Platelets Pheresis Leukocytes Reduced Irradiated
Blood products,  with incomplete documentation of the irradiation process, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood product, which did not meet the acceptable product specifications for release, was distributed.
Blood products, which were collected from a donor with a history of high risk behaviors, were distributed.
Blood products, collected from a donor who received body piercing's, were distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood product, for which the quality control testing was incomplete, was distributed.
Worldwide Distribution - USA including AL, CA, CO, FL, GA, IL, IN, IA, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX , UT, VA, WI and Internationally to the following countries:   VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, THAILAND, TAIWAN, SWITZERLAND, SPAIN, SOUTH AFRICA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIA, ROMANIA, REUNION, PORTUGAL, POLAND, PHILIPPINES, PERU, PANAMA, NORWAY, NIGERIA, NEW CALEDONIA, NEPAL, MEXICO, MALAYSIA, KOREA, JAPAN, ITALY, IRELAND, INDONESIA, INDIA, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, ECUADOR, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, BULGARIA, BRAZIL, BELGIUM, BELARUS, AUSTRIA, AUSTRALIA, ARGENTINA ALGERIA.
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 packag
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.
Worldwide distribution: USA (nationwide) and countries of: Australia, Bermuda, Brazil, Canada, China, Chile, Denmark, Dominican Republic, Estonia,  Finland, France, Germany, Great Britain, Guam, Hong Kong, India, Israel, Italy, Japan, Korea, Lebanon, Mexico, Malaysia, Netherland, Poland, Portugal, Puerto Rico, Sweden, Singapore, Taiwan, Thailand, and Venezula.
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.
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(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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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.
BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.
Nationwide distribution: USA states of: GA, MA, MN, SC and VA.
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.
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.
Worldwide Distribution-USA (nationwide) including the states of  IL, IN, MI, OH, WI, IA, KS, MN, MO, NE, SD, AR, LA,OK, TX. AZ, CO, ID, MT, NM, UT, MT, AK, CA, HI, OR, WA, AL, FL, GA, KY, NC,  SC, TN, MD, PA, VA, WV, CT, MA, ME, NH, NJ, NY, RI and VT and the countries of  Canada, Nova Scotia and British Columbia
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.
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.
Worldwide Distribution was made in the U.S., Canada, Australia, Singapore, Korea, Switzerland, France, Germany, United Kingdom, Portugal, Italy, Spain, Ireland, Africa, UAE, Jordan, Turkey, Ukraine, and Lebanon.   There was no government or military distribution.
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.
Posterior fluidics modules installed in the system may need to be recalibrated.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, with an unacceptable total hemoglobin level, were distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor who was previously deferred, were distributed.
Blood product, collected from a donor with a history of incarceration, was distributed.
Blood product, collected from a donor who received a piercing within 12 months of donation, was distributed.
Hoxworth Blood Center  UC Medical Center
Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Blood product, which was labeled as leukoreduced, but was not tested to verify white blood cell count, was distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Blood Centers of the Pacific - Irwin Center
Red Blood Cells Leukocytes Reduced Washed
Blood product,, which was collected from a donor who traveled to a malarial endemic area, was distributed.
American Red Cross Blood Svs. Indiana-Ohio Region
Blood and Blood Products for Reprocessing
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, which were not tested to verify the White Blood Cell count, were distributed.
''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.
1 case ( 40 x 200 gram packages per case)
The imported processed fish was found to be uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets.
US (nationwide) in the state of West Virginia
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
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.
Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose, Rx Only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ  08543, by Hollister-Stier Laboratories LLC, Spokane Washington 99207, NDC 0270-0083-20.
Presence of Particulate Matter; potential for charcoal particulates
Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.
Stryker Medical Division of Stryker Corporation
USA, Nationwide including the states of PA, NM, MI, IA, CA, CO, WA, VA, IL, WI, NY, WY, MO, TX, and CT.
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.
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.
Worldwide distribution - USA nationwide and the countries of:  Canada,  Germany, Finland, Japan, Italy, San Juan, Switzerland, and UK.
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.
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 .
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.
Worldwide Distribution -- USA (nationwide) including the countries of  AUSTRALIA, ANGOLA,ARGENTINA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GHANA, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNG ARIA, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAHSTAN, KENYA, KOREA, KUWAIT, LATIVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MEXICO, MALTA, MOROCCO, NEPAL, NETHERLAND, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PALESTINIAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN THAILAND, TRINIDAD AND TOBAGO,K TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARB EMIRATES , UNITED KINGDOM and URUGUAY
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.
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.
Mindray DS USA, Inc. d.b.a. Mindray North America
Worldwide Distribution - USA (nationwide) and internationally to Great Britian, Colombia, and Australia.
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.
206 units (180 units domestic, 26 units foreign)
Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch.
Nationwide Distribution, including the states of MO, TX, and IN.
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Broken screw insertor hardness was measured and found to be below the acceptable limits.
