Recall Z-1459-2014 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
SmartSite Extension Set, Model No. 20029E, intravascular administration set.
| Date | Apr 16, 2014 (initiated Mar 19, 2014) |
| Status | Terminated |
| Reason | Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port. |
| Root cause | Nonconforming Material/Component |
| Action | CareFusion sent an Urgent Medical Device Recall Notification letter dated March 2014 to all customers. The letter informs the customers of the problems identified, potential risk and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclosed recall response card. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266 or email customerfeedback@carefusion.com. Customers with technical questions reg |
| Quantity | 7,700 units |
| Distribution | USA Nationwide Distribution in the states of: AR, AZ, CA, CO, FL, ID, MD, MI, NC, NV, OK, OR, PA, TX, VA, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960280 | IVAC NEEDLE FREE VALVE ADMINISTRATION SETS Y, Apr 4, 1996 |