Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Class I - DangerousWhat Should You Do?
- Check if you have this product: LOT NUMBER: 24G1739
- 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:
- Carwild Corporation
- Reason for Recall:
- Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Product Codes/Lot Numbers:
LOT NUMBER: 24G1739
Distribution:
Distributed in: IL, FL, SC, PA, AL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0799-2025
Related Recalls
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Sterility with new cotton source not validated