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Recall Observatory FDA recall evidence

Device product

Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q770410

Z-0800-2025

October 22, 2024

Class II

Product summary

Firm
Carwild Corporation
Event
Event 95909
Status
Ongoing
Classification
Class II
Quantity
140 units
Official record key
device-enforcement:Z-0800-2025

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: 24F1638

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