BEUDAMED
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    ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills

    FDA Recall
    Terminated ·Cardinal Health·Product code LZA·March 22, 2019

    Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.

    FDA Recall
    Terminated ·Halyard Health·Product code LZA·November 10, 2016

    ChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills

    FDA Recall
    Terminated ·Cardinal Health·Product code LZA·March 22, 2019

    ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills

    FDA Recall
    Terminated ·Cardinal Health·Product code LZA·March 22, 2019

    Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

    FDA Recall
    Terminated ·Cardinal Health·Product code LZA·August 25, 2015

    ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills

    FDA Recall
    Terminated ·Cardinal Health·Product code LZA·March 22, 2019

    Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage.

    FDA Recall
    Terminated ·Atricure Inc·Product code HBT·January 23, 2014

    Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System

    FDA Recall
    Terminated ·Smith & Nephew Inc.·Product code OMP·November 14, 2013

    WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code NGV·May 7, 2018

    Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage.

    FDA Enforcement
    Class II ·Terminated·Atricure Inc·March 26, 2014

    Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew Inc.·March 5, 2014

    WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.

    FDA Enforcement
    Class I ·Terminated·Biosense Webster, Inc.·September 5, 2018

    Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.

    FDA Recall
    Terminated ·Accelerate Diagnostics Inc·Product code PRH·March 14, 2018

    TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).

    FDA Recall
    Terminated ·Laax, Inc.·Product code GDW·March 25, 2015

    TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).

    FDA Recall
    Terminated ·Laax, Inc.·Product code GDW·March 25, 2015

    AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

    FDA Recall
    Terminated ·AtriCure, Inc.·Product code FZP·September 22, 2016

    TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).

    FDA Enforcement
    Class I ·Terminated·Laax, Inc.·April 29, 2015

    TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).

    FDA Enforcement
    Class I ·Terminated·Laax, Inc.·April 29, 2015

    Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.

    FDA Enforcement
    Class II ·Terminated·Accelerate Diagnostics Inc·May 2, 2018

    AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

    FDA Enforcement
    Class II ·Terminated·AtriCure, Inc.·November 16, 2016