ICU Medical, Inc. recalls 133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usag…

Recall date

November 30, 2016

Source

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

Recall number

Z-0980-2017

FDA classification

Class II

Brand / firm

ICU Medical, Inc.

Sold / distributed

US: NC

Why it was recalled

ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber.

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

What was recalled

133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). Each set will be manufactured to a unique specifications using dimensions, components and configurations specified by the customer.