BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-0800-2025 · Initiated October 22, 2024

    Recall

    Recall Number
    Z-0800-2025
    Event Number
    95909
    Firm
    Carwild Corporation
    FEI Number
    1219313
    Product Code
    HOZ
    Status
    Open, Classified
    Root Cause
    Equipment maintenance
    Initiated
    October 22, 2024
    Posted
    January 2, 2025
    Address
    3 State Pier Rd, New London, CT, 06320-5817

    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

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

    Action

    Carwild Corp issued letter On Behalf Of First Aid Bandage Company (Fabco) Recall Notice Urgent via email 12/22/24. Letter states reason for recall, health risk and action to take; Cease Further Distribution Or Use Of Any Remaining Product Immediately . Distributors are responsible to notify all your customers who may have received this product. Please provide shipment history. Call for questions or additional information: Regulatory 1-860-442-4914 x111 Customer Service 1-860-442-4914 x110 .

    Distribution

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

    Quantity

    140 units