FDA Device recall Z-1304-2025
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
- FDA Device
- Class I
- ongoing
- Published 2025-03-19
On 2025-03-19 the FDA classified a Class I recall of BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software by Carefusion 303, citing software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1304-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-02-18 |
| Published | 2025-03-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Carefusion 303 |
| Distribution | AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI |
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Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Identifiers
| 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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1304-2025%22
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