BEUDAMED
    FDA Enforcement Class I Terminated

    H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit

    Recall: Z-2540-2014 · Reported September 3, 2014

    Enforcement

    Recall Number
    Z-2540-2014
    Event ID
    68739
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 3, 2014
    Initiation Date
    July 7, 2014
    Classification Date
    August 28, 2014
    Termination Date
    May 26, 2021
    Address
    10 Bowman Dr, N/A, Keene, NH, 03431-5043, United States

    Description

    H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit

    Reason

    The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

    Code Info

    Lot Numbers: 2597332, 2585074, 2580798, 2576365, 2564404, 2564403, 2563088, 2549367, 2519413, 2500170, 2488207, 2474646, 2465828, 2453473, 2443378, 2438615, 2433450, 2412145, 2380351, 2376498, 2365494, 2365493, 2361580, 2357823, 2353347, 2343313, 2329583, 2326899, 2322825, 2298752, 2286594, 2278069, 2271358, 2263553, 2260562, 2260561, 2250053, 2250052, 2250050, 2250049, 2244749, 2228363, 2219213, 2211929, 2208194, 2191930, 2179229, 2175056, 2154534, 2142178, 2135983, 2128635, 2124241, 2120119, 2116099, 2090223, 2077179, 2063989, 2063988, 12040, 12033, 11877, 11876, 11874, 11873, 11679, 11655, 11407, 11405

    Distribution

    Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.

    Quantity

    135,518 (110,246 nationwide)