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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Platelets Pheresis Leukocytes Reduced Irradiated KN07318; E21696 Class II Blood products, with incomplete documentation of the irradiation process, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced Irradiated GR16594; GW35113 Class II Blood products, with incomplete documentation of the irradiation process, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Platelets Pheresis Leukocytes Reduced KW08484 Class II Blood product, which did not meet the acceptable product specifications for release, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Source Plasma 07FMOA7705; 07FMOA8345; 07FMOA8742 Class II Blood products, which were collected from a donor with a history of high risk behaviors, were distributed. BioLife Plasma Services L.P.
Biologics Source Plasma 05FMOB6449; 05FMOB6705; 05FMOB7366; 05FMOB7579; 05FMOB8236 Class II Blood products, collected from a donor who received body piercing's, were distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced 020GK00640 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. American National Red Cross (The)
Biologics Red Blood Cells 6667628 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Community Blood Center of the Ozarks
Biologics Platelets 6667628 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Community Blood Center of the Ozarks
Biologics Platelets Pheresis Leukocytes Reduced KT06186 Class III Blood product, for which the quality control testing was incomplete, was distributed. Mississippi Valley Reg Bld Ctr
Devices Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more of these applications is installed: " VesselIQ Xpress or AVA Xpress " CardIQ Xpress Pro or Plus " CardEP " CardIQ Fusion PET or SPECT Advantage Workstations Volume Share (v.AW4.3) and AW4.2 (version4.2-05 and above) provided with Volume Viewer 2(version6.0 to version6.11) and only when one or both of these applications is installed: " CardIQ Xpress Pro or Plus " CardEP Advantage Workstations AW Volume Share 2 (AW version 4.4). ONLY IF ONE OF FOLLOWING APPLICATIONS IS INSTALLED: ¿ VesselIQ Xpress or AVA Xpress ¿ CardIQ Xpress Pro or Plus ¿ CardEP ¿ CardIQ Fusion PET or SPECT provided with Volume Viewer 3 and 3.1 from versions 7.0 to 7.5 and 8.1. To verify the version installed on your system: Select the Admin menu from the Patient list page. Then select Display Configuration . You will find the version of your system in Installed Application(s) . This version will appear as vxtl_7.x or vxtl_8.x. Intended use: K993792: Smart Vessel Analysis (Smart VA) is a software post-processing option for the Advantage Workstation (AW) platform, which can be used in the analysis of 3D angiography data. It provides a number of display, measurement and batch filming/archive features and will aid physicians in studying user-selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization. K031261: Card EP is a post processing software option for the Advantage Workstation (AW) Platform. This product can be used for the analysis of CT angiographic images for the assessment of the heart to include the atria, pulmonary veins, and coronary sinus. It provides quantitative analysis tools which include a number of display, measurement and model export capabilities. This product can be used to aid trained physicians in the visualization and assessment of cardiac anatomy. K041267: CardIQ Analysis III is a CT image analysis software package, which allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionally for 2D/3D rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician to process, render, review, archive, print and visualizing cardiac anatomy and coronary vessels. CardIQ Analysis II will run on the AW workstation, scanner operator console and PACS system. K061370: CardIQ Fusion is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology, aid in the assessment of functional data e.g. PET perfusion, and aid in tailoring treatment plans based on the fused anatomical and functional information. Anatomical data could be from a set of Computed Tomography (CT) Angiographic images while functional data could be from PET, SPECT, or processed CT data. CardIQ Fusion is a software post-processing package for the Advantage Workstation (AW) platform, PET/CT and CT scanners and PACS reading stations. It is an additional tool for the analysis of 3D CT angiographic cardiac images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels. Also included is the capability to visualize reformatted CT/PET/SPECT perfusion and viability data. Finally, it provides different ways of visualizing CT anatomy fused with PET/SPECT functional information. With CardIQ Fusion, clinicians have the opportunity to overlay functional information over the (CT) anatomy of a patient's heart, and thus, they can potentially tailor their decision for that particular patient. CardIQ Fusion provides the visualization of the vessels in several different formats including 3D rendering, curved reformats. Once vessels are visualized, tools are available for sizing the vessel, analyzing calcified and non-calcified plaque to determine the densities of plaque within a vessel, measure areas of abnormalities within a vessel (like stenosis, plaque). Functional data could come from PET, SPECT, or processed CT data for perfusion information. The functional and anatomical data could come from the same scanner as in the case of PET/CT scanner; or they could come from separate scanners like stand-alone NUC camera and stand-alone CT scanner. K060779: Advanced Vessel Analysis II is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. Advanced Vessel Analysis II (AVA II) is a post processing application option for the Advantage Workstation (AW) platform, CT scanner or PACS stations, which can be used in the analysis of 2D and 3D CT Angiography images/data derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular and vascular disease assessment. This software is designed to support the physician in assessment of stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization. AVA II automatic visualization tools provide the users with the capabilities to facilitate segmentation of bony structures for accurate identification of the vessels. Once vessels are visualized, tools are available for sizing the vessel, analyzing calcified and non-calcified plaque to determine the densities of plaque within a coronary artery, measure areas of abnormalities within a vessel. "FMI# & Description : FMI 25409 VESSEL LABELLING MISMATCH" Mfg Lot or Serial # 00000L0219A4C4 00000L02167897 00000L022D0776 00000L0240826C 00000L022924AF 00000L02408728 00000L020E7DEF 00000L02167D50 00000L0219CA0A 00000L025A16BA 00000L02408829 00000L02A1CED2 00000L02127C08 00000L021DFF09 00000L021DFE8C 00000L022925D3 00000L0246B1BB 00000L020E81FF 00000L027461C8 00000L02A13D92 00000L020E0003 00000L021653EE 00000L0213E474 00000L0213E7BA 00000L020E0A27 00000LEE1A74B4 00000L022EE8A6 00000L0235EED0 00000L022922EE 00000L026FFFE3 00000L02127CD6 00000L020E7E4E 00000L0215A47D 00000L6100B6EA 00000L0271A0AE 00000L020E0B95  ...
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Class II GE Healthcare has became aware of two issues with the Advantage Workstation. 1) A possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage workstation that may impact patient safety. 2) A refresh problem of the stenosis / aneurysm measurement tools associated with the cardio-vascular applications of your Advantage Workstation that may impact patient safety. The refresh problem of the stenosis / aneurysm tools will occur when at least 3 of these measurements are deposited and then the first measurements are deleted. GE Healthcare, LLC
Devices Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. Material numbers 3009135, 3015550, and 3013365. See firm's website - www.medrad.com for specific serial and lot numbers. Class II Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues. In addition, they are recalling select Continuum pumps, calibrated using the tubing associated with this recall. Medrad Inc
Devices Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. Catalog number - Standard Kit: MIK 200A. See firm's website - www.medrad.com for specific serial and lot numbers. Class II Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues. In addition, they are recalling select Continuum pumps, calibrated using the tubing associated with this recall. Medrad Inc
Devices Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. Catalog number - Secondary Kit: MIL 200B. See firm's website - www.medrad.com for specific serial and lot numbers. Class II Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues. In addition, they are recalling select Continuum pumps, calibrated using the tubing associated with this recall. Medrad Inc
Devices Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. Catalog number - Primary Set: 3015153. See firm's website - www.medrad.com for specific serial and lot numbers. Class II Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues. In addition, they are recalling select Continuum pumps, calibrated using the tubing associated with this recall. Medrad Inc
Devices Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. Catalog number - Primary VSA Stopcock Set: 3015156. See firm's website - www.medrad.com for specific serial and lot numbers. Class II Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues. In addition, they are recalling select Continuum pumps, calibrated using the tubing associated with this recall. Medrad Inc
Devices Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. Catalog number - Primary VSA Set: 3015157. See firm's website - www.medrad.com for specific serial and lot numbers. Class II Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues. In addition, they are recalling select Continuum pumps, calibrated using the tubing associated with this recall. Medrad Inc
Devices Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. Catalog number - Primary Spike Set: 3015158. See firm's website - www.medrad.com for specific serial and lot numbers. Class II Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues. In addition, they are recalling select Continuum pumps, calibrated using the tubing associated with this recall. Medrad Inc
Devices Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. Catalog number - Secondary Set: 3015155. See firm's website - www.medrad.com for specific serial and lot numbers. Class II Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues. In addition, they are recalling select Continuum pumps, calibrated using the tubing associated with this recall. Medrad Inc
Devices Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. Catalog number - Secondary Spike Set: 3015160. See firm's website - www.medrad.com for specific serial and lot numbers. Class II Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues. In addition, they are recalling select Continuum pumps, calibrated using the tubing associated with this recall. Medrad Inc
Devices Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. Catalog number - Secondary VSA Set: 3015161. See firm's website - www.medrad.com for specific serial and lot numbers. Class II Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues. In addition, they are recalling select Continuum pumps, calibrated using the tubing associated with this recall. Medrad Inc
Devices Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. Catalog number - Side Step Set: 3015159. See firm's website - www.medrad.com for specific serial and lot numbers. Class II Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues. In addition, they are recalling select Continuum pumps, calibrated using the tubing associated with this recall. Medrad Inc
Devices Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications. Device Listing Number - R060456 REF Lot # 305217 2076404 305217 2055156 305217 2020057 305217 2020056 305219 1346419 Class II BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot. Becton Dickinson & Company
Devices Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This package is placed into a paperboard carton, labeled and shrink-wrapped. PINNACLE® CANCELLOUS Bone Screws are ancillary fixation devices used in total hip arthroplasties. These screws are used to secure PINNACLE ACETABULAR Shell implants to the acetabulum via screw holes designed in the shell. Intended Use: This product is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Catalog number: 121708500 and Lot numbers: 227619, 227620, 227621, 227622, 227627, 227630, 227646, 227650, 227651, and 227656. Class II DePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle® Cancellous Screw due to an incorrect description on the label. The label description reads Pinnacle Cannulated Screw and should read Pinnacle Cancellous Screw. DePuy Orthopaedics, Inc.
