Company: Baxter Healthcare Corporation
Date of Enforcement Report: 2/16/2024
Class I
PRODUCT
Baxter Exactamix Pro 1200, REF EXM12DY
Recall Number:
Z-1001-2024
REASON:
An error was identified in software versions 2.0.8 and 2.1.8 while using the “Use Some Overfill” feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.
RECALLING FIRM/MANUFACTURER:
Baxter Healthcare Corporation
VOLUME OF PRODUCT IN COMMERCE:
8 devices
DISTRIBUTION:
US: AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR, SD, TX, WA, WI,
