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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Merit Medical Systems, Inc.: Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)

Agency Publication Date: October 1, 2019
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Affected Products

Product: Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409

Catalog #K12T-03688H - Lot #T1401193 and #T1419935

Lot Numbers:
T1401193
Product: Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580

Catalog # K12T-10167, Lot # K12T-10167, Use By: 2018-11-05

Lot Numbers:
K12T-10167

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83738
Status: Resolved
Manufacturer: Merit Medical Systems, Inc.
Manufactured In: United States
Units Affected: 2 products (88 Kits; 24 kits)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.