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U.S. Department of Health and Human Services

Enforcement Report - Week of October 29, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle" Product Code CRN20, lot numbers 14N02, 15E01, 15A02 Class II Product has the potential to have a clear debris on the tip of the needle. Intra Pump Infusion Systems
Devices Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ. *** 1) Part Number 10275879; Serial Numbers: 1001  ...
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Class II Reports of loose bolts in the detector support structure of Symbia and E.CAM systems. Siemens Medical Solutions USA, Inc.
Devices e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ. *** 1) Part Number: 10151531; Serial Numbers: 1002  ...
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Class II Reports of loose bolts in the detector support structure of Symbia and e.cam systems. Siemens Medical Solutions USA, Inc.
Food Wild'erb Seasoning 2 oz and 4 oz plastic jars; seasoning contained less than 1% sassafras leaves. All lots Class III The firm was notified by the Ohio Department of Agriculture that Sassafras Leaves may be an illegal ingredient for their product. Ohio Valley Herbal Products, Inc.
Food Wild'erb Herbal Tea 1.2 oz. and 4 oz. paper bags, tea contained less than 5% sassafras leaves. All lots Class III The firm was notified by the Ohio Department of Agriculture that Sassafras Leaves may be an illegal ingredient for their product. Ohio Valley Herbal Products, Inc.
Food SWISS CHOCOLATE CHOCOLAT ALPROSE 52% CACAO PREMIUM DARK CHOCOLATE, within stand-up maroon colored gift box. NET WT 3.5 oz (100g). Packed as a carton containing 6 boxes x 20 units. UPC 689423025038. Product of Swtizerland. Distributed By: BBM CHOCOLATE DISTRIBUTORS, LTD. Brooklyn, NY 11205. all lots, Item number 5120 Class I BBM Chocolate Distributors, Ltd. has recalled three (3) Alprose Dark Chocolate products due to the presence of undeclared milk allergen. BBM Chocolate Distributors, Ltd.
Food Alprose Swiss Chocolate Dark Chocolate within a gold colored pillow gift box. NET WT 3.5 oz (100g). Packed as a carton with 6 boxes x 20 units. UPC 689423027308. Product of Switzerland. Distributed By: BBM CHOCOLATE DISTRIBUTORS, LTD. Brooklyn, NY 12205. all lots, Item number 5106 Class I BBM Chocolate Distributors, Ltd. has recalled three (3) Alprose Dark Chocolate products due to the presence of undeclared milk allergen. BBM Chocolate Distributors, Ltd.
Food CHOCOLAT Alprose NAPOLITAINS SWITZERLAND, NET WT. 1 Kg (35 oz). Product packed as the following: 1) bulk in clear plastic bags, 230 pieces with gold, black and white labeling, each carton contains 6 x 1 Kg bags, 2) 100g packages (3.5oz/~24 pieces. UPC 712963000354. Produced in Switzerland for: GROSS & COMPANY INTERNATIONAL, LONDON UK. US Importer: BBM CHOCOLATE DISTRIBUTORS, BROOKLYN, NY 11205. all lots, Item numbers 6359 Class I BBM Chocolate Distributors, Ltd. has recalled three (3) Alprose Dark Chocolate products due to the presence of undeclared milk allergen. BBM Chocolate Distributors, Ltd.
Food OSCAR'S SMOKE HOUSE JALAPENO PEPPER CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885. lot numbers: 719-959 Class I Products were recalled due to potential Listeria monocytogenes contamination. Oscar's Hickory House, Inc.
Food OSCAR'S SMOKE HOUSE CHEDDAR SPREAD & BLUE CHEESE, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885. lot numbers: 719-959 Class I Products were recalled due to potential Listeria monocytogenes contamination. Oscar's Hickory House, Inc.
Food OSCAR'S SMOKE HOUSE CHAMPAGNE CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885. lot numbers: 719-959 Class I Products were recalled due to potential Listeria monocytogenes contamination. Oscar's Hickory House, Inc.
Food OSCAR'S SMOKE HOUSE GARLIC CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885. lot numbers: 719-959 Class I Products were recalled due to potential Listeria monocytogenes contamination. Oscar's Hickory House, Inc.
Food OSCAR'S SMOKE HOUSE PORT WINE CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885. lot numbers: 719-959 Class I Products were recalled due to potential Listeria monocytogenes contamination. Oscar's Hickory House, Inc.
Food OSCAR'S SMOKE HOUSE TANGY HORSERADISH CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885. lot numbers: 719-959 Class I Products were recalled due to potential Listeria monocytogenes contamination. Oscar's Hickory House, Inc.
Food OSCAR'S SMOKE HOUSE PLAIN CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885. lot numbers: 719-959 Class I Products were recalled due to potential Listeria monocytogenes contamination. Oscar's Hickory House, Inc.
Food OSCAR'S SMOKE HOUSE "MORE THAN" CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885. lot numbers: 719-959 Class I Products were recalled due to potential Listeria monocytogenes contamination. Oscar's Hickory House, Inc.
Food OSCAR'S SMOKE HOUSE HICKORY SMOKED CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885. lot numbers: 719-959 Class I Products were recalled due to potential Listeria monocytogenes contamination. Oscar's Hickory House, Inc.
Food OSCAR'S SMOKE HOUSE BACON & HORSERADISH CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885. lot numbers: 719-959 Class I Products were recalled due to potential Listeria monocytogenes contamination. Oscar's Hickory House, Inc.
