Z-2716-2017 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
- 304 units
Product Description
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, 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. 3172948, 3192947, 3224228, 3246765, 3260270. Item No. 011-AM6111