Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Peel-Away Introducer - Intended for the percutaneous introduction of balloon Recalled by Cook Incorporated Due to Packaging may have low seal strength and not...
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
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0-35 G01844 : DTVN-5.0-19-10.0- YUEH : G09490
Quantity: 55 units
Why Was This Recalled?
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
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