Company: Baxter Healthcare Corporation
Date of Enforcement Report: 12/30/2020
Class II
PRODUCT
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) – Product Usage: intended to be used for the controlled administration of fluids.
Recall Number: Z-0712-2021
REASON
There is a potential software error during programming.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corporation on 11/23/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
9,353 devices
DISTRIBUTION
U.S. Nationwide and International