FDA Medical Device Recalls (openFDA)
CareFusion Corporation: 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.
- Recall number
- Z-1015-2013
- Recalling firm
- CareFusion Corporation
- 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.
- Status
- Terminated
- Initiated
- 2009-11-20
- Posted
- 2013-03-28
- Terminated
- 2013-03-28
- 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.
- 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 customer.advocacy@carefusion.com.
- Quantity
- 2637
- Distribution
- Worldwide Distribution - USA (Nationwide) including CANADA.
- Lot, serial or model codes
- All Pyxis Anesthesia System Model 2000
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BRY
- Firm FEI
- 2016493
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28