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
- Recall Number
- Z-1015-2013
- Event Number
- 53991
- Firm
- CareFusion Corporation
- FEI Number
- 2016493
- Product Code
- BRY
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- November 20, 2009
- Posted
- March 28, 2013
- Terminated
- March 28, 2013
- Address
- 10020 Pacific Mesa Blvd, San Diego, CA, 92121
Description
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.
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.
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].
Worldwide Distribution - USA (Nationwide) including CANADA.
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