Recall Z-0555-2007 ยท BRY Cabinet, Table And Tray, Anesthesia
Cardinal Health 303 Inc DBA Alaris Products
Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA
| Date | Sep 26, 2007 (initiated Aug 13, 2007) |
| Status | Terminated |
| Reason | System lock up; mini-drawers -under certain circumstances during use, are not accessable, delaying the user from accessing critical medications. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.