Worldwide Distribution - US including MN and Internationally to India, Australia, Canada, and England.
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact.   The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users
GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instrument Interface (IF) where free-text sent from IM is not being transcribed into free-text in iNET. The instrument may upload results to IF/iNET when order/request is not yet in IF/iNET. In such a situation, test level supporting free-text sent from the instrument is discarded (not captured).
Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada. .
Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012   The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.
Part Number 05.001.012, lot number AV18166
Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly.  The ''on'' and ''lock'' labels were interchanged.
The refrigerated vacuum packed hot smoked oysters, Original flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product.   The product main label is read in part ''***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***''.
73/4 oz. packages; unknown amount for 2.5 oz. packages
T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Original flavor, is recalled due to the potential contamination with Clostridium botulinum.
The refrigerated vacuum packed hot smoked oysters, Garlic Pepper flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product.   The product main label is read in part ''***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***''.    Sticker is placed on the package to identify the ''GARLIC PEPPER'' flavor.
103/ 4 oz. packages; Unknown amount of 2 oz. packages
T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Garlic Pepper flavor, is recalled due to the potential contamination with Clostridium botulinum.
The refrigerated vacuum packed hot smoked oysters, Teriyaki flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product.   The product main label is read in part ''***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***''.    Sticker is placed on the package to identify the ''TERIYAKI'' flavor.
103/4 oz. packages; unknown amount for 2.5 oz. packages
T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Teriyaki flavor, is recalled due to the potential contamination with Clostridium botulinum.
The refrigerated vacuum packed hot smoked oysters, Habanero flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product.   The product main label is read in part ''***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***''.    Sticker is placed on the package to identify the ''HABANERO'' flavor.
98/4 oz. packages; unknown amount for 2.5 oz. packages
T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Habanero flavor, is recalled due to the potential contamination with Clostridium botulinum.
The refrigerated vacuum packed hot smoked oysters, Lemon Pepper flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product.   The product main label is read in part ''***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***''.    Sticker is placed on the package to identify the ''LEMON PEPPER'' flavor.
T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Lemon Pepper flavor, is recalled due to the potential contamination with Clostridium botulinum.
The refrigerated vacuum packed hot smoked oysters, Peppered flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product.   The product main label is read in part ''***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***''.    Sticker is placed on the package to identify the ''PEPPERED'' flavor.
95/4 oz. packages; unknown amount for 2.5 oz. packages
T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Peppered flavor, is recalled due to the potential contamination with Clostridium botulinum.
Nature Science Dym-Sdrol capsules, packaged as a bulk product in clear plastic bags.
All lots within expiry and distributed prior to August 2013
The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.
Nature Science Super Drol capsules, packaged as a bulk product in clear plastic bags.
Nature Science Super DMZ capsules packaged in plastic bottle with 60 capsules per bottle and packaged as a bulk product in clear plastic bags.
Nature Science Energize capsules, packaged as a bulk product in clear plastic bags.
Nature Science Equibolix capsules, packaged as a bulk product in clear plastic bags.
Nature Science ADT capsules, packaged as a bulk product in clear plastic bags.
Nature Science M1 capsules, packaged as a bulk product in clear plastic bags.
Nature Science Formex capsules, packaged as a bulk product in clear plastic bags.
Nature Science Estro Fuze capsules, packaged as a bulk product in clear plastic bags.
Nature Science Alpha Male capsules, packaged as a bulk product in clear plastic bags.
Nature Science Bolasterol capsules, packaged as a bulk product in clear plastic bags.
Nature Science Cyanostane capsules, packed in plastic bottles with 60 capsules per bottle and packaged as a bulk product in clear plastic bags.
Nature Science E-Control capsules packed in plastic bottles with 60 capsules per bottle and packaged as a bulk product in clear plastic bags.
Nature Science Decadrol capsules packed in plastic bottles with 90 capsules per bottle and packaged as a bulk product in clear plastic bags.
Nature Science Halostane capsules packaged as a bulk product in clear plastic bags.
Nature Science Halo capsules packed in plastic bottles with 60 capsules per bottle and packaged as a bulk product in clear plastic bags.
Nature Science Sports A-Acid capsules packaged as a bulk product in clear plastic bags.
Nature Science Serenity capsules packaged as a bulk product in clear plastic bags.
Nature Science Yohimbe capsules packaged as a bulk product in clear plastic bags.
