BEUDAMED
    FDA Enforcement Class II Terminated

    ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.

    Recall: Z-0356-2016 · Reported December 9, 2015

    Enforcement

    Recall Number
    Z-0356-2016
    Event ID
    72539
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baylis Medical Corp *
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 9, 2015
    Initiation Date
    October 28, 2015
    Classification Date
    December 1, 2015
    Termination Date
    November 17, 2016
    Address
    5959 TransCanada Highway, Montreal, N/A, Canada

    Description

    ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.

    Reason

    Microcatheter may have circumferential defects (cracks) along its shaft.

    Code Info

    CIFA161013, CIFA131113, CIFA271113, CIFA311213, CIFA210214, CIFA070314, CIFA270314, CIFA070514, CIFA210514, CIFA100614, CIFA240614, CIFB100714, CIFA100714, CIFA180814, CIFA080914, CIFA241014, CIFA221014, CIFA050115, CIFA210115, CIFA060215

    Distribution

    Nationwide Distribution.

    Quantity

    433 units