Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog #K12T-03688H - Lot #T1401193 and #T1419935
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Merit Medical Systems, Inc.
- Reason for Recall:
- Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Product Codes/Lot Numbers:
Catalog #K12T-03688H - Lot #T1401193 and #T1419935
Distribution:
Distributed in: VA, IL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0026-2020
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