Recall Z-0659-06 ยท FPA Set, Administration, Intravascular
Smiths Medical MD, Inc.
Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. ------Model Number RC4106 (Reorder No. 21-0402-25) Primary Administration Set. Sterile, non-pyrogenic. Length 105 inch/267 cm, 25 ml priming volume, 20 drops/ml and 1 needless injection site. Manufactured for Deltec SIMS Deltec, Inc., St. Paul, MN 55112 U.S.A. sims Smiths Industries
| Date | Mar 18, 2006 (initiated Dec 8, 2005) |
| Status | Terminated |
| Reason | Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely. |
| Root cause | Other |
| Action | Affected customers were notified of the recall and asked to return or destroy any unused product. |
| Quantity | 4 boxes of 40 Admin. Sets (160 sets in total) |
| Distribution | South Carolina, Australia, Canada and Puerto Rico. |
| FDA record | Open on fda.gov |