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
This recall has been terminated (originally issued April 26, 2007).
- Company
- Smiths Medical Md, Inc.
- Recall Initiated
- February 3, 2007
- Posted
- April 26, 2007
- Terminated
- February 10, 2011
- Recall Number
- Z-0768-2007
- Quantity
- 23,519
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide, Canada, and Italy.
Lot / Code Info
Model 3500 pump with 4.1.4 or 4.1.3 software.
Root Cause
Other
Action Taken
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.