Recall Z-0307-2018 ยท FRN Pump, Infusion
Smiths Medical ASD Inc.
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
| Date | Jan 2, 2018 (initiated Nov 22, 2017) |
| Status | Terminated |
| Reason | Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The label attached to the back of the pump may list a serial number that does not match the correct serial number programmed into the software of the pump. |
| Root cause | Process design |
| Action | The recall notices were disseminated via FedEx to US consignees on November 22, 2017. The recall notices were disseminated via email to Australian consignees on November 27, 2017. The consignee was directed to turn on the pump and check the serial against the serial number on the label. If they did not match, then they were directed to return the unit. |
| Quantity | 58 units |
| Distribution | US, Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982838 | CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 Sims Deltec, Inc., Nov 4, 1998 |