BEUDAMED
    FDA Enforcement Class II Terminated

    Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.

    Recall: Z-0116-2016 · Reported October 21, 2015

    Enforcement

    Recall Number
    Z-0116-2016
    Event ID
    72247
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Concentric Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    October 21, 2015
    Initiation Date
    August 19, 2015
    Classification Date
    October 9, 2015
    Termination Date
    October 9, 2015
    Address
    301 E Evelyn Ave, N/A, Mountain View, CA, 94041-1530, United States

    Description

    Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.

    Reason

    One Distal Access Catheter intended for distribution in Korea, was found at a US location.

    Code Info

    Lot no. 37603 Expiration date: September 2016

    Distribution

    US Distribution to one location in KY.

    Quantity

    1