Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Flexor Check-Flo Introducer Recalled by Cook Inc. Due to Incorrect packaging. Reports of packages labeled as 6.0Fr...
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, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices
Quantity: 25
Why Was This Recalled?
Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
Where Was This Sold?
This product was distributed to 8 states: CA, FL, MI, NJ, NY, OH, OK, TX
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