Devices ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically transport one mobility impaired person in a fold-down seat up and down straight stairs, indoors and outdoors. Stairlifts sold between 12/5/08-7/31/12. The product does not have lot numbers assigned and no expiration date. Class II The seat could break as a result of damage resulting from a seat belt being trapped underneath the foldable part of the seat when the seat belt is not buckled. ThyssenKrupp Access Corp
Devices Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy. Installed by field service 1/3/12-8/8/12. Serial numbers: PFM00034, PFM00038, PFM00043, PFM00047, PFM00052, PFM00056, PFM00063, PFM00067, PFM00076, PFM00082, PFM00085, PFM00099, PFM00102, PFM00110, PFM00131, PFM00134, PFM00140, PFM00141, PFM00142, PFM00143, PFM00160, PFM00163, PFM00168, PFM00170, PFM00174, PFM00175, PFM00177, PFM00182, PFM00183, PFM00194, PFM00197, PFM00201, PFM00203, PFM00204, PFM00232, PFM00233, PFM00239, PFM00245, PFM00246, PFM00249, PFM00263, PFM00265, PFM00271,  ...
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Class II Posterior fluidics modules installed in the system may need to be recalibrated. Bausch & Lomb Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W066210035932(Part A) ; W066210035932(Part B) Class II Blood products, with an unacceptable total hemoglobin level, were distributed. Blood Center of New Jersey, The
Biologics Source Plasma 4230121389; 4230121023; 4230120541; 4230120128; 4230119683; 4230118872; 4230118433; 4230118080; 4230116953; 4230116186; 4230114681; 4230114168; 4230113941; 4230113001; 4230112515; 4230112226; 4230111720; 4230111277; 4230111032; 4230110515; 4230110166; 4230109726; 4230109421; 4230108887; 4230108696; 4230108182; 4230107744; 4230135463; 4230135232; 4230134899; 4230134599; 4230134323; 4230134063; 4230133791; 4230133524; 4230133253; 4230133003; 4230132702; 4230132443; 4230131915; 4230131395; 4230127003; 4230121870; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma AQ144401; AQ144089; AQ143718; AQ140899; AQ140693; AQ140228; AQ139799; AQ139211; AQ136600; AQ136181; AQ133655; AQ133443; AQ132855; AQ132172; AQ131787; AQ130758; AQ130582; AQ129397; AQ127862; AQ127594; AQ126826; AQ125854; AQ125627; AQ125087; AQ124730; AQ124400; AQ124180; Class III Blood products, collected from a donor who was previously deferred, were distributed. Plasma Biological Services
Biologics Source Plasma 12ANCB7909; Class II Blood product, collected from a donor with a history of incarceration, was distributed. Plasma Biological Services
Biologics Red Blood Cells Leukocytes Reduced W0470122702660; Class II Blood product, collected from a donor who received a piercing within 12 months of donation, was distributed. New York Blood Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced W037710033331; Class II Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed. Hoxworth Blood Center UC Medical Center
Biologics Platelets Leukocytes Reduced W037710033331; Class II Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed. Hoxworth Blood Center UC Medical Center
Biologics Red Blood Cells Leukocytes Reduced W069112102182; Class II Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed. Mississippi Blood Services Inc.
Biologics Fresh Frozen Plasma W037711145019; Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. Hoxworth Blood Center UC Medical Center
Biologics Platelets Pheresis Leukocytes Reduced W037712023218; Class II Blood product, which was labeled as leukoreduced, but was not tested to verify white blood cell count, was distributed. Hoxworth Blood Center UC Medical Center
Biologics Red Blood Cells Leukocytes Reduced W037712051286; Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Hoxworth Blood Center UC Medical Center
Biologics Red Blood Cells Leukocytes Reduced Washed W1170121337776; Class II Blood product,, which was collected from a donor who traveled to a malarial endemic area, was distributed. Blood Centers of the Pacific - Irwin Center
Biologics Blood and Blood Products for Reprocessing 38W76182; Class III Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. American Red Cross Blood Svs. Indiana-Ohio Region
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W044212470022; Class II Blood products, which were not tested to verify the White Blood Cell count, were distributed. San Diego Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced W044212457639; W044212470022; Class II Blood products, which were not tested to verify the White Blood Cell count, were distributed. San Diego Blood Bank
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W140912169750; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. South Texas Blood & Tissue Center
Biologics Platelets Pheresis Leukocytes Reduced W140912169750; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. South Texas Blood & Tissue Center
Food "beer set dried rudd", NET WT 200 g (7 oz), PRODUCT OF RUSSIA, BEST BEFORE 10.22.2012 --- The product was packaged in a vacuum packed bag. According to the Food Lab Report, the sample consisted of two (2) whole fish measuring 8 inches and 10 inches in length. BEST BEFORE 10.22.2012 Class I The imported processed fish was found to be uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets. KRASNYI OKTYABR INC
Devices Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete Delivery Systems (CDS) custom pack includes components necessary for a total knee replacement surgical procedure. Reorder #CDS983828, lot numbers 12HD0901 and 12IB1848, expiration date 09/30/2013 Class II The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pack when it should have been in the sterile portion. Medline Industries Inc
Drugs Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose, Rx Only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543, by Hollister-Stier Laboratories LLC, Spokane Washington 99207, NDC 0270-0083-20. Lot #s: C0672, Exp 09/30/2012; C0689, Exp 10/31/2012; C0723, Exp 12/31/2012; C0799, Exp 02/28/2013; C0852, Exp 05/31/2013. Class III Presence of Particulate Matter; potential for charcoal particulates Bracco Diagnostic Inc
Devices SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157215121 and Lot codes: 105800, 132795, 134667, AB8D51000, AB8D5A, AB8HE1000, AB8HE1A, AE3L11000, AF1EP1000, AF1EP1A, AF7KK1000, AV7JW1000, AW8F21000, AW8F2A000, BR4J81000, C15AN1000, C34B61000, C61CA1000, C77A81000, CE6FF1000, CE6FK1000, CG5B41000, CG5B41A, CK6BN1000, CK6BP1000, CK6BPA000, D32J41000, D46LD1000, D58EW1000, D74FB1000, DD3BP1000, DG1N71000, DH9JV1000, DH9JVA000, DW2A11000, E1RHD1000, E3SDC1000, E45LR1, E51E11, EB4MY1000, ED1DF1000, EH6B31000, ET4FG1000, EW7CD1000,  ...
