FDA Recalls in 2012

Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at the scissor blades. The Monopolar Curved Scissors are intended for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery. This accessory is to be used with the Intuitive Surgical

There is potential for the sterility of the product to be compromised.

Intuitive Surgical sent a "MEDICAL DEVICE CORRECTION" letter dated August 9, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return via fax to (408) 716-3040. Contact Customer Service at 1-800-876-1310 for questions regarding this recall.

Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid.

The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Multi Calibrator Diskettes (REF 442600, lot M002642G) may actually be Thyroxine (T4) Reagent Calibrator Diskettes.

Beckman Coulter sent an Urgent Product Correction letter dated December 15, 2011, withan attached Fax Back Response Form to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. If customers are currently using Multi Calibrator lot M002642, then they were instructed to verified diskette and discard all Multi Calibrator diskettes lot M002642 and M002642G without a dark green dot. Customers were instructed to complete and return the enclosed Response Form within 10 days. Customers were instructed to contact Beckman Coulter Support Center at http:www.beckmancoulter.com/customersupport/support/ or call (800) 854-3633 in the US and Canada. Outside of the US or Canada, customers were instructed to contact their local Beckman Coulter Representatives. For questions regarding this recall call 714-961-4483.

ENDO-FUSE(TM) FUSION ROD 7 mm X 50 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF: 500005950, LOT 088605355, IMPLANT MATERIAL: Wright Medical Technology, Inc , 5677 Airline Road, Arlington, TN 38002 The ENDO-FUSE(R) Intra-Osseous Fusion Rods are indicated for the reduction and fixation of fractures. They are indicated for the integral fixation of fractures, bony fusions, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments a

Two lots- one lot of Endo-Fuse Fusion Rod, 7x50mm was commingled one lot of Endo-Fuse(R) Fusion Rod, 7x70mm. Not all parts in each lot are affected. The commingled rod sizes might not be detected prior to surgery.

The firm, Wright Medical, sent an "URGENT: Medical Device Voluntary Recall" letter dated May 6, 2011 to their customers via FedEx . The letter describes the product, problem, and actions to be taken. The customers were instructed to examine their inventory for the affected products; immediately return any affected product to Wright Technology as soon as possible (contact Customer Service at 800-238-7117 for return instructions and replacement inventory), and immediately complete and return the attached response form via fax to: 901-867-7401. If you have any questions regarding this matter, please contact 800-874-5630.

LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment

The recall was initiated because LMANA has received a complaint that the Esophageal Intubation Detector (EID100) has a potential to create a false positive if used on a patient during confirmation of intubation.

LMA North America Inc. sent a recall letter dated May 23, 2012, for US customers, and May 24, 2012, for International customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to fill out the bottom portion of the recall letter and promptly fax it back to LMA North America at (858) 622-4130. If customers have units of EID100 from the affected lots remaining in stock, customers were instructed to arrange for immediate return by contacting LMANA's customer service department at (800) 788-7999, menu selection #2. For further questions please contact Customer Service Representative at (800) 788-7999.

"beer set dried rudd", NET WT 200 g (7 oz), PRODUCT OF RUSSIA, BEST BEFORE 10.22.2012 --- The product was packaged in a vacuum packed bag. According to the Food Lab Report, the sample consisted of two (2) whole fish measuring 8 inches and 10 inches in length.

The imported processed fish was found to be uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets.

Frozen Tuna Loins 3/5, 30lbs., UPC 8 29838 82310 7.

Unified Seafood Co is recalling Frozen Yellowfin Tuna Loin 3/5 due to possible contamination with Scombroid Toxin.

#326 RS PrimarqueLobster Base, Net Weight 50 Pounds;, PackedFor Primarque Products, Worcester, MA 01610

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

#222-C, Primarque Clam Base, Net Weight 5 pounds (2.27kg) & 16 oz ( 1 LB) 454G Packed for Primarque Products, Worcester, MA 01610 #222-C, Cook's Delight Clam Base, Net Weight 5 pounds (2.27kg) & 16 oz ( 1 LB) 454G Packed By Integrative Flavors, Michigan City, Indiana 46360

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Dried Apricots 6 oz UPC 7203670494

Undeclared sulphur dioxide

Garden Fresh Gourmet Kettle Style Original Salted Tortilla Chips 14oz (397 g) bags

Beginning 11/01/2012 Garden Fresh Gourmet recalled El Matador & Garden Fresh Gourmet Salted Tortilla Chips because quality standards of ingredients used in the products were not met.

#425N Primarque Fish Base, Net Weight 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

#223-E Primarque Clam Base, Net Weight 50 pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

#122-A, Piazza Produce Clam Base, Net Weight 16 oz (1 lb) 454G Packed For: Piazza Produce, Indianapolis, IN 46268: #122-A, Primarque Clam Base, Net Wt 16 oz (1 lb) 454 grams Manufactured for Primarque Products Co. Worcester, MA 01610 #122-A, Clam Base, Cook's Delight Clam Base, Net WT.16 oz (1 pound) and 50 Lb tub Packed By Integrative Flavors, Michigan City, Indiana 46360

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Newman's Own Lite Honey Mustard Dressing, 16 FL.OZ (473 mL)

Newman's Own Lite Honey Mustard Dressing was labeled with an incorrect back label that did not list the allergen milk.

#321N Primarque Crab Base, Net Weight 50 Pounds, Packed For Primarque Products, Worcester, MA 01610 #321 N Cook's Delight,Crab Base, Net Weight 50 Pounds, Packed By Integrative Flavors, Michigan City, Indiana 46360

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

#822- M PrimarqueClam Base, Net Weight 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Frozen Yellowfin Tuna Loin 3/5, 30lbs/case.

Red Chamber is recalling Frozen Yellowfin Tuna Loin due to customer complaints with scromboid illnesses when consuming the products.

Veggie Patch Falafel Chickpea Balls, Net Wt 9 oz tray, Refrigerated UPC code 6-10129-06619-3

Product contaminated with Listeria monocytogenes

Arnold's Candies Handmade Since 1953 www.arnoldscandies.com Wintergreen Puffs***INGREDIENTS: Sugar, Cream of Tarter, Artificial Flavoring and Coloring WARNING: Manufactured in a facility that also handles peanuts NET WT 6 oz (170g) 0 73629 00308 0 931 High Grove Blvd Akron, OH 44312 Best By: 07/11/14(19)1 lot code 06282012

The firm was notified by the New York State Department of Agriculture & Marketing, that they failed to include the colors Yellow #5 and Blue #1 on their label.

El Matador Mexican Style Salted Tortilla Chips 16oz (454 g) bags &32 oz (908 g) bags

Beginning 11/01/2012 Garden Fresh Gourmet recalled El Matador & Garden Fresh Gourmet Salted Tortilla Chips because quality standards of ingredients used in the products were not met.

#124-M Primarque Lobster Base, Net Weight (1LB) 454 G & 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610 #124-M Cook's Delight Lobster Base, Net Weight (1LB) 454 G & 50 Pounds (22.68 kg) Packed By Integrative Flavors, Michigan City, Indiana 46360 #124-M Piazza Lobster Base, Net Wt. 16 oz (1LB) 454G Packed For Piazza Produce, Indianapolis Indiana 46268

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Dried Golden Raisins 8 oz UPC 7203670490

Undeclared sulphur dioxide

Tak Shing Hong Dried Taiwan Shrimp, all sizes

Grand Products is recalling Tak Shing Hong Dried Taiwan shrimp products due to undeclared sulfites.

#428N Cook's Delight Shrimp Base, Net Weight 50 Pounds (22.68 kg) Packed by Integrative Flavors, Michigan City, Indiana

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Meatless Burger: 1) Veggie Patch Ultimate Meatless Burger - Net Wt. 9 oz. tray, UPC Code 6-10129-00211-5; 2) Veggie Patch The Ultimate Meatless Burger - Le burger sans-viande ultime, Net Wt 1.02Kg/ 2.25 Lb, UPC Code: 6-10129-08477-7

Product contaminated with Listeria monocytogenes

Yellow rice mixes with the following g brand names: (1) Shurfine brand Yellow Rice with Saffron, NET WT 5 OZ (142g), distributed by TOPCO ASSOCIATES, LLC, 7711 GROSS POINT ROAD, SKOKIE, IL 60077. UPC 011161159834 and (2) Hannaford brand Yellow Rice with real saffron & other seasonings, NET WT. 5 OZ (142g), distributed by HANNAFORD BROS. CO., SCARBOROUGH, ME 04074. UPC 041268184699

Undeclared hydrolyzed soy protein in yellow rice with saffron

Procrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial; Mfg By: Amgen Inc., Thousand Oaks, CA 91320; Dist. By: Physicians Total Care, Tulsa, OK 74146; NDC 54868-5673-1.