Worldwide distribution, including the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, LA, KS, KY, LA, ME,MD, MA, MI, MN, MS,MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK OR, PA, SC, TN,TX, UT,VA, WA, WT, WY and the countries of the UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAK IA, SINGAPORE, SAUDI ARABIA, QATAR, POLAND, PERU, PANAMA, NORWAY, NEW ZEALAND, NETHERLAND, MEXICO, MALAYSIA, LEBANON, KUWAIT, KOREA, JAPAN, ITALY, INDONESIA, INDIA, IRELAND, GERMANY FRANCE, FINLAND, EGYPT, CZECH REPUBLIC, COSTA RICA, COLOMBIA, CHILE CANADA, BRAZIL, BELGIUM, AUSTRIA, AUSTRALIA, ARGENTINA, and ALGERIA.
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.
GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.
Garden Fresh Gourmet Nacho Cheese Tortilla Chips  14oz bags
Beginning 11/01/2012 Garden Fresh Gourmet recalled Garden Fresh Nacho Cheese Tortilla chips (exp 11/26/2012) because quality standards of ingredients used in the products were not met.
El Matador Mexican Style Salted Tortilla Chips  16oz (454 g) bags &32 oz (908 g) bags
Beginning 11/01/2012 Garden Fresh Gourmet recalled El Matador & Garden Fresh Gourmet Salted Tortilla Chips because quality standards of ingredients used in the products were not met.
Garden Fresh Gourmet Kettle Style Original  Salted Tortilla Chips  14oz (397 g) bags
Worldwide Distribution - U.S. state of Georgia and the countries of Canada, Germany, India, Poland, and Thailand.
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.
The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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
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
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
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
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
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
Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Malaysia, and Uruguay (animal study only).
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.
5743 patient circuits distributed in commerce
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.
Varian Medical Systems, Inc. Oncology Systems
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
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.
Worldwide Distribution--USA (nationwide) including states of North Carolina and Oklahoma and the countries of Algeria, Argentina, Bahrain, Bangladesh, Bolivia, Chile, China, Columbia, Dominican Republic, Ecuador, Egypt, Finland, Ghana, Great Britian, Guatemala, Honduras, Hong Kong, India, Indonesia, Iraq, Jamaica, Jordan, Lebanon, Libya, Malaysia, Mauritius, Mexico, Moldova, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Pakistan, Palestine, Paraguay, Peru, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates , Uruguay, Venezuela, and Vietnam.
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.
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.
Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia.
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)
It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
DePuy Mitek, Inc., a Johnson & Johnson Co.
Nationwide Distribution including IL and NJ
DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423    DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee.
Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly,  7 units were labeled as 11MM while the box actually contained a 10 MM reamer
Harris Teeter Distribution centers then to 210 stores over NC, SC, VA, FL, GA,TN, MD, DE, and District of Columbia
Dried Golden Raisins 8 oz UPC 7203670490
Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.
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.
An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventional Radiology Department; Packaged for Medline Industries, Inc.; Reorder #DYNJ35993D   This custom pack includes components necessary for a specific procedure.
The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in its own packaging. The product was not labeled or identified as sterile, but was assumed to be sterile by the customer.
Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Brazil, Bulgaria, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Ecuador, Egypt, Fiji, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Panama, Peru, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.
AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL  35244.   Dental.
The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL  35244.   Dental.
Newman's Own Lite Honey Mustard Dressing, 16 FL.OZ (473 mL)
Newman's Own Lite Honey Mustard Dressing was labeled with an incorrect back label that did not list the allergen milk.
Meatless Burger: 1) Veggie Patch Ultimate Meatless Burger - Net Wt. 9 oz. tray, UPC Code 6-10129-00211-5; 2) Veggie Patch The Ultimate Meatless Burger  - Le burger sans-viande ultime, Net Wt 1.02Kg/ 2.25 Lb, UPC Code: 6-10129-08477-7
Product contaminated with Listeria monocytogenes
Veggie Patch Falafel Chickpea Balls, Net Wt 9 oz tray, Refrigerated UPC code 6-10129-06619-3
Worldwide distribution: USA (nationwide) including states of:  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN KS, KY, LA,MA, MD ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH,OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries of: Australia, Puerto Rico, and Taiwan Province of China.
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
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.
Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA TN, TX, UT, VA, WA and WI.
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.
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.
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.
Worldwide Distribution -- USA (nationwide)  including the states of CT, MI, NH, NY, OH, PA and  VT., and the countries of  AUSTRALIA, JAPAN, BELGIUM, FRANCE, GERMANY, ITALY, NETHERLANDS, POLAND, SPAIN, SWITZERLAND, TURKEY and  UNITED KINGDOM.
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:  Kinetra Model 7428 or Soletra Model 7426 Neurostimulator  Activa PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator  Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension  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:  Soletra Model 7426 Neurostimulator  Activa PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator  Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension  Model 3387 or Model 3389 Lead.
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.
