Recall Z-0221-2016 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
| Date | Nov 5, 2015 (initiated Oct 9, 2015) |
| Status | Terminated |
| Reason | CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues. |
| Root cause | Process control |
| Action | An urgent medical device recall notification was sent to customers on 10/9/15 who purchased the SmartSite Extension Set. The letter informs the customers that CareFusion has identified potential risks with model code 20029E, lot numbers 1503541, 15015769 and 15045950 due to disconnection and leakage issues. The letter also provides the customers with the potential risk involved and the actions to be taken. Customers are instructed to complete and return to CareFusion the recall response card. Customers with recall related questions are instructed to contact CareFusion Support Center at (88 |
| Quantity | 21,000 units |
| Distribution | Distributed US (nationwide) and in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960280 | IVAC NEEDLE FREE VALVE ADMINISTRATION SETS Y, Apr 4, 1996 |