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Recall Observatory FDA recall evidence

Device product

BD Pyxis MedBank MedPass Software, REF: 139088-01

Z-2646-2023

August 18, 2023

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 92967
Status
Ongoing
Classification
Class II
Quantity
37
Official record key
device-enforcement:Z-2646-2023

Official wording

Reason: After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still available for dispense, which could lead to duplicate medication administration.

Code information: UDI-DI: 10885403513817, Software versions prior to but not including v1.2.3.23

Distribution pattern: US: FL, MI, KS

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software may continue to show the already dispensed medication dose is still available for dispense, which could