• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

  • Print
  • Share
  • E-mail
-
Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 9745660 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. South Florida Blood Banks, Inc.
Biologics Platelets 9745660 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. South Florida Blood Banks, Inc.
Biologics Fresh Frozen Plasma 9745660 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. South Florida Blood Banks, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated 007FJ94213; 007FQ43738 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 007FK98535;007GQ24832;007FQ44104;007FE46653; 007FJ93898;007FJ94001;007FJ94015;007FQ43731; 007FK98533 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 007GG17861(1);007GG17861(2). Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 007FC32093; 007FJ93492; 07FQ43480; 07FQ43504; 007FY65994; 007FY66020;007FY66113;007FY66334; 007FY66339 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 007FR30726 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 07GJ22668 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 07GJ22668 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Source Plasma 41500410323; 41500406367; 41500361365; 41500358115; 41500693300; 41500388963; 41500312432; 41500297930; 41500284769; 41500280653; 41500379899; 41500376284; 41500240900; 41500236326; 41500232070; 41500213506; 41500201433; 41500156302; 41500143085; 41500139916; 41500127245; 41500151472; 41500107990; 41500097816; 41500095140; 41500190279; 41500178190; 41500289375; 41500260193; 41500304660; 41500252214; 41500396330; 41500373606; 41500230550; 41500221354; 41500213282; 41500204335; 41500146729; 41500115252; 41500109127; 41500101395; 41500196970; 41500196267; 41500110144; 41500089445; 41500082374; 41500080424; 41500191837 Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. Csl Plasma Inc
Devices Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity Cardio Imaging is intended to assist trained professionals in the viewing, analysis and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians and assistants. Centricity Cardio Imaging is not intended for use in the patient vicinity. Software Version: 5.0 Class II GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may be displayed side by side by selecting "Compare Study" from the Study List, or by opening prior studies in the Patient Folder. In these cases, the Viewer differentiates the studies wityh a label (Current, Prior or Baseline), with a border color, and with Study Date anotation. The newest study is labeled "Current", the next newest study is labeled "Prior", and if there are 3 or more studies open the oldest study is labeled "Baseline". When viewing multiple studies simultaneously, the border color and "Current"/"Prior"/"Baseline" labeling may be incorrect. GE Healthcare It
Devices pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO). Product Code: 023-1861-8; Serial Numbers: B1677 - B1826, F1827 - F2161, F2178 - F2198, F2216 - F2396, F2411 - F2452, F2464 - F2472, F2495 - F2523, F2533, F2550 - F2560, F2592 - F2601, F2614 - F2635, F2640 - F2648, F2662 - F2679, F2710 - F2853, F2855 - F2871, F2878 - F2922, F2945, F2946, F2962 - F2970, F2998 - F3008, F3072 - F3080, F3083 - F3098 Class II The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number. Sysmex America Inc
Devices Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the partial pressure of oxygen. K040235 Lot 160812 Class II Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit. Integra LifeSciences Corp.
Devices Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the partial pressure of oxygen. K040235 Lot #020712;040912;050712;080612;110912;120912;140612;290812 Class II Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit. Integra LifeSciences Corp.
Devices Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen. K040235 Lot #020812l 050712; 070612; 090812; 140612;173419; 173438; 173515; 173538; 173540; 173720; 173725; 173887; 173918; 190712; 210612; 230812; 260712 Class II Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit. Integra LifeSciences Corp.
Devices Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen. K040244 Lot #190712; 240512;280612 Class II Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit. Integra LifeSciences Corp.
Devices Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen. K002765 Lot # 130712, 210912, 220612, 172281, 172647, 172690, 173170, 173260, 173548, 173580, 173917, 173942 Class II Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit. Integra LifeSciences Corp.
Devices Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen. K002765 Lot # 090812, 170812 Class II Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit. Integra LifeSciences Corp.
Devices Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen. Lot # 010612, 140512, 140612 Class II Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit. Integra LifeSciences Corp.
Devices Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen. Lot # 030912, 110612, 170812, 230812 Class II Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit. Integra LifeSciences Corp.
Devices Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen. Lot #170812 Class II Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit. Integra LifeSciences Corp.
Devices Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.ST_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen. Lot #060712, 170812 Class II Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit. Integra LifeSciences Corp.
Biologics Platelets Pheresis Leukocytes Reduced W047013141970 Class II Blood product, with an unacceptable pH, was distributed. New York Blood Center, Inc.
Biologics Red Blood Cells W036810053195; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Blood and Blood Products for Reprocessing W036810053195; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Source Plasma 0630289013; Class II Blood product, collected from a donor who received a tattoo within 12 months of donation, was distributed. Biomat USA, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W333611036170; W039512040813; Class III Blood products, with outdated satellite bags attached, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced W333611112431; W333611072795; W333611048740; W333611032457; W333612096401; Class III Blood products, with outdated satellite bags attached, were distributed. Mississippi Valley Reg Bld Ctr
Devices Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes. Model# 10433816 Software Version 3.0 Serial#'s: 401239 401189 401214 400416 400599 400600 401254 401260 401259 401161 400836 401111 401290 400641 401116 401236 401245 401241 401255 401361 400141 401108 401109 401213 400675 400882 Class II Software issue results in inaccurate 3D image may result in ablation in wrong location. Siemens Medical Solutions USA, Inc.
Biologics Red Blood Cells Leukocytes Reduced W043209035415; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W043209035415; Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Platelets W043209035415; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Platelets Pheresis Leukocytes Reduced W227013030339; Class II Blood product, collected in a manner that may have compromised the sterility of the collection system, was distributed. Community Blood Center of Carolinas
Biologics Red Blood Cells Leukocytes Reduced W051513071676; W051513071671; Class III Blood products, which may have reached an unacceptable temperature during storage, were distributed. Innovative Blood Resources
Biologics Red Blood Cells Leukocytes Reduced W069111133260; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Mississippi Blood Services Inc.
Biologics Blood and Blood Products for Reprocessing W069111133260; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Mississippi Blood Services Inc.
