Cook Inc. recalls Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of b…

Recall date

January 20, 2016

Source

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

Recall number

Z-0865-2016

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.

Why it was recalled

Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.

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

What was recalled

Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices