Z-0799-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 8, 2025
- Initiation Date
- October 22, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 300 units
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.
Distribution Pattern
IL, FL, SC. PA, AL Foreign: Netherlands
Code Information
LOT NUMBER: 24G1739