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Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157215136 and Lot codes: 169458, AB8F51000, AF1ED1000, AF1EDA000, AF1EG1000, AF1EGA000, AF1EGB000, AF7KH1000, AV7JX1000, AW8F11000, BR4J91000, BT9FM1000, BT9FMA000, BT9FMB000, C1PC61000, C35D51000, C35D5A000, C3WCX1000, C4YBF1000, C5FH51000, C5FH5A000, C77A71000, C77A7B, CG5B51000, CH1AE1000, CH1AEA000, CH1AEB000, CH1AF1000, D1TLE1000, D3RFF1000, D46LE1000, D52LY1000, D5FDJ1000, D74ER1000, DA8MC1000, DD6E51000, DG1N81000, DN5HY1000, DS7KB1000, E1RHH1000, E1RHHA000, E3SDE1000, E45LS1, E5LCW1,  ...
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Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157215150 and Lot codes: 111620, DD3BR1000, 126364, DD3BRA000, 134668A, DG1N91000, A37A71000, DN5H11000, A37A7A000, DN5H1B000, A37A7C, DT6ED1000, A3RBC1000, E1RHJ1000, A3RBCA000, E4HSE1000, A3YAV1000, E4LLG1000, A4VAK1000, E5EB41000, A6ACH1000, E5EB4A000, A88AA1000, E5WJ81000, AP2BB1000, E73B51, AV3DP1000, EC3DN1000, B2LAB1000, ED5KV1000, B3FAE1000, EJ4EG1000, B46AH1000, ER8EY1000, B54FC1000, EW6G31000, BS2GG1000, EY2ET1000, BY3BD1000, FB3E21, C1PC91000, FB8P81, C34B71000, FD4SX1,  ...
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Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157215165 and Lot codes: 111621, FG9KT1, 126365, X3VB41000, A19GL1000, X4SC51000, A3XF31000, X4SC5A000, A3XF3A000, X4SC61000, A63GR1000, X53B11000, A6AE81000, X5REA1000, A6AE8A000, YF4AX1000, AY7KN1000, YF4AXA000, AY7KNA000, YG2CY1000, B19CJ1000, Z41AT1000, B3BJV1000, Z6BB91000, B3CAX1000, Z83BA1000, B65DF1000, Z83BAB000, B65DFA000, ZL9FW1000, C1YLX1000, ZL9FWA000, C34B81000, C34B8A000, C4JCR1000, C4JCRA000, C4VCR1000, C4VCRA000, CB2K71000, CH7ED1000, CK3EX1000, D32J61000, D46LG1000, D6DDD1000,  ...
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Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157215180 and Lot codes: 116897, 126366, A63GP1000, A63GPA000, AP2BD1000, B19CL1000, B19CLA000, B19CLC000, B3DE71000, B3DE7A000, B5CA41000, C1PDC1000, C4YBG1000, C4YBGB, CB1EX1000, CC5JR1000, CH1AC1000, CH7EG1000, CL5PF1000, DD3BT1000, DD3BTA000, DH9JW1000, E1KKA1000, EC8DY1000, ET4FH1000, FB8RA1, FG9KV1, X2HD31000, X2HD41000, X2HD4B000, X2HD4C000, X2HD4D000, X2HD51000, X2HD5A000, X5REB1000, X5REBB000, XY7F71000, YA6GS1000, YG3DE1000, YH8AK1000, YH8AKA000, and Z5VAP1000. Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157215195 and Lot codes: 126367, A34FG1000, A63GS1000, B19HM1000, B3DE61000, B46AJ1000, BY6G81000, C4YBH1000, C5FH81000, CB9L21000, CH7EH1000, CP8NJ1000, D83FY1000, DG1PB1000, X24EW1000, X24EX1000, X24EY1000, X24EYB000, X3DC51000, X5SB31000, X5SB3A000, YA6GT1000, YF6AE1000, YF6AEA000, Z5VAN1000, and Z5VANB000. Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157225136 and Lot codes: AB8GM1000, AF7KD1000, AF7KE1000, AF7KEC, AF7KG1000, AV7JY1000, AV7JYA000, AW8FY1000, AW8FYA000, AW8FYD, BR4KA1000, C77A51000, C77A5A000, CK6BR1000, DW2A31000, DW2A3A000, E1KKB1000, E3RLJ1000, EE5M81000, EP3BH1000, and FJ2L81. Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157225150 and Lot codes: 107076, X4SE71000, 117308, X4SE7A000, A38B51000, X4SE7B000, AV3DR1000, YA9BN1000, B2DB11000, YF3E71000, BA4GR1000, YF3E7A000, BA4GRA000, YG4AF1000, BC4HR1000, Z47HE1000, C49A61000, Z4RJE1000, C6ACN1000, Z81H61000, C77A61000, CD1ER1000, , CD1ERA000, CK3E21000, CK3E2A, CY4GB1000, DX7J21000, DX7J2A000, E3FH61000, E4HB41000, E5DDA1000, E6BKR1, EJ4EH1000, EW9J61000, X32HH1000, X43C71000, X43C91000, and X43C9B000. Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157225165 and Lot codes: 105802, A19GM1000, A38B61000, B28JL1000, B2PAV1000, BB6KJ1000, C49A91000, C4JCS1000, C6ACS1000, CD1ET1000, CK3E71000, DH9JX1000, E3TF91000, E5LCS1000, EF1ES1000, FF8DW1, X32HF1000, X43DG1000, X4GEJ1000, X4GEK1000, X4GEM1000, X4GEMB000, X5RED1000, X78CM1000, YG1B51000, YG1B5A000, Z2HC31000, and Z81H71000. Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157225180 and Lot codes: B19HN1000, B19HNA000, B3FAF1000, BF6A21000, C32GEA, C5PRY1000, C61CD1000, CD1EW1000, EE5K61000, X33GC1000, X49FV1000, X4KF91000, X4KGA1000, X4KGB1000, X5SB41000, X5SB4A000, X5SB4B000, X5SB4C000, Y14GJ1000, Y14GJA000, YD3H31000, YD3HY1000, YG8B11000, YH9E21000, and YH9E2B000. Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157225195 and Lot codes: B2WBP1000, B34H81000, B34H8A000, BB1AJ1000, CD1EX1000, D5NEH1000, X4SF21000, X5FBT1000, X5FBTA000, X5FBV1000, X5FBVA000, X5PGM1000, X5PGN1000, X5PGNA000, X83KD1000, YF3E81000, YF6AF1000, YG4AG1000, ZA7JB1000, and ZA7JBA000. Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS L 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157225210 and Lot codes: C69C81000, X4BFN1000, X4SC81000, X57HS1000, X57HSA000, X5SB51000, YA9BP1000, YF3E91000, and YG3DF1000. Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157225225 and Lot codes: YF3FA1000 and YG9AW1000. Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157226136 and Lot codes: 126676, AB8GD1000, AB8GDA000, AF1EJ1000, AF1EK1000, AF1EKA000, AF1EKB000, AF7KF1000, AT4GJ1000, AT4GJA000, AW8FX1000, BR4KB1000, C4VCSA, C76FC1000, C82MV1000, D5LLL1000, D6DE51A, DG4FW1000, E5RKD1, E5RKDA, E79KF1, EJ4EJ1000, and FH8H6A. Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 1157226150 and Lot codes: 126677, B1PAN1000, B3PAH1000, B5CA51000, BE7J41000, BK1F11000, BP6CY1000, BP6CYA000, C61CE1000, CH7EE1000, CL5PH1000, CT8BF1000, D5NEJ1000, DA2EL1000, DA2ELA, E1VFG1000, E1VFGA000, E45LT1000, EL2EM1000, ES6CW1000, X5GB51000, X5HCE1000, X5SCC1000, X66BN1000, X83KE1000, YA6AF1000, YA6AFA000, YA6AFB, YD9EX1000, YG1B71000, Z5VJW1000, ZJ6FA1000, and ZL9FX1000. Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157226165 and Lot codes: A46AN1000, B12LE1000, B12LEA000, B12LEB000, B3XAG1000, BP7E41000, C76FB1000, C82MW1000, CK3FJ1000, DD3BV1000, E12BV1000, E5WAY1000, EF1E41000, ER8L11000, FG7DR1, FJ9MB1, X57HV1000, X5HCC1000, X5PGR1000, X5PGS1000, X83KF1000, X83KFA000, YD9EY1000, YD9EYA000, YD9EYB000, YG1B81000, YG1B8A000, Z2HDE1000, Z2HDEA000, Z2HDEB000, Z5WFB1000, and Z5WFBB000. Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157226180 and Lot codes: 118843, A31E61000, B12LF1000, B2PAW1000, BC4HS1000, C5FH91000, C76FD1000, CK3FM1000, DG4FX1000, E6BKV1, ER8L21000, X34C41000, X49FG1000, X4SE81000, X4SE91000, X53B21000, YF4A61000, YF4A71000, YF4A7A000, YG4AH1000, YG4AHA000, YH9E51000, and YH9E5A000. Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157226195 and Lot codes: B2LAC1000, BN1K6A000, CE3FH1000, CL5PJ1000, X5GB61000, X5GB6A000, X5HCV1000, X5PGT1000, X5PGV1000, X5PGW1000, YF4A81000, YF5DP1000, YG7D61000, and Z41AV1000. Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157226210 and Lot codes: X43EX1000, X43EXA000, X43EY1000, X49FH1000, X4GDG1000, X57HX1000, and YH1ENA000. Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Product Code: 157226225 and lot code: YG9AX1000 Class II An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a typical -2mm head touches on both the inferior and superior aspects of the neck. DePuy Orthopaedics, Inc.
