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Recall Observatory FDA recall evidence

Device product

Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00

Z-0369-2026

September 30, 2025

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 97566
Status
Ongoing
Classification
Class II
Quantity
32 units
Official record key
device-enforcement:Z-0369-2026

Official wording

Reason: Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Code information: All Serial Numbers/Ref #/UDI: 1149-00 10885403517822 and 1152-00 10885403517839

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.