BEUDAMED
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    Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.

    FDA Recall
    Terminated ·Helena Laboratories, Inc.·Product code JPB·April 20, 2016

    Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY

    FDA Recall
    Terminated ·Helena Laboratories, Inc.·Product code JPB·February 24, 2017

    daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·May 14, 2007

    Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. Manufactured by: RanD S.r.l 41036 Mendolla (MO) Italy. Distributed exclusively by Medtronic, Inc.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DTQ·June 4, 2007

    Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019

    Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK Material: 701055372

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019

    Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK Material: 701056041

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019

    BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system

    FDA Recall
    Terminated ·BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy·Product code LOD·March 22, 2021

    BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111

    FDA Recall
    Terminated ·BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy·Product code KNW·March 22, 2021

    BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US

    FDA Recall
    Terminated ·BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy·Product code LOD·March 22, 2021

    Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DWF·January 3, 2018

    Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWA·March 3, 2021

    Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00

    FDA Recall
    Completed ·Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom·Product code DTQ·March 13, 2023

    COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002

    FDA Recall
    Terminated ·AtriCure, Inc.·Product code OCL·January 22, 2019

    COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S

    FDA Recall
    Terminated ·AtriCure, Inc.·Product code OCL·January 22, 2019

    COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI

    FDA Recall
    Terminated ·AtriCure, Inc.·Product code OCL·January 22, 2019

    COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001

    FDA Recall
    Terminated ·AtriCure, Inc.·Product code OCL·January 22, 2019

    CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·May 9, 2012

    CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·May 9, 2012

    CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·May 23, 2014