Nature Science Male Pill capsules packaged as a bulk product in clear plastic bags.
Nature Science Vitalikor capsules packaged in a plastic bottle with 40 capsules per bottle.
Nature Science Tendex capsules packaged as a bulk product in clear plastic bags.
Nature Science Prematif Male capsules packaged as a bulk product in clear plastic bags.
Nature Science HAM capsules packaged as a bulk product in clear plastic bags.
Nature Science M-Sten capsules packaged in a plastic bottle with 60 capsules per bottle.
Nature Science 4 Andro capsules packaged in a plastic bottle with 60 capsules per bottle.
Nature Science 1 Andro capsules packaged in a plastic bottle with 60 capsules per bottle.
Nature Science Methadrol capsules packaged in a plastic bottle with 60 capsules per bottle.
CoQ10 capsules, labeled in part as ''Healthy Life Chemistry'' By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017.
L-Glutamine capsules, labeled in part as ''Healthy Life Chemistry'' By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017.
L-Serine capsules, labeled in part as ''Healthy Life Chemistry'' By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017.
Vitamin C, labeled in part as ''Healthy Life Chemistry'' By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017.
B Complex, labeled in part as ''Healthy Life Chemistry'' By Purity First, Est. 1991, packaged in white bottles (180 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017.
L-Carnitine, labeled in part as ''Healthy Life Chemistry'' By Purity First, Est. 1991, packaged in white bottles (90 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017.
B-50, labeled in part as ''Healthy Life Chemistry'' By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017.
Mineral Complex, labeled in part as ''Healthy Life Chemistry'' By Purity First, Est. 1991, packaged in white bottles (200 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017.
Nisha Male Pill capsules packaged as a bulk product in clear plastic bags.
Nisha Blue Diamond capsules packaged as a bulk product in clear plastic bags.
Nisha Mojo Nights capsules packaged as a bulk product in clear plastic bags.
Nisha Libigrow capsules packaged as a bulk product in clear plastic bags.
Nisha Power Pill capsules packaged as a bulk product in clear plastic bags.
New Age Solutions Uri-Flow capsules packaged in a plastic bottle with 60 capsules per bottle.
Park Labs Reparagen EX capsules packaged in a plastic bottle with 60 capsules per bottle.
Park Labs Reparagen + Glucosamine capsules packaged in a plastic bottle with 60 capsules per bottle.
Park Labs Reparagen Pro capsules packaged in a plastic bottle with 60 capsules per bottle.
Park Labs Vinicol capsules packaged in a plastic bottle with 30 capsules per bottle.
Swiss Labs Rem Tyme capsules packaged in a plastic bottle with 30 capsules per bottle.
Nature Bee Bee Pollen capsules packaged in a plastic bottle with containing: 1) 360 capsules per bottle, 2) 180 capsules per bottle and 3) 60 capsules per bottle.
Biogenix USA Dym-Sdrol capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA Super Drol capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA Super DMZ capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA Energize capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA Equibolix capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA ADT capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA M1 capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA Formex capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA Estro Fuze capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA Estro Fuse capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA Alpha Male capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA Bolasterol capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA Cyanostane capsules, packaged in plastic bottles with 60 capsules per bottle and also packaged as a bulk product in clear plastic bags.
Biogenix USA E-Control capsules, packaged in plastic bottles with 60 capsules per bottle and also packaged as a bulk product in clear plastic bags.
Biogenix USA Decadrol capsules, packaged in plastic bottles with 90 capsules per bottle and also packaged as a bulk product in clear plastic bags.
Biogenix USA Halostane capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA Halo capsules, packaged in plastic bottles with 60 capsules per bottle and also packaged as a bulk product in clear plastic bags.
Biogenix USA Sports A-Acid capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA Serenity capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA Yohimbe capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA Male Pill capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA Vitalikor capsules, packaged in plastic bottles with 40 capsules per bottle.
Biogenix USA Tendex capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA Prematif Male capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA HAM capsules, packaged as a bulk product in clear plastic bags.
Biogenix USA M-Sten capsules, packaged in plastic bottles with 60 capsules per bottle.
Biogenix USA 4 Andro capsules, packaged in plastic bottles with 60 capsules per bottle.
Biogenix USA 1 Andro capsules, packaged in plastic bottles with 60 capsules per bottle.
Biogenix USA Methadrol capsules, packaged in plastic bottles with 60 capsules per bottle.
