BEUDAMED
    FDA Recall Terminated

    AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.

    Recall: Z-1223-2017 · Initiated January 19, 2017

    Recall

    Recall Number
    Z-1223-2017
    Event Number
    76264
    Firm
    Applied Medical Technology Inc
    FEI Number
    1526012
    Product Code
    KNT
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    January 19, 2017
    Posted
    February 17, 2017
    Terminated
    December 15, 2017
    Address
    8000 Katherine Blvd, Brecksville, OH, 44141-4202

    Description

    AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.

    Reason

    Expired expiration dates are listed on the pouches.

    Action

    Applied Medical Technology Inc. sent an Urgent Medical Device Recall letter dated January 19, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTIONS TO BE TAKEN BY THE CUSTOMER OR USER: Applied Medical Technology requests that customers IMMEDIATELY TAKE THE ACTION and return all devices in inventory subject to this recall. Do not use any device subject to this recall. Complete and return to Applied Medical Technology the enclosed RECALL NOTIFICATION. For further questions please call (440) 717- 4000.

    Distribution

    US Distribution to the states of : AZ, CA, CO, CT, FL, GA, ID, LA, ME, MO, MN, NC, OH, OK, OR, TN, TX, UT, WA, and WI., and to the United Kingdom.

    Quantity

    110