Recall Z-0450-2014 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
| Date | Dec 4, 2013 (initiated Nov 8, 2013) |
| Status | Terminated |
| Reason | CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing. |
| Root cause | Employee error |
| Action | The firm, CareFusion, sent an "URGENT: Medical Device Recall Notification" letter dated November 8, 2013 to all customers who purchased the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to immediately complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card and return all recalled product directly to the distributor form whom it was purchased. Customers with questions are instructed to contact their distributor direct |
| Quantity | 480 units |
| Distribution | US Distribution in CA, WY, OH, UT, and MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944320 | VENTED/NON-VENTED GEMINI ADMINISTRATION SET Imed Corp., Feb 14, 1995 |