Food OSCAR'S SMOKE HOUSE BACON CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885. lot numbers: 719-959 Class I Products were recalled due to potential Listeria monocytogenes contamination. Oscar's Hickory House, Inc.
Biologics Red Blood Cells Leukocytes Reduced W128713221857 Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Delta Blood Bank
Drugs Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India Lot 39661-3 Exp. 07/15 Class II Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg Aidarex Pharmaceuticals LLC
Drugs Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle, OTC, Distributed by: Rugby Laboratories Livonia, MI 48150, NDC 0536-3606-96 Major Children's Mapap Suspension Liquid, Cherry Flavor, 4 FL OZ bottle, OTC, Distributed by: Major Pharmaceuticals Livonia, MI 48150 , NDC 0904-6308-20, Lot 3L20, Exp. 11/15 Class II Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at the 6 month timepoint. Bio-pharm, Inc.
Drugs CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC Codes: L049J12A, L067M12A, L079B13A, L079B13B, L077E13A, L010H13A, L011J13A, L101K13A Class II Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint. Qualitest Pharmaceuticals
Drugs CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0842-54, OTC Codes: L084A13A, L095F13A, L027H13A, L102K13A Class II Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint. Qualitest Pharmaceuticals
Drugs CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0843-54, OTC Codes: L084G12A, L097K12A, L001B13A, L001B13B, L079D13A, L102G13A, L007J13A Class II Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint. Qualitest Pharmaceuticals
Food All Raw Vegan, Raw Carob Powder, Net Wt. 8 oz. and 5 lb bag, - Keep Cool & Dry. Glaser Organic Farms, Miami, FL. (305) 238-7747. UPC Code: 83291005567 Lot #0507081456 Class I Glaser Organic Farms has been notified by its supplier Earth Circle Organics, of a recall of Organic Carob Powder due to possible health risks related to Salmonella contamination. Glaser Organic Farms
Food All Raw Vegan Certified Organic Carob Fudgy Brownie, Net WT. 5.5 oz. (156 g) - Keep Cool & Dry. Glaser Organic Farms, 19100 SW M13 Avenue, Miami, FL 33177. (305) 238-7747. UPC Code: 832910002061. Lot #0207211406 Class I Glaser Organic Farms has been notified by its supplier Earth Circle Organics, of a recall of Organic Carob Powder due to possible health risks related to Salmonella contamination. Glaser Organic Farms
Food All Raw Vegan Carob Pudding Pie, Net WT. 4.0 oz. - Keep Refrigerated. Glaser Organic Farms, 19100 SW M13 Avenue, Miami, FL 33177. (305) 238-7747. Lot #0207151478 Class I Glaser Organic Farms has been notified by its supplier Earth Circle Organics, of a recall of Organic Carob Powder due to possible health risks related to Salmonella contamination. Glaser Organic Farms
Food All Raw Vegan Carob Coconut Raspberry Raw Fruit Pie, Net WT. 8.0 oz. - Keep Refrigerated. Glaser Organic Farms, 19100 SW M13 Avenue, Miami, FL 33177. (305) 238-7747. Lot #0207151474 Class I Glaser Organic Farms has been notified by its supplier Earth Circle Organics, of a recall of Organic Carob Powder due to possible health risks related to Salmonella contamination. Glaser Organic Farms
Food Papetti's Table Ready Refrigerated pre-cooked scrambled eggs with butter flavor. Keep refrigerated 33 - 40 degrees F. Packaged in 12- 1.85 pound bags with Net Wt. 22.2 lbs (10.06 kg). Product code: 46025-85877. UPC Code: 1 07 46025 85877 2. Lot Nos. with exp. date: Lots 4156L-4184L with exp. dates 8/28-9/25/2014; Lots 4188L-4234L with exp. dates 9/29-11/14/2014; Lot 4237L with exp. date 11/17/2014; and Lot 4238L with exp. date 11/18/2014 Class II Product may be contaminated with spoilage microorganism. Michael Foods, Inc.
Food Papetti's Table Ready Refrigerated pre-cooked scrambled eggs. Keep refrigerated 33 - 40 degrees F. Packaged in two different size configurations: (1) 12- 1.85 pound bags, Net Wt. 22.2 lbs (10.06 kg). Product code: 46025-85878. UPC Code: 1 07 46025 85878 9, and (2) 8- 3.25 lb bags, Net Wt. 26 lbs (11.79 kg). Product code: 46025-85858. UPC Code: 1 07 46025 85858 1. Lot Numbers with Exp. dates for the following packaging configurations: Product code: 46025-85858, packaged as 8 / 3.25 lb. bags per case: 4169L, exp.  ...
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Class II Product may be contaminated with spoilage microorganism. Michael Foods, Inc.
Food Plum Organics Little Cremes: Organic Rice Milk Snacks; Super Greens: Kale, Apple and Sweet Potato; Net Wt. 1 oz. (28 grams) 8 CT. USDA Organic; Dairy Free. Ingredients: ORGANIC SWEET POTATO PUREE, ORGANIC APPLE PUREE, ORGANIC RICE MILK (ORGANIC BROWN RICE, WATER), ORGANIC EVAPORATED CANE SYRUP, ORGANIC TAPIOCA STARCH, ORGANIC DRIED KALE, ORGANIC APPLE FLAVOR, ORGANIC CINNAMON. Plum Inc., Emeryville, CA 94608 Item number 1559; Seling unit UPC 846675000330; Case UPC: 84665001559; All codes and sell by dates of BB 05 AUG 14 to 12Aug 15. Class II Increased number of complaints that product is not softening as intended and causes a potential choking hazard in babies and young children,. Plum, Inc.
