Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4. Medex, 4350 Gr
FDA device recall Z-0768-2007 · posted 2007-04-26 · Terminated
Recall details
- Recalling firm
- Smiths Medical MD, Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 23,519
- Distribution
- Nationwide, Canada, and Italy.
- Date initiated
- 2007-02-03
- Date posted
- 2007-04-26
- Date terminated
- 2011-02-10
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDEX 3000 SERIES SYRINGE INFUSION PUMP (K982640) | Medex, Inc. | 1999-04-06 |