Recall Z-0931-2014 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
| Date | Feb 4, 2014 (initiated Jan 16, 2014) |
| Status | Terminated |
| Reason | CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak. |
| Root cause | Nonconforming Material/Component |
| Action | A customer notification letter and a distribution letter are dated 1/22/14 were sent to customers to inform them that CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230 may have a defect in the trifurcated component that could result in the component to leak. The letters inform the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclose, pre-addressed and postage paid, recall response card. Customers are instructed that once CareFusion receives the recall response card, the Car |
| Quantity | 9,550 units |
| Distribution | Nationwide in US and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051499 | INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET Medegen Medical Manufacturing Services, Jun 22, 2005 |