Z-2724-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2017
- Initiation Date
- May 30, 2017
- Termination Date
- September 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 units
Product Description
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
Reason for Recall
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Distribution Pattern
Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
Code Information
Lot No. 3321776. Item No. AM6122