Biogenix USA Green Coffee Bean capsules, packaged as a bulk product in clear plastic bags.
Atlantic Pro Nutrients, Inc. dba  XYMOGEN
XYMOGEN LipiChol (Omega-3 Phospholipid 540 mg) Medical Food Distributed by Xymogen Orlando, Florida. Also sold and distributed under various brands and firms: *1. 4XLipidComplete (Omega-3 Phospholipid 540 mg) Medical Food Distributed by: N2 Health, La Quinta, CA. *2. AL Metabolic P Manufactured for Integrated Medical Center, Mesa AZ. *3. AstaMega-3 Balance Medical Food Distributed by: Lifestyle Research, Cheyenne, WY. *4.Body Balance H.E.M.M.L.A. Manufactured for: Health Masters, Auburndale, FL. *5. Cardio Protect Manufactured for: Shop The Care Group, LLC, Aurora, CO *6. Cardio-Krill Manufactured for: Whole Health Center, Lone Tree, CO. *7. CardiOmega Distributed by: Vail Valley Pharmacy, Edwards, CO. *8. CholeCare Manufactured for: Dr. Christina M. Tondora Scottsdale, AZ. *9. CHOLESTO-BUST Manufactured for: Clear Sky Medical, Centennial, CO. *10. Manufactured for: Arne Chiropractic & Wellness Center PC, Littleton, CO. *11. Dr. Elkin's CardioBlend Manufactured for: Medical Advocated Inc. Whittier, CA. *12. FaB Fats Manufactured for:Bukovina, Auburn, CA. *13. FEM Lipid Support Manufactured for:FEM Centre, Fort Worth, TX. *14.InflmmaChol Distributed By: INNER SCIENCE, Denver, CO. *15. Integrative Bio-Omega Distributed By: Center for Integrative Bio-Energetics, Santa Monica, CA. *16. ItisControl Distributed By: The 2nd Opinion Inc.Chattanooga, OK. *17. Killer Krill Manufactured for: Integrated Medical Care, Littleton, CO. *18. 360 Medicine Krill Pills Manufactured for: Russ Canfield, MD Santa Fe, NM. *19. Krill Supreme Manufactured for: Health Bridge, Great Neck, NY. *20. Krill-Xanthin Manufactured for: Envita Lifestyle, Scottsdale, AZ. *21. '' Li-Chol Manufactured for: Pierce Integrative Medical Center, West Bloomfield, MI. *22. Antarctic Omega Cholesterol Free Distributed By: Villa Park Medical , Villa Park, CA. *23.Lipechol Manufactured For: Women's View Medical Group Holistic Center for Integrated Family Health Care, Upland, CA. *24. Lipical Manufactured For: Ruben Ruiz, M.D.,Montebello, CA. *25. Lipicare Ma
Product was labeled as a medical food as opposed to a dietary supplement.
LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by: PharmaceutiX Orlando, Florida
Gold Label Shrimp Dip in 7 oz plastic containers, Manufactured by Adelphia Seafood, ingredients: cream cheese (pasteurized milk & cream, cheese culture, salt, stabilizers (carob bean and/or xanthan gums), water, shrimp, surimi (fish protein (pollock, cod and/or pacific whiting), water, wheat/corn starch, natural crab extract, soy oil), shrimp base (shrimp, salt, monosodium glutamate, spices), contains 2% or less of the following: spices, natural preservative (inactive dry yeast, lactic acid, cultured dextrose, maltodextrin, sodium diacetate, egg white lysozyme, nisin preparation)   Allergens: milk, fish, crustacean shellfish, egg, wheat, soy.
Red #40 color additive in shrimp raw ingredient undeclared on finished product label of various shrimp dips and salads.
Adelphia Seafood Shrimp Salad, in 5 lb. plastic tubs, Adelphia Seafood, West Lawn, PA, Ingredients: shrimp, celery, mayonnaise, onion, green pepper, relish, sweet pickle, chili sauce (sugar, water, picked red chili, vinegar, garlic, salt, stabilizer, xanthan gum), gum cellulose. Allergens: Soybeans, egg, shellfish, wheat.
