Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Flexor Check-Flo Introducer - Raabe Modification Recalled by Cook Inc. Due to Affected lots may be manufactured incorrectly with the...
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 Inc. directly.
Affected Products
Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
Quantity: 48 (US)
Why Was This Recalled?
Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time.
Where Was This Sold?
This product was distributed to 17 states: AZ, AR, CT, FL, GA, IL, LA, ME, MA, MN, NJ, NY, ND, OH, PA, TX, WA
About Cook Inc.
Cook Inc. has 262 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report