Company: Baxter Healthcare Corporation
Date of Enforcement Report: 11/17/2021
Class II
PRODUCT
Hemodialysis Delivery System, Software Version 2.x.
Recall Number: Z-0215-2022
REASON
If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corporation on 9/29/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4248
DISTRIBUTION
U.S. Nationwide and International