BEUDAMED
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    Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, Product numbers: 1425, 1430 (d) Battery Pack, Product number: 1650DE Indication for Use for OUS HVAD System: The HVAD System is intended for use in patients at risk of death from refractory end-stage heart failure. The HVAD System is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter.

    FDA Recall
    Open, Classified ·Heartware·Product code DSQ·May 2, 2018

    Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ; (6)2012-320 DRAIN, OCEAN PEDI W/S; (7)2050-000 DRAIN, OCEAN BRU W/AC,S

    FDA Recall
    Open, Classified ·Atrium Medical Corporation·Product code CAC·September 18, 2023

    SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code CAC·November 27, 2018

    Atrium Oasis Drain Single W / AC, Part No. 3600-100

    FDA Recall
    Open, Classified ·Atrium Medical Corporation·Product code CAC·November 1, 2023

    Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY

    FDA Recall
    Open, Classified ·Atrium Medical Corporation·Product code CAC·September 5, 2023

    Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code CAC·December 13, 2023

    RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code CAC·November 27, 2018

    Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code CAC·December 13, 2023

    Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU

    FDA Recall
    Open, Classified ·Atrium Medical Corporation·Product code CAC·September 18, 2023

    Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;

    FDA Recall
    Open, Classified ·Atrium Medical Corporation·Product code CAC·September 18, 2023

    1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray

    FDA Recall
    Open, Classified ·American Contract Systems, Inc.·Product code OJG·March 22, 2022

    1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack

    FDA Recall
    Open, Classified ·American Contract Systems, Inc.·Product code OJH·March 22, 2022

    Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system

    FDA Recall
    Open, Classified ·NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark·Product code OWB·April 17, 2024

    Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code OTE·January 16, 2023

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code MUE·April 8, 2026

    NavitrackER Kit A: Knee, Model Number 20-8000-000-07,

    FDA Recall
    Open, Classified ·Orthosoft, Inc. dba Zimmer CAS 3300-75 Queen St Montreal Canada·Product code OLO·January 7, 2022

    biokitHSV-2 Rapid Test, REF: 300028001

    FDA Recall
    Open, Classified ·Biokit, S.A. Avinguda De Can Montcau 7 (Barcelona) Llica D'Amunt Spain·Product code LGC·September 28, 2022

    KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422

    FDA Recall
    Open, Classified ·King Systems Corp. dba Ambu, Inc.·Product code CAE·September 26, 2024

    AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0 60305 4.0 60405

    FDA Recall
    Open, Classified ·SunMed Holdings, LLC·Product code CAE·December 22, 2022

    KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD430

    FDA Recall
    Open, Classified ·King Systems Corp. dba Ambu, Inc.·Product code CAE·September 26, 2024