Class II

Medical Device Recall: Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237

Carwild Corporation · October 22, 2024

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.

Distribution

IL, FL, SC. PA, AL Foreign: Netherlands

States Affected

AL, FL, IL, PA, SC

Quantity Affected

300 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0799-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Carwild Corporation Medical Device Recall: Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237 | SafeCheck