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
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