1506; Batch #s:1515323214, 1514712148, 1514712022 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Cosmetics Spa Therapy Shampoo 1oz Item #: B128SH010; Lot 1506; Batch #s:1515323214, 1514712148, 1514712022 Class II Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria. Gilchrist & Soames
Devices 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Part Number Lot Number Product Description 212.818 7856527 Synthes 2.4mm Locking Screw SLF-TPNG with Stardrive Recess 18mm Class II It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System). Synthes (USA) Products LLC
Devices 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Part Number Lot Number Product Description 212.818 7856527 Synthes 2.4mm Locking Screw SLF-TPNG with Stardrive Recess 18mm Class II It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System). Synthes (USA) Products LLC
Devices NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis. Software version 4.9 and 4.10 Class II Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed NxStage Medical, Inc.
Devices NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis. Software version 4.9 and 4.10 Class II Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed NxStage Medical, Inc.
Devices NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis. Software version 4.9 and 4.10 Class II Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed NxStage Medical, Inc.
Devices NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis. Software version 4.9 and 4.10 Class II Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed NxStage Medical, Inc.
Devices NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4 Software version 4.9 and 4.10 Class II Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed NxStage Medical, Inc.
Devices NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4 Software version 4.9 and 4.10 Class II Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed NxStage Medical, Inc.
Devices Syngo Imaging VB36D_HF02. Radiological image processing system. model# 10014063 and 10014064 Class II To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D. Siemens Medical Solutions USA, Inc
Devices Syngo Imaging VB36D_HF02. Radiological image processing system. model# 10014063 and 10014064 Class II To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D. Siemens Medical Solutions USA, Inc
Devices rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check or continuous non-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate. 2201 2407 2696 2697 Class II These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters. Masimo Corporation
Devices rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check or continuous non-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate. 2201 2407 2696 2697 Class II These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters. Masimo Corporation
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