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Recall Observatory FDA recall evidence

Device product

BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system

Z-2948-2024

July 09, 2024

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 95070
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2948-2024

Official wording

Reason: Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.

Code information: serial numbers: 16056243 16068264 16082950 16142772 16192674 16208218 16208219 16284106 16346254 16388826 16388833 16623139 / UDI: None

Distribution pattern: US Nationwide distribution in the states of CA, FL, KS, MN, NJ, NY, PA.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software issue