FDA recall Z-0799-2025

Carwild Corporation · Class II · device

Product

Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237

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

IL, FL, SC. PA, AL Foreign: Netherlands

Key facts

Status
Ongoing
Initiation date
2024-10-22
Report date
2025-01-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
New London, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0799-2025