Company: Baxter Healthcare Corporation
Date of Enforcement Report 5/30/2018
Class II:

PRODUCT
Prismaflex 7.20 US: The Prismaflex Control Unit is intended for: ” Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. ” Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. Recall Number: Z-1926-2018

REASON
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring

RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corporation, Deerfield, IL on 4/24/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
231 units

DISTRIBUTION
Nationwide and Internationally