BEUDAMED
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    Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

    FDA Recall
    Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

    Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality.

    FDA Recall
    Terminated ·Medtronic Vascular·Product code DXF·August 25, 2020

    Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)

    FDA Recall
    Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

    Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)

    FDA Recall
    Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

    ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312

    FDA Recall
    Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

    ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220

    FDA Recall
    Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

    Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), Heparin COATED, Sterile EO, Rx Only, UDI: (01)00849111075541

    FDA Recall
    Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

    Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI: (01)00849111075282

    FDA Recall
    Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

    Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

    FDA Recall
    Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

    Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)

    FDA Recall
    Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

    HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P060040) and the HeartMate XVE LVAS (PMA P920014) Systems. The HeartMate II and the HeartMate XVE LVAS are intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate XVE LVAS is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days and who are not candidates for cardiac transplantation. The HeartMate II and XVE LVAS are intended for use both inside and outside the hospital, for transportation of Ventricular Assist Device (VAD) patients via ground ambulance, fixed-wing aircraft or helicopter. The devices consist of an implantable blood pump connected to an external System Controller by a percutaneous lead. The external controller is powered by AC electrical power, via the Power Module or Power Base Unit, or by battery power with a pair of rechargeable HeartMate batteries. Two batteries are used simultaneously for power. The LVAS is also designed to operate on a single battery, facilitating battery changes without interruption of VAD support.

    FDA Recall
    Terminated ·Thoratec Corp·Product code DSQ·October 14, 2009

    Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305

    FDA Recall
    Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

    ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075510

    FDA Recall
    Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

    Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075275

    FDA Recall
    Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

    Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)

    FDA Recall
    Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

    Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality.

    FDA Recall
    Terminated ·Medtronic Vascular·Product code DXF·August 25, 2020

    ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:

    FDA Recall
    Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

    CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2

    FDA Recall
    Terminated ·Zeltiq Aesthetics, Inc·Product code OOK·July 5, 2021

    Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro. The CT cardiac function analysis software is used to analyze cardiac function using data obtained by performing cardiac MPR processing for ECG-gated scan data according to the cardiac axis. Aquilion ONE is a dynamic volume CT system that supports whole-body scanning. This 320-detector row system generates 640 slices per rotation using the coneXact reconstruction algorithm. In addition, the high-speed rotation mechanism and the fast reconstruction unit of the system allow the rapid image acquisition to further improve throughput in CT examinations.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·November 5, 2014

    Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3

    FDA Recall
    Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021