Cook Incorporated recalls Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers a…

Recall date

September 16, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0045-2025

FDA classification

Class II

Brand / firm

Cook Incorporated

Sold / distributed

International distribution to the country of Australia.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.