OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypas ...
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass.
OXY-1 System consists of Console, Pump Drive,
E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall.
Components:
Recall Date: Dec 14, 2021
Mfg:
Abiomed, Inc.
Mfg Country:
United States
Recall ID: 89328
Product ID: 191283
Enforcement Date: Feb 9, 2022
Last Published: Feb 4, 2022
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Emert Number: Z-0550-2022
Emert Status: Updated