Biologics Platelets Pheresis Leukocytes Reduced W280313700618 Part 1 ; W280313700618 Part 2; Class II Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed. Upstate New York Transplant Services
Biologics Blood and Blood Products for Reprocessing 16GQ57757; Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. American National Red Cross
Biologics Fresh Frozen Plasma (Apheresis) W036809423169; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells(Apheresis) W036809423169; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W036809423169; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Devices PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105005 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. DePuy Spine, Inc.
Devices PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105010 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. DePuy Spine, Inc.
Devices PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105014 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. DePuy Spine, Inc.
Devices PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105018 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. DePuy Spine, Inc.
Devices PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105090 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. DePuy Spine, Inc.
Food Coconut Tree Brand; Mut Gung Non; Ginger Candy; Ing: Ginger, Sugar, Water Sold in 8 oz sealed plastic pouches, and 12 oz sealed shrink wrapped plastic tubs. P. By: E.T.I. San Jose, CA 8 oz UPC: 000008000750 12 oz UPC: 000000991711 Class II California Department of Public Health tested Ginger Candy and found that it may contain as much as .012 ppm of lead. Evershing International Trading Inc.
Biologics Red Blood Cells W036810224582; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Blood and Blood Products for Reprocessing W036810224582; Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Source Plasma NQ126229; NQ126044; NQ125644; NQ125453; NQ125068; NQ124769; NQ124420; NQ124111; NQ123788; NQ123524; NQ123203; NQ122916; NQ122657; NQ122282; NQ122128; NQ121618; NQ121429; NQ121047; NQ120771; NQ120365; Class II Blood products, collected from a donor who had been incarcerated, were distributed. Plasma Biological Services, Inc
Biologics Blood and Blood Products for Reprocessing W036812437523; Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036812437523; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W039713782345J; Class III Blood product, which did not have the preservative solution added but labeled with a 42 day expiration date, was distributed. Aurora Area Blood Bank Dba Heartland Blood Centers
Biologics Source Plasma EQ106253; EQ105947; EQ105459; EQ105170; EQ104654; EQ124089; EQ123960; EQ123314; EQ122809; EQ122671; EQ122209; EQ122069; EQ121555; EQ121413; EQ120915; EQ120791; EQ120126; EQ119852; EQ119408; EQ119135; EQ118703; EQ118393; EQ117915; EQ117613; EQ117124; EQ116884; EQ116419; EQ116185; EQ115852; EQ115647; EQ115360; EQ115201; EQ114725; EQ114465; EQ113950; EQ113660; EQ113179; EQ112872; EQ112372; EQ111782; EQ111478; EQ110987; EQ110222; EQ109101; EQ108674; EQ107866; EQ107498; EQ107057; EQ106737; Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. Interstate Blood Bank, Inc of Wisconsin
Biologics Red Blood Cells 2640057; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Cryoprecipitated AHF 2640057; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing 2640057; Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Fresh Frozen Plasma W036808175079; W036812434119; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells W036808175079; W036812434119; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Source Plasma 12SWYC8777; Class II Blood product, which was not quarantined subsequent to receiving post donation information, was distributed. BioLife Plasma Services, L.P.
Devices UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures. RT040R, all lot numbers Class II Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the life of the product. This included recommending the use of Sterile Cover JG901 and new Quick Release Coupling RT02OR to eliminate the need to sterilize the UNITRAC and a functional check was added prior to use to ensure optimal functionality of the UNITRAC system. Aesculap, Inc.
Biologics Platelets W227713402838; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Mid-South Regional Blood Center
Biologics Red Blood Cells Leukocytes Reduced W087913304839; Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Community Blood Bank of Lancaster County Medical Society
Devices Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery. Lot number: M222240 Class II One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas. Synergetics Inc
Biologics Red Blood Cells Leukocytes Reduced W040712114281; Class II Blood product, collected from a donor who provided history that warranted a deferral, was distributed. Indiana Blood Center
Biologics Red Blood Cells Leukocytes Reduced W087613930893; W087613930899; W087613930895; W087613930891; Class III Blood products, labeled with an incorrect expiration date, were distributed. Virginia Blood Services
Biologics Fresh Frozen Plasma W087613930901; Class III Blood products, labeled with an incorrect expiration date, were distributed. Virginia Blood Services
Devices Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma. Lots 252810, 315815, 319810, 319815, 321817, 367812, 370812 Class II OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer was getting QC failures. OPTI Medical Systems, Inc
Devices VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA Lots #6078184-1, #6078184-2, #6078184-4 Class II The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization. Varian Medical Systems, Inc.
Food 12/6 oz. Chobani 0% Non-Fat Greek Yogurt Plain, UPC 8-94700-01001-4; 6/16 oz. Chobani 0% Non-Fat Greek Yogurt Plain, UPC 8-94700-01007-6; 6/32 oz. Chobani 0% Non-Fat Greek Yogurt Plain, UPC 8-94700-01013-7; 6/32 oz. Chobani 0% Non-Fat Greek Yogurt Plain-Club Pack, UPC 8-94700-10184-2 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Plain, UPC 8-94700-01031-1; 6/16 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Plain, UPC 8-94700-01037-3; 6/32 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Plain, UPC 8-94700-01043-4 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 0% Non-Fat Greek Yogurt Vanilla Blended, UPC 8-94700-01002-1; 6/16 oz. Chobani 0% Non-Fat Greek Yogurt Vanilla Blended, UPC 8-94700-01008-3; 6/32 oz. Chobani 0% Non-Fat Greek Yogurt Vanilla Blended, UPC 8-94700-01014-4; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Vanilla Blended-4 Value Pack, UPC 8-18290-01279-1 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food The Chobani Flip products come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 0% Non-Fat Greek Yogurt Vanilla Golden Crunch-Flip, UPC 8-18290-01229-6 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/16 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Vanilla Chocolate Chunk Blended, UPC 8-94700-01045-8 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Vanilla Chocolate Chunk, UPC 8-94700-01048-9 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 0% Non-Fat Greek Yogurt Honey Blended, UPC 8-94700-01003-8 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/4/3.5 oz. Chobani Bite 2% Milkfat Greek Yogurt Honey With Ginger, UPC 8-18290-01213-5 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry Fruit on the Bottom, UPC 8-94700-01004-5; 6/6 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry on the Bottom-6 Value Pack, UPC 8-94700-01040-3; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry on the Bottom-4 Value Pack, UPC 8-18290-01281-4 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/32 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry Blended, UPC 8-94700-01026-7 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Strawberry, UPC 8-18290-01261-6 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Strawberry Banana Blended, UPC 8-94700-01032-8; 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Strawberry Banana Blended, UPC 8-18290-01280-7 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Swirlin Strawberry Banana-Tubes, 8-18290-01207-4 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 3/8/3.5 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry & Peach Blended-8 Value Pack, UPC 8-18290-01287-6 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 3/8/3.5 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry & Blueberry Blended-8 Value Pack, UPC 8-18290-01288-3 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages: 8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Jammin Strawberry-Tubes, UPC 8-18290-01204-3 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani Champions brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages: 6/36/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Rockin Blueberry & Jammin Strawberry-Tubes Variety Pack, UPC 8-18290-01230-2 6/16/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Rockin Blueberry & Jammin Strawberry-Tubes, UPC 8-18290-01225-8; Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani Champions brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 0% Non-Fat Greek Yogurt Strawberry Sunrise-Flip, UPC 8-18290-01226-5 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 0% Non-Fat Greek Yogurt Blueberry Fruit on the Bottom, UPC 8-94700-01005-2; 6/6 oz. Chobani 0% Non-Fat Greek Yogurt Blueberry Fruit on the Bottom-6 Value Pack, UPC 8-94700-01041-0; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Blueberry Fruit on the Bottom-4 Value Pack, UPC 8-18290-01282-1 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages: 6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Blueberry, UPC 8-18290-01262-3; Chobani Champions also comes in 3.5 oz plastic cups: 8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Rockin Blueberry-Tubes, UPC 8-18290-01205-0 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani Champions brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/16 oz. Chobani 0% Non-Fat Greek Yogurt Blueberry Blended, UPC 8-94700-01055-7 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 0% Non-Fat Greek Yogurt Blueberry Power-Flip, UPC 8-18290-01247-0 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 0% Non-Fat Greek Yogurt Peach Fruit on the Bottom, UPC 8-94700-01006-9; 6/6 oz. Chobani 0% Non-Fat Greek Yogurt Peach on the Bottom-6 Value Pack, UPC 8-94700-01030-4; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Peach on the Bottom-4 Value Pack, UPC 8-18290-01284-5 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/16 oz. Chobani 0% Non-Fat Greek Yogurt Peach Blended, UPC 8-94700-01029-8 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 1.5% Milkfat Low-Fat Greek Yogurt Peachy Pistachio-Flip, UPC 8-18290-01248-7 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 15/6 oz. Chobani 0% Non-Fat Greek Yogurt, BB, Straw, Peach Fruit on the Bottom-15 Variety Pack, UPC 8-18290-01216-6 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 0% Non-Fat Greek Yogurt Lemon Blended, UPC 8-94700-01009-0 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Pineapple Fruit on the Bottom, 8-94700-01010-6; 6/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Pineapple on the Bottom-6 Value Pack, 8-94700-01038-0; 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Pineapple on the Bottom-4 Value Pack, 8-18290-01285-2 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/16 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Pineapple Blended, UPC 8-94700-01046-5 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/4/3.5 oz. Chobani Bite 2% Milkfat Low-Fat Greek Yogurt Caramel w/ Pineapple Chunks-Bite, UPC 8-18290-01211-1 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Passion Fruit Fruit on the Bottom, UPC 8-94700-01011-3 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 0% Non-Fat Greek Yogurt Raspberry Fruit on the Bottom, UPC 8-94700-01012-0 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Raspberry Blended-4 Value Pack, UPC 8-18290-01276-0 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 0% Non-Fat Greek Yogurt Pomegranate Fruit on the Bottom, UPC 8-94700-01015-1 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry Fruit on the Bottom, UPC 8-94700-01016-8; 6/6 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry on the Bottom-6 Value Pack, UPC 8-94700-01039-7; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry on the Bottom-4 Value Pack, UPC 8-18290-01283-8 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/16 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry Blended, UPC 8-94700-01056-4 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 0% Non-Fat Greek Yogurt Apple Cinnamon Fruit on the Bottom, UPC 8-94700-01017-5 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Mango Fruit on the Bottom, UPC 8-94700-01033-5 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/16 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Mango Blended, UPC 8-94700-01018-2 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 3/8/3.5 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Mango & Pineapple Blended-8 Value Pack, UPC 8-18290-01290-6 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 0% Non-Fat Greek Yogurt Blood Orange Fruit on the Bottom, UPC 8-94700-01034-2 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Orange Vanilla, UPC 8-94700-01058-8 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Orange Vanilla Blended, UPC 8-18290-01274-6; 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Orange Vanilla Blended-4 Value Pack, UPC 8-18290-01278-4 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/4/3.5 oz. Chobani Bite 2% Milkfat Low-Fat Greek Yogurt Fig with Orange Zest, UPC 8-18290-01210-4 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Banana Fruit on the Bottom, UPC 8-94700-01044-1 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Banana Honey, UPC 8-94700-01052-6 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 0% Non-Fat Greek Yogurt Pear Fruit on the Bottom, UPC 8-18290-01202-9 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Apricot Fruit on the Bottom, UPC 8-18290-01258-6 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 0% Non-Fat Greek Yogurt Blackberry Fruit on the Bottom, UPC 8-18290-01259-3; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Blackberry on the Bottom-4 Value Pack, UPC 8-18290-01286-9 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 3/8/3.5 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry & Blackberry Blended-8 Value Pack, UPC 8-18290-01289-0 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Key Lime Blended, UPC 8-18290-01271-5; 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Key Lime Blended-4 Value Pack, UPC 8-18290-01275-3 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 1.5% Milkfat Low-Fat Greek Yogurt Key Lime Crumble-Flip, UPC 8-18290-01227-2 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Coconut Blended, UPC 8-18290-01273-9 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Coconut Blended-4 Value pack, UPC 8-18290-01277-7 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/4/3.5 oz. Chobani Bite 0% Non-Fat Greek Yogurt Raspberry with Dark Chocolate Chips, UPC 8-18290-01208-1 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/4/3.5 oz. Chobani Bite 0% Non-Fat Greek Yogurt Coffee with Dark Chocolate Chips-Bite, UPC 8-18290-01209-8 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/4/3.5 oz. Chobani Bite 0% Non-Fat Greek Yogurt Mint with Dark Chocolate Chips-Bite, UPC 8-18290-01293-7 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Very Berry, UPC 8-94700-01049-6 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food 4/4/3.5 oz. Champions 2% Milkfat Low-Fat Greek Yogurt Banana Honey & Very Berry-16 Variety Pack, UPC 8-94700-10102-6 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages: 8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Flyin Dragon Fruit-Tubes, UPC 8-18290-01265-4 Chobani Champions product also comes in 3.5 oz. plastic cups: 6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Dragon Fruit, UPC 8-18290-01264-7; Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani Champions brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages. 8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Chillin Cherry-Tubes, UPC 8-18290-01206-7 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani Champions brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages. 16/2.25 oz. Chobani Champions Tubes -1.5% Milkfat Low-Fat Greek Yogurt Chillin Cherry & Swirlin Strawberry Banana-Tubes Variety Pack, UPC 8-18290-01240-1 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani Champtions brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 1.5% Milkfat Low-Fat Greek Yogurt Almond Coco Loco-Flip, UPC 8-18290-01228-9 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 1.5% Milkfat Low-Fat Greek Yogurt Tropical Escape-Flip, UPC 8-18290-01249-4 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Food The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 1.5% Milkfat Low-Fat Greek Yogurt Nutty for Nana-Flip, UPC 8-18290-01260-9 Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. Class II Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen. Chobani Idaho
Biologics Red Blood Cells Leukocytes Reduced W20061303009800C is the Unit Class II Blood product, manufactured from an overweight whole blood unit, was distributed. American National Red Cross The
Biologics Red Blood Cells Leukocytes Reduced Irradiated W127813702227; W127813702232; Class III Blood products, collected using equipment for which quality control was not performed, were distributed. Tacoma Pierce County Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W127813702233; W127813702234; W127813702236; W127813702215; W127813702216; W127813702217; W127813702219; W127813702223; W127813702224; W127813702225; W127813702226; W127813702228; W127813702231; W127813702209; W127813702211; W127813702202; W127813702203; W127813702204; W127813702205; W127813702206; W127813702207; W127813702208; W127813702242; Class III Blood products, collected using equipment for which quality control was not performed, were distributed. Tacoma Pierce County Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced W045013900556; W045013904307; W045013900566; W045013904334; W045013905579; W045013900557; W045013900566; W045013904334; W045013900555; W045013904474; W045013904527; W045013905579; Class II Blood products, for which the quality control testing was incomplete, were distributed. Community Blood Center Of Gtr KC
Biologics Platelets Pheresis Leukocytes Reduced W200413816944P1; W200413816944P2; Class II Blood products, for which the quality control testing was incomplete, were distributed. Arc Blood Services, New England Region
Biologics Source Plasma GA1515074; GA1515597; GA1517031; GA1517352; GA1518671; GA1519093; Class II Blood products, which were not quarantined subsequent to receiving information regarding a post donation information, were distributed. DCI Biologicals LLC
Biologics Source Plasma JV0116772; JV0117212; JV0118666; JV0119251; JV0119886; Class II Blood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed. DCI Biologicals Orlando LLC
Drugs GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716 1 fl. oz. and 8 fl. oz.: Batch/Lot 615688 (exp. 06/2014) and Batch/Lot 617689 (exp. 11/2014); 16 fl. oz: Batch/Lot 615649 (exp. 05/2014). Class III Subpotent; phenylephrine HCl Hi-Tech Pharmacal Co., Inc.
Food Vinco's OsteoSheath Enhanced Bone Support, Calcium Supplement, 90 Tablets, distributed by Vinco, Inc., Evans City, PA; Osteoshealth UPC 739930205048, lot numbers 11080772 through 11080775, 12040763 through 12040767, 120101069 through 12101073 with expiration dates 10/13 to 2/15. Class II The soy ingredient used to manufacture certain lots of Vinco's Osteosheath was potentially contaminated with Salmonella. Vinco Inc.
Food Vinco's OsteoSheath 4 Enhanced Bone Support, Calcium Supplement, 120 Tablets, distributed by Vinco, Inc., Evans City, PA Osteosheath 4 UPC 739930275195, lot numbers 11060198 through 1106199, 11100897through 1110898, 1204780 through 1204781, 120101089 through 120101090, 13020640 through 13020641 with expiration dates 10/13 to 2/15. Class II The soy ingredient used to manufacture certain lots of Vinco's Osteosheath 4 was potentially contaminated with Salmonella. Vinco Inc.
Food Vinco's Fem-Vite Women's Anti-Oxidant Formula, Dietary Supplement, 60 Tablets, distributed by Vinco, Inc., Evans City, PA Fem-Vite UPC 739930205086, lot numbers 11080560, 11080562, 12100217, 12100218 with expiration dates 10/13 to 2/15. Class II The soy ingredient used to manufacture certain lots of Vinco's Fem-Vite was potentially contaminated with Salmonella. Vinco Inc.
Food DANNON OIKOS Fruit on the Bottom GREEK NONFAT YOGURT BLUEBERRY 0% FAT Expiration codes: 24 SEP 2013 PS and 25 SEP 2013 PS Class II OIKOS Nonfat Yogurt Blueberry Flavor Single Serve 5.3 oz cups were recalled because the lid correctly identifies the product but the cup is incorrectly labeled as blackberry flavor. Additionally, the product is blueberry flavored but the ingredient statement is for the blackberry flavor, which does not declare carmine, a potential allergen ingredient that is used in manufacturing the blueberry flavored product. The Dannon Company, Inc.
Devices SmartSet® Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin-sensitive organisms is a potential risk. .Lot #s: 1866567 2492886 2844909 3106436 3299572 3434618 F049Z40 1890991 2521804 2866892 3115022 3310546 3466958 1927220 2585596 2888115 3134757 3339992 3475370 1933603 2589374 2889319 3166736 3347549 3483245 1985488 2589379 2981608 3175434 3362229 3498627 2047388 2610503 2991395 3205074 3378764 3528522 2064474 2610505 3011228 3223183 3380098 3572240 2332458 2641279 3042105 3236354 3403313 3572270 2354798 2803352 3062608 3249497 3412748 3590469 2374539 2839097 3078622 3249526 3416122 F024ZA40 Class II The SmartSet® GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the US FDA. The intended use stated in the IFU for the SmartSet® GMV Endurance Gentamicin Bone Cement is for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentamicin-sensitive organisms is a potential risk. SmartSet® GMV Endurance Gentamicin Bone Cement has only been cleared by the U.S. FDA for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. DePuy Orthopaedics, Inc.
Food Green Leaf Lettuce is sold in bulk cases under "Garre Farms" or "Rossi Farms" brand. There are 24 heads of green leaf lettuce packed in each cardboard box. The Garre Farms brand is labeled in parts: "***OREGON'S OWN!***Fresh Produce***GARRE FARMS, LLC***PORTLAND, OR 97230***PRODUCE OF U.S.A***". The Rossi Farms brand is labeled as "***ROSSI FARMS***3701 N.E. 122nd AVE PORTLAND, OR 97230*** PRODUCE OF U.S.A.***". NONE. No best by dates, no expiration dates, no lot codes. Class I Garre Farms is recalling green leaf lettuce due to a potential contamination with Listeria monocytogenes. Garre Farms
Devices FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System. Lot 122822 Class III The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA Quantitative Determination in EVOLIS APF version 6.0. Bio-Rad Laboratories
Devices STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations. All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems. Class II This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB). Abbott Medical Optics, Inc.
Devices STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations. All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems. Class II This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB). Abbott Medical Optics, Inc.
Devices STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations. All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems. Class II This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB). Abbott Medical Optics, Inc.
Devices STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations. All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems. Class II This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB). Abbott Medical Optics, Inc.
Devices Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information. Job number: 313119, Item Lot number: Ohio HEA 2518, Serial numbers: 06132903 - 06198900. Class II Some devices may be contaminated on the back side of the device with glue in the blood application area. Perkin Elmer Health Sciences, Inc.
Devices Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications. M/N: 781220, 781230, 781301, 78129 and 78127. Codes: AM128, 1510, 1518, BA318, AM120, ZA178, ZA196, ZA107, ZA133, ZA172, ZA158, BA149 and ZA208. Class II There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system. Philips Medical Systems (Cleveland) Inc
Devices STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Lot# 13F050, 13F051, 13F049 Class II Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life. Advanced Sterilization Products
Food Fruit Rush Black Cherry Artificially Flavored Fruit Drink, One Gallon, Plant 06-704 All production dates from May 21 to September 16, 2013, UPC: 0-41900-07369-5. Recall includes "Best By" dates through January 10, 2014. Class III The product has the potential to spoil prematurely. Dean Foods, Inc.
Food Fruit Rush Fruit Punch Artificially Flavored Fruit Drink, One Gallon, Plant 06-704 All production dates from May 21 to September 16, 2013, UPC: 0-41900-07362-6. Recall includes "Best By" dates through January 10, 2014. Class III The product has the potential to spoil prematurely. Dean Foods, Inc.
Food Fruit Rush Lemon Lime Artificially Flavored Fruit Drink, One Gallon, Plant 06-704 All production dates from May 21 to September 16, 2013, UPC: 0-41900-07368-8. Recall includes "Best By" dates through January 10, 2014. Class III The product has the potential to spoil prematurely. Dean Foods, Inc.
Devices BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood). Lot Number/ Exp. Date 3070436 September 12, 2014 3042466 August 16, 2014 3053239 August 30, 2014 3053240 August 30, 2014 3061013 September 6, 2014 3061014 September 6, 2014 3070433 September 12, 2014 3070437 September 12 , 2014 Class II An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result. Becton Dickinson & Co.
