BEUDAMED
    FDA Enforcement Class II Terminated

    TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)

    Recall: Z-2539-2016 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2539-2016
    Event ID
    74672
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TYRX Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 24, 2016
    Initiation Date
    June 29, 2016
    Classification Date
    August 15, 2016
    Termination Date
    December 12, 2017
    Address
    1 Deerpark Dr Ste G, N/A, Monmouth Junction, NJ, 08852-1920, United States

    Description

    TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)

    Reason

    TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.

    Code Info

    model number CMRM3122 lot number 15F30614 15F30614-A 15H10630 15K29659 16B05695 model number CMRM3133 lot number 15F18607 15G14620 15J29647 16C03706

    Distribution

    US Nationwide Distribution

    Quantity

    3460 units