FDAClass IIJanuary 8, 2025

Ivalon Anatomical Nasal Packing with Airway Tube and recall: Sterility Concern

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…

Why was Ivalon Anatomical Nasal Packing with Airway Tube and recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

LOT NUMBER: 24F1638

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…
Recalling firm
Carwild Corporation
Quantity
140 units
Distribution
IL, FL, SC. PA, AL Foreign: Netherlands
Recall date
January 8, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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