BEUDAMED
    FDA Enforcement Class I Terminated

    H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain fracture alignment.

    Recall: Z-0006-2014 · Reported October 9, 2013

    Enforcement

    Recall Number
    Z-0006-2014
    Event ID
    66128
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    H & H Associates
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2013
    Initiation Date
    August 27, 2013
    Classification Date
    October 1, 2013
    Termination Date
    January 13, 2015
    Address
    4173 G.W. Memorial Highway, Ordinary, VA, 23131, United States

    Description

    H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain fracture alignment.

    Reason

    Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective.

    Code Info

    Lots\EXP Dates: CKBD033, CKBE033 August 2015 CKBD034, CKBF034, CKBG034 August 2015 CKBP045 November 2015 CKBP047, CKBQ047 November 2015 CKBR060 February 2016 CKBT065 April 2016 CKBV070, CKBW070, CKBX070 May 2016 CKBX071 May 2016 CKBX076 June 2016 CKBX078 July 2016 CKBX079, CKBY079 July 2016 CKBY080, CKBZ080, CKCA080 July 2016.

    Distribution

    Nationwide distribution.

    Quantity

    6,619 kits