Device product
PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿ (Red Rings), 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)..
Z-2720-2017
Product summary
- Event
- Event 77560
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70 units
- Official record key
device-enforcement:Z-2720-2017
Official wording
Reason: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Code information: Lot No. 3316827. Item No. 011-AM6118
Distribution pattern: Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
Derived failure modes
-
Unknown
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.