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Recall Observatory FDA recall evidence

Device product

BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software

Z-1305-2025

February 18, 2025

Class I

Product summary

Firm
CareFusion 303, Inc.
Event
Event 96323
Status
Ongoing
Classification
Class I
Quantity
Unavailable
Official record key
device-enforcement:Z-1305-2025

Official wording

Reason: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

Code information: Software: v1.7.2/UDI: 10885403510472

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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software issue