Recall Z-1482-2017 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may incorporate components that aid in the prevention of accidental needle sticks. The set s components are commonly found on intravasc
| Date | Feb 28, 2017 (initiated Feb 20, 2017) |
| Status | Terminated |
| Reason | CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter. |
| Root cause | Under Investigation by firm |
| Action | CareFusion sent an Urgent Medical Device Recall Notification letter dated February 2017 to all affected customers inform them that CareFusion is recalling the MaxGuard Extension Set model codes ME20164, MP9009-C, MP9209, MP9254-C with multiple lot numbers. CareFusion has received reports of leaks occurring with the 0.2 micron filter. Customers were informed that leakages on an extension can cause delay of infusion, interruption of infusion, exposure to medication or hazardous infusates, underinfusion or air in line. Customers were instructed to discontinue use of the affected product and c |
| Quantity | 12,850 units |
| Distribution | Nationwide Distribution |
| 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 |