Recall Z-0658-06 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 CC1301 (Reorder No. 21-0334-01) Primary Checkvalve set for Secondary (piggyback) Administration. Sterile, non-pyrogenic. Length 115 inch/292 cm, 27 ml priming volume, 20 drops/ml and 3 SureSite Prepierced Injection sites. Manufactured for Deltec SIMS Deltec, Inc., St
| 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 | 2 boxes of 40 Admin. Sets (80 sets in total) |
| Distribution | South Carolina, Australia, Canada and Puerto Rico. |
| FDA record | Open on fda.gov |