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