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Recall Observatory FDA recall evidence

Device product

(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00

Z-1119-2025

January 08, 2025

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 96055
Status
Ongoing
Classification
Class II
Quantity
137,741 total
Official record key
device-enforcement:Z-1119-2025

Official wording

Reason: Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues

Code information: (1) Pyxis MedStation ES, Catalog No. 323, UDI-DI 10885403512667; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327, UDI-DI 10885403477836; (3) Pyxis MedStation ES Tower, Catalog No. 352, UDI-DI 10885403512674; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00, UDI-DI 10885403512605; All Serial Numbers; Software Versions v1.10 and prior Affected

Distribution pattern: Domestic distribution nationwide. International distribution to North America, Latin America, EMEA, and Greater Asia.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software issues could potentially result in