BEUDAMED
    FDA Recall Open, Classified

    smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000

    Recall: Z-0146-2025 · Initiated July 18, 2024

    Recall

    Recall Number
    Z-0146-2025
    Event Number
    95181
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    BYD
    Status
    Open, Classified
    Root Cause
    Packaging process control
    Initiated
    July 18, 2024
    Posted
    October 23, 2024
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000

    Reason

    Uncertainty in the seal integrity of the sterile packaging.

    Action

    Smiths medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 07/18/2024 via traceable mailing. The notice explained the issue with the products, potential risk and requested the affected devices be destroyed. Distributors were directed to notify their customers by forwarding the notice. Questions - contact [email protected].

    Distribution

    Worldwide distribution.

    Quantity

    27,971 units