Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0555-2007

Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA

CareFusion 303, Inc / initiated 2007-08-13 / Terminated

Cardinal Health 303 Inc DBA Alaris Products began a recall of Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA on . The reason FDA records is "System lock up; mini-drawers -under certain circumstances during use, are not accessable, delaying the user from accessing critical medications". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0555-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
CareFusion 303, Inc
Product
Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA
Product code
BRY Cabinet, Table And Tray, Anesthesia
Reason for recall
System lock up; mini-drawers -under certain circumstances during use, are not accessable, delaying the user from accessing critical medications.
FDA root cause
Other
Action
The field action consisted of phone calls and a mailing conducted to all customers for the Pyxis Anesthesia System 3500 beginning on 08/13/2007. The customers will be notified by registered return receipt mail by Recall Notifications dated August 14, 2007. Separate letters will be sent to the Director of Pharmacy, Chief of Anesthesia, Director of Risk Management, and Director of Surgery at each facility. Recommended actions will be provided as a short-term fix and a long-term fix of the software will be issued shortly.
Quantity in commerce
369
Distribution
Nationwide to Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Missouri, Mississippi, Montana, New Jersey, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, and Wyoming.
Product codes and lots
All serial numbers of the Pyxis Anesthesia Station, Model 3500