Carwild Corporation: Device Recall
Recall #Z-0799-2025 · 10/22/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0799-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Carwild Corporation
- Status
- Ongoing
- Date Initiated
- 10/22/2024
- Location
- New London, CT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 300 units
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.
Product Description
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Distribution Pattern
IL, FL, SC. PA, AL Foreign: Netherlands
Other Recalls by Carwild Corporation
- Class II: Risk 10/22/2024
- Class II: Risk 10/22/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.