BEUDAMED
    FDA Recall Terminated

    AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075

    Recall: Z-0698-2021 · Initiated November 10, 2020

    Recall

    Recall Number
    Z-0698-2021
    Event Number
    86828
    Firm
    Applied Medical Technology Inc
    FEI Number
    1526012
    Product Code
    PIO
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    November 10, 2020
    Terminated
    September 3, 2021
    Address
    8006 Katherine Blvd, Brecksville, OH, 44141-4202

    Description

    AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075

    Reason

    The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.

    Action

    On November 10, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed that incorrect labels were used for the internal pouches of the devices subject to this recall, while the outer box has the correct label. Customers were informed that a box containing pouches with lot number 200902-075 should be returned to Applied Medical Technology, Inc. Customers were instructed to take the following immediate actions: - Do not use any device subject to this recall - Complete and return the enclosed acknowledgement form - Contact Applied Medical Technology, Inc. to make arrangements for the return of any devices related to the recall. - Continue to inspect and prepare any devices prior to use according to its standard operating procedures and good medical practices.

    Distribution

    US Nationwide distribution in the states of CA, GA, IL, MA, MO, PA, TX, VA. No foreign distribution.