Worldwide distribution - USA (nationwide) and the countries of Australia,  Canada, Chile, Europe, Japan,  Korea, Panama, Puerto Rico and Thailand.
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
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.
Worldwide Distribution-USA (nationwide) and the countries of Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Djibouti, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Macao, Malaysia, Mexico, Moldova Republic, Morocco, Myanmar, Namibia, Netherlands, Netherlands Antilles, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, Yemen, Zambia, and Zimbabwe
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.
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.
Nationwide in the US: NJ, FL, TX, HI, KS, VA, CA, CO, NV
Frozen Yellowfin Tuna Loin 3/5, 30lbs/case.
Red Chamber is recalling Frozen Yellowfin Tuna Loin due to customer complaints with scromboid illnesses when consuming the products.
nationwide in the US: CA and WA and to Canada.
Frozen Tuna Loins 3/5, 30lbs., UPC 8 29838 82310 7.
Unified Seafood Co is recalling Frozen Yellowfin Tuna Loin 3/5 due to possible contamination with Scombroid Toxin.
Clean & Clear advantage, 3-in-1 foaming wash  8 FL. OZ. (240 mL) bottle, OTC, Distributed in the US by: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. Skillman, NJ 08558-9418 NDC 58232-0326-8
Superpotent (Single Ingredient Drug): salicylic acid
Distributed in Florida, Georgia, Tennessee, New Jersey, New York, Pennsylvania, and Wisconsin.
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.
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.
#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
The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen.  Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.
#222-C,  Primarque Clam Base, Net Weight 5 pounds (2.27kg) & 16 oz ( 1 LB) 454G Packed for Primarque Products, Worcester, MA 01610   #222-C, Cook's Delight Clam Base, Net Weight 5 pounds (2.27kg) & 16 oz ( 1 LB) 454G Packed By Integrative Flavors, Michigan City, Indiana 46360
#223-E  Primarque Clam Base, Net Weight 50 pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610
#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
#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
#425N  Primarque Fish Base, Net Weight 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610
#822- M  PrimarqueClam Base, Net Weight 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610
#428N Cook's Delight Shrimp Base, Net Weight 50 Pounds (22.68 kg) Packed by Integrative Flavors, Michigan City, Indiana
#272N  Cook's Delight Mushroom Base, Net Weight 50 Pounds (22.68 kg) Packed by Integrative Flavors, Michigan City, Indiana 46360
#828 Cook's Delight Shrimp Base, Net Weight 30 Pounds; 5 Pounds, Packed by Integrative Flavors, Michigan City, Indian
#226 Cook's Delight Lobster Base, Net Weight 30 Pounds; 5 Pounds, Packed by Integrative Flavors, Michigan City, Indian
#326 RS PrimarqueLobster Base, Net Weight 50 Pounds;, PackedFor Primarque Products, Worcester, MA 01610
#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
Worldwide Distribution - USA (nationwide) and the following countries: Australia  France   Rep. of Korea  Belgium   Germany   Russia  Brazil   Israel   Saudi Arabia  Canada   Italy   Spain  Chile   Japan   Sweden  China   Mexico   Taiwan  Denmark   Netherlands   Turkey  Ecuador   Norway   UK  Finland   Poland
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.
25 Units US (50-100 racks per unit) 106 total
The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process.
Worldwide distribution - US (nationwide) and the states of AL, CA, ID, IN, IA, MI, MN, MS, NJ, NM, OH, PA. SC, TX, UT, VA, WI. including the country of SAUDI ARABIA.
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.
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.
EEG NeuroAmp, Model Number: CS 10090; CS 10137.   Biofeedback and Relaxation
EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices.
Procrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial; Mfg By: Amgen Inc., Thousand Oaks, CA  91320; Dist. By: Physicians Total Care, Tulsa, OK  74146; NDC 54868-5673-1.
Presence of Particulate Matter: This is a subrecall of Amgen's Procrit due to glass delamination
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
Undeclared hydrolyzed soy protein in yellow rice with saffron
Tak Shing Hong Dried Taiwan Shrimp, all sizes
Grand Products is recalling Tak Shing Hong Dried Taiwan shrimp products due to undeclared sulfites.
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.
Short Fill: some bottles contained less than 120-count per labeled claim
Dauphin Holdings, Inc. DBA Arnolds Candies
Product was shipped to the following states: NY, OH & PA.
Arnold's Candies  Handmade Since 1953 www.arnoldscandies.com Wintergreen Puffs***INGREDIENTS: Sugar, Cream of Tarter, Artificial Flavoring and Coloring WARNING: Manufactured in a facility that also handles peanuts NET WT 6 oz (170g) 0 73629 00308 0 931 High Grove Blvd Akron, OH 44312 Best By: 07/11/14(19)1 lot code 06282012
The firm was notified by the New York State Department of Agriculture & Marketing, that they failed to include the colors Yellow #5 and Blue #1 on their label.
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
Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01
Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880.
Impurities/Degradation Products: Out-of-specification results were obtained for a known  impurities.
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
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.