Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device

FDA device recall Z-1015-2013 · posted 2013-03-28 · Terminated

Recall details

Recalling firm

CareFusion Corporation

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

BRY

Quantity affected

2637

Distribution

Worldwide Distribution - USA (Nationwide) including CANADA.

Date initiated

2009-11-20

Date posted

2013-03-28

Date terminated

2013-03-28

Location

San Diego, CA