Recall Z-1445-06 ยท FRN Pump, Infusion
Delphi Medical Systems
Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8.
| Date | Aug 26, 2006 (initiated Mar 29, 2006) |
| Status | Terminated |
| Reason | Potential for under-infusion without alarm; cassette rollers stop moving , but the pump shaft continues rotating without alarm. |
| Root cause | Other |
| Action | Distributors were notified via letter dated 3/29/05 instructing them to retrieve and return the product. |
| Quantity | 22 US and 147 international. |
| Distribution | Florida, Austria, Denmark, Finland, Germany, Norway, Sweden, Switzerland and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953896 | THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS Imed Corp., Mar 20, 1996 |