CareFusion 303, Inc.: Device Recall

Recall #Z-1304-2025 · 02/18/2025

Class I: Dangerous

Recall Details

Recall Number: Z-1304-2025
Classification: Class I
Product Type: Device
Recalling Firm: CareFusion 303, Inc.
Status: Ongoing
Date Initiated: 02/18/2025
Location: San Diego, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated

Reason for Recall

Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

Product Description

BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

Distribution Pattern

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

Other Recalls by CareFusion 303, Inc.

Class II: Risk 12/03/2025

Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
Class II: Risk 11/20/2025

Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.
Class II: Risk 11/06/2025

Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network
Class I: Dangerous 10/17/2025

If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.
Class II: Risk 09/30/2025

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

View all recalls by CareFusion 303, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.