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