BEUDAMED
    FDA Enforcement Class III Terminated

    AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.

    Recall: Z-1224-2017 · Reported March 1, 2017

    Enforcement

    Recall Number
    Z-1224-2017
    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 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.

    Reason

    Expired expiration dates are listed on the pouches.

    Code Info

    Table 5: 8-1222 Box P/N - 8-1222 Box Lot Number - 161003-312 Box Exp. - 2019-09-01 Box UDI - (01)00842071108649(17)190901(10)161003-312 Pouch P/N - E8-1222 Pouch Lot Number - 160923-222 Pouch Exp. - 2016-09-01 Pouch UDI - (01)00842071107536(17)160901(10)160923-222

    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