FDA recall Z-1305-2025

CareFusion 303, Inc. · Class I · device

Product

BD Care Coordination Engine (CCE) Infusion Adapter, 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Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).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-1305-2025