Recall archive / FDA device enforcement
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software — FDA record Z-1304-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 18, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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- Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
- Classification
- Class I
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- Not supplied
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1304-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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) |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 19, 2025
- Recall initiation date
- Feb 18, 2025
- Center classification date
- Mar 13, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.