FDA-Device2025-01-08Class II
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Carwild Corporation
Hazard
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Sold states
IL, FL, SC. PA, AL Foreign: Netherlands
Affected count
300 units
Manufactured in
3 State Pier Rd, New London, CT, United States
Products
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0799-2025Don't want to check this manually?
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