Cook Incorporated recalls Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08…

Recall date

April 17, 2025

Source

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

Recall number

Z-1787-2025

FDA classification

Class II

Brand / firm

Cook Incorporated

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.

Why it was recalled

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

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

What was recalled

Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,