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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Platelets Pheresis Leukocytes Reduced Irradiated K42637 Class II Blood products, for which the quality control testing was incomplete, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Platelets Pheresis Leukocytes Reduced K42721;K42646 Class II Blood products, for which the quality control testing was incomplete, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Platelets Pheresis Leukocytes Reduced K43528; K43528; K43528 Class II Blood products, for which the quality control testing was incomplete, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Source Plasma 06FMOD0209 Class II Blood product, identified as unsuitable due to a donor screening deviation, was distributed. BioLife Plasma Services L.P.
Biologics Platelets Pheresis Leukocytes Reduced W045008906241; W045008906253; W04500905684; W045008905688; W045008900312; W045008906240; W045008906244; W045008906405; W045008906405; W045008903920; W045008905682; W045008905696; W045008906241 Class III Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed. Community Blood Center Of Gtr KC
Biologics Platelets Pheresis Leukocytes Reduced W045008906919; W045008904192; W045008904744; W045008906497; W045008906041; W045008906040; W045008905082; W045008907864; W045008907896; W045008905476 Class III Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed. Community Blood Center Of Gtr KC
Biologics Source Plasma 0141396753, Class III Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. ZLB Bioplasma, Inc.
Biologics Red Blood Cells Leukocytes Reduced 55C41646;55C38742;55C36864 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. American National Red Cross (The)
Biologics Source Plasma 08FMOD0324 Class II Blood product, collected from a donor who did not have a required physical examination, was distributed. BioLife Plasma Services L.P.
Devices Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts. The Liko Standard Slingbar 450 accessory has been supplied under multiple product numbers and combined with the sale of mobile lifts. The Standard Slingbar 450 is not serialized and has been distributed between January 1980 and the present. Here are the different Product Numbers in which the Slingbar has been shipped under: Standard Slingbar 450: 20090029, 20190024, 20190041, 31190015, 31290017, 31290043, 3156001, 3156003, 3156007, 3156014, 3156016, 31590043, and 5019013. Packaged with Golvo up to April of 2005: 2000001, 2000003, 2000005, 2000006, 2000007, 2000008, 2000009, 2000009CH, 2000009D, 2000009DK, 2000009EU, 2000009F, 2000009FIN, 2000009J, 2000009N, 2000009NL, 2000009UK, 2000009U5, 2000010, 20000100, 20000100K, 2000010EU, 2000010F, 2000010FIN, 2000010H, 2000010J, 2000010N, 2000010NL, 2000010UK, 200001OU5, 2000050, 2000051, 2000061, IN8000, and IN8061. Packaged with Viking up to December of 2004: 2040003, 2040003L, 2040004, 2040005, 2040006, 2040007, 2040013, 2040014, 2040015, 2040033, 2040034, and 2040035. Packaged with LikoLight up to December of 2004: 2030001 and 2030001H. Packaged with Uno lifts up to present: 2010001, 2010002, 2010003, 2010003D, 2010003EU, 2010003F, 2010003H, 2010003N, 2010003UK, 2010003US, 2010004, 2010004D, 2010004EU, 2010004F, 2010004H, 2010004N, 2010004UK, 2010004US, 2010005, 20100050, 2010005EU, 2010005F, 2010005N, 2010005UK, 2010005U5, 2010011, 2010012, 5E2010004, and 5E2010011. Packaged with Caroli lifts up to present: 5011001. Class II Liko/Hill-Rom has received reports from facilities which indicate that serious injuries have been received related to the Standard Sling bar 450. There have been 6 complaints of injury related to the product over the past 32 years (6 out of 838,687,856 estimated patient uses). One of the injuries was associated with a patient during use, four injuries occurred when the slingbar was not in use where someone tripped and fell onto the unit, and one where a child was playing on a lift and was injured when they tried to jump from the lift. Hill-Rom, Inc.
Drugs Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01 Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 & 2002157 Exp. 9/12 Class II Failed USP Content Uniformity Requirements: OOS result reported on retained samples. Mylan LLC.
Drugs Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA All Lot codes Class I Non-Sterility New England Compounding Center
Drugs Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class I Non-Sterility New England Compounding Center
Drugs Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class I Non-Sterility New England Compounding Center
Drugs Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class I Non-Sterility New England Compounding Center
Drugs Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Biologics Blood and Blood Products for Reprocessing W0416120040230; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Systems Inc/dba United Blood Services
Biologics Red Blood Cells Leukocytes Reduced W0416120040230; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Systems Inc/dba United Blood Services
Biologics Red Blood Cells Leukocytes Reduced W037911147282; Class II Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated W036912222319; Class II Blood product, labeled with an incorrect expiration date, was distributed. Blood Bank Of Delmarva, Inc
Biologics Blood and Blood Products for Reprocessing 06LZ34745; Class III Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. American National Red Cross The
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W117012518302Q; W117012518302Q; Class II Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell counts, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Platelets Pheresis Leukocytes Reduced W117012326743U; W117012326743U; W117012326743U; W117011507369G; W117011507369G; W1170114535114; Class II Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell counts, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Red Blood Cells Leukocytes Reduced W045012008969; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells W036810255653; W036810190296; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036810814828; W036811813763; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036811169821; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Fresh Frozen Plasma W036810255653; W036811169821; W036810190296; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W071812000498; Class II Blood products, which were collected from a donor who lived in a malarial endemic area, were distributed. Southern California Permanente Medical Group Blood Donor Ctr
Biologics Fresh Frozen Plasma W071812000498; Class II Blood products, which were collected from a donor who lived in a malarial endemic area, were distributed. Southern California Permanente Medical Group Blood Donor Ctr
Biologics Red Blood Cells W089212004412; Class II Blood product, collected from a donor who emigrated from an area considered endemic for malaria, was distributed. Sanford Medical Center (blood Bank)
Biologics Source Plasma 5090183875; 5090182331; Class II Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Talecris Plasma Resources
Drugs Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01 Lot 100953A, Exp 01OCT2013; Lot 120803A Exp 01DEC2013 Class II Presence of Particulates; may contain glass particles Hospira Inc.
Devices Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls Model 3002SEX, Serial Number 120315371-120315379 Class II Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. The affected beds may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes. Stryker Medical Division of Stryker Corporation
Devices Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg Bed, Model 3005 is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls. Model 3005S3EX, Serial Number 120415087 - 120515468, Class II Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes. Stryker Medical Division of Stryker Corporation
Devices DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions. 510 K K080192 P/N 300BF-PA200002 Class II There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient. Mindray DS USA, Inc. d.b.a. Mindray North America
Food Fresh Express brand, Fresh Spinach, 9 oz. Lot #S299B25 Class I Product tested positive for Salmonella Fresh Express Incorporated
Food Cocoa~Latte Hot Drink Maker; an electric hot drink mixer and dispenser with a 32 fl.oz. heating and mixing jar, twist and lock lid, "perfect temperature" feature, mixing paddle, and dripless faucet; Focus Electrics, LLC, West Bend, WI 53095 West Bend brand - model number 65032; Back to Basics brand - model numbers CM300BK, CM300BKL, CM300BLSS, CM300BR, CM300BR-BRL, CM300BRL and CM300W Class II The Cocoa~Latte Hot Drink Maker was manufactured with a small brass metal bushing in the liquid containing vessel that may leach lead. Focus Products Group Llc
Devices AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses 10447500016006, 10519550007006, 10537500016014 Class II The lenses exceeded the acceptance limit for silicone oil residual. Cooper Vision Caribbean Corp.
Devices Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14 The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories. list 09K14, all serial numbers and all software versions 1.0 - 5.0 Class II An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the Sample Extraction Assay Details screen, the changes are not saved. Abbott Molecular
Devices Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers: 0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M13R1, 7M14R1, 7N16R, 7P25R1, 7P93R1, 7Q11R1, BB7L63R2, BB7N26R, CB5174R11, CB175R13, CB5Q03R6, CB5Q03R7, CB6C53R6, CB7C15R2, CB7C59R2, CB7C60R2, CB7C74R2, CB7D91R5, CB7E35R2, CB7E38R1, CB7G21R4, CB7L48R1, CB7L72R1, CB7P82R1, HY6U96R2, HY6Y52R2, HY7E87R1, SS7J91R3, SSCB7L48R, SSTL7G78R1,TL5S33R7, TL6VTTR1, TL7B51R1, TL7G20R3, TL7G78R3, TL7R87R1. Sterilized Using Ethylene Oxide, Nonpyrogenic, Assembled in Mexico, Manufacturer Medtronic, Inc, Minneapolis, Mn 55432 Product is used by perfusionists as part of the extracorporeal circuit during cardiopulmonary bypass procedures, and is configured specifically as designated by each customer. Pack Model Pack Lot 0E27R16- 11239917 11252800 11264666; 1A30R6- 12132577 12219267; 2493R24- 11187015 11199707 11224309 11227205 11556735; 2493R25- 11646941 11713200 11745242 11813334 11852673 11886412 11990393 12033630 12114699 12178107 12191642 12450856; 5D56R5- 11298229 11357085 11465358 11541270 11601193 11654853 11702415 11745232 11766305 11822320 11838721 11852677 11930380 12024708 12166379 12292156; 5Z93R4- 11713132 11736880 11749958 11766283 11808651 11860604 11878689 11911068 11948473 5Z93R5- 12236493; 12411746 7E64R2- 11933798; 7J53R2- 12172725; 7M13R1- 12168157; 7M14R1- 12349772; 7N16R- 12349786; 7P25R1- 12327801 12449801 12457250; 7P93R1- 12349795 12374420; 7Q11R1- 12344028 12456303; BB7L63R2- 12408737; BB7N26R- 12312571; CB5174R11- 11293051 11315344 11334856 11489271 11745162 11886341 11977682 12019852 12062713 12098852 12139621 12146752 12258941 12277502 12326468 12421465 206110946; CB5175R13- 11292866 11334859 11432873 11442937 12182778 12411655; CB5Q03R6- 11713162 11766245 11787583 11923139 11934952; CB5Q03R7- 12114626; CB6C53R6- 12423767; CB7C15R2- 12411647; CB7C59R2- 11731501; 11813316 11838743 11869767 11908794 11982413 12019907 12146796 12151706 12201727 12292133 12423702; CB7C60R2- 11687047 11724030 11843434 11878672; CB7C74R2- 11895167; CB7D91R5- 11961280 12130493 12146882 12191604 12277455 12411687 12423760; CB7E35R2- 11839101; CB7E38R1- 11843886 11885844 11990360 12105025 12133083 12159400; CB7G21R4- 12032413 12033728 12040524 12083359 12360622; CB7L48R1- 12301694; CB7L72R1- 12155258; CB7P82R1- 12440601; HY6U96R2- 206133995; HY6Y52R2- 11826276; HY7E87R1- 11830948 11898103 11923498 12323794 12435409; SS7J91R3- 12175428; SSCB7L48R- 12120109; SSTL7G78R1 -11986264; TL5S33R7- 12093478; 12139612 12172589 12315375; TL6V77R1- 11217931 11260111; TL7B51R1- 11559097 11622968 11664762 11687063 11712834; TL7G20R3- 12258680 12271138 12360554 TL7G78R3- 12067309; TL7R87R1- 206114578 206145379 Class II Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility. Medtronic Inc. Cardiac Rhythm Disease Management
Devices Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792 - Hospira MedNet Software; Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care list numbers 11971, 11973, 12391, 20679, and 20792; all serial numbers Class II The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump. Hospira Inc.
Devices Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care list numbers 12348, 12618, and 20678; all serial numbers Class II The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump. Hospira Inc.
Devices Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers. list number 11005; all serial numbers Class II The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump. Hospira Inc.
Drugs Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A. LOT # 18262A8 Exp. 09/13 Class II Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets. Abbott Laboratories
Devices Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient. Lots 110810 and 111020 Class I FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy. Fisher & Paykel Healthcare, Ltd.
Food Sanh Yuan Preserved Plum Candy (Sweet and Sour Prune), 5 oz (142g) The manufacturer did not use lot number or code number Class II CHO Fuku Group Inc. is recalling Sanh Yuan Preserved Plum Candy (Sweet and Sour Prune) because of unacceptable levels of lead. Cho Fuku Group (usa) Inc
Food La Madeleine Potato Soup, 5 lb clear Cryovac pouches, 4 pouches per case. All potato soup manufactured 08/09&10/2012. Expiration dates Aug 21 - Oct 21, 2012 Class I The potato in the potato soup is treated with sulfites. Sulfites were not declared on the firm's product label. Gourmet Cuisine, Inc.
