Cook Incorporated recalls Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08

Recalled May 28, 2025 · FDA recall Z-1786-2025 · Cook Incorporated

Hazard

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

Units

99 units

Sold at

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

Description

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

Product

Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,

Manufacturer(s)

Cook Incorporated

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →