medical Class II Updated 2025-05-28

Cook Incorporated recalls Check=Flo Performer Introducer, 14.0Fr, Reference Part Numbe

Recalled Product

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


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 00827002089570, Lot Number 16376242
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →