BEUDAMED
    FDA Enforcement Class II Terminated

    Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher

    Recall: Z-1184-2016 · Reported March 23, 2016

    Enforcement

    Recall Number
    Z-1184-2016
    Event ID
    73403
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Medical Division of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2016
    Initiation Date
    February 5, 2016
    Classification Date
    March 17, 2016
    Termination Date
    September 6, 2016
    Address
    3800 E Centre Ave, Portage, MI, 49002-5826, United States

    Description

    Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher

    Reason

    The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wear resistance additives as the specified oils and therefore its use increases the potential for wear which may cause a leak event or jack drift. Testing was done to evaluate the jacks with incorrect oil and leak events we

    Code Info

    The hydraulic jack assemblies (Part numbers: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) used as service parts on Stretchers assembled from 8/28/15 - 8/29/15

    Distribution

    Distributed in DC and the states of AL, CA, FL, MN, MT, NC, NE, NY, PA, RI, TN, TX, UT, and WV.

    Quantity

    36