RegWardenFDA facility compliance records
Recall

Class II — 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 II
StatusOngoing
ReasonWhen global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty), 4) CII Safe Stock Out Notice are, without user warning, overwritten to the value NO , which could result in diversion of controlled substances from the automated dispensing cabinet.
ProductBD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-01
Quantity61
DistributionUS Nationwide distribution in the states of LA, NC, NY, MI, MA, NV, KS, IA, CA.
Initiated2023-09-06
Classified2023-10-10
Recall numberZ-0093-2024
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 II recall — CareFusion 303, Inc. (Z-0093-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93016/

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