Devices STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Lot A: 0009*ENG 0003*FG 0048*FG 0050*MRB 0237*YAMATO 0239*YAMATO 0097*FSRIP 0097*FG 315*TTL 316*TTL 317*TTL 318*TTL 314*FG 325*TTL 326*TTL 334*FG 335*FG 329*TTL 345*TTL 357*FG 359*FG 358*FG 344*TTL 351*FG 347*TTL 352*TTL 348*TTL 348*FG 360*TTL 361*TTL 364*FG 362*TTL 383*YAMATO 365*TTL 368*TTL 371*FG 369*TTL 370*TTL 374*TTL 378*TTL 379*TTL 397*TTL 376*TTL 398*TTL 400*TTL 401*TTL 402*TTL 386*TTL 403*TTL 404*TTL 406*TTL 405*TTL 399*TTL 419*TTL 388*TTL 420*TTL 421*TTL 0239*CD33 422*TTL 423*TTL 429*YAMATO 424*TTL 439*YAMATO 425*TTL 427*TTL 346*TTL 423*TTL 372*TTL 430*TTL 428*TTL 395*TTL 431*TTL 433*TTL 447*YAMATO 432*TTL 434*TTL 435*TTL 437*TTL 436*TTL 453*YAMATO 454*YAMATO 452*YAMATO 440*TTL 412*TTL 455*YAMATO 456*YAMATO 468*FG 460*FG 458*FG 459*FG 462*FG 463*FG 464*FG 473*FG 470*FG 465*FG 488*YAMATO 476*FG 481*FG 487*YAMATO 502*FG 482*FG 501*FG 484*FG 485*FG 486*FG 483*FG 479*TTL 493*FG 492*FG 495*YAMATO 494*FG 509*YAMATO 504*TTL 503*TTL 505*TTL 506*TTL 507*TTL 512*TTL 524*TTL 540*YAMATO 538*YAMATO 539*YAMATO 537*YAMATO 541*YAMATO 508*TTL 520*TTL 519*TTL 518*TTL 516*TTL 521*TTL 522*TTL 523*TTL 556*TTL 525*TTL 526*TTL 524*TTL 528*TTL 529*TTL 530*TTL 532*TTL 531*TTL 515*FG 533*TTL 534*TTL 535*TTL 557*TTL 536*TTL 568*YAMATO 570*YAMATO 575*YAMATO 543*TTL 545*TTL 544*TTL 571*YAMATO 546*TTL 548*TTL 547*TTL 549*TTL 550*TTL 554*TTL 553*TTL 552*TTL 558*TTL 555*TTL 581*YAMATO 559*TTL 560*TTL 561*TTL 585*YAMATO 562*TTL 563*TTL 576*TTL 579*TTL 593*TTL 595*TTL 591*YAMATO 590*YAMATO 596*FG 597*TTL 606*YAMATO 602*TTL 601*TTL 599*TTL 598*TTL 607*YAMATO 604*TTL 603*TTL 612*FG 616*YAMATO 611*TTL 628*TTL 615*TTL 629*TTL 632*TTL 630*TTL 631*TTL 605*TTL 625*YAMATO 621*YAMATO 643*TTL 633*TTL 644*TTL 645*TTL 656*TTL 652*TTL 655*TTL 658*TTL 646*TTL 654*FG 659*FG 660*TTL 662*TTL 680*TTL 663*TTL 665*TTL 666*TTL 664*TTL 667*TTL 683*TTL 685*TTL 686*TTL 684*TTL 650*YAMATO 620*YAMATO 653*TTL 679*TTL 682*TTL 690*TTL 692*TTL 691*TTL 693*TTL 694*TTL 695*TTL 696*TTL 689*TTL 688*TTL 687*TTL 661*TTL 703*TTL 699*TTL 697*YAMATO 706*TTL 705*TTL 704*TTL 707*TTL 708*TTL 709*TTL 710*TTL 722*TTL 717*TTL 716*TTL 712*TTL 715*TTL 725*TTL 726*TTL 711*TTL 714*TTL 718*TTL 719*TTL 721*TTL 723*TTL 727*TTL 641*TTL 728*TTL 729*TTL 731*TTL 732*TTL 713*TTL 737*TTL 734*TTL 735*TTL 736*TTL 724*TTL 730*TTL 733*TTL 642*TTL 738*TTL 740*TTL 739*TTL 741*TTL 742*TTL 743*TTL 744*TTL 745*TTL 746*TTL 747*TTL 748*TTL 749*TTL 750*TTL 751*TTL 754*TTL 755*TTL 756*TTL 648*YAMATO 758*TTL 757*TTL 759*TTL 762*TTL 761*TTL 763*TTL 764*TTL 765*TTL 698*YAMATO 675*YAMATO 766*TTL 767*TTL 768*TTL 779*TTL 780*TTL 781*TTL 782*TTL 783*TTL 770*YAMATO 784*TTL 785*TTL 786*TTL 788*TTL 637*TTL 791*TTL 793*TTL 792*TTL 787*TTL 790*TTL 790*TTL 794*TTL 796*TTL 795*TTL 797*TTL 798*TTL 800*TTL 802*TTL 801*TTL 803*TTL 804*TTL 805*TTL 806*TTL 807*TTL 808*TTL 809*TTL 810*TTL 811*FG 813*TTL 814*TTL 815*TTL 673*YAMATO 816*TTL 817*TTL 818*TTL 819*TTL 884*YAMATO 822*TTL 824*TTL 821*TTL 820*FG 823*TTL 825*TTL 826*TTL 883*TTL 828*TTL 829*TTL 812*TTL 832*TTL 830*TTL 831*TTL 839*TTL 833*TTL 841*TTL 840*TTL 846*TTL 847*TTL 845*TTL 844*TTL 842*TTL 827*TTL 811*TTL 848*TTL 849*TTL 850*TTL 875*YAMATO 870*YAMATO 856*TTL 855*TTL 853*TTL 852*TTL 851*TTL 858*TTL 863*TTL 862*TTL 861*TTL 859*TTL 864*TTL 860*TTL 865*TTL 867*TTL 866*TTL 890*TTL 868*TTL 903*TTL 901*TTL 899*TTL 891*TTL 897*TTL 890*TTL 896*TTL 892*TTL 893*TTL 894*TTL 885*TTL 889*TTL 904*TTL 905*TTL 902*TTL 908*TTL 907*TTL 909*TTL 906*TTL 910*TTL 912*TTL 911*TTL 914*TTL 913*TTL 915*TTL 916*TTL 918*TTL 917*TTL 920*TTL 919*TTL 877*YAMATO 922*TTL 835*YAMATO 923*TTL 927*TTL 926*TTL 925*TTL 924*TTL 928*TTL 931*TTL 932*TTL 838*YAMATO 934*TTL 967*FG 935*TTL 936*TTL 938*TTL 939*TTL 945*TTL 947*TTL 940*TTL 946*TTL 950*TTL 973*TTL 950*TTL 976*TTL 951*TTL 974*TTL 984*TTL 949*FG 953*TTL 978*TTL 982*TTL 986*TTL 994*TTL 995*TTL 996*TTL 954*TTL 955*TTL 956*TTL 957*TTL 0201080042* 0201080027* 0201080041* 958* 959* 960* 961* 962* 975* 972* 971* 977* 985* 0201080051* 0201080052* 0201080045* 0201080055* 0201080053* 0201080054* 0201080044* 0201080057* 0201080046* 0201080061* 0201080063* 0201080062* 0201080031* 0201080039* 0201080040* 0201080035* 0201080065* 0201080064* 0201080074* 0201080072* 0201080073* 0201080069* 0201080070* 0201080066* 0201080048* 0202100004* 0201080075* 0201080077* 0201080076* 330*YAMATO 0137*FG 0136*FG 333*YAMATO 0139*FG 0097*FSRIP 194*FG 0130*FG 0135*FG 0260*YAMATO 0261*YAMATO 0201100001* 0058*FG 0064*FG 514*YAMATO 0202100030* 0202100032* 0202100033* 0202100034* 0202100035* 0202100036* 0202100037* 0202100045* 0141*FG 0195*FGYAMATO 0192*FGYAMATO 331*YAMATO 332*YAMATO 