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Recall Observatory FDA recall evidence

Device product

BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.

Z-1125-2025

February 23, 2024

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 96041
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1125-2025

Official wording

Reason: Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.

Code information: UDI: 10885403512629/ Serial Numbers: 16153360 16161369 16161370 16161371 16187328 16187329 16187330 15495060 15930189 16161368 16173444 16283947

Distribution pattern: US: Nationwide OUS:JP IT IN DE GB KR NL TW ES BE AU BH CA BR NZ FR AR QA MX CL TR SA MY CH IL IE TH SG KW MA FI AE EG BS BM GR MC PL LB MO IQ TN NO PH CN HK CO JO OM

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.