STRADIS HEALTHCARE, Endo Pack, Item No.682-509,
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI (case) M7526825091, UDI/DI (kit)M7526825090, Serial/Lot Numbers: 22256490827
- 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:
- Stradis Medical, LLC dba Stradis Healthcare
- Reason for Recall:
- Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
STRADIS HEALTHCARE, Endo Pack, Item No.682-509,
Product Codes/Lot Numbers:
UDI/DI (case) M7526825091, UDI/DI (kit)M7526825090, Serial/Lot Numbers: 22256490827
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0550-2023
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