Carwild Corporation recalls Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthal…

Recall date

October 22, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0800-2025

FDA classification

Class II

Brand / firm

Carwild Corporation

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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