BEUDAMED
    FDA Enforcement Class II Terminated

    ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.

    Recall: Z-1442-2015 · Reported April 22, 2015

    Enforcement

    Recall Number
    Z-1442-2015
    Event ID
    70896
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baylis Medical Corp *
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 22, 2015
    Initiation Date
    March 30, 2015
    Classification Date
    April 13, 2015
    Termination Date
    November 17, 2016
    Address
    5959 TransCanada Highway, N/A, Montreal, N/A, N/A, Canada

    Description

    ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.

    Reason

    Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.

    Code Info

    Lots CIFA180814 and CIFA080914

    Distribution

    US Nationwide Distribution - US Nationwide in the states of MO, MA, OH, CA, AR, MA, FL, GA, CO, TX, KY, NY, MI, WI, OR

    Quantity

    58 units