Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Ord...
FDA Recall #Z-1786-2025 — Class II — April 17, 2025
Product Description
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Reason for Recall
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Recalling Firm
Cook Incorporated — Bloomington, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
99 units
Distribution
Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.
Code Information
UDI/DI 00827002086869, Lot Number 16376248
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated