FDA recall Z-1304-2025

CareFusion 303, Inc. · Class I · device

Product

BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

Reason for recall

Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

Distribution

US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None

Key facts

Status
Ongoing
Initiation date
2025-02-18
Report date
2025-03-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1304-2025