394*TTL 0202090032* 0202090036* 0202090038* 0202090039* 0202090040* 0202080018* 0202090001* 0232*YAMATO 0262*YAMATO 0070*FG 0071*FG 879*YAMATO 0193*FGYAMATO 753*YAMATO 752*YAMATO 0202100054* 0202100001* 0067*FG 0263*YAMATO 0199*FGYAMATO 0143*FG 0200*FGYAMATO 0072*FG 0066*FG 0201*FGYAMATO 887*YAMATO 887*YAMATO 0065*FG 0068*FG 0067*FG 0069*FG 0070*FG 0071*FG 0072*FG 0202*FGYAMATO 0202090003* 0202090008* 0202090034* 0202090007* 0265*YAMATO 0202090005* 0056*FG 0197*YAMATO 0207*YAMATO 0271*YAMATO 413*YAMATO 198*TTL 210*TTL 209*TTL 0265*FG 0266*YAMATO 264*YAMATO 204*TTL 203*TTL 0273*YAMATO 0272*YAMATO 0270*YAMATO 0212*YAMATO 0205*YAMATO 769*YAMATO 0202090010* 0211*YAMATO 0213*YAMATO 0202100002* 672*YAMATO 0216*YAMATO 0202100021* 0202100026* 0202100027* 0202100028* 0202100046* 0202100047* 0202100055* 0202100056* 336*TTL 0144*FG 441*YAMATO 339*TTL 0218*YAMATO 0217*YAMATO 0279*YAMATO 0275*YAMATO 340*TTL 0147*FG 343*FG 341*TTL 342*YAMATO 219*TTL 874*YAMATO 0155*FG 442*YAMATO 564*TTL 0223*YAMATO 0221*YAMATO 0220*YAMATO 0146*FG 565*TTL 0221*TTL 0201100002* 0202090012* 449*YAMATO 578*YAMATO 0076*FG 0145*FG 0156*FG 277*YAMATO 274*TTL 0224*YAMATO 0225*YAMATO 0222*YAMATO 276*YAMATO 0202090017* 0080*FG 0079*FG 353*TTL 0201080023* 775*YAMATO 0086*FG 0082*FG 0151*FG 0157*FG 0226*YAMATO 880*YAMATO 445*YAMATO 0202090024* 285*YAMATO 281*YAMATO 514*FG 0201080032* 0202090011* 582*FG 0202100020* 0202100040* 0202100041* 0202100053* 284*YAMATO 280*YAMATO 282*YAMATO 0246*YAMATO 0083*FG 0087*FG 356*TTL 446*YAMATO 584*YAMATO 944*YAMATO 0087*FG 777*YAMATO 771*YAMATO 514*FG 228*YAMATO 227*YAMATO 586*YAMATO 0202100007* 0201100003* 0201100004* 987*YAMATO 0202100006* 363*FG 0229*YAMATO 0233*YAMATO 286*YAMATO 291*YAMATO 0230*YAMATO 0234*YAMATO 0201080034* 588*YAMATO 0161*FGYAMATO 0236*YAMATO 0088*FG 0092*FG 0201080043* 367*YAMATO 0153*FGYAMATO 0158*FGYAMATO 0202100005* 0202100008* 610*YAMATO 701*TTL 0093*FG 0159*FGYAMATO 292*YAMATO 287*YAMATO 0240*YAMATO 0201090001* 98*FG 580*YAMATO 101*FG 0099*FG 472*YAMATO 471*YAMATO 375*YAMATO 0202090027* 290*YAMATO 0105*FG 0103*FG 0104*FG 0162*FGYAMATO 869*YAMATO 0165*FGYAMATO 0164*FGYAMATO 0163*FGYAMATO 0169*FGYAMATO 0166*FGYAMATO 380*YAMATO 0238*FG 0237*FG 293*YAMATO 295*YAMATO 773*YAMATO 0202090025* 106*FG 778*YAMATO 871*YAMATO 0175*FGYAMATO 382*YAMATO 375*FG 384*YAMATO 474*YAMATO 0201080067* 0241*YAMATO 294*YAMATO 296*YAMATO 298*YAMATO 634*YAMATO 0109*FG 0108*FG 381*YAMATO 385*YAMATO 389*YAMATO 0110*FG 0202100040* 0202100041* 0202100053* 0189*FGYAMATO 0170*FGYAMATO 303*YAMATO 300*YAMATO 0111*FG 987* 0202080006* 0202080008* 635*YAMATO 112*FG 0167*FGYAMATO 0184*FGYAMATO 0201070005* 0202080012* 0201080060* 0201080058* 0201080059* 0201070004* 0201080068* 305*YAMATO 302*YAMATO 390*YAMATO 872*YAMATO 0243*YAMATO 0107*FG 0202100003* 0202100009* 0202100011* 392*YAMATO 313*YAMATO 308*YAMATO 0202080010* 190*YAMATO 306*YAMATO 0113*FG 0115*FG 491*TTL 489*TTL 498*YAMATO 0116*FG 247*FG 500*YAMATO 0202100010* 0117*FG 0171*FGYAMATO 0118*FG 0202100015* 0202100016* 0202100012* 123*TTL 0202090026* 0172*FGYAMATO 408*YAMATO 0231*YAMATO 301*YAMATO 309*YAMATO 0201080002* 125*FG 122*FG 124*FG 396*F08A 414*YAMATO 407*YAMATO 415*YAMATO 410*YAMATO 0201070003* 0202080002* 0202080006* 181*FG 191*FG 320*YAMATO 321*YAMATO 0202100017* 0202100018* 0202100022* 0250*YAMATO 0201090002* 322*YAMATO 873*YAMATO 0127*FG 0253*YAMATO 0129*FG 513*YAMATO 668*YAMATO 0182*FGYAMATO 0176*FGYAMATO 834*YAMATO 324*YAMATO 327*YAMATO 0201080049* 0201080050* 0201080071* 0251*YAMATO 0256*YAMATO 128*FG 0179*FGYAMATO 0257*YAMATO 669*YAMATO 0202100058* 0202100059* 0202100057* 132*FG 636*YAMATO 0202090028* 0202100023* 0202080015* 0201070004* 00249*YAMATO 0202080001* 0185*FGYAMATO 0180*FGYAMATO 0121*FG 681*YAMATO 0202080020* 0202080021* 0202080022* 328*YAMATO 0201090003* 0202080019* 0202100019* 0202100024* 0202100025* 0202100029* 0202100031* 0186*FGYAMATO 0187*FGYAMATO 671*YAMATO 774*YAMATO 837*YAMATO 411*YAMATO 0244*TTL 0202080016* 438*YAMATO Class II Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions. Advanced Sterilization Products
Devices GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy. GE Brivo OEC715: Serial Numbers B2S13001 ~ B2S13010. GE Brivo OEC785: Serial Numbers B3S13005 ~ B3S13008. GE Brivo OEC865: Serial Numbers B4S13001 ~ B4S13015 Class II GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high voltage cable bundle to fail, resulting in loss of system functionality. GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
Food NatureMost LABORATORIES NATURAL WHEY POWER W / YERBA MATE VANILLA / ALMOND Dietary Supplement NET WEIGHT 3 LBS. (1362g). Product Number: 9950 Lot Numbers: 9950/3491, 9950/3636, 9950/3766, 9950/4011, 9950/4374, 9950/5025, 9950/5559 Class I Undeclared allergens, milk,almond and soy. NatureMost of New England, Inc.
