medical Class II Updated 2025-05-28

Cook Incorporated recalls Check=Flo Performer Introducer, 10.0Fr, Reference Part Numbe

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI/DI 00827002086869, Lot Number 16376248
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →