FDA Enforcement
Class II
Ongoing
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Recall: Z-0799-2025
·
Reported January 8, 2025
Enforcement
- Recall Number
- Z-0799-2025
- Event ID
- 95909
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Carwild Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- January 8, 2025
- Initiation Date
- October 22, 2024
- Classification Date
- January 2, 2025
- Address
- 3 State Pier Rd, New London, CT, 06320-5817, United States
Description
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Reason
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Code Info
LOT NUMBER: 24G1739
Distribution
IL, FL, SC. PA, AL Foreign: Netherlands
Quantity
300 units