Device product
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 intravascular administration sets and extension sets
Z-1482-2017
Product summary
- Event
- Event 76440
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,850 units
- Official record key
device-enforcement:Z-1482-2017
Official wording
Reason: CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter.
Code information: Lot No. 15045419 15075822 15086644 16036290 16056204 16075270 15086404 16067461 16046571 16045810
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter.