BEUDAMED
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    Access Immunoassay Systems CORTISOL, Part Number: 33600

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGR·February 17, 2010

    The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGR·September 18, 2018

    Active Cortisol EIA, 96 Wells, DSL-10-2000 The DSL-10-2000 Active Cortisol Enzyme Immunoassay (EIA) kit provides materials for the quantitative measurement of cortisol in serum, plasma or urine. This assay is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGR·July 20, 2009

    IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code CGR·September 19, 2014

    ATLAS Loading Car

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·February 20, 2019

    Invacare 2G Tarsys Seating System, Model 2GR.

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITI·December 15, 2003

    Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).

    FDA Enforcement
    Class I ·Terminated·Medtronic Perfusion Systems·March 24, 2021

    Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·December 11, 2019

    BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code FAD·October 13, 2016

    BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc.·November 23, 2016

    Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code FAD·October 13, 2016

    Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc.·November 23, 2016

    Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA.

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code FPA·April 2, 2009

    Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code EZN·November 3, 2005

    C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014.

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc.·November 23, 2016

    DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·June 16, 2021

    AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·December 18, 2013

    C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014.

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code FAS·October 12, 2016

    Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coil Stent; Bard¿ Silicone Uretera l Coil Stent with Figure Four, End, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc.·November 23, 2016

    Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with Stent and Multi- Length Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc.·November 23, 2016