BEUDAMED
    FDA Enforcement Class II Terminated

    Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.

    Recall: Z-1997-2014 · Reported July 16, 2014

    Enforcement

    Recall Number
    Z-1997-2014
    Event ID
    68243
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 16, 2014
    Initiation Date
    May 8, 2014
    Classification Date
    July 6, 2014
    Termination Date
    September 4, 2015
    Address
    15 Hampshire Street, Mansfield, MA, 02048-1113, United States

    Description

    Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.

    Reason

    Straps may separate from the foam pad.

    Code Info

    14085, 14086, 14092, 14095, 14101, 14106 *The original recall submission listed 14084 and 14094, these were reported by Covidien in error on the original submission.

    Distribution

    US Nationwide Distribution in the states of NJ, CA, TX, IL, MO, PA, OH, IN, MI, MN, FL, IN, DC, PA, VA, MS, ME, NV, AR, KY, NY, KS, SC

    Quantity

    264 devices