BEUDAMED
    FDA Enforcement Class II Terminated

    Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)

    Recall: Z-2402-2015 · Reported August 26, 2015

    Enforcement

    Recall Number
    Z-2402-2015
    Event ID
    71496
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Winco Mfg., LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 26, 2015
    Initiation Date
    April 2, 2015
    Classification Date
    August 14, 2015
    Termination Date
    December 14, 2016
    Address
    5516 SW 1st Ln, Ocala, FL, 34474-9307, United States

    Description

    Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)

    Reason

    Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.

    Code Info

    Model Number: 6240, Serial Numbers: 624100510, 624100511, 624100512, 624100513, 624100514, 624100515, 624100516, 624100519, 624100520, 624100521, 624100522, 624100523, 624100524, 624100525, 624100526, 624100527, 624100528, 624100529, 624100530, 624100531, 624100532, 624100533, 624100534, 624100535, 624100536, 624100537, 624100538, 624100539 and 624100540

    Distribution

    Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.

    Quantity

    29 chairs