FDA recall Z-2718-2017

Product

28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 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

Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.

Key facts

Status

Terminated

Initiation date

2017-05-30

Report date

2017-07-19

Termination date

2024-09-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Clemente, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2718-2017