Cook Inc. recalls Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.

Recall date

October 21, 2015

Source

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

Recall number

Z-0244-2016

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

Worldwide Distribution - US Distribution to the states of : CA, FL, ID, IL, MA, NY, OK, TX, UT and VA., and to the countries of Canada, Austria, Germany, Spain, France, Hungary, Sweden and UK.

Why it was recalled

Cook Medical has received six product complaints associated with reports of the 2.6FR curved catheter being mixed with the 4.0FR straight catheter and vice versa. Investigation revealed the products were mixed during processing.

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

What was recalled

Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.