Devices Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are mixed through vibration. Within 90 seconds, the immunochemical reaction is completed and the turbidity is measured photometrically at 610 nm. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. See serial numbers of affected devices in attachment profided by firm. Class III Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. In addition, a warranty statement was missing in the analyzer package. HemoCue AB
Food Nature's Plus GLUTEN Free SPIRU-TEIN HIGH PROTEIN ENERGY MEAL, S'mores (Flavor), 1.2 OZ. (34g) Packet, Display Box Product No. 95903, Individual Packet Product No. 45905, UPC Code 097467459052. There are 8 foil packets per corrugated display box. --- Serving Size - 1 packet (1.2 oz.). Lot /Batch Number 1243522, Best By Date 06/2016 Class II One lot of 1.2 oz. packets of Spiru-tein High Protein Energy Meal, S'mores flavor, is labeled as "Gluten Free" but actually contains gluten. Lot 1243522 of the product with Best Buy Date 06 2016 is being recalled. Natural Organics
Devices ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry. Lot number: 00456-4108 Class II Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm. Horiba Instruments, Inc dba Horiba Medical
Devices PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and uring. Lot number: 00456-4108 Class II Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm. Horiba Instruments, Inc dba Horiba Medical
Devices Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum. Model no. 406586 Batch no. 3619533 Class III St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling. St Jude Medical Inc
Devices Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole. Model number 8713130 and lot numbers 209, 309, 409, 509, 809, 909, 60939747, 60943679, 60945966, 60948966, 60959578, 60960830, 60962412, 61170378, 5048020067, 5048805107, 5048920117, 5049152127, 5049484028, 5049545028, 5049614028, 5049704038, 5049788048, 5049821048, 5050123058, 5050297068, 5050385078, 5051802039, 5051879039, 5051893059, 5051940049, 5051999049, 5052519099, 5052638099, 5052690109, 5052692109, 5052711109, 5052726119, 5052788119, 5052920119, 5053045129, 5053112010, 5053129129, 5053146010, 5053207010, 5053269020, 5053449020, 5053505030, 5053534040, 5053584030, 5053605040, and 5053645040. Class II Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps. B. Braun Medical, Inc.
Food Hemp Plus Granola. The product is packaged in a 25 lb. container. The UPC is 0 58449 88001 1. The product is labeled in parts: "***HempPlus Granola***INGREDIENTS: Organic rolled oats, organic evaporated cane juice, organic soybean oil, organic brown rice flour, organic flax seeds, organic hemp seed, organic oat syrup solids (organic oat syrups solids, tocopherol, sea salt, organic molasses***25 lb.***Nature's Path Foods, Blaine, WA 98230***www.naturespath.com***". Best Before 2013 June 12; 2013 June 13; 2013 June 14 002 12 261 02:59. This number is explained as: 002: Internal code for Blaine production facility; 12 261: Internal code for year, product manufacturing date based on Julian calendar date (for this case 2012, September 17); 02:59: product packaging time. Class II Undeclared almond. Vanilla Almond Granola which contains almonds but it was mis-labeled as Hemp Plus Granola and almond was not declared on label. Nature'S Path Foods Inc
Devices Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used to support the lower extremities immediately before during and after surgery. The extension device is mounted to the YUNO operating table. The product may only be operated by medically trained staff within the OR environment. Class I exempt Device Listing Number A922956 Class II There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table. Maquet Inc.
Devices Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. Serial # Lot# 00067 11/12 00071 11/12 00073 11/12 00076 11/12 00079 11/12 00085 11/12 00086 11/12 00087 11/12 00089 28/12 00091 28/12 00092 28/12 00093 28/12 00094 28/12 00095 28/12 00098 28/12 00099 28/12 00101 28/12 00102 28/12 00103 28/12 00104 28/12 00105 28/12 00106 28/12 00107 28/12 00108 28/12 00109 28/12 00110 28/12 00111 28/12 00112 28/12 00113 28/12 00114 28/12 00115 28/12 00116 28/12 00117 28/12 00118 28/12 00119 28/12 00120 28/12 00121 28/12 00122 28/12 00123 28/12 00124 28/12 00125 28/12 00126 28/12 00127 28/12 00128 28/12 00129 28/12 00130 28/12 00131 28/12 00132 28/12 00133 28/12 00134 28/12 00135 28/12 00136 28/12 00137 28/12 00138 28/12 00139 28/12 00140 28/12 00141 28/12 00142 28/12 00143 28/12 00144 28/12 00145 28/12 00146 28/12 00147 28/12 00148 28/12 00068 11/12 00069 11/12 00070 11/12 00072 11/12 00075 11/12 00077 11/12 00078 11/12 00080 11/12 00081 11/12 00082 11/12 00083 11/12 00084 11/12 00088 11/12 00090 28/12 00096 28/12 00097 28/12 00100 28/12 Class II Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver System because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring and/or burning. SynCardia Systems Inc.
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