Z-0798-2025 Class II Ongoing
FDA device recall Z-0798-2025 was initiated by Carwild Corporation on October 22, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 120 units.
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
- 120 units
Product Description
Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206
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: 24G1880