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Recall Observatory FDA recall evidence

Device product

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

Z-0799-2025

October 22, 2024

Class II

Product summary

Firm
Carwild Corporation
Event
Event 95909
Status
Ongoing
Classification
Class II
Quantity
300 units
Official record key
device-enforcement:Z-0799-2025

Official wording

Reason: Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.

Code information: LOT NUMBER: 24G1739

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

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification