Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To ...
FDA Recall #Z-0800-2025 — Class II — October 22, 2024
Product Description
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
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.
Recalling Firm
Carwild Corporation — New London, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
140 units
Distribution
IL, FL, SC. PA, AL Foreign: Netherlands
Code Information
LOT NUMBER: 24F1638
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated