Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Custom Procedure Kit Recalled by Merit Medical Systems, Inc. Due to Labeling error; It was identified that a Procedure...
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 Merit Medical Systems, Inc. directly.
Affected Products
Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Quantity: 88 Kits
Why Was This Recalled?
Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
Where Was This Sold?
This product was distributed to 2 states: IL, VA
About Merit Medical Systems, Inc.
Merit Medical Systems, Inc. has 135 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report