FDA-Device2025-03-19Class I

BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

Hazard

Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

Sold states
US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

Official notice

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

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