ICU Medical, Inc. recalls 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron F…

Recall date

May 30, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2724-2017

FDA classification

Class II

Brand / firm

ICU Medical, Inc.

Sold / distributed

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

Why it was recalled

The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).