RegWardenFDA facility compliance records
Recall

Class I — CareFusion 303, Inc.

Recalling firmCareFusion 303, INC.
Registered facilityView this company's 3 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass I
StatusOngoing
ReasonSoftware issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
ProductBD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
DistributionUS: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None
Initiated2025-02-18
Classified2025-03-13
Recall numberZ-1305-2025
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class I recall — CareFusion 303, Inc. (Z-1305-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96323/

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