Devices Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-0220 20mm Large Endoskeleton Implant VBR Endoskeleton TA VBR is intended for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma. Model # / Lot # 2107-0118: A110822, A120907. 2107-0120 : A110812, A110830, A120263, A120909. 2107-0218: A110813. 2107-0220: A110828, A120262, A120305, A120801, A120901. Class II Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use. TITAN SPINE, LLC
Devices The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance. Item 6390000000 Serial Numbers: 120940217 120940257 120940259 120940260 120940261 120940275 120940276 120940277 120940290 120940291 120940292 120940293 120940294 120940431 120940435 120940436 120940437 120940448 120940449 120940454 120940458 120940459 120940203 120940258 Class II Model 6390 Power-LOAD systems built between September 12, 2012 and September 27, 2012 may have been built with a load switch slide that does not meet specifications causing the lifting ability of the arms to be negatively impacted. Stryker Medical Division of Stryker Corporation
Devices COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET STERILE PROD CLASS: 4100 OPERATION:9000 QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow. Catalog 32-8106-000-03; Lot 61644802 Class II Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit . Zimmer, Inc.
Devices Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow. Catalog 32-8105-029-00-29; Lot 61722176 Class II Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit . Zimmer, Inc.
Devices GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes, but is not limited to: electrocardiogram, invasive blood pressure, noninvasive blood pressure (NBP), heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operator's manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORKTM indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs. FMI# & Descr: 36080 DASH 3/4/5k Custom Auto NBP System ID (As required) SD010210331GA SD010262074GA SD010262088GA SD010272286GA SD010272290GA SD010272298GA SD010272299GA SD010272300GA SD010272304GA SD010272306GA SD010272307GA SD010272308GA SD010272518GA SD010272529GA SD010272531GA SD010272533GA SD010272535GA SD010272536GA SD010272537GA SD010272539GA SD010272541GA SD010272542GA SD010272544GA SD010272545GA SD010272546GA SD010272547GA SD010292708GA SD010292709GA SD010292711GA SD010292836GA SD010292904GA SD010292966GA SD010292968GA SD010292969GA SD010292977GA SD010292978GA SD010292980GA  ...
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Class II GE Healthcare has recently become aware of a potential issue due to an unexpected loss of Custom Automatic NBP Measurement cycling associated with the Dash 3000/4000/5000 patient monitors. GE Healthcare, LLC
Devices Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch screen. The V Series Monitor is a Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. It also monitors of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements, 2) Heart Rate, 3) Pulse Oximetry (Sp O2), 4) ST Segment Analysis, 5) Arrhythmia Detection, 6) Non Invasive Blood Pressure (NIBP), 7) Invasive Blood Pressure (IBP), 8) Cardiac Output (CO), 9) Respiratory Gasses, 10) Respiration Rate, 11) Temperature, It is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. V Series Monitor P/N's 0998-00-1800-101 and 0998-00-1800- 201. Class II Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch. Mindray DS USA, Inc. d.b.a. Mindray North America
Devices Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178 Lot Numbers 540199, 540199-1 Class II Broken screw insertor hardness was measured and found to be below the acceptable limits. Ebi, Llc
Devices GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes. Parent SN SA310310978GA SA310454946GA SA310475517GA SA310475525GA SA310475536GA SA310475537GA SA310475540GA SA310475566GA SA310475575GA SA310475581GA SA310475582GA SA310475585GA SA310475591GA SA310475598GA SA310475600GA SA310475608GA SA310475609GA SA310475610GA SA310475611GA SA310028114GR SA310028140GR SA310028149GR SA310149355GR SA310259884GA SA310259951GR SA310260040GA SA310260303GR SA310260308GR SA310260320GA SA310260359GR SA310260383GA SA310260402GA SA310260553GA SA310290668GA SA310310883GA SA310310926GA SA310310993GA SA310321001GA SA310341381GA SA310351501GA SA310361698GA SA310361707GA SA310361785GA SA310361945GA SA310372076GA SA310372167GR SA310372294GA SA310382325GR  ...
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Class II GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care. GE Healthcare, LLC
Food Garden Fresh Gourmet Nacho Cheese Tortilla Chips 14oz bags 14 oz bag UPC 4767131090 Lot 112612 Best By 11/26/12 Class III Beginning 11/01/2012 Garden Fresh Gourmet recalled Garden Fresh Nacho Cheese Tortilla chips (exp 11/26/2012) because quality standards of ingredients used in the products were not met. Garden Fresh Salsa, Inc.
Food El Matador Mexican Style Salted Tortilla Chips 16oz (454 g) bags &32 oz (908 g) bags 16 oz bag, UPC 4367820751, lot 112512 Best By 112512 32 oz bag, UPC 4367813033, lot 112612 Best By 112612 Class III Beginning 11/01/2012 Garden Fresh Gourmet recalled El Matador & Garden Fresh Gourmet Salted Tortilla Chips because quality standards of ingredients used in the products were not met. Garden Fresh Salsa, Inc.
Food Garden Fresh Gourmet Kettle Style Original Salted Tortilla Chips 14oz (397 g) bags 14 oz bag, UPC 4767100220, lot 112612 Best By 11/26/2012 Class III Beginning 11/01/2012 Garden Fresh Gourmet recalled El Matador & Garden Fresh Gourmet Salted Tortilla Chips because quality standards of ingredients used in the products were not met. Garden Fresh Salsa, Inc.
Devices Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, vaginal stump and uterus. It is used for Brachytherapy. Lot L33, Serial numbers H64Y009-GM, H64A056, H640576, H600272, H640784, H640774, H640764, H600603, H640547, Class II The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve. Varian Medical Systems, Inc.
Devices Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT; SIZE C RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities. Part Number 42-5320-064-01 TIBIA SIZE C, LEFT Lots: 62018336, 62018337, 62033380, 62051020, 62060739, 62068413, 62076438, 62079740, 62091360, 62117665, and 77001708, Part Number 42-5320-064-02 TIBIA SIZE C RIGHT Lot: 62018338, 62018339, 62033383, 62051021, 62060740, 62060742, 62068415, 62076439, 62079741, 62091361,and 62117666 Class II All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening due to loss of bone cement pressurization; local pain and/or irritation such as tendonitis or bursitis if bone cement escapes from a perforation; and medial collateral ligament (MCL) instability if the ligament insertion point is compromised by a perforation or if bone cement escapes from the perforation and is located near insertion point of the MCL. Zimmer has received 4 complaints of tibial perforation using these devices. The enhanced product and instruments will include a shorter drill depth as well as updates to surgical technique 97-5026-001-00. Zimmer, Inc.
Devices Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities. Part Number 42-5320-067-01 TIBIA SIZE D, LEFT, Lot: 62018341, 62018342, 62030572, 62030573, 62033385, 62051022, 62068416, 62076576, 62079742, 62091362, 62103717, 62103718, 62110194, 62117656, 11007593, 11007636, 11007592, 11007635, 11007594, 11007634 Part Number 42-5320-067-02 TIBIA SIZE D RIGHT, Lot: 11006514, 11007138, 11007214, 62018343, 62018344, 62033386, 62040513, 62060743, 62068417, 62076577, 62079743, 62079744, 62091363, 62103720, 62117657,  ...
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Class II All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening due to loss of bone cement pressurization; local pain and/or irritation such as tendonitis or bursitis if bone cement escapes from a perforation; and medial collateral ligament (MCL) instability if the ligament insertion point is compromised by a perforation or if bone cement escapes from the perforation and is located near insertion point of the MCL. Zimmer has received 4 complaints of tibial perforation using these devices. The enhanced product and instruments will include a shorter drill depth as well as updates to surgical technique 97-5026-001-00. Zimmer, Inc.
Devices Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE E, LEFT TIBIA SIZE E RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities. Part Number 42-5320-071-01 TIBIA SIZE E, LEFT, Lot 11005332, 11005333, 11005334, 11005359, 11005360, 11005361, 11006133, 11006134, 11006135, 11006136, 11006137, 11006138, 11006712, 11007124, 61956760, 61956761, 61956762, 61978561, 61978562, 61978563, 62022179, 62030574, 62033389, 62079745, 62030575, 11007596, 62091364, 62103722, 62060744, 62068418, 62079746, 62103723, 62110198, 62117658, 62076580, 62128899, 11007595, 11007597, 62144992, 62150529, 62150530 ,  ...
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Class II All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening due to loss of bone cement pressurization; local pain and/or irritation such as tendonitis or bursitis if bone cement escapes from a perforation; and medial collateral ligament (MCL) instability if the ligament insertion point is compromised by a perforation or if bone cement escapes from the perforation and is located near insertion point of the MCL. Zimmer has received 4 complaints of tibial perforation using these devices. The enhanced product and instruments will include a shorter drill depth as well as updates to surgical technique 97-5026-001-00. Zimmer, Inc.
Devices Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE F, LEFT TIBIA SIZE F RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities. Part Number 42-5320-075-01 TIBIA SIZE F, LEFT, Lot: 11006654, 11007213, 11007237, 62018347, 62018348, 62033393, 62040514, 62060745, 62068420, 62076584, 62079762, 62079763, 62079764, 62091367, 62110202, 62110203, 62117661, 62144988, Part Number 42-5320-075-02 TIBIA SIZE F RIGHT, Lot: 11006575, 11006983, 11007033, 62018349, 62018350, 62033395, 62040515, 62065655, 62067342, 62076587, 62079765, 62079766, 62091368, 62110204, 62117662, 62103728,  ...
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Class II All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening due to loss of bone cement pressurization; local pain and/or irritation such as tendonitis or bursitis if bone cement escapes from a perforation; and medial collateral ligament (MCL) instability if the ligament insertion point is compromised by a perforation or if bone cement escapes from the perforation and is located near insertion point of the MCL. Zimmer has received 4 complaints of tibial perforation using these devices. The enhanced product and instruments will include a shorter drill depth as well as updates to surgical technique 97-5026-001-00. Zimmer, Inc.
Devices Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE G, LEFT TIBIA SIZE G RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities. Part Number 42-5320-079-01 TIBIA SIZEG, LEFT, Lot 11007106, 62018351, 62018352, 62033397, 62051024, 62060746, 62068421, 62076590, 62079768, 62079769, 62091369, 62117663, 11007728, 62144994 Part Number 42-5320-079-02 TIBIA SIZEG, RIGHT, Lot: 11007168, 11007488, 62018353, 62018354, 62033399, 62051025, 62060747, 62068422, 62076592, 62079770, 62091370, 62103729, 62110206, 62117664, 77001682, 11007727 Class II All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening due to loss of bone cement pressurization; local pain and/or irritation such as tendonitis or bursitis if bone cement escapes from a perforation; and medial collateral ligament (MCL) instability if the ligament insertion point is compromised by a perforation or if bone cement escapes from the perforation and is located near insertion point of the MCL. Zimmer has received 4 complaints of tibial perforation using these devices. The enhanced product and instruments will include a shorter drill depth as well as updates to surgical technique 97-5026-001-00. Zimmer, Inc.
Devices Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE H, LEFT TIBIA SIZE H RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities. Part Number 42-5320-083-01 TIBIA SIZE H, LEFT, Lot: 11006513, 11006722, 11007119, 62018828, 62018829, 62033403, 62060748, 62068423, 62076595, 62079771, 62091371, 62110207, 62117667 Part Number 42-5320-083-02 TIBIA SIZE H, RIGHT, Lot: 11007062, 11007123, 62018830, 62018831, 62033404, 62051804, 62060749, 62068424, 62076597, 62079772, 62091372, 62117668, 77001707 Class II All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening due to loss of bone cement pressurization; local pain and/or irritation such as tendonitis or bursitis if bone cement escapes from a perforation; and medial collateral ligament (MCL) instability if the ligament insertion point is compromised by a perforation or if bone cement escapes from the perforation and is located near insertion point of the MCL. Zimmer has received 4 complaints of tibial perforation using these devices. The enhanced product and instruments will include a shorter drill depth as well as updates to surgical technique 97-5026-001-00. Zimmer, Inc.
Devices Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities. Part Number 42-5399-018-00,Lot 77001868 Class II All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening due to loss of bone cement pressurization; local pain and/or irritation such as tendonitis or bursitis if bone cement escapes from a perforation; and medial collateral ligament (MCL) instability if the ligament insertion point is compromised by a perforation or if bone cement escapes from the perforation and is located near insertion point of the MCL. Zimmer has received 4 complaints of tibial perforation using these devices. The enhanced product and instruments will include a shorter drill depth as well as updates to surgical technique 97-5026-001-00. Zimmer, Inc.
Devices Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Nonsterile, Nonsterile This drill guide is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities Part Number 42-5399-020-00, Lot 62059525, 62087055 Class II All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening due to loss of bone cement pressurization; local pain and/or irritation such as tendonitis or bursitis if bone cement escapes from a perforation; and medial collateral ligament (MCL) instability if the ligament insertion point is compromised by a perforation or if bone cement escapes from the perforation and is located near insertion point of the MCL. Zimmer has received 4 complaints of tibial perforation using these devices. The enhanced product and instruments will include a shorter drill depth as well as updates to surgical technique 97-5026-001-00. Zimmer, Inc.
Devices Persona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities. Part Number 42-5399-022-03, Lot 62032101, 62117750 Class II All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening due to loss of bone cement pressurization; local pain and/or irritation such as tendonitis or bursitis if bone cement escapes from a perforation; and medial collateral ligament (MCL) instability if the ligament insertion point is compromised by a perforation or if bone cement escapes from the perforation and is located near insertion point of the MCL. Zimmer has received 4 complaints of tibial perforation using these devices. The enhanced product and instruments will include a shorter drill depth as well as updates to surgical technique 97-5026-001-00. Zimmer, Inc.
Devices Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities. Part Number 42-5399-022-05, Lot 62032102, 62087056 Class II All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening due to loss of bone cement pressurization; local pain and/or irritation such as tendonitis or bursitis if bone cement escapes from a perforation; and medial collateral ligament (MCL) instability if the ligament insertion point is compromised by a perforation or if bone cement escapes from the perforation and is located near insertion point of the MCL. Zimmer has received 4 complaints of tibial perforation using these devices. The enhanced product and instruments will include a shorter drill depth as well as updates to surgical technique 97-5026-001-00. Zimmer, Inc.
Devices Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities. Part Number 42-5399-022-07, Lot 62032102, 62087056, 62162437 Class II All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening due to loss of bone cement pressurization; local pain and/or irritation such as tendonitis or bursitis if bone cement escapes from a perforation; and medial collateral ligament (MCL) instability if the ligament insertion point is compromised by a perforation or if bone cement escapes from the perforation and is located near insertion point of the MCL. Zimmer has received 4 complaints of tibial perforation using these devices. The enhanced product and instruments will include a shorter drill depth as well as updates to surgical technique 97-5026-001-00. Zimmer, Inc.
Devices Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left; Size C Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities Part Number 42-5399-064-01(left) Lot 62052717, 62079727, 62121519 Part 42-5399-064-02 (right) Lot 62055081, 62121526 Part Number 42-5399-064-02 (right) Class II All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening due to loss of bone cement pressurization; local pain and/or irritation such as tendonitis or bursitis if bone cement escapes from a perforation; and medial collateral ligament (MCL) instability if the ligament insertion point is compromised by a perforation or if bone cement escapes from the perforation and is located near insertion point of the MCL. Zimmer has received 4 complaints of tibial perforation using these devices. The enhanced product and instruments will include a shorter drill depth as well as updates to surgical technique 97-5026-001-00. Zimmer, Inc.
Devices Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size D Left; Size D Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities Part Number 42-5399-067-01(left) Lot 62050138, 62121496 Part Number 42-5399-067-02 (right), Lot 62067442, 62075280, 62121527 Class II All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening due to loss of bone cement pressurization; local pain and/or irritation such as tendonitis or bursitis if bone cement escapes from a perforation; and medial collateral ligament (MCL) instability if the ligament insertion point is compromised by a perforation or if bone cement escapes from the perforation and is located near insertion point of the MCL. Zimmer has received 4 complaints of tibial perforation using these devices. The enhanced product and instruments will include a shorter drill depth as well as updates to surgical technique 97-5026-001-00. Zimmer, Inc.
Devices Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size E Left; Size E Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities Part Number 42-5399-071-01(left) Lot 62052718, 62121498 Part Number 42-5399-071-02 (right) Lot 62055082, 62121499 Class II All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening due to loss of bone cement pressurization; local pain and/or irritation such as tendonitis or bursitis if bone cement escapes from a perforation; and medial collateral ligament (MCL) instability if the ligament insertion point is compromised by a perforation or if bone cement escapes from the perforation and is located near insertion point of the MCL. Zimmer has received 4 complaints of tibial perforation using these devices. The enhanced product and instruments will include a shorter drill depth as well as updates to surgical technique 97-5026-001-00. Zimmer, Inc.
Devices Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F Left; Size F Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities Part Number 42-5399-075-01(left) Lot 62052719, 62121529 Part Number 42-5399-075-02 (right), Lot 62072309, 62072566, 62121524 Class II All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening due to loss of bone cement pressurization; local pain and/or irritation such as tendonitis or bursitis if bone cement escapes from a perforation; and medial collateral ligament (MCL) instability if the ligament insertion point is compromised by a perforation or if bone cement escapes from the perforation and is located near insertion point of the MCL. Zimmer has received 4 complaints of tibial perforation using these devices. The enhanced product and instruments will include a shorter drill depth as well as updates to surgical technique 97-5026-001-00. Zimmer, Inc.
Devices Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size G Left; Size G Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities Part Number 42-5399-079-01(left) Lot 62061017, 62121502 Part Number 42-5399-079-02 (right) Lot 62072310, 62072567, 62121503 Class II All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening due to loss of bone cement pressurization; local pain and/or irritation such as tendonitis or bursitis if bone cement escapes from a perforation; and medial collateral ligament (MCL) instability if the ligament insertion point is compromised by a perforation or if bone cement escapes from the perforation and is located near insertion point of the MCL. Zimmer has received 4 complaints of tibial perforation using these devices. The enhanced product and instruments will include a shorter drill depth as well as updates to surgical technique 97-5026-001-00. Zimmer, Inc.
Devices Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size H Left; Size H Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities Part Number 42-5399-083-01(left) Lot 62052720, 62121504 Part Number 42-5399-083-02 (right), Lot 62061018, 62121506 Class II All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening due to loss of bone cement pressurization; local pain and/or irritation such as tendonitis or bursitis if bone cement escapes from a perforation; and medial collateral ligament (MCL) instability if the ligament insertion point is compromised by a perforation or if bone cement escapes from the perforation and is located near insertion point of the MCL. Zimmer has received 4 complaints of tibial perforation using these devices. The enhanced product and instruments will include a shorter drill depth as well as updates to surgical technique 97-5026-001-00. Zimmer, Inc.
Devices Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. Model #(s): Individual Patient Circuit - catalog # 902 Patient Circuit Kit - catalog # 937: contains 2 circuits and 2 x 2.5 & 2 x 3.5 LifePort Adapters. Labeling states manufactured by: Bunnell Incorporated 436 Lawndale Drive, Salt Lake City, Utah 84115. Used for ventilating critically ill infants with pulmonary interstitial emphysema and infants with respiratory distress syndrome complicated by pulmonary air leaks, who are, in the opinion of their physicians, failing on conventional ventilation. The Patient Circuit is to provide a conduit for the humidification, warming, and temperature monitoring of the pressurized gas. The Patient Circuit is indicated for seven day single use. Patient Circuit (catalog # 902) lot # on each individual patient circuit label: 12C092, 12C102, 12C115, 12C125, 12C136, 12D159, 12D172, 12D189, 12E204, 12E211, 12E224, 12F241, 12F254, 12F271, 12G279, 12G290, 12G307, 12G321, 12H330, 12H349, 12I362, 12I371, 12I397, 12J413, 12J430, 12J448, 12K457, 12K471 Patient Circuit Kit (catalog # 397) lot #  ...
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Class I Customer complaints received indicate the heater wire insulation can melt, causing a short which creates sparking and smoke, in the circuit close to the humidifier cartridge. Bunnell is recalling all lots of circuits distributed between March 12, 2012 and November 30, 2012. Bunnell, Inc.
Devices Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA CODES: HITOO28, HIT0963, HITl780, HIT242S, HIT4118RI, HIT0632M, HITIS87R4, HIT2208RS, HID088R6, HITOO32, HIT0983M, HITl800, HIT2434, HIT4263, HlT0632Rl, HlTlS89M, HIT2212, HIT3097, HITOO49M, HIT0983RI, HITI8S4, HIT244I, HIT438I, HIT0632R2, HITlS89Rl, HlT2237M, HIT316S, HITOl16M, HIT0983R2, HITl874, HIT2477M, HIT4439RI, HIT0668, HITIS89R2, HlT2237RI, HIT3206, HITOI16RI, HIT0998, HITl898, HIT2477RI, HIT4SSS, HIT0691M, HITIS89R3, HIT2267M, HIT3267, HIT0134, HITI036, HITl9S8, HlT2477R2,  ...
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Class II Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology [ARIA RO] DICOM import/export functionality where a 360 degree arc field may convert to static field during DICOM export or import. Varian Medical Systems, Inc. Oncology Systems
Devices BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date. Serial numbers for three workstations in the US: focu-101917; focu-101909; and focu-101881. Serial numbers for BleaseFocus workstations in other countries: FOCO-100076, FOCO-100077, FOCO-100078, FOCO-100079, FOCO-100080, FOCO-100081, FOCU-000353, FOCU-000354, FOCU-000355, FOCU-000356, FOCU-000357, FOCU-000364, FOCU-000365, FOCU-000405, FOCU-000406, FOCU-000407, FOCU-000408, FOCU-000409, FOCU-000410, FOCU-000411, FOCU-000412, FOCU-000413, FOCU-000414, FOCU-000415, FOCU-000416, FOCU-000417, FOCU-000418, FOCU-000419, FOCU-000420, FOCU-000421,  ...
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Class II The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system. The manuals were prematurely updated for a feature that is not yet available. Del Mar Reynolds Medical, Ltd.
Devices EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures. Catalog Number 06350 and Lot Number Identification 994790 (packaged as 042210) Class II It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp. Biomet, Inc.
Devices DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee. Lot Number: 3611687 Class II Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labeled as 11MM while the box actually contained a 10 MM reamer DePuy Mitek, Inc., a Johnson & Johnson Co.
Food Dried Apricots 6 oz UPC 7203670494 All Lots 128522L 5/10/13 177532L 6/29/13 191522L 7/9/13 226562L 8/16/13 254512L 9/11/13 296532L 10/23/13 Class I Undeclared sulphur dioxide Whole Alternatives Llc
Food Dried Golden Raisins 8 oz UPC 7203670490 All Lots 142512L 5/21/13 156552L 6/6/13 184522L 7/3/13 233542L 8/25/13 275532L 10/3/13 303522L 10/31/13 Class I Undeclared sulphur dioxide Whole Alternatives Llc
Devices BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. Lot number 2053373 Class II An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria. Becton Dickinson & Co.
Devices Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventional Radiology Department; Packaged for Medline Industries, Inc.; Reorder #DYNJ35993D This custom pack includes components necessary for a specific procedure. Reorder #DYNJ35993D, lot numbers 12HD2126, exp. 5/31/2015; 12IB5014, exp. 7/31/2015 and 12JB8311, exp. 5/31/2015 Class II The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in its own packaging. The product was not labeled or identified as sterile, but was assumed to be sterile by the customer. Medline Industries Inc
Devices AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental. Lot Numbers: 02070051, 04070030, 0800152, 06070018, 0801863, 0802225, 0802469, 0900838, 0901751, 0902145, 0902956, 1000003, 1001504, 1004620, 1101301, 1101802, 1103359, 1104032, 1104976, 1200616, and 1202282 Class II The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use. BioHorizons Implant Systems Inc
Devices Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental. Lot Numbers: K0207015, K0307007, K0407011, K0507007, K0507008, K0507010, K0607003, K0607008, K0607009, K0607017, K0707010, K0707014, K0907001, K0907009, K0907011, K1007006, K1007007, K1007008, K1107009, K1107010, K1107012, K1207002, K0208005, K0208005R, K0308003, 0800120, 0800450, 0800451, 0800674, 0801215, 0801256, 0801728, 0801894, 0802232, 0802528, 0803139, 0900023, 0900884, 0901727, 0902402, 0903145, 0903480, 1000059, 1001465, 1002292, 1004118, 1005055, 1100381,  ...
