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

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

Code information: UDI/DI 00827002086869, Lot Number 16376248

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