BEUDAMED
    FDA Recall Terminated

    VentStar Coax (P) 150, MP00379

    Recall: Z-1451-2023 · Initiated April 17, 2023

    Recall

    Recall Number
    Z-1451-2023
    Event Number
    92049
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    BZO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 17, 2023
    Posted
    May 17, 2023
    Terminated
    September 3, 2024
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    VentStar Coax (P) 150, MP00379

    Reason

    Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

    Action

    The firm distributed recall notifications to consignees via FedEx starting on 4/17/2023. Consignees are instructed to immediately stop use of affected devices, inspect current stock, and quarantine any affected devices to prevent use. Alternative therapy for patients should be instituted as soon as possible and ensure all users of affected devices within consignee organizations are aware of the recall, with copies being forwarded if devices were further distributed. To replace or return unused products, consignees are to call Draeger Customer Success between 8:00 AM - 6:00 PM EST, Monday thru Friday, at 1-800-437-2437 (option 2, then option 1), or via email at [email protected]. A Return Materials Authorization and pre-paid shipping label will be provided upon request. Any additional questions regarding the recall communication may be directed to Mr. Michael Kelhart between the hours of 8:00 AM - 4:30 PM by phone at 267-664-1131 or by email at [email protected].

    Distribution

    Domestic: US Nationwide Distribution.

    Quantity

    280 units