FDA Device Recall Z-1304-2025

CareFusion 303, Inc. · San Diego, CA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

Lot / serial / GTIN: Software v12.5.1 or v12.5.2, and prior versions (4.33, 12.0.1, 12.0.2, 12.1, 12.1.2, 12.3) UDIs: 10885403960123 10885403519666 (10885403960116)

Reason for recall

Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

Recall record

Recall number: Z-1304-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
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
Recall initiated: 2025-02-18
Classified by FDA Center: 2025-03-13
FDA published: 2025-03-19
Recalling firm: CareFusion 303, Inc.
Firm location: San Diego, CA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All device recalls