Food NatureMost LABORATORIES NATURAL WHEY POWER W / YERBA MATE STRAWBERRY / BANANA Dietary Supplement NET WEIGHT 3 LBS. (1362g). Lot Numbers: 9954/3793, 9954/4043, 9954/4205, 9954/4861 Class I Undeclared allergens, milk and soy. NatureMost of New England, Inc.
Devices Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology. Serial Numbers: CDS1-DVSU-1B-JU-13; CDS1-7QRE-1B-JU-13; CDS1-22TZ-1B-JU-13; CDS1-PNJZ-1B-AU-13; CDS1-A4CQ-1B-AU-13 Class II Specific error condition could lead to unintended laser emission during laser activation. Convergent Dental
Food Frozen Sliced Carrots, packaged in 2 lbs. bag, sold under Simplot Classic brand. The UPC is 0 71179 1846 3 1. The product is labeled in parts: "***SIMPLOT CLASSIC***Sliced Carrots***NET WT 32 OZ. (2 LBS)***INGREDIENTS: CARROTS***KEEP FROZEN UNTIL READY TO USE. IF THAWED. DO NOT REFREEZE***Preparation Instructions***DISTRIBUTED BY: JR SIMPLOT COMPANY***BOISE, IDAHO 83707***PRODUCT OF U.S.A***". BEST BY SEP 2015/ 5M3 13X2L4 HH:MM. Product has Best By SEPTEMBER 2015. The code 5M3 13X2L4 HH:MM meant the product was repacked into Poly Bags on September 13, 2013, 07:47 am to 14:32 pm at NORPAC Foods, Inc., Quincy Foods, LLC Plant 2, 222 Columbia Way, PO Box 127, Quincy, WA 98848. Class I Green shelled soybeans (Edamame) are potentially mixed in with sliced carrots. Norpac Foods, Inc.
Devices Alere Triage® TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage® Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage® TOX Drug Screen package insert, provide this capability. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Alere Triage® TOX Drug Screen Control 1 or Alere Triage® TOX Drug Screen Control 2 consist of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. 510(k)/IDE/PMA number: K060788 Type of Packaging: 5 vials per level in a labeled kit box. Indications for use: The Alere Triage® TOX Drug Screen Controls are to be used with the Alere Triage® TOX Drug Screen tests and Alere Triage® Meters to assist the laboratory in monitoring test performance. Part Number 94413. Lot Number C2681A. Class III Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN 94413, Lot C2681A) because the CODE CHIP that was provided with this lot causes the control to fail when run in the QC Sample Mode using Alere Triage TOX Drug Screeen products. The Alere Triage TOX Drug Screen test devices and patient results are not affected. Alere San Diego, Inc.
Devices Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3. Part Number/Lot Number: 7560-43/I663860, 7560-43/I663861, 7560-G3/I664519 and 7560-G3/I666388. Class II 4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape. Merit Medical Systems, Inc.
Drugs Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04. Lots: 6111A exp 8/14, 6191A exp 10/14, 5523A exp1/14, 5617A exp 2/14, 5619A exp2/14, 5660A exp 3/14, 5689A exp 3/14, 5690A exp 3/14, 6114A exp 9/14, 6115A exp 9/14,6118A exp 9/14, 6122A exp 9/14, 5307A exp 8/13, 5391A exp 10/13, 5393A exp 10/13, 5392A exp 10/13, 5394A exp 10/13, 5396A exp 11/13, 5430A exp 11/13, 5431A exp 11/13, 5432A exp 11/13, 5434A exp 11/13, 5578A exp 11/13, 5491A exp 11/13, 5492A exp 11/13, 5493A exp 12/13, 5494A exp 12/13, 5531A exp 1/14 5661A exp 3/14, 5490A exp 11/13, 5533A exp 2/14, 5495A exp 12/13, 5534A exp 2/14, 5535A exp 2/14, 5621A exp 2/14, 5728A exp 3/14, 6117A exp 9/14, 6113A exp 9/14, 5776A exp 4/14, 6112A exp 8/14, 6119A exp 9/14, 6192A exp 10/14,and 6123A exp 10/14 Class III Subpotent Tolmar, Inc.
Devices IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS). N/A Class II System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels. AGFA Corp.
Drugs Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25 Lots #: A3A33A, A3A33B, A3A34A, A3A35A. A3A36A, A3A37A, A3A38A, Exp 06/15; A3A40A, A3A41A, A3A42A, Exp 07/15 Class II Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit. Nephron Pharmaceuticals Corp.
-
-