Recall Z-0718-2007 ยท FRN Pump, Infusion
Smiths Medical MD, Inc.
Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS II) and 21-8821-01 (VIP). Smiths Medical MD, Inc., St. Paul, MN 55112 USA; RX ONLY.
| Date | Apr 5, 2007 (initiated Jan 19, 2007) |
| Status | Terminated |
| Reason | The year of manufacture had been incorrectly entered as 1980 into the pumps software during the manufacture process. As a result the pump may go into an immediate 'Clock battery is Low/Service Immediately' or 'Clock Battery needs service soon' alarm message indicating that the pump requires servicing. |
| Root cause | Other |
| Action | All consignees who have received the affected CADD-Prizm PCS II ambulatory infusion pumps and the CADD-Prizm VIP System ambulatory infusion pumps were contacted via telephone by February 1, 2007. The problem will be explained to the consignee and they will be asked to return the pumps to Smiths Medical MD in order for the problem to be corrected. |
| Quantity | 27 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |