FDAFDA · Food and drugs·Recall number Z-1304-2025
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Published March 19, 2025 · Recall initiated: February 18, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CareFusion 303, Inc.
- Distributor
- US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None
- Lot
- 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)
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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