BEUDAMED
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    ATLAS Loading Car

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

    ATLAS Loading Car

    FDA Recall
    Terminated ·Steris Corporation·Product code FLE·December 26, 2018

    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

    NxStage Cartridge Express, CAR-170, for hemodialysis.

    FDA Recall
    Terminated ·NxStage Medical, Inc.·Product code KDI·July 27, 2007

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

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

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

    FDA Recall
    Terminated ·Steris Corporation·Product code FLE·October 22, 2019

    The Evolution steam sterilizers, manufactured by Steris Corporation, utilize a loading system to assist the operator in transporting, loading and unloading items to be sterilized. It consists of two major components: -Loading Car: Shelving unit which holds the items to be sterilized; and the -Transfer Carriage: Wheeled unit which loads/unloads the loading car and transports it from one location to another. Product shipped in crate. Product Usage: The Evolution Transfer Carriage is a wheeled unit which loads/unloads the sterilizer loading car and transports it from one location to another.

    FDA Recall
    Terminated ·Steris Corporation·Product code FLE·March 23, 2012

    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

    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

    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

    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

    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

    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

    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

    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

    NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-124, 6 units per case.

    FDA Recall
    Terminated ·NxStage Medical, Inc.·Product code KDI·April 14, 2004

    NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-153 Cartridge Express. 6 units per case.

    FDA Recall
    Terminated ·NxStage Medical, Inc.·Product code KDI·April 14, 2004

    NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model # CAR-154 Cartridge Express, 6 units per case.

    FDA Recall
    Terminated ·NxStage Medical, Inc.·Product code KDI·April 14, 2004

    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

    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