Company: Baxter Healthcare Corporation
Date of Enforcement Report: 11/13/2019
Class II

PRODUCT

Prismaflex Control Unit, software versions below 7.21

• Recall Number: Z-0276-2020

REASON

Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

RECALLING FIRM/MANUFACTURER

Baxter Healthcare Corporation on 10/4/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

2,760 units

DISTRIBUTION

Nationwide and International