BEUDAMED
    FDA Recall Terminated

    STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should only be used by personnel trained in CPR procedures. The ACE/STAT-Check II is intended for use as an adjunct assessment tool for verification of successful ventilation / intubation in patients > 2.2 kilograms (5lbs.).

    Recall: Z-1880-2016 · Initiated March 15, 2016

    Recall

    Recall Number
    Z-1880-2016
    Event Number
    73766
    Firm
    Ventlab LLC
    FEI Number
    1314417
    Product Code
    CCK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 15, 2016
    Posted
    June 1, 2016
    Terminated
    November 1, 2016
    Address
    2710 Northridge Dr NW, Ste A, Grand Rapids, MI, 49544-9112

    Description

    STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should only be used by personnel trained in CPR procedures. The ACE/STAT-Check II is intended for use as an adjunct assessment tool for verification of successful ventilation / intubation in patients > 2.2 kilograms (5lbs.).

    Reason

    Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an indicator of CO2 level or improper performance of cardiac message and ventilation.

    Action

    Ventlab sent an URGENT: MEDICAL DEVICE PRODUCT REMOVAL notification dated March 14, 2016, on March 15, 2016, electronically to all affected customers. Customers were instructed to return the affected product and notify affected consignees of the recall. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any questions regarding this action, please call Ventlab at 1-844-635-5326, or email at [email protected].

    Distribution

    Nationwide distribution to AZ, MS, NY, MO, FL, WI, TX, FL, and CA.

    Quantity

    2430