Z-1464-2017 Class II Terminated
FDA device recall Z-1464-2017 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 with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing. The recall status is terminated (terminated November 17, 2017). Affected quantity: 1,200 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2017
- Initiation Date
- February 20, 2017
- Termination Date
- November 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,200 units
Product Description
MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
Reason for Recall
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.
Distribution Pattern
US Distribution including MA and MD
Code Information
Lot No. 16016790