Z-1482-2017 Class II Terminated
FDA device recall Z-1482-2017 was initiated by CareFusion 303, Inc. on February 20, 2017 and is designated Class II. Reason for recall: CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter. The recall status is terminated (terminated October 29, 2018). Affected quantity: 12,850 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2017
- Initiation Date
- February 20, 2017
- Termination Date
- October 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,850 units
Product Description
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
Reason for Recall
CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter.
Distribution Pattern
Nationwide Distribution
Code Information
Lot No. 15045419 15075822 15086644 16036290 16056204 16075270 15086404 16067461 16046571 16045810