Recall Z-0768-2007 ยท FRN Pump, Infusion
Smiths Medical MD, Inc.
Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4. Medex, 4350 Green Parkway, Suite 200. Duluth, GA 30096
| Date | Apr 26, 2007 (initiated Feb 3, 2007) |
| Status | Terminated |
| Reason | Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump's startup sequence when the pump's Preventative Maintenance Alarm goes off, preventing the pump from completing its power up routine. Lock-up occurs and the pump will not function. |
| Root cause | Other |
| Action | Consignees were initially notified of the recall via a Customer Information Bulletin which was sent via electronic mail 2/3/07 and confimed with a telephone conversation. A Product Recall Notification and a Product Recall Bulletin will be sent to all consignees via the mail on 2/16/07. |
| Quantity | 23,519 |
| Distribution | Nationwide, Canada, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982640 | MEDEX 3000 SERIES SYRINGE INFUSION PUMP Medex, Inc., Apr 6, 1999 |