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Class II The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use. BioHorizons Implant Systems Inc
Food Newman's Own Lite Honey Mustard Dressing, 16 FL.OZ (473 mL) Lot Code: 16 OCT 13 M Class I Newman's Own Lite Honey Mustard Dressing was labeled with an incorrect back label that did not list the allergen milk. Newman'S Own Inc.
Food Meatless Burger: 1) Veggie Patch Ultimate Meatless Burger - Net Wt. 9 oz. tray, UPC Code 6-10129-00211-5; 2) Veggie Patch The Ultimate Meatless Burger - Le burger sans-viande ultime, Net Wt 1.02Kg/ 2.25 Lb, UPC Code: 6-10129-08477-7 1) Use-by-date: JAN/12/2013; 2) Use-by-date: Jan/12/2013 and Jan/17/2013 Class I Product contaminated with Listeria monocytogenes Tribe Mediterranean Foods Inc.
Food Veggie Patch Falafel Chickpea Balls, Net Wt 9 oz tray, Refrigerated UPC code 6-10129-06619-3 Use-By date, Jan/15/2013 Class I Product contaminated with Listeria monocytogenes Tribe Mediterranean Foods Inc.
Devices Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping carton. The cane is used as an aid in walking or ambulation. The Lot Codes subject to recall are: PW111201, PW120201, PW120101, PW120301, and PW120401 Class II Following their receipt of several customer complaints, Invacare recalled their height adjustable walking canes. The device was recalled from distribution based on reports indicating that there is a possibility that the button which holds the cane at the desired height, may suddenly and unexpectedly compress, causing the cane to collapse and cause possible injury to the user. Invacare Corporation
Devices MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. The MAYFIELD Base Unit (A3101) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used. A Swivel Adaptor (A3018) is an integral component of the Base Unit A3101. The recalle product is identified with the Lot Numbers: 097547 and 096546. Class II An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm's Mayfield Composite Series Base Units and Mayfield Skull Clamps. In order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the Base Units and Skull Clamps that were determined to be subject to performance issues. Integra LifeSciences Corporation
Devices MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary. The recalled product is identified with the Lot Numbers: 096455 and 097546. Class II An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm's Mayfield Composite Series Base Units and Mayfield Skull Clamps. In order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the Base Units and Skull Clamps that were determined to be subject to performance issues. Integra LifeSciences Corporation
Devices Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic® DBSTM Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. STN/GPi target system components: ª Kinetra® Model 7428 or Soletra® Model 7426 Neurostimulator ª Activa® PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator ª Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension ª Model 3387 or Model 3389 Lead Medtronic DBS Therapy for Tremor - Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) using Medtronic DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. VIM target system components: ª Soletra Model 7426 Neurostimulator ª Activa PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator ª Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension ª Model 3387 or Model 3389 Lead. NHU236350V to NHU236373V; NKN037257V to NKN037259V; NKN037372V to NKN037387V; NKN037476V to NKN037507V; NKN037692V to NKN037698V; NKN037772V to NKN037779V; NKN037790V to NKN037810V; NKN037812V to NKN037840V. Class II Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), which may contain a damaged winged connector boot. The connector boot may not have been molded properly and may be cracked. Approximately 14% of the 140 affected extension kits may contain a damaged radiopaque winged connector boot. Medtronic Neuromodulation
Devices Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both primary and revision applications. Indications: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis when one or more compartments are involved, 2) correction of varus, valgus, or posttraumatic deformity, 3) correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure Catalog Number: 141490 Lot 378330,378320,407230,485010,505140,485000,506070,533400,54048, 439700,797820 Class II Biomet investigation identified that the square end of the offset tibial tray adaptor locking insert is oversized and may not engage insert tool screwdriver. This could cause a possible delay in surgery greater than 30 minutes, potentially exposing the patient to the increased risks from being under anesthesia for a longer duration. Biomet, Inc.
Devices The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. Lots: 220438, 122157, 118299, 113689, 109784, 022519, 014099, 011895, 008546, 916872 Class II Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots have failed the 13-month and 14-month time points. Per BEC's real time stability procedure, in order to verify expiration dating, one additional month is needed beyond the claimed expiration period. Therefore, these lots did not meet BEC's procedural requirements for a 12-month shelf-life claim. Source of the initial complaint: This issue was discovered internally by BEC during real time stability testing of the lots described in the above paragraph. Beckman Coulter Inc.
Food Frozen Yellowfin Tuna Loin 3/5, 30lbs/case. Lot# 172080-V and 172083-V Class II Red Chamber is recalling Frozen Yellowfin Tuna Loin due to customer complaints with scromboid illnesses when consuming the products. Red Chamber Company
Food Frozen Tuna Loins 3/5, 30lbs., UPC 8 29838 82310 7. Lot and (Code): 93514 (436-9) 93453 (431-4) 93431 (426-8) Class II Unified Seafood Co is recalling Frozen Yellowfin Tuna Loin 3/5 due to possible contamination with Scombroid Toxin. Unified Seafood Company., Inc.
Drugs Clean & Clear advantage, 3-in-1 foaming wash 8 FL. OZ. (240 mL) bottle, OTC, Distributed in the US by: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. Skillman, NJ 08558-9418 NDC 58232-0326-8 0142VA, 0132VB, 0112VC, 0122VB, 0102VA, 0102VB, 0112VB 0122VA, 0092VB, 0112VA, 0092VA, 0082VA, 0072VA, 0062VA 0062VB, 0052VA, 0052VB, 0042VA, 0032VA, 0022VA, 0012VA, 0171VA, 0171VB, 0161VB, 0151VA, 0161VA, 0141VA, 0131VA 0131VB, 0121VA, 0111VA, 0101VA, 0091VA, 0081VB, 0081VA 0071VA, 0061VA, 0051VB, 0051VA, 0041VA, 0031VA, 0021VB 0011VC, 0011VB, 0190VA, 0011VA, 0180VB, 0170VB, 0180VA 0722RT, 0732RT, 0742RT, 0752RT, 1722RD, 1732RD, 1772RD 1782RD, 1792RD,  ...
