Recall – Specific sequence can lead to wrong hemodialysis delivery

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

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