Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Amplatz extra Stiff Wire Guide Recalled by Cook Incorporated Due to Cook Medical identified that devices from the affected...
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
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
Quantity: 204 OUS
Why Was This Recalled?
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cook Incorporated
Cook Incorporated has 64 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report