BEUDAMED
    FDA Enforcement Class I Terminated

    Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Dr¿ger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.

    Recall: Z-2215-2016 · Reported August 10, 2016

    Enforcement

    Recall Number
    Z-2215-2016
    Event ID
    74469
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 10, 2016
    Initiation Date
    May 31, 2016
    Classification Date
    August 4, 2016
    Termination Date
    March 14, 2018
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042, United States

    Description

    Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Dr¿ger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.

    Reason

    Isolated episodes of leakage at the check valve were found

    Code Info

    Catalog Number: 5704964

    Distribution

    US Nationwide Distribution including states of: AK, CA, FL, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NY,OH,OK,OR,PA,TN,TX,UT,VA,WA, and WI.

    Quantity

    42,922 units worldwide (US distribution 1,530)