Recall Z-1053-2015 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion p
| Date | Feb 4, 2015 (initiated Jan 13, 2015) |
| Status | Terminated |
| Reason | CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues. |
| Root cause | Under Investigation by firm |
| Action | CareFusion sent an Urgent Medical Device Recall Notification letter dated January 13, 2015, to all affected customers. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return to CareFusion the recall response card. Customers with questions were instructed to CareFusion: Recall related questions, (888) 562-6018; Adverse Event Reports, (888) 812-3266; Technical Questions regarding the Alaris System, (888) 812-3229. |
| Quantity | 7,440 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960280 | IVAC NEEDLE FREE VALVE ADMINISTRATION SETS Y, Apr 4, 1996 |