Z-1015-2013Class II

Pyxis Anesthesia System Model 2000 (PAS 2000)

Name: Z-1015-2013 Pyxis Anesthesia System Model 2000 (PAS 2000)
Creator: CareFusion Corporation
Published: 2009-11-20
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2009-11-20 / Terminated / root cause: design

FDA source

CareFusion Corporation began a recall of Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory... on 2009-11-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1015-2013
Classification: Class II
Status: Terminated
Initiated: 2009-11-20
Posted: 2013-03-28
Terminated: 2013-03-28
Recalling firm: CareFusion 303, Inc
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.
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Carefusion sent a Safety Alert Notification letter dated January 13, 2010 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to ensure back-up procedures were in place in case of system down-time or lock-up, including review of the back-up procedures with staff. The letter included an update to the PAS 2000 User Guide. The letterstates that a CareFusion field representative will be contacting customers to make arrangements to apply warning labels to the PAS 2000 electronics doors. Customers were instructed to complete and return the Response Card included. For questions contact your local field support representative ot the Advocacy department at [email protected].
Quantity in commerce: 2637
Distribution: Worldwide Distribution - USA (Nationwide) including CANADA.
Product codes and lots: All Pyxis Anesthesia System Model 2000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1015-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1015-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-28

Product code BRY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)