FDA Medical devices recall ·
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic… recall
- Recall number
- Z-0799-2025
- Date
- (initiated October 22, 2024)
- Company / brand
- Carwild Corporation
3 State Pier Rd, New London, CT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 300 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Why was it recalled?
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
LOT NUMBER: 24G1739
Distribution
IL, FL, SC. PA, AL Foreign: Netherlands
States: Alabama Florida Illinois Pennsylvania South Carolina
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0799-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.