Presence of Particulate Matter: glass delamination

Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880.

Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.

Clean & Clear advantage, 3-in-1 foaming wash 8 FL. OZ. (240 mL) bottle, OTC, Distributed in the US by: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. Skillman, NJ 08558-9418 NDC 58232-0326-8

Superpotent (Single Ingredient Drug): salicylic acid

CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b) 120-count capsules per bottle, NDC 0004-0259-51; Made in Ireland; Distributed by: Genentech USA, Inc., South San Francisco, CA 94080.

Short Fill: some bottles contained less than 120-count per labeled claim.

Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose, Rx Only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543, by Hollister-Stier Laboratories LLC, Spokane Washington 99207, NDC 0270-0083-20.

Presence of Particulate Matter; potential for charcoal particulates

Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01

Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.

Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-4279-02.

Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.

Heritage Labs Blood/Urine Collection Kit, Product A1100, packed in bags in bulk, 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and a form to accompany the specimen . Blood specimen collection

Kits contain recalled Triad alcohol pads

Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis. Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads. Users are to use the replacement wipes instead of the wipes contained in the kits. For any questions call (888)764-4120.

Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.

A recall communication was initiated because Beckman has identified that Access Total T4 calibrator lots 019818, 021654, and 024072 do not meet their 12 month expiration date claim.

A recall communication was initiated on July 27, 2011 with Beckman forwarding a Product Corrective Action (PCA) letter with attached PCA response form to all their customers who purchased the Access Immunoassay Systems Total T4 Calibrators. The letter provides the customers with an explanation of the problems identified and actions to be taken. Customers were instructed to complete and return the enclosed response form within 10 days. Customers can call for product replacement in the US, by contacting Client Services at (800) 526-3821, option 1. Customers in Canada can contact Customer service at (800) 463-7828. Customers with questions regarding this notice can contact Customer Support Center at http:www.beckmancoulter.com or call (800) 854-3633 in the US and Canada.

Garden Fresh Gourmet Nacho Cheese Tortilla Chips 14oz bags

Beginning 11/01/2012 Garden Fresh Gourmet recalled Garden Fresh Nacho Cheese Tortilla chips (exp 11/26/2012) because quality standards of ingredients used in the products were not met.

#828 Cook's Delight Shrimp Base, Net Weight 30 Pounds; 5 Pounds, Packed by Integrative Flavors, Michigan City, Indian

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

#126 Primarque Seafood Base, Net Weight 16 oz, 1LB, 454 G & 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610 #126 Cook's Delight Seafood Base, Net Weight 16 oz (1LB) 454 G & 50 Pounds (22.68 kg) Packed By Integrative Flavors, Michigan City, Indiana 46360

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

#272N Cook's Delight Mushroom Base, Net Weight 50 Pounds (22.68 kg) Packed by Integrative Flavors, Michigan City, Indiana 46360

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

#226 Cook's Delight Lobster Base, Net Weight 30 Pounds; 5 Pounds, Packed by Integrative Flavors, Michigan City, Indian

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Arnold's Candies Handmade Since 1953 www.arnoldscandies.com Root Beer Puffs Puffs***INGREDIENTS: Sugar, Cream of Tarter, Artificial Flavoring and Coloring WARNING: Manufactured in a facility that also handles peanuts NET WT 6 oz (170g) 0 73629 00307 3 931 High Grove Blvd Akron, OH 44312 Best By: 06/04/2014(19)1 lot code 05212012

The firm was notified by the New York State Department of Agriculture & Marketing, that they failed to include the colors Yellow #5 and Blue #1 on their label.

CD HORIZON (R) LEGACY (TM) FAS, REF 7542535, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

Screws are longer then size etched on the screw.

Medtronic sent a Voluntary Recall letter dated June 28, 2011, directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included. The letter identified the product, the problem, and the action to be taken by the affected customers. If appropriate, personal follow up with Sales Representatives will be made to assure that the recall communication is understood by Risk Managers and to facilitate return of product and the associated Recall response documentation. Foreign consignees will be notified by email on June 29, 2011. For any questions or concerns regarding this recall customers were to contact their Medtronic Sales Representative or the Global Quality Department at 800-876-3133, ext 3173.

Access Immunoassay Systems Part Number: 81600 Access 2 Immunoassay Systems Part Number: 81600N Access Immunoassay Systems LXi 725 Part Number: 386200 Subsequent Product Codes: JGS The Access/DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

The recall was initiated because certain Access immunoassays can produce inaccurate results when performed within the published UniCel DxI Immunoassay Systems* room temperature operating specification of 18 degrees C to 32 degrees C (64.4 degrees F to 89.6 degrees F). An increase in room temperature causes assay results for some assays to decrease, while results for other assays increase with an i

Beckman Coulter sent an "URGENT FIELD SAFETY NOTICE" letter dated April 18, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter includes information on the new room temperature operating range for all UniCel DxI Immunoassay Systems and Access Immunoassay Systems during system operation. Customers were instructed to review their historical room temperature records to determine if their Access Immunoassay System and UniCel DxI Immunoassay System were operating outside the revised temperature range. An attached Response Form was included for customers to complete and return. Please contact Beckman Coulter Customer Support Center for questions regarding this notice at 1-800-854-3633.

SKYLight Gamma Camera System; SKYLIGHT 8FT, 3/8" SPECT Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.

Philips Medical Systems sent a "Customer Information" letter dated September 27, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter lists additional precautions the customers should use while operating the device. Philips will notify customers for replacing the affected product through an Action for Performance-Proactive Field Change Order to resolve the issue. Contact Philips Customer Care Solutions at 1-800-722-9377, option 5, for questions concerning this notice.

ANGIOSTAR X-Ray System, Model numbers 9359142 and 6379668.

Unintended movement of the system table and/or C arm.

Siemens Medical Solutions issued a letter to consignees on 8/11/2008 to inform them of the problem and a workaround should the issue occur prior to software revision.

DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee.

Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labeled as 11MM while the box actually contained a 10 MM reamer

DePuy Mitek sent an Urgent Voluntary Product Recall letter dated November 16, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to refer to the attached instructions to report their inventory status and for returning the affected product. Customers with questions should call 1-508-880-8477. For questions regarding this recall call 508-880-8100.

Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.

Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading.

Biomet 3 i sent an Urgent Medical Device Recall letter dated August 3, 2012, to all affected customers via e-mail, facsimile, telephone, or postal mail. Each customer was instructed to check their inventory for the affected product and provide feedback to Biomet 3i. Product is to be returned to: Biomet 3i P.M. Regulatory Compliance 4555 Riverside Drive Palm Beach Gardens, Florida 33410 For questions customers were instructed to call 1-800-342-5454. For questions regarding this recall call 561-776-6700.

Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.

Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.

Kimberly Clark sent an Urgent Field Corrective Action letter dated September 16, 2010, to all affected customers. The letter identified the product, the problem, and the aciton to be taken by the customer. Customers were asked to confirm whether their facility as the affected product by faxing the completed Field Corrective Action Response Form to 920-380-6682. Kimberly-Clark will arrange to perform the upgrade at the customer's facility. Customers with questions should call the Field Corrective Action Coordinator at 770-587-7400. For questions regarding this recall call 770-587-8393.

Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventional Radiology Department; Packaged for Medline Industries, Inc.; Reorder #DYNJ35993D This custom pack includes components necessary for a specific procedure.

The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in its own packaging. The product was not labeled or identified as sterile, but was assumed to be sterile by the customer.

The firm, Medline Industries, Inc., telephoned the consignee/customer on November 8, 2012. The phone call informed the customer of the product, problem and actions to be taken. The customer was instructed to inform the staff at the facility not to use the pack until it had been reworked to replace the non-sterile waste bag with the sterile equivalent. It was also noted that the product does not need to be returned as it is being replaced directly at the facility. If you have any question call 847-837-2759 or email lsimmons@medline.com.

Berres Brothers Coffee Roasters Lunch with Elvis regular whole bean coffee packaged in the following sizes: 12 oz. (340g) bags with no UPC, and 5 lb bulk bags with UPC 746774-5093

Berres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis