Medical device recalls High risk

CareFusion 303, Inc. recalls BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

Recall date
February 18, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1304-2025
FDA classification
Class I
Brand / firm
CareFusion 303, Inc.
Sold / distributed
US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None

Why it was recalled

Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

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