Food Plum Organics Little Cremes: Organic Rice Milk Snacks; Super Purples: Acai, Blackberry and Purple Carrot; Net Wt. 1 oz. (28 grams) 8 CT. USDA Organic; Dairy Free. Ingredients: ORGANIC SWEET POTATO PUREE, ORGANIC BLACKBERRY PUREE, ORGANIC APPLE PUREE, ORGANIC ACAI PUREE, ORGANIC RICE MILK (ORGANIC BROWN RICE, WATER), ORGANIC EVAPORATED CANE SYRUP, ORGANIC TAPIOCA STARCH, ORGANIC PURPLE CARROT JUICE CONCENTRATE, NATURAL FLAVOR. Plum Inc., Emeryville, CA 94608 Item number 1542; Seling unit UPC 846675000347; Case UPC: 84665001542; All codes and sell by dates of BB 05 AUG 14 to 12Aug 15.. Class II Increased number of complaints that product is not softening as intended and causes a potential choking hazard in babies and young children,. Plum, Inc.
Food Plum Organics Little Cremes: Organic Rice Milk Snacks; Super Reds: Pomegranate, Beet and Berry; Net Wt. 1 oz. (28 grams) 8 CT. USDA Organic; Dairy Free. Ingredients:ORGANIC SWEET POTATO PUREE, ORGANIC STRAWBERRY PUREE, ORGANIC POMEGRANATE JUICE CONCENTRATE, ORGANIC RICE MILK (ORGANIC BROWN RICE, WATER), ORGANIC EVAPORATED CANE SYRUP, ORGANIC TAPIOCA STARCH, ORGANIC BEET JUICE CONCENTRATE Plum Inc., Emeryville, CA 94608 Item number 1535; Seling unit UPC 846675000323; Case UPC: 84665001535; All codes and sell by dates of BB 05 AUG 14 to 12Aug 15.. Class II Increased number of complaints that product is not softening as intended and causes a potential choking hazard in babies and young children,. Plum, Inc.
Food soft caramel balls coated in chocolate in orange plastic bag with labeling: palmer Creepy Peepers Chocolaty Coated Soft Caramel Filled Eyeballs NET WT 9 OZ Creepy Peepers Lot/Code Date: 066113 UPC 00041269503734 MANUFACTURED ON EQUIPMENT WHICH PROCESSES WHEAT, PEANUT BUTTER AND ALMONDS Inside plastic bag: Foil wrapped balls with appearance of an eyeball. On back of candy, labeled: "peanut butter" Lot/Code: 066113 Class II Product contains undeclared peanut butter. Peanut butter coated chocolate balls packed in bags labeled as Creepy Peepers Chocolaty Coated Soft Caramel Filled Eyeballs R.M. Palmer Company
Devices Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation. Product code and lot numbers: Product Code: 896.038, with lot Numbers: 291113EE, 070214EE, 210314EE, 280314EE. Class II Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector. Vygon Corporation
Drugs alcosulph Moisturizing Cream, Net Contents: 60g. Product packaged within a plastic container individually placed in small carton. Country of Origin Guyana. Batch Numbers: 201158, 307056, 311457 Class II Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.. New Gpc Inc.
Drugs alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL. Product packaged within a glass container individually placed in small carton. Country of Origin Guyana. Batch Numbers: 304159, 211463, 308345 Class II Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.. New Gpc Inc.
Drugs MUSTARCREME, Net Contents: 60g (21 oz) Country of Origin Guyana. Batch Numbers: 305150, 312236, 311231 Class II Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.. New Gpc Inc.
Drugs Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic bottle individually placed in small blue carton. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana. Batch Numbers: 305206 Class II Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.. New Gpc Inc.
Drugs WHITFIELD LOTION, Net Contents: 60 mL. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana. Batch Numbers: 308289 Class II Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.. New Gpc Inc.
Drugs Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana. Batch Numbers: 202504, 310455 Class II Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A. New Gpc Inc.
Drugs Rector's Remedy OINTMENT, Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana. Batch Numbers: 311478, 305207 Class II Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing and lack of OTC drug labeling requirements. New Gpc Inc.
Biologics Source Plasma 0350632946; 0350644300; 0350645314; 0350646230; 0350647321; 0350648230; 0350649235; 0350650853; 0350651962; 0350653025; 0350653985; 0350655122; 0350656116; 0350657175; 0350658080; 0350662599; 0350663442; 0350664621; 0350666007; 0350666839; 0350668164; 0350668940; 0350670225; 0350633685; 0350634717; 0350635503; 0350636595; 0350637419; 0350638492; 0350639322; 0350640401; 0350641396; 0350642339; 0350643386; 0350674554; 0350675403; 0350679907; 0350671021; 0350672439; 0350673212; 0350680205; 0350681590; 0350682450; 0350683335; 0350684133; 0350685060; 0350685784; 0350686948; 0350687658; 0350688972;  ...
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Class II Blood products, collected from a donor who was previously deferred by another donor center, were distributed. Biomat USA, Inc
Biologics Red Blood Cells Leukocytes Reduced W036814207426; Class III Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed. OneBlood, Inc.
Biologics Source Plasma 0091157340; 0091156797; 0091157792; 0091155084; 0091153966; 0091153711; 0091152803; 0091152605; Class II Blood products, collected from a donor who was previously deferred, were distributed. Biotest Pharmaceuticals Corp.