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Class III Superpotent (Single Ingredient Drug): salicylic acid Johnson & Johnson
Devices SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch Color LCD touch screen that displays treatment time, positioning and magnitude and direction of motion. There are eight fully customizable Patient Protocol settings for commonly used treatment settings. The SpineSix BioMotion Spinal System is intended to reproduce normal spine mechanics and physiological movements so that a patient can comfortably and safely experience functional range of motion in a non-weight-bearing environment. serial numbers: 1001 through 1054 Class II BioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to rectify all regulatory deficiencies involving the former owners of the SpineSix product and concurrently preparing the submission of a 510(k) application in order to receive premarket clearance for SpineSix. BioMotion Medical Systems, LLC
Food #122-A, Piazza Produce Clam Base, Net Weight 16 oz (1 lb) 454G Packed For: Piazza Produce, Indianapolis, IN 46268: #122-A, Primarque Clam Base, Net Wt 16 oz (1 lb) 454 grams Manufactured for Primarque Products Co. Worcester, MA 01610 #122-A, Clam Base, Cook's Delight Clam Base, Net WT.16 oz (1 pound) and 50 Lb tub Packed By Integrative Flavors, Michigan City, Indiana 46360 Cooks Delight 50 Lb tub Lot 141208B; Pimarque 141208C, 141208D; Piazza Lot 141208 Class II The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products. Williams West & Witt's Products Company
Food #222-C, Primarque Clam Base, Net Weight 5 pounds (2.27kg) & 16 oz ( 1 LB) 454G Packed for Primarque Products, Worcester, MA 01610 #222-C, Cook's Delight Clam Base, Net Weight 5 pounds (2.27kg) & 16 oz ( 1 LB) 454G Packed By Integrative Flavors, Michigan City, Indiana 46360 Lot 161211C for all brands Class II The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products. Williams West & Witt's Products Company
Food #223-E Primarque Clam Base, Net Weight 50 pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610 Lot 111207A,B, C, D; 221208A, B, C,D; 281209A, B,C, D, E, F Class II The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products. Williams West & Witt's Products Company
Food #124-M Primarque Lobster Base, Net Weight (1LB) 454 G & 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610 #124-M Cook's Delight Lobster Base, Net Weight (1LB) 454 G & 50 Pounds (22.68 kg) Packed By Integrative Flavors, Michigan City, Indiana 46360 #124-M Piazza Lobster Base, Net Wt. 16 oz (1LB) 454G Packed For Piazza Produce, Indianapolis Indiana 46268 50 LB container Lot 171207E-F, 1 LB container 211209B, 211209C Class II The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products. Williams West & Witt's Products Company
Food #126 Primarque Seafood Base, Net Weight 16 oz, 1LB, 454 G & 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610 #126 Cook's Delight Seafood Base, Net Weight 16 oz (1LB) 454 G & 50 Pounds (22.68 kg) Packed By Integrative Flavors, Michigan City, Indiana 46360 Lot 211209D Class II The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products. Williams West & Witt's Products Company
Food #425N Primarque Fish Base, Net Weight 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610 Lot 291203A, 191210A Class II The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products. Williams West & Witt's Products Company
Food #822- M PrimarqueClam Base, Net Weight 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610 Lot 141208E, 161211D Class II The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products. Williams West & Witt's Products Company
Food #428N Cook's Delight Shrimp Base, Net Weight 50 Pounds (22.68 kg) Packed by Integrative Flavors, Michigan City, Indiana Lot 151205B, C, D, E; 151207A, B, C, D, E; 21108A, B, C, D, E; 1091210C, D, E, F, G Class II The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products. Williams West & Witt's Products Company
Food #272N Cook's Delight Mushroom Base, Net Weight 50 Pounds (22.68 kg) Packed by Integrative Flavors, Michigan City, Indiana 46360 Lot 201112A, 061207C, 11210D, E Class II The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products. Williams West & Witt's Products Company
Food #828 Cook's Delight Shrimp Base, Net Weight 30 Pounds; 5 Pounds, Packed by Integrative Flavors, Michigan City, Indian Lot 091210A Class II The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products. Williams West & Witt's Products Company
Food #226 Cook's Delight Lobster Base, Net Weight 30 Pounds; 5 Pounds, Packed by Integrative Flavors, Michigan City, Indian Lot 091210A Class II The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products. Williams West & Witt's Products Company
Food #326 RS PrimarqueLobster Base, Net Weight 50 Pounds;, PackedFor Primarque Products, Worcester, MA 01610 Lot 281206A-D; 071211C-D Class II The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products. Williams West & Witt's Products Company
Food #321N Primarque Crab Base, Net Weight 50 Pounds, Packed For Primarque Products, Worcester, MA 01610 #321 N Cook's Delight,Crab Base, Net Weight 50 Pounds, Packed By Integrative Flavors, Michigan City, Indiana 46360 Lot 021205D, 211209A, 201211B-C, 211202B-C Class II The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products. Williams West & Witt's Products Company
Devices CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic slides, during transfer through the staining process. The rack can hold up to 10 slides at a time, and is necessary for optimal CoverStainer instrument performance. The racks affected by this recall were distributed with the following CoverStainer instrument serial numbers in the U.S.: CS 100-10031 CS 100-10033 CS 100-10035 CS 100-10054 CS 100-10080 CS 100-10081 CS 100-10082 CS 100-10083 CS 100-10093 CS 100-10094 CS 100-10106 CS 100-10107 CS 100-10110 CS 100-10113 CS 100-10117 CS 100-10123 CS 100-10124 CS 100-10125 CS 100-10133 CS 100-10135 CS 100-10148 CS 100-10149 CS 100-10150 CS 100-10152 CS 100-10159 Class II The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process. Dako Denmark A/S
Devices Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. Product Usage: The Arobella Medical AR1000 Wound Therapy System is interned for the selective dissection and fragmentation of tissue, wound debridement ( of acute and chronic wounds, burns, and diseased or necrotic tissue), and cleansing irrigation of the wound site for the removal of debris, exudates, fragments, and other matter. 0001 and 0002 Class II This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and 0002 can fracture during use and may release a fragment or fragments. The 6 mm Qurette is a component of the AR1000 Quostic Wound Therapy System. Arobella Medical, LLC
Devices EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation Serial Number: 0001-3343. Class II EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices. EEG Info
Drugs Procrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial; Mfg By: Amgen Inc., Thousand Oaks, CA 91320; Dist. By: Physicians Total Care, Tulsa, OK 74146; NDC 54868-5673-1. Lot #: 44TK, Exp 09/10; 4NQE, Exp 05/11; 4WKN, Exp 11/11; 5KZT, 5RCM, Exp 09/12; 5RZN, Exp 10/12; 5Y8Y, 60E2, Exp 12/12 Class II Presence of Particulate Matter: This is a subrecall of Amgen's Procrit due to glass delamination Physicians Total Care, Inc.
Food Yellow rice mixes with the following g brand names: (1) Shurfine brand Yellow Rice with Saffron, NET WT 5 OZ (142g), distributed by TOPCO ASSOCIATES, LLC, 7711 GROSS POINT ROAD, SKOKIE, IL 60077. UPC 011161159834 and (2) Hannaford brand Yellow Rice with real saffron & other seasonings, NET WT. 5 OZ (142g), distributed by HANNAFORD BROS. CO., SCARBOROUGH, ME 04074. UPC 041268184699 Shurfine: BEST BY: March 2013, 259M120 Hannaford: BEST BY MARCH 2014, 250M219 Class II Undeclared hydrolyzed soy protein in yellow rice with saffron Riviana International, Inc
Food Tak Shing Hong Dried Taiwan Shrimp, all sizes none Class I Grand Products is recalling Tak Shing Hong Dried Taiwan shrimp products due to undeclared sulfites. Grand Products Inc.
Drugs CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count capsules per NDC 0004-0259-05; b) 120-count capsules per bottle, NDC 0004-0259-51; Made in Ireland; Distributed by: Genentech USA, Inc., South San Francisco, CA 94080. Lot #: a) M1365B01, Exp 04/15; b) M1365, Exp 04/15 Class III Short Fill: some bottles contained less than 120-count per labeled claim Genentech, Inc.
Food Arnold's Candies Handmade Since 1953 www.arnoldscandies.com Wintergreen Puffs***INGREDIENTS: Sugar, Cream of Tarter, Artificial Flavoring and Coloring WARNING: Manufactured in a facility that also handles peanuts NET WT 6 oz (170g) 0 73629 00308 0 931 High Grove Blvd Akron, OH 44312 Best By: 07/11/14(19)1 lot code 06282012 UPC 0 73629 00308 0; Best By: 07/11/14(19)1 lot code 06282012 Class II The firm was notified by the New York State Department of Agriculture & Marketing, that they failed to include the colors Yellow #5 and Blue #1 on their label. Dauphin Holdings, Inc. DBA Arnolds Candies
Food Arnold's Candies Handmade Since 1953 www.arnoldscandies.com Root Beer Puffs Puffs***INGREDIENTS: Sugar, Cream of Tarter, Artificial Flavoring and Coloring WARNING: Manufactured in a facility that also handles peanuts NET WT 6 oz (170g) 0 73629 00307 3 931 High Grove Blvd Akron, OH 44312 Best By: 06/04/2014(19)1 lot code 05212012 UPC 0 73629 00307 3; Best By: 06/04/2014(19)1 lot code 05212012 Class II The firm was notified by the New York State Department of Agriculture & Marketing, that they failed to include the colors Yellow #5 and Blue #1 on their label. Dauphin Holdings, Inc. DBA Arnolds Candies
Drugs Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01 Lot #: 11-293-DK, Exp 05/01/13 Class II Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured. Hospira, Inc.
Drugs Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880. 432127A Exp. 01/13, 478076A Exp. 05/13, 515539B Exp.09/13 Class III Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities. Watson Laboratories Inc
Drugs Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-4279-02. Lot #: 14-277-DK*, Exp 02/01/14; * may be followed by 01 Class II Defective Container: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product. Hospira, Inc.
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