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Recall Observatory FDA recall evidence

Device product

Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.

Z-1015-2013

November 20, 2009

Class II

Product summary

Firm
CareFusion Corporation
Event
Event 53991
Status
Terminated
Classification
Class II
Quantity
2637
Official record key
device-enforcement:Z-1015-2013

Official wording

Reason: The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.

Code information: All Pyxis Anesthesia System Model 2000

Distribution pattern: Worldwide Distribution - USA (Nationwide) including CANADA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.