Recall Z-1464-2017 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
| Date | Feb 28, 2017 (initiated Feb 20, 2017) |
| Status | Terminated |
| Reason | CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing. |
| Root cause | Process control |
| Action | An Urgent Medical Device Recall Notification letter will be sent to customers on February 20, 2017 to inform them that CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter model number ME3305 Lot Number 16016790. Customers are informed that CareFusion has received reports of separation and/or leakages between theY-connector and tubing. Customers are informed that leakages from an extension set can cause delay of infusion, interruption of infusion, exposure to medication or hazardous infusates, or underinfusion. The letter informs the customers of the |
| Quantity | 1,200 units |
| Distribution | US Distribution including MA and MD |
| 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 |