Recall Z-1235-2010 ยท FRN Pump, Infusion
Smiths Medical ASD, Inc.
CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only, Smiths Medical MD, Inc.., St. Paul, MN 55112.
| Date | Apr 5, 2010 (initiated Dec 23, 2009) |
| Status | Terminated |
| Reason | The CADD-Legacy 1 Model 6400 Ambulatory Infusion Pump (Serial Number 370969) was shipped without documentation that the required accuracy testing had been performed during the manufacturing process. If the subject infusion pump did not go through the accuracy testing, and if it does not meet accuracy specifications, there is a potential for over or under-delivery. |
| Root cause | Employee error |
| Action | Smiths Medical telephoned the customer on December 23, 2009, to return the CADD-Legacy 1 Ambulatory Infusion Pump, serial number 370969, since there was no record of the completed accuracy testing for the infusion pump. |
| Quantity | 1 |
| Distribution | MI |
| 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 |