Z-0800-2025 Class II Ongoing

Recalled by Carwild Corporation — New London, CT

Recall Details

Product Type
Devices
Report Date
January 8, 2025
Initiation Date
October 22, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
140 units

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.

Distribution Pattern

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

Code Information

LOT NUMBER: 24F1638