BD Alaris Systems Manager — Class I medical device recall Z-1304-2025
Ongoing recall by CareFusion 303, Inc., reported 2025-03-19, distributed in AZ, CA, DC, FL, GA, IL, IN, MI…. Software issue that may result in outdated automated programming request(APR) being sent to the progressive ca
| Recall number | Z-1304-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2025-02-18 |
| Classified | 2025-03-13 |
| Reported by FDA | 2025-03-19 |
| Distributed | AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10885403519666, 10885403960116, 10885403960123 |
| Model numbers | 9601 |
Product
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Reason for recall
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1304-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.