Devices GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps 5mm/45cm Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures. All product manufactured before July 28, 2014. Class II Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. Gyrus Medical, Inc
Devices The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers. FRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer Pro family of systems: and their respective model numbers: 1) Model  ...
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Class II Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use. Aerogen Ltd.
Devices The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers. FRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers: 1) Model Number: AG-AS3000-AU; Lot Numbers: 9144140519057 , 9144140616062 , 9144140702155 , 9144140710034; 2) Model Number: AG-AS3000-IN; Lot Numbers: 9125140522116 , 9125140526101 , 9125140527077 , 9125140609002 , 9125140609007 , 9125140616064 , 9125140627057 , 9125140702166 , 9125140710031 , 9125140805010 , 9125140805134; 3) Model Number: AG-AS3000-NE; Lot Numbers: 9122140520089 , 9122140521089 , 9122140528119 , 9122140609041 , 9122140626100 , 9122140728097 , 9122140730088; 4) Model Number: AG-AS3000-SC; Lot Numbers:  ...
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Class II Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use. Aerogen Ltd.
Devices The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers. FRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers: 1) Model Number: 1079422; Lot Numbers: 9070140620088 , 9070140723088 , 9070140723088; 2) Model Number: 1082693; Lot Numbers: 9073140618134; 3) Model Number: 1082694; Lot Numbers: 9074140530079 Class II Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use. Aerogen Ltd.
Devices The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers. FRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers: 1) Model Number: AG-UC1000-NE; Lot Numbers: 9263140718116 , 9263140718137 , 9263140730049; 2) Model Number: AG-UC1000-UK; Lot Numbers: 9235140718022 , 9235140718093 , 9235140718154; 3) Model Number: AG-UC1500-NE; Lot Numbers: 9264140627057 , 9264140627100 , 9264140721112 , 9264140724100; 4) Model Number: AG-UC1500-SC; Lot Numbers:  ...
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Class II Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use. Aerogen Ltd.
Food Frozen battered onion rings packaged in 40 oz plastic bags, 6/case under the following private labels: (1) Imperial Sysco 3/8" Battered Onion Rings, Distributed by Sysco Corporation, Houston, Texas 77077-2099, Product no.: 41010044, and UPC code: 074865 84822 0; and (2) KickStarts Batter Dipt Onion Rings, Net Wt. 40 oz (2.5 lb), Distributed by Food Services of America, Inc., Seattle, WA 98106, Product no. 10210070, UPC 0 41493 49025 0; and (3) McCain Onion Rings, Net Wt. 3.18 kg, packaged as 8 x 397g boxes, Product of U.S.A., Prepared for: McCain Foods (Canada) A Division of McCain Foods Limited, Florenceville-Bristol, New Brunswick, Canada E7L 1B2, Product No. 1000001362, UPC 0 55773 00089 4. (1) Product no. 41010044, Lot no. 1000843118; and (2) Product no. 10210070, Lot no. 1000843114; and (3) Product no. 1000001362, Lot no. V40728 Class II Product may be contaminated with glass. McCain Foods USA
Food Frozen beer battered onion rings packaged in 40 oz plastic bags, 6/case under the following private labels: (1) Intros Appetizers & Snacks Beer Battered Thin Cut Onion Rings, Marketed by Independent Marketing Alliance, Houston, Texas 77079, Product no.: 5791088, and UPC code: 8 22468 13390 0; and (2) Freddy's Onion Rings, Net Wt. 40 oz (2.5 lb), Packed for Freddy's Frozen Custard & Steakburgers, Wichita, KS 67206, Product no. 100000640, UPC 0 72714 00081 2. (1) Product no. 5791088, Lot no. 1000843147; and (2) Product no. 100000640, Lot no. 1000843148 Class II Product may be contaminated with glass. McCain Foods USA
Devices Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one liter of blood or IV fluid infusion to a trauma patient. 06-2011; 07-2011; 08-2011; 09-2011; 03-2012; 04-2012; 05-2012; 06-2012; 07-2012; 08-2012; 01-2013; 03-2013; 08-2013; 09-2013; 10-2013; 11-2013; 12-2013; 01-2014; 02-2014; 04-2014; 07-2012; 02-2014 Class II Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its capacity during a 60 minute charging period. If you have a fully discharged Ultra Battery 1 (TA-UB1), in order to achieve a 100% of charge capacity you should charge it for a period of 90 minutes. In addition, the charging voltage range of 10-36V specified on the Ultra Battery 1 (TA-UB1) label and in the instructions for use are incorrect. The corrected voltage range is 12-30V. The product is marketed for vehicle systems operating at 12 V and 28V. Estill Medical Technologies, Inc
Drugs Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbrier International, Inc., Chesapeake, VA 23320 Lot#12084; Exp. 05/16 Class II Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution. American Family Pharmacy, LLC
Biologics Red Blood Cells Leukocytes Reduced W037714031050; Class II Blood product, collected from a donor who lived in a malarial endemic area, was distributed. Hoxworth Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W205514802424; Class II Plateletpheresis product, which failed a monthly product QC test, was distributed. American National Red Cross, Greater Ozark-Arkansas Region
Devices ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit Catalog No. ASK-05501-AFH1 Lot Number 23F13K0969 Class II Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component. The lidstock indicates that the kit contains one Syringe, 10mL, Luer-Slip Loss of Resistance, Glass but contains one Syringe, 10mL, Luer-Lock Loss of Resistance, G Arrow International Inc
Devices Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use include the monitoring of ECG waveform derived from 3,5,6 and 12-lead measurements, Heart Rate, Pulse Oximetry (Sp)s), ST Segment Analysis, Arrhythmia Detection, Non Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Cardia Output (CO), Respiratory Gases, Respiration Rate and Temperature. V-Series Monitoring System, P/N: 0998-00-1800-101, 0998-00-1800-201 and DA6KB-CTO-S01. Class II Mindray DS USA Inc. initiated a voluntary field corrective action for V-Series Patient Monitor because there is an issue with the V-Series Drug Calculator function. Mindray DS USA, Inc. dba Mindray North America
Devices Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated All lots with expiration on or before August 2017 (2017-08) Class II tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus) Codman & Shurtleff, Inc.
