BEUDAMED
    FDA Recall Terminated

    H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit

    Recall: Z-2537-2014 · Initiated July 7, 2014

    Recall

    Recall Number
    Z-2537-2014
    Event Number
    68739
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1217052
    Product Code
    BTR
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    July 7, 2014
    Posted
    August 28, 2014
    Terminated
    May 26, 2021
    Address
    10 Bowman Dr, Keene, NH, 03431-5043

    Description

    H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder 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.

    Action

    Smiths Medical sent an Urgent Medical Device Recall Notice dated July 11, 2014, to all affected customers. The letter informed customers of the recall and instructed them to inspect their inventory and segregate any unused affected products and to complete and return the Recall Confirmation Form, by Fax 1-800-621-2590 or email to [email protected]. Customers with questions were instructed to call Smiths Medical's Customer Service Department at 1-800-258-5361. For questions regarading this recall call 866-216-8806.

    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)