16
Feb
2024

FDA Recall: Software Error May Lead to Over-Delivery of Ingredient

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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,

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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