Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. P...
FDA Recall #Z-0045-2025 — Class II — September 16, 2024
Product Description
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve.
Reason for Recall
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
Recalling Firm
Cook Incorporated — Bloomington, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
50 units
Distribution
International distribution to the country of Australia.
Code Information
UDI-DI: 00827002272422; Lot Number: 15506769
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated