BEUDAMED
    FDA Enforcement Class II Terminated

    STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1

    Recall: Z-2145-2018 · Reported June 20, 2018

    Enforcement

    Recall Number
    Z-2145-2018
    Event ID
    80201
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sun Med, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2018
    Initiation Date
    May 24, 2018
    Classification Date
    June 9, 2018
    Termination Date
    May 12, 2020
    Address
    2710 Northridge Dr NW Ste A, N/A, Grand Rapids, MI, 49544-9112, United States

    Description

    STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1

    Reason

    There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.

    Code Info

    Lot Numbers: 313406, 313447, 313164, 313165 & 313166

    Distribution

    IL & OH distributors

    Quantity

    76 cases