FDA Enforcement
Class I
Ongoing
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Recall: Z-1304-2025
·
Reported March 19, 2025
Enforcement
- Recall Number
- Z-1304-2025
- Event ID
- 96323
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- CareFusion 303, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 19, 2025
- Initiation Date
- February 18, 2025
- Classification Date
- March 13, 2025
- Address
- 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States
Description
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Reason
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Code Info
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)
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