BEUDAMED
    FDA Enforcement Class II Terminated

    Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615; and 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615

    Recall: Z-1143-2015 · Reported March 4, 2015

    Enforcement

    Recall Number
    Z-1143-2015
    Event ID
    70388
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiodynamics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 4, 2015
    Initiation Date
    December 19, 2014
    Classification Date
    February 24, 2015
    Termination Date
    November 27, 2015
    Address
    10 Technical Park, N/A, Glens Falls, NY, 12804, United States

    Description

    Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615; and 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615

    Reason

    Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually located 4cm from the distal tip of the needle.

    Code Info

    Lot No. 4773676, 4776428 and 4780110

    