Adelphia Seafood Shrimp & Scallop Rotini, in 5 lb. plastic tubs, Adelphia Seafood, West Lawn, PA. Ingredients: pasta, oil (soybean and olive), cider vinegar, water, shrimp, scallops, red & green peppers, red onion, food starch, salt, spices, natural preservatives. Allergens: soybeans, shellfish, wheat
Adelphia Seafood Mermaid Salad in a 5 lb. plastic tub.    Ingredients: surimi (alaska pollock, water, wheat flour, soybean oil, natural and artificial flavor), shrimp, pasta shell, mayonnaise (vegetable oil (soybean, canola), egg yolk, water, corn syrup, vinegar), lemon juice, spices, peppers, (diced green), natural and artificial flavors, natural preservatives.    Allergens: Soybeans, milk, egg, fish, shellfish, wheat    Adelphia Seafood, West Lawn, PA
G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080
Failed Content Uniformity Specifications; at the 18 month time point.
Stryker Medical Division of Stryker Corporation
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, China, Argentina, Brazil, Germany, Korea, Mexico, Singapore, UK, Europe, Middle East, Africa, and Latin America.
Secure II Med/Surg Bed   Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual for each device. There are minimal differences between the functionality of the two models, each of which function as a highly complex system of a large number of individual components.
Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. The affected beds have the potential to experience damage to the Foot End Cover and/or Power Coil Cable due to reduced clearance between the Foot End Cover and Foot End Lift Header.
S3 Med/Surg Bed   Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual for each device. There are minimal differences between the functionality of the two models, each of which function as a highly complex system of a large number of individual components.
Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity.  This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed.
Item Number:  47-2357-102-14  47-2357-102-18    All lots with an expiration date prior to July 24, 2023
Item Numbers:  47-2258-067-00 All Lots with an expiration date prior to July 24, 2023
Item Numbers:  32-5988-012-24 All lots with an expiration date prior to July 24, 2023
Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,
Subpotent; Hydrochlorothiazide at the 9 month time point.
Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only, Manufactured By: Teva parenteral Medicines, Inc., Irvine, CA NOVAPlus labels.  NDC 0703-5233-13 (carton), NDC 0703-5233-11 (vial) or NDC 0703-5233-93 (carton), NDC 0703-5233-91 (vial)
Presence of Precipitate; precipitation of drug product
Chewable EnZym-Complete/DPPIV with Isogest,  Kirkman brand.  Item # 0934-090.
114 bottles (87 bottles in US and 27 bottles outside US)
Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol
Chewable Maximum Spectrum EnZym-Complete/DPPIV with Isogest, Kirkmand brand.  Item # 0893-090
79 bottles (43 bottles in US and 36 bottles outside US)
9486 bottles (5584 bottles in the US and 3902 bottles outside US)
Enzym-Complete/DPP-IV, Kirkman brand.  Item numbers 0234-060, 0234-120, 0234-200, 5234-200
11944 bottles (5956 bottles in the US and 5988 bottles outside the US)
Maximum Spectrum EnZym-Complete/DPP-IV Fruit Free w/Isogest, Kirkman brand, Item # 0869A-120 and 0932-120.
2273 bottles (1735 bottles in the US and 538 bottles outside the US)
Phenol Assist, Kirkman brand, Item # 0835-090
1774 bottles (1313 bottles in the US and 461 outside of the US)
Biofilm Defense, Kirkman brand, Item # 0881-060 and  5881-060 Biofilm Defense, Pure Compounding brand, Item # 1881-060.
6099 bottles (5489 bottles in US and 610 outside the US)
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Wegman's Brand New England Clam Chowder (refrigerated at 38F or below) in a 16 oz plastic cup.
May contain undeclared shellfish (crab).
Labeled to be Antiseptic Skin Freshener, packaged in one gallon containers. The product is shipped in boxes containing 4 one gallon containers. Firm name on the label is La Palm Products, Wichita, KS.
Labels on the recalled product do not match the product.
Labeled to be Antibacterial Sea Spa Tablet, packaged in five gallon buckets. Firm name on the label is La Palm Products, Wichita, KS.
Labeled to be Antibacterial Ocean Fresh Super Dark Green Antiseptic, packaged in one gallon containers. The product is shipped in cases containing 4 one gallon containers. Firm name on the label is La Palm Products, Wichita, KS.
Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4)   Manufactured for:  Asante Solutions  Sunnyvale, CA;  Manufactured by:  Unomedical  Lejre, Denmark
Asante Catalog number: FG-4123-5 FG-4123T  Unomedical Item number: 87-060-2562;  Lot numbers: 0230118  0230122  5036994
Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4).   Manufactured for:  Asante Solutions  Sunnyvale, CA;  Manufactured by:  Unomedical  Lejre, Denmark
Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4).   Manufactured for:  Asante Solutions  Sunnyvale, CA;  Manufactured by:  Unomedical  Lejre, Denmark
Asante Catalog number: FG-4143-5, FG-4143T. Unomedical Item number: 87-110-2562  Lot numbers:   0230120;  0230124  5031108.
Asante Comfort Infusion Set with  110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination  Kit (FG-5147-4).   Manufactured for:  Asante Solutions  Sunnyvale, CA;  Manufactured by:  Unomedical,  Lejre, Denmark
Asante Catalog number:FG-4147-5, FG-4147T Unomedical Item number:87-110-2662;  Lot numbers:   0230121  0230125  5025227.
Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4)   Distributed by Asante Solutions,  Sunnyvale, CA;  Manufactured by Convatec;  Lejre, Denmark.
Asante Catalog number: FG-4226-5, G-4147T; Unomedical Item number:43-060-5266;  Lot numbers:   0230126  5005801  5030167.
Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distributed by Asante Solutions,  Sunnyvale, CA;  Manufactured by Convatec;  Lejre, Denmark.
Asante Catalog number:FG-4229-5 FG-4229T; Unomedical Item number:43-060-5269;  Lot numbers:   0230127  5005802  5038313.
Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4)   Distributed by Asante Solutions,  Sunnyvale, CA;  Manufactured by Convatec;  Lejre, Denmark.
Asante Catalog number:FG-4246-5, FG-4246T; Unomedical Item number:43-110-5266;  Lot numbers:   0230128  5005803  5030168.
Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by Asante Solutions,  Sunnyvale, CA;  Manufactured by Convatec;  Lejre, Denmark.
Asante Catalog number:FG-4249-5, FG-4249T;   Unomedical Item number: 43-110-5269;  Lot numbers:   0230129  5005804  5040412.
RTC 25-C Inline Aerosol Tee Adapter.   Intended to be used to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a ventilator circuit.
Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and Usage Directions due to a printing error.
Nationwide and Puerto Rico, American Samoa, Virgin Islands, and Canal Zone
Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98
Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Worldwide Distribution -USA including OH, FL, WI, MI NJ, SC, CA, NC, PA, OR, WA, TN, KY, OK, KS, AZ, TX, CO, NV and Internationally to Germany.   There have been 71 distribution events.  Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf. 7 units have been returned, including three through the complaint process, which leaves 64 affected units in the field subject to removal.
CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis.    The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures. 510(k) K960658
Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct.
Trabecular Metal (TM) Reverse Glenosphere 36mm  Part 00-4349-036-11    The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661
Versys Build-Up Block   The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by defi ciencies of the femoral head, neck, or portions of the proximal femur. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief and when there is progressive disability.
Nationwide Distribution including the states of CA, CO, CT, FL, IL, LA, MA, MD, MI, NC, NE, NY, OH, OR, PA, TN, TX, and WV.
IntelliFill i.v. Pharmacy Compounding Device (PCD).   Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders.
Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the IntelliFill i.v. Pharmacy Compounding Device (PCD) (product code: IFIV) has the potential to continue to run and fill syringes with the HEPA filtration disabled.
STERRAD Cyclesure Biological Indicator (BI, Part No. 14324.   Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the STERRAD Cyclesure 24 Biological Indicator.
Nationwide Distribution - USA (nationwide) and the District of Columbia and Puerto Rico.   Product was also shipped to the following countries: Afghanistan, Bahrain, Hong Kong, Italy, Saudi Arabia, Turkey & United Kingdom.
SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH   The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts.
Organic Forbidden RICE RAMEN; Gluten Free/Vegan, Black Rice Noodles  Ready in 4 minutes;  Net Wt. 10 oz;  (283 g) 4 ramen per bag  USDA Organic;  Lotus Foods, Richmond, CA.
Customer complaint of mold on Lotus Foods Ramen.
Organic Jade Pearl RICE RAMEN; Gluten Free/Vegan, Infused Noodles  Ready in 4 minutes;  Net Wt. 10 oz; (283 g) ramen per bag  USDA Organic;  Lotus Foods, Richmond, CA.
Organic Millet & Brown RICE RAMEN; Gluten Free/Vegan  Ready in 4 minutes;  Net Wt. 10 oz;  (283g) 4 ramen per bag  USDA Organic;  Lotus Foods, Richmond, CA.
