Carwild Corporation recalls Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model N…
- Recall date
- October 22, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0799-2025
- FDA classification
- Class II
- Brand / firm
- Carwild Corporation
- Sold / distributed
- IL, FL, SC. PA, AL Foreign: Netherlands
Why it was recalled
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
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