Devices Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated All lots with expiration on or before August 2017 (2017-08) Class II tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus) Codman & Shurtleff, Inc.
Devices Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated All lots with expiration on or before August 2017 (2017-08) Class II tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus) Codman & Shurtleff, Inc.
Biologics Red Blood Cells Leukocytes Reduced W044214163535; Class III Blood product, not prepared in accordance with standard operating procedure, was distributed. San Diego Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W044214148970; Class III Blood product, not prepared in accordance with standard operating procedure, was distributed. San Diego Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W120614089852; Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Michigan Blood
Biologics Red Blood Cells Leukocytes Reduced W036214233130; Class III Blood product, for which donor suitability was not fully determined, was distributed. Belle Bonfils Memorial Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W051714111922; Class III Plateletpheresis product, labeled with an incorrect volume, was distributed. Rhode Island Blood Center
Devices Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias Model E102 - Serial Numbers: 240307, 240308, 240310, 240312, 240313, 240318, 240319, 240320, 240321, 240324, 240325, 240326, 240327, 240329, 240330, 240332, 240336, 240338, 240340, 240342, 240344, 240345, 240346, 240348, 240349, 240350, 240351, 240354, 240355, 240356, 240358, 240359, 240360, 240363, 240365, 240366, 240367, 240368, 240369, 240371, 240372, 240373, 240374, 240375, 240376,  ...
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Class II Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (LV) capacitor. Boston Scientific updated their August 2013 Physician communication to include additional devices that may experience premature battery depletion due to compromised performance of a low voltage (LV) capacitor. Boston Scientific CRM Corp
Devices Siemens ADVIA Centaur® Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system. Lot Number: 100064 Exp.Date:February 10, 2015 Class II Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results. Siemens Healthcare Diagnostics, Inc
Devices ADVIA Centaur® Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system. Lot Number: 36217064, 36281064, 36449064, 37406064, 38177064 Exp.Date:February 10, 2015 Class II Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results. Siemens Healthcare Diagnostics, Inc
Drugs Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07 Lot A369286, exp. date 31 Jan 2016 Class II Failed Dissolution Specification; at the 6-month stability time point Forest Pharmaceuticals Inc
Devices Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer Part Number: 00-8757-068-02; Lot Number: 62207029 Class II The affected products are missing polar boss threads. Zimmer, Inc.
Biologics Cryoprecipitated AHF, Pooled W036814807525; Class II Blood product, that did not meet homologous criteria, was distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036813271047; Class III Blood product, that did not meet allogeneic criteria, was distributed. OneBlood, Inc.
Food President's Choice- PC Organics brand Original Stoned Wheat Crackers, 200 g UPC: 0 60383 70928 0 Lot : 2015JA21 Class II Product contains undeclared sesame seeds Venus Wafers Inc.
Devices Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician. Serial Numbers: VS0002577 VS0002579 VS0002580 VS0002581 VS0002583 VS0002584 VS0002585 VS0002586 VS0002587 VS0002588 VS0002589 VS0002590 VS0002593 VS0002595 VS0002596 VS0002599 VS0002602 VS0002603 VS0002604 VS0002605 VS0002606 VS0002609 VS0002610 VS0002611 VS0002613 VS0002615 VS0002616 VS0002625 VS0002630 VS0002746 VS0002750 VS0002752 VS0002753 VS0002759 VS0002728 VS0002773 VS0002765 VS0002772 VS0002828 VS0002842 VS0002830 VS0002834 VS0002859 VS0002873 VS0002874 VS0002877 VS0002879 VS0002884  ...
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Class I A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is depleted the ventilators will not operate. This failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia. Respironics California Inc
Drugs Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01), packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0703-0110-03); Mfd By: Hospira Inc., Lake Forest, IL 60045; Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618; and b) 1 mL Single-dose Vial, packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0409-2634-01), Hospira, Inc., Lake Forest, IL 60045. Lot #: a) 260753F, 261403F, Exp 1FEB2015; 290153F, Exp 1MAY2015; b) 24-080-DD, Exp 1DEC2014; 25-475-DD, Exp 1JAN2015 Class II Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked. Hospira Inc.
Devices Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital 1) DeRoyal(R), REF 71-6510, Lot 36408631 2) NOVAPLUS(TM) Cat. No. V71-6510, Lot 36408622 Class II These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition. DeRoyal Industries Inc
Devices DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital Lot 364817213 Class II These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition. DeRoyal Industries Inc
Devices IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status. Lots: 381 (exp. 10/31/2014), 382 (exp. 10/31/2014) and 383 (exp. 11/30/2014) Class II Customer complaints were received for positive bias reported on the controls used on the IMMULITE /IMMULITE 1000 on the Cortisol Assay reagent lots IMMULITE /IMMULITE 1000 (LKCO1) Lots 381,382 and 383 . Subsequently, the firm confirmed a positive bias on the IMMULITE/IMMULITE 1000 (LKCO1) Lots 381, 382 and 383. Siemens Healthcare Diagnostics
Biologics Red Blood Cells Deglycerolized Leukocytes Reduced W043813005867; Class III Blood product, labeled with incorrect expiration date, was distributed. LifeShare Community Blood Services
Biologics Platelets Pheresis Leukocytes Reduced W035814074688 (Portions 1 & 2) Class II Plateletpheresis products, collected in a manner that may have compromised sterility of the units, were distributed. BloodSource, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036809310644; W036809310644; Class II Misbranded Red Blood Cells were distributed. OneBlood, Inc.
