BEUDAMED
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    Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.

    FDA Recall
    Terminated ·Perouse Medical 135, Route Neuve Irigny France·Product code MAV·May 10, 2012

    OPERON D850 Surgical Table Product Usage: Surgical Table

    FDA Recall
    Terminated ·Berchtold Corp.·Product code GDC·April 16, 2012

    CADD High Volume Administration Set, REF 21-7081V-01, Sterile EO, Rx only, Made in Mexico, Smith Medical ASD, Inc., 1265 Grey Fox Road, St Paul, Minnesota 55112. Designed for use with CADD pumps to allow fluid delivery from an IV bag. EXPANDED: Catalog No./ REF 21-7381-01

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code FPA·December 9, 2011

    DePuy Attune Impaction Handle Warsaw, IN 46582 Packaging: Product is packed within a polyethylene bag, with protection added as needed for sharp and/or fragile points. Product Usage: The ATTUNE Impaction handle is intended to act as a removable interface for several of the instruments that may be used throughout a procedure. The Attune Impaction Handle is used to impact, insert, and extract various Attune Instruments. The handle interfaces with the Keel Punch, Tibial Tower, Evaluation Bullet, Fixed Bearing Tibial Impactor, Rotating Platform Tibial Impactor and the Femoral Impactor.

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code LXH·March 16, 2012

    Knee walker, one unit per box. Manufacturer Kenstone Metal (Kunshan) Co., LTD. The intended use is to provide additional mobility to individuals who have difficulty walking.

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITJ·April 6, 2012

    DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012

    DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012

    DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012

    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.

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code HTO·November 16, 2012

    The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012

    Siemens Axiom Luminos dRF solid state x-ray imager Solid state x-ray imager (flat panel/dig. imager)

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code MQB·February 16, 2012

    The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012

    The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012

    IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.

    FDA Recall
    Terminated ·Innovative Magnetic Resonance Imaging Systems Inc.·Product code LNH·October 19, 2012

    Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIT·October 10, 2012

    Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code LRO·June 16, 2012

    LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012

    Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FDI·May 16, 2012

    LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis with corresponding assays.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012

    0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride injections, and the system is designed to use 0.45%-0.50% sodium chloride concentration only.

    FDA Recall
    Terminated ·Biomerieux Inc·October 17, 2012