Legion FMS Pak
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog No. 8065753164, 8065753165, 8065753166; Product Code 100205822, 100207728, 100207729; UDI-DI: 380657531646, 380657531653, 380657531660; Lots 14YTR7, 153UW1, 156YMH, 157R2M.
- 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:
- Alcon Research, LTD.
- Reason for Recall:
- Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Legion FMS Pak
Product Codes/Lot Numbers:
Catalog No. 8065753164, 8065753165, 8065753166; Product Code 100205822, 100207728, 100207729; UDI-DI: 380657531646, 380657531653, 380657531660; Lots 14YTR7, 153UW1, 156YMH, 157R2M.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2409-2023
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Class I - Dangerous
Potential for a weak seal in some units resulting in compromise in sterility.
Due to incomplete seals in the pouch which provide the sterile barrier.