BEUDAMED
    FDA Enforcement Class III Terminated

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

    Recall: Z-1223-2017 · Reported March 1, 2017

    Enforcement

    Recall Number
    Z-1223-2017
    Event ID
    76264
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Applied Medical Technology Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 1, 2017
    Initiation Date
    January 19, 2017
    Classification Date
    February 17, 2017
    Termination Date
    December 15, 2017
    Address
    8000 Katherine Blvd, N/A, Brecksville, OH, 44141-4202, United States

    Description

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

    Reason

    Expired expiration dates are listed on the pouches.

    Code Info

    Table 1: 4-4108M Box P/N - 4-4108M Box Lot Number - 161018-193 Box Exp. - 2019-09-01 Box UDI - (01)00842071106638(17)190901(10)161018-193 Pouch P/N - E4-4108M Pouch Lot Number - 160930-186 Pouch Exp. - 2010-09-01 Pouch UDI - (01)00842071103934(17)100901(10)160930-186 Table 2: 4-4110 Box P/N - 4-4110 Box Lot Number - 161014-166 Box Exp. - 2019-10-01 Box UDI - (01)00842071106645(17)191001(10)161014-166 Pouch P/N - E4-4110 Pouch Lot Number - 161010-090 Pouch Exp. - 2010-10-01 Pouch UDI - (01)00842071103941(17)101001(10)161010-090 Table 3: 4-4114 Box P/N - 4-4114 Box Lot Number - 161021-139 Box Exp. - 2019-09-01 Box UDI - (01)00842071106669(17)190901(10)161021-139 Pouch P/N - E4-4114 Pouch Lot Number - 160926-242 Pouch Exp. - 2010-09-01 Pouch UDI - (01)00842071103965(17)100901(10)160926-242 Table 4: 4-4116 Box P/N - 4-4116 Box Lot Number - 161019-105 Box Exp. - 2019-09-01 Box UDI - (01)00842071106676(17)190901(10)161019-105 Pouch P/N - E4-4116 Pouch Lot Number - 161007-038 Pouch Exp. - 2010-10-01 Pouch UDI - (01)00842071103972(17)101001(10)161007-038

    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