Recall Z-1883-2017 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
SmartSite Add-On Bag Access Device, Model No. 10013365
| Date | Nov 17, 2016 |
| Status | Terminated |
| Reason | CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. A separation or leak can cause a delay of infusion, an interruption of infusion, exposure to medication or hazardous infusates, or underinfusion. |
| Root cause | Other |
| Action | CareFusion sent an Urgent Medical Device Recall Notification letter dated November 2016, to inform their customers that CareFusion is recalling the SmartSite Add-On Bag Access Device Model 10013365 because of reports of leakages between the spike port and the drip chamber spike. The letter informs the customers of the lot numbers, potential risk and immediate actions to be taken. Customers with questions are instructed to contact CareFusion Support Center at (888) 562-6018 for recall related questions. Customers with adverse event report questions are instructed to contact Customer Advocacy |
| Quantity | 384,923 units |
| Distribution | US Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970485 | SMARTSITE ACCESS PIN Ivac Medical Systems, Apr 21, 1997 |