Z-1305-2025 Class I Ongoing
FDA device recall Z-1305-2025 was initiated by CareFusion 303, Inc. on February 18, 2025 and is designated Class I. Reason for recall: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- March 19, 2025
- Initiation Date
- February 18, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
BD Care Coordination Engine (CCE) Infusion Adapter, 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Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Distribution Pattern
US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None
Code Information
Software: v1.7.2/UDI: 10885403510472