Devices Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. software revisions J.21.03, J.21.19 Class II Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped Philips Medical Systems, Inc.
Devices Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements. software revision J.30.58: Class II Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped Philips Medical Systems, Inc.
Devices The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial baseplate. Part Number 42-5299-001-00 Lots: 56572679; 56573170; 56572918; 56573378; 56572975; 56573379; 56572978; 56574223; 56572981; 56574291; 56572982; 56574292; 56573071; 56574316; 56573115; 56574317; 56573116; 56574318; 56573154. Class II Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip. Zimmer, Inc.
Food Nettle Leaf powder Gross Wt: 55.5 Lbs. Net Wt: 55.0 Lbs. This material is being sold for further processing, and for Manufacturing use only. Distributed by Whole Herb Company UPC: 010020559358 Item No: NET17000 Lot No: 319349HT Class I The product was tested and found to be positive for Salmonella. Whole Herb Company
Devices Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation. material #10140000, with serial numbers: 5018 3849 5042 Class II The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. The needle positioning device may move even with the safety switch being set sideward. If this occurs with the needle being already inserted, it could lead to an unintentional patient injury. Siemens Medical Solutions USA, Inc
Biologics Platelets Pheresis Leukocytes Reduced W311214001571; Class II Plateletpheresis product, for which leukoreduction specifications were not met, was distributed. Atlanta Blood Services
Devices Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive® 8mm, Roxolid®, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Lot number: GY030 Exp. 2019-04 Class II Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC) Straumann USA, LLC
Devices McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology TM Hemo versions: 11.0HF5, 11.1, 11.1SP5, 11.1SP6, 11.1SP6HF1, 11.1SP6HF3, 12SP1, 12.1, 12.1HF1, 12.1HF2, 12.2, 12.2HF1, 12.2HF2, 12.2HF3, 12.2HF4. Class II McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes, and to identify in a timely manner whether a parameter box is out of calibration. McKesson has identified that its communication to customers regarding the required maintenance tests was insufficient. While each unit has an attached sticker indicating the date of the next maintenance test the need for performing annual maintenance testing is not reiterated in 12.2 HF4 and earlier versions of the McKesson Cardiology Hemo user guides. Mckesson Information Solutions LLC
Food Outer Carton labeled in part as: Multiple Organics Certified 100% Organic Mango Fillets Net Weight 20 Lbs. (9.07 kgs) In 5 X 4 Lb. bags Product of Mexico Certified Organic by QAI www.multipleorganics.com USDA Organic Inner plastic bag labeled in part as: Organic Mango Filets Net Weight 5Lbs (2.26 kgs) Product of Mexico Certified Organic by QAI www.multipleorganics.com 209 Linus Pauling Dr., Hercules, CA 94547 Organic lot #s 12030614, 12180614, 12100614, 12230614 Dates of production are 6/3/2014, 6/18/2014, 6/10/2014 and 6/23/2014 Item Code 2-MA-20-24073 No UPC codes Class II Firm was notified that the product may contain fragments of metal that if ingested, may be injurious to human health. Firm has not been able to independently verify the reports, but believes it prudent to take this action. Multiple Organics, Inc.
Food next by Nature brand DARK CHOCOLATE CHERRIES, NET WT. 3 Oz (85 g), UPC 817582252006 --- Produced by Tropical Valley Foods PO Box 2994 Plattsburgh, NY 12901 Lot 460013; Best by: 2016.03.31 (on back label) Class II Next by Nature brand Dark Chocolate Cherries Lot 460013 may contain undeclared peanuts (from bulk product). Tropical Valley Foods, Inc.
Food Kupiec Rice Cakes with Dark Chocolate, 3.1 oz (90g), 6 cakes packaged in white foil with a photo image of the rice cake on the front of the packaging. Sold to retail locations with 16 packages per case. Lot Number: 149/MA/8 and 149/JP/3 Expiration Date: 05/29/2015 UPC Code: 5 906747 171742 Class I This voluntary recall has been initiated because the Kupiec Rice Cakes with Dark Chocolate may contain undeclared milk. Markpol Distributors Inc.
Devices Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20. Device is intended for use with Whiteside Biomechanics, Inc./Signal Medical Corporation Micro-Seal Shell in an uncemented Total Hip Replacement. Catalog #: WB-1-1122, Size: 36x52x20, Serial # B13085 Catalog #. WB-1-1110 Size: 36x50x20, Serial # B13099 Catalog # WB-1-1110, Size: 36x50x20, Serial #: B13105 Catalog # WB-1-1110, Size: 36x50x20, Serial # B13106 Class II Incorrect dimension on four liners was detected Signal Medical Corporation
Devices Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75). Catalog # 22-01-02106; Lot # 1110; Serial # L0259; Size 6R Catalog #22-01-02106; Lot # 2910; Serial # L0533; Size 6R Catalog # 22-01-02003, Serial #s L0280,L0283, L0284, L0285, L0287, L0288, L0615, Size 3 L Catalog # 22-01-02004, Serial # l0358, Size 4L Catalog # 22-01-02005, Serial # L0809; Size 5L Catalog #22-01-02006; Serial #s  ...
