Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Check=Flo Performer Introducer 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
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Quantity: 99 units
Why Was This Recalled?
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
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