BEUDAMED
    FDA Recall Terminated

    Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the AutoPulse operation. Used in the AutoPulse Resuscitation System Model 100, for chest compressions as an adjunct to manual CPR.

    Recall: Z-2090-2014 · Initiated July 16, 2013

    Recall

    Recall Number
    Z-2090-2014
    Event Number
    68718
    Firm
    Zoll Circulation, Inc.
    FEI Number
    3003793491
    Product Code
    DRM
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    July 16, 2013
    Posted
    July 22, 2014
    Terminated
    July 22, 2014
    Address
    2000 Ringwood Ave, San Jose, CA, 95131-1728

    Description

    Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the AutoPulse operation. Used in the AutoPulse Resuscitation System Model 100, for chest compressions as an adjunct to manual CPR.

    Reason

    Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. The label is specific to the Japanese version of the product.

    Action

    Zoll Japan handled the recall.

    Distribution

    Distributed in Japan.

    Quantity

    161 Nickel Metal batteries, 40 LifeBand