Forbidden RICE RAMEN with miso soup Gluten Free/Reduced Sodium; made with organic rice  Ready in 4 minutes;  Net Wt.2.8 oz. (80 g) 1 Ramen per bag  USDA Organic;  Lotus Foods, Richmond, CA.
Jade Pearl RICE RAMEN with miso soup Gluten Free/Reduced Sodium; made with organic rice  Ready in 4 minutes;  Net Wt.2.8 oz. (80 g) 1 Ramen per bag  USDA Organic;  Lotus Foods, Richmond, CA.
Millet & Brown  RICE RAMEN with miso soup Gluten Free/Reduced Sodium; made with organic rice  Ready in 4 minutes;  Net Wt.2.8 oz. (80 g) 1 Ramen per bag  USDA Organic;  Lotus Foods, Richmond, CA.
Worldwide Distribution - USA (Nationwide) including Puerto Rico and the countries of : Afghanistan, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hungary, India, Indonesia Iran,Italy, Jordan, Kazakstan, Kenya, Liberia, Lithuania, Morocco, Netherlands, New Zealand, Nigeria, Poland,  Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Thailand, Turkey, Ukraine, United Arab, United Kingdom and Viet nam.
Philips Essenta DR,  a Stationary x-ray system, X-ray system Model: 712070    The Essenta DR is a multifunctional stationary X-ray system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent, standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command.
X-ray system C-arm casting may loosen and fall
Coca Cola Bottling Company United-East, LLC
FEB1714GBA2 with time stamps:  1830 through 1908
One lot of Diet Coke, 2L, may contain regular Cherry Coke which contains sugar.
Joseph's Gourmet Pasta and Sauces-  Asiago and Garlic Tortelloni (par cooked).  Sold Frozen in 5 lb. plastic bags for food service Item Number: 22273 (G11008331) UPC Code: 00048769222738
Worldwide Distribution - USA (nationwide) and Internationally to the following countries: AFGHANISTAN  ALBANIA  ARGENTINA  ARUBA  AUSTRALIA  AUSTRIA  AZERBAIJAN  BAHRAIN  BANGLADESH  BELGIUM  BOLIVIA  BOSNIA AND HERZEGOWINA  BRAZIL  BRUNEI DARUSSALAM  BULGARIA  CAMBODIA  CANADA  CHILE  CHINA  COLOMBIA  COSTA RICA  CROATIA (local name: Hrvatska)  CYPRUS  CZECH REPUBLIC  DENMARK  ECUADOR  EGYPT  EL SALVADOR  ESTONIA  ETHIOPIA  FINLAND  FRANCE  GERMANY  GREECE  GUADELOUPE  HONG KONG  ICELAND  INDIA  INDONESIA  IRAQ  IRELAND  ISRAEL  ITALY  JAPAN  JORDAN  KAZAKHSTAN  KENYA  KOREA, REPUBLIC OF  KUWAIT  LAOS  LATVIA  LEBANON  LIBYAN ARAB JAMAHIRIYA  LITHUANIA  LUXEMBOURG  MACAU  MACEDONIA  MALAYSIA  MALTA  MEXICO  MONGOLIA  MOROCCO  NAMIBIA  NEPAL  NETHERLANDS  NETHERLANDS ANTILLES  NEW CALEDONIA  NEW ZEALAND  NICARAGUA  NIGERIA  NORWAY  OMAN  PAKISTAN  PALESTINE  PANAMA  PAPUA NEW GUINEA  PARAGUAY  PERU  PHILIPPINES  POLAND  PORTUGAL  PUERTO RICO  QATAR  REUNION  ROMANIA  RUSSIAN FEDERATION  SAUDI ARABIA  SERBIA  SINGAPORE  SLOVENIA  SOUTH AFRICA  SPAIN  SRI LANKA  SWEDEN  SWITZERLAND  TAIWAN, PROVINCE OF CHINA  TANZANIA, UNITED REPUBLIC OF  THAILAND  TRINIDAD AND TOBAGO  TUNISIA  TURKEY  TURKMENISTAN  UGANDA  UKRAINE  UNITED ARAB EMIRATES  UNITED KINGDOM  UZBEKISTAN  VENEZUELA  VIET NAM  YEMEN
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6  The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
Serial numbers ranging:  From US00100100 to US00210461
Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources and
Worldwide Distribution-USA (nationwide) including the states of AK, Al, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY, and the countries of BAHRAIN, CANADA, COLUMBIA, GERMANY, ITALY, MALAYSIA, PHILIPPINES, ROMANIA, SPAIN, and  THE NETHERLANDS.
VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH.   Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.
STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators.  As a result the spore count on the affected product is lower than the labeled minimum and the product may incorrectly indicate that a 5-log spore kill was achieved.
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Worldwide Distribution - US Distribution including the states of IN, MS, TX and VA., and the countries of DENMARK, FRANCE, GERMANY, SPAIN and SWITZERLAND.
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS  Monitor (Grey)    The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monitor/Defibrillators.   The first energy setting is labeled 10 when it should be labeled1-10
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
Worldwide Distribution - USA including CA, IL, IN,  OH, NJ, MI , MO, NY, WI.  Internationally to Denmark.
AdvanDx Gram-Negative QuickFISH BC.  In-Vitro Diagnostic for the identification of Enterobacteriacae  Catalog Number: QFGNRBC1-25    Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures
Kits incompatible with certain fluorescence microscope light sources
Distributed directly in WA and product was further distributed to grocery stores in Oregon and Washington
Antonina's Artisan Bakery brand,  Gluten Free,  Blueberry Mini Muffins,  12 pieces per package.  Net wt. 12.6 oz.  The UPC Code is  8 18703 01102 1.
Lot Code - 051114; Expiration Date:  5/11/14 (if kept frozen)
Antonina's Artisan Bakery Gluten Free Blueberry Mini Muffins are recalled due to undeclared walnuts.
CT, DE, FL, GA, ME, MD, MA, NH, NJ, NY, NC, OH, PA, RI, VA
Stuffed Foods Asiago Risotto Bites; UPC 850821-00301
Best By Dates:  November 7, 2014, November 13, 2014,  November 14, 2014, November 20, 2014, November 22, 2014
Supplier informed manufacturer that cheese used in asiago risotto bites may contain small pieces of plastic.
Worldwide Distribution - USA ( Nationwide ) and the countries of : UK, Saudi Arabia, South Africa, Brunei, China, France, Poland, Turkey, Greece, Sweden, United Arab Emirates, Russia, Spain, Pakistan, Finland, Israel, Italy, Slovenia, Japan, Poland, Malaysia, Germany and Panama.
Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA   The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure Transducer-Tipped Catheters. Pressure and/or Temperature are measured at the Catheter tip, eliminating the need for external transducers, fluid, pressure tubing, and flush devices. The Camino displays intracranial pressure (ICP), intracranial temperature (ICT), and calculates cerebral perfusion pressure (CPP) (CPP = mean arterial pressure - mean intracranial pressure). The Camino provides a continuous display of the ICP waveform, as well as mean ICP, CPP, ICT, or systolic and diastolic waveform values. A continuous record of mean pressure and CPP values over the most recent 24-hour period is stored in memory, and can be displayed on command as a TREND either as the most recent 12 or 24 hour period. Outputs for ICP and ICT are available for use with patient bedside monitors. An isolated analogue output provides a continuous ICP waveform for hard copy documentation or data acquisition. An input to receive mean arterial pressure from a compatible patient bedside monitor is available for use when it is desired to have a CPP reading. The mean arterial pressure cannot be acquired from a non-invasive blood pressure cuff. Although the Camino is intended to be a stand-alone system, it also conveniently connects to hospital bedside monitoring systems.
Integra became aware through a complaint from a single non-US customer that if the optional SYS/DIAS mode is used on CAM01 monitor that contains Mod 4 Firmware, the displayed values for the systolic and diastolic intracranial pressure (ICP) are reversed.  But, if the CAM01 is used with an auxiliary bedside monitor, the bedside monitor displays these values correctly.
Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Down Unders Cookie Mobile Meal sold under brand Down Unders, approximately 6.75 oz. (189 gram).
Down Unders Cookie Mobile Meal is recalled because the coconut is declared in the ingredient statement but the label also lists NO NUTS.
Worldwide Distribution - USA (nationwide) and Internationally to Canada.
Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.
Catalog Numbers: 28MC24110ST with Lot Number: H548211, and Catalog Number: 28MC24130SN with Lot Numbers: H549598, or H553237
Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton  box (correct) and the graphic on the end panel (incorrect) do not match.