Cook Inc. recalls Urethral Dilator Set, Global Product No. G14185

Recall date

January 4, 2019

Source

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

Recall number

Z-0971-2020

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia,…

Why it was recalled

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

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

What was recalled

Urethral Dilator Set, Global Product No. G14185