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Class II Packaging of a device was compromised Signal Medical Corporation
Food Golden Corral MEATLOAF MIX #18028, Keep Frozen, Net Weight: 20 Lbs. (4 - 5 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Manufactured Exclusively for GC Corporation, Raleigh, NC 27612 082814 Class III Products contain eggs which were recalled due to susceptibility to premature spoilage. Processed Foods, Inc.- Custom Foods
Food Golden Corral MEATLOAF MIX #18029, KEEP FROZEN, NET WEIGHT: 20 lbs (4 - 5 lb Bags), FOR INSTITUTIONAL USE ONLY, Manufactured Exclusively for GC Corporation, Raleigh, NC 27612 082814 Class III Products contain eggs which were recalled due to susceptibility to premature spoilage. Processed Foods, Inc.- Custom Foods
Food Logan's Roadhouse Meatloaf Mix #25018, Keep Frozen, Net Weight: 40 Lbs. (20 - 2 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Custom Foods of America, Knoxville, TN 37921 091914 Class III Products contain eggs which were recalled due to susceptibility to premature spoilage. Processed Foods, Inc.- Custom Foods
Food PERKINS Meatloaf Mix #31607, Keep Frozen, Net Weight: 20.125 Lbs. (7 - 2.875 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Custom Foods of America, Knoxville, TN 37921 091214 Class III Products contain eggs which were recalled due to susceptibility to premature spoilage. Processed Foods, Inc.- Custom Foods
Food FLYING BISCUIT, Oatmeal Pancake Batter #70002, Keep Frozen, Net Weight: 20 Lbs. (4 - 5 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Custom Foods of America, Knoxville, TN 37921 090314 Class III Products contain eggs which were recalled due to susceptibility to premature spoilage. Processed Foods, Inc.- Custom Foods
Food Ovation Brands Bead Pudding Base #67008, Keep Frozen, Net Weight: 20 Lbs. (4 - 5 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Custom Foods of America, Knoxville, TN 37921 091714 Class III Products contain eggs which were recalled due to susceptibility to premature spoilage. Processed Foods, Inc.- Custom Foods
Devices DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715 Radiolucent Retractor for Upper Cervical Spine part number 387.580, lot number 3620715. Class II Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy. Synthes, Inc.
Devices Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. Box Label: 2 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-2KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-2X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. Lot number 208140447 Batch Number 0060002; Lot Number 208140458 Batch Number 0061723; LotNumber208140487R Batch Number 0067938. Class II The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. . Ad-Tech Medical Instrument Corporation
Food Lotte European Waffle, Net Wt. 40g, 160g UPC 8801062518111, 8801062518135 UPC 8 801062 518111 14.07.04 14.07.05 14.07.15 14.07.14 14.07.15 14.07.16 14.07.17 14.07.18 14.08.06 14.08.07 14.08.08 14.08.09 14.08.11 14.08.12 14.08.13 14.08.15 14.08.16 14.08.29 14.09.01 14.09.02 14.09.03 14.09.04 14.09.06 14.09.14 14.09.22 14.09.23 14.09.24 14.09.25 14.09.26 14.10.06 14.10.07 14.10.08 14.10.09 14.10.10 14.10.15 14.10.27 14.10.28 14.10.29 14.10.30 14.10.31 14.11.30 14.12.01 14.12.02 14.12.03 14.12.04 14.12.05 14.12.06 14.12.07 14.12.15 14.12.16 14.12.17 14.12.18 14.12.19 14.12.20 15.01.01 15.01.02 15.01.03 15.01.12 15.01.13 15.01.14 15.01.15 15.01.26 15.01.27 15.01.28 15.01.31 15.02.09 15.02.10 15.02.11 15.02.12 15.02.25 15.02.26 15.02.27 15.02.28 15.03.02 15.03.03 15.03.11 15.03.12 15.03.13 15.03.14 15.03.23 15.03.24 15.03.25 15.03.26 15.03.27 15.03.31 15.04.06 15.04.07 15.04.08 15.04.09 15.04.10 15.04.11 15.04.20 15.04.27 15.04.28 15.04.29 15.04.30 15.05.01 15.05.11 15.05.12 15.05.13 15.05.14 15.05.15 15.05.16 15.05.18 15.05.19 15.05.20 15.06.01 15.06.02 15.06.03 15.06.04 15.06.05 15.06.06 15.06.15 15.06.16 15.06.30 15.07.06 15.07.07 15.07.08 15.07.22 15.07.23 15.07.24 15.07.25 15.07.31 15.08.10 15.08.11 15.08.12 15.08.13 15.08.14 15.08.20 15.08.31 15.09.01 15.09.02 15.09.03 15.09.04 15.09.05 15.09.06 15.09.14 15.09.15 15.09.16 15.09.17 15.09.18 15.09.19 UPC 8801062 518135 14.06.30 14.07.01 14.07.02 14.07.03 14.07.07 14.07.08 14.07.09 14.07.10 14.07.11 14.07.12 14.07.18 14.07.19 14.07.20 14.07.21 14.07.22 14.07.23 14.07.24 14.07.25 14.07.26 14.07.28 14.07.29 14.07.31 14.08.01 14.08.04 14.08.05 14.08.06 14.08.10 14.08.18 14.08.19 14.08.20 14.08.21 14.08.22 14.08.25 14.08.26 14.08.27 14.08.31 14.09.08 14.09.09 14.09.10 14.09.13 14.09.14 14.09.29 14.09.30 14.10.01 14.10.02 14.10.03 14.10.04 14.10.11 14.10.13 14.10.14 14.10.15 14.10.16 14.10.17 14.10.18 14.10.20 14.10.21 14.10.22 14.10.23 14.10.24 14.10.25 14.10.26 14.11.03 14.11.04 14.11.05 14.11.06 14.11.07 14.11.08 14.11.24 14.11.25 14.11.26 14.11.27 14.11.28 14.11.29 14.11.30 14.12.08 14.12.09 14.12.10 14.12.11 14.12.12 14.12.13 14.12.15 14.12.22 14.12.23 14.12.24 14.12.25 14.12.26 14.12.27 14.12.31 15.01.05 15.01.06 15.01.07 15.01.08 15.01.09 15.01.10 15.01.15 15.01.16 15.01.17 15.01.18 15.01.19 15.01.20 15.01.21 15.01.22 15.01.23 15.01.24 15.01.25 15.01.28 15.02.02 15.02.03 15.02.04 15.02.05 15.02.06 15.02.07 15.02.16 15.02.17 15.02.18 15.02.19 15.02.20 15.02.21 15.02.23 15.02.24 14.02.25 15.02.28 15.03.03 15.03.04 15.03.05 15.03.06 15.03.09 15.03.10 15.03.16 15.03.17 15.03.18 15.03.19 15.03.20 15.03.21 15.03.28 15.03.30 15.03.31 15.04.01 15.04.02 15.04.03 15.04.13 15.04.14 15.04.15 15.04.16 15.04.17 15.04.21 15.04.22 15.04.23 15.04.24 15.04.25 15.05.06 15.05.08 15.05.09 15.05.19 15.05.20 15.05.21 15.05.22 15.05.23 15.05.25 15.05.26 15.05.27 15.05.28 15.05.29 15.05.30 15.05.31 15.06.08 15.06.09 15.06.10 15.06.11 15.06.12 15.06.17 15.06.18 15.06.19 15.06.20 15.06.22 15.06.23 15.06.24 15.06.25 15.06.26 15.06.27 15.07.09 15.07.10 15.07.11 15.07.13 15.07.14 15.07.15 15.07.16 15.07.17 15.07.18 15.07.20 15.07.21 15.07.31 15.08.03 15.08.04 15.08.05 15.08.06 15.08.07 15.08.08 15.08.17 15.08.18 15.08.21 15.08.22 15.08.24 15.08.25 15.08.26 15.08.27 15.08.28 15.08.29 15.09.11 15.09.12 15.09.21 15.09.22 15.09.23 15.09.24 15.09.25 15.09.26 15.09.28 15.09.29 Class I Lotte International is recalling the Lotte Waffles because it contains undeclared eggs. Lotte International America Corp (LA Branch)
Devices Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood pressure (NIBP), Impedance respiration, Invasive blood pressure (P1-P4), Temperature, Functional arterial oxygen saturation (SpO2), End-tidal & inspired CO2, ECG monitoring with arrhythmia and ST-segment analysis, 12-Lead resting ECG, Cardiac output (C)). The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility. Unit Serial Number 113400177138 113400177139 114260218985 114260218986 114260218987 114360228306 114330225509 114330225510 114330225511 114330225512 114330225513 114330225514 114330225515 114330225516 113430180113 114100196465 114040191976 114090196324 113490185858 113490185860 112090110348 113030149744 113030149745 113460182773 113460182774 113460182775 113460182776 113460182777 113460182778 113460182779 113460182780 113460182781 113460182782 113460182783 113460182784 113460182785 113460182786 113470184344 112090110349 112090110359 112090110360 112100110533 112100110538 112480143971 112480143973 112480143974 112490144251  ...
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Class II Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Surveyor rand S12 S19 Patient Monitors. A hazardous situation may be created when mounting these monitors using the 75mm VESA mounting hole pattern provided in the battery cover of these monitors. If the mounting screws provided by Mortara are not used and if the mounting screws used are longer than the provided screws, it is then possible for the longer screws to be driven completely through the battery cover and then possibly penetrate the protective casing of the lithium-ion battery which may result in a fire. Mortara Instrument, Inc
Food Hapi Pudding, 3-pack, net wt. 8.46oz, UPC 11152 13417, JFC item #13417 all lots Class I Product's label fails to declare milk. J F C International Inc
Devices St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock"), dilator (10F) and 0.038 guidewire. See product labeling for diagram of contents. Batch 4641580 Class II St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio" Hemostasis Introducer, Catalog number 406308. The inner diameter of the 10F dilator is too small, such that the guidewire cannot advance through the device which may result in a procedural delay while another dilator of the desired size is obtained. St Jude Medical
Drugs MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton of 100 NDC 68084-149-01, Individual Dose NDC 68084-149-11 AHP Lot #: 134124 and 140364 Expiration Date of both lots: 05/2015 Carton NDC #: 68084-149-01 Single Dose NDC #: 68084-149-11 Class III Subpotent; 6 month stability time point American Health Packaging
Drugs ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528 Lot No. AK5425, AK5172, AK5548, AK6047, AK6114, AK5865, AK5963, AK6175, AK6346, AK6438, AK7062 Class II Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label. Zee Medical Products Inc
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