Recall Z-0445-2016 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
| Date | Dec 17, 2015 (initiated Nov 5, 2015) |
| Status | Terminated |
| Reason | CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion. |
| Root cause | Other |
| Action | An urgent recall letter dated 11/6/15 will be sent to all customers who purchased the Alaris Pump Module SmartSite Infusion Set because CareFusion has received reports of breakage of the spin collar on the male luer. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclosed recall response card. Customers with questions related to recall are instructed to contact CareFusion Support Center at (888) 562-6018, 7am-4pm PST. Customers with adverse event reports are instructed to contact cus |
| Quantity | 1,445,180 units |
| Distribution | Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, and New Zealand. |
| 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 |