FDA Medical devices recall ·
BD Alaris Systems Manager recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1304-2025
- Date
- (initiated February 18, 2025)
- Company / brand
- CareFusion 303, Inc.
10020 Pacific Mesa Blvd, San Diego, CA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Why was it recalled?
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
States: Arizona California District of Columbia Florida Georgia Illinois Indiana Michigan Missouri North Carolina New Jersey New York Ohio Oregon Pennsylvania South Carolina Texas Utah Virginia Washington Wisconsin
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1304-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.