Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Check-Flo Performer Introducer Set Recalled by Cook Incorporated Due to Cook Medical is conducting removal of a lot...

Date: September 16, 2024
Company: Cook Incorporated
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cook Incorporated directly.

Affected Products

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.

Quantity: 50 units

Why Was This 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.

Where Was This Sold?

International distribution to the country of Australia.

About Cook Incorporated

Cook Incorporated has 64 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report