Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For F...
FDA Recall #Z-0799-2025 — Class II — October 22, 2024
Product Description
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
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.
Recalling Firm
Carwild Corporation — New London, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
300 units
Distribution
IL, FL, SC. PA, AL Foreign: Netherlands
Code Information
LOT NUMBER: 24G1739
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated