BEUDAMED
    FDA Recall 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 · Initiated August 30, 2012

    Recall

    Recall Number
    Z-0840-2013
    Event Number
    63692
    Firm
    Stryker Sustainability Solutions
    FEI Number
    3009350690
    Product Code
    JOW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 30, 2012
    Posted
    February 20, 2013
    Terminated
    September 30, 2014
    Address
    1810 W Drake Dr, Tempe, AZ, 85283-4327

    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.

    Action

    Stryker Sustainability Solutions sent a Urgent Medical Device Removal Notification letter dated September 5, 2012, to all affected customers. The letter identified the product, problem and the action to be taken by the customer. The firm notified that affected AC Power Adaptors would be replaced with improved Adaptors. Any affected lots would be removed and shipped back to Stryker Sustainability Solutions for final disposition. Customers were instructed to fill out the attached Recall Effectiveness Form even if no affected product was found and fax to Stryker Sustainability Solutions at (480) 809-4957

    Distribution

    Distributed in Arizona and New Jersey.

    Quantity

    1,311