BEUDAMED
    FDA Enforcement Class II Terminated

    STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 (AC Power Adaptor).

    Recall: Z-0840-2013 · Reported February 27, 2013

    Enforcement

    Recall Number
    Z-0840-2013
    Event ID
    63692
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Sustainability Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 27, 2013
    Initiation Date
    August 30, 2012
    Classification Date
    February 20, 2013
    Termination Date
    September 30, 2014
    Address
    1810 W Drake Dr, N/A, Tempe, AZ, 85283-4327, United States

    Description

    STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 (AC Power Adaptor).

    Reason

    Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.

    Code Info

    108851407, 108851408, 108870192, 108874144, 108883271, 108886340, and 108888023.

    Distribution

    Distributed in Arizona and New Jersey.

    Quantity

    1,311