Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Merit Medical's Custom Procedural Tray or Kits K12T-03162B & Recalled by Merit Medical Systems, Inc. Due to Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection...
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
Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
Quantity: 422 total kits/trays
Why Was This Recalled?
Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual flexible containers. The particular matter may result acutely in local inflammation, phlebitis and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the
Where Was This Sold?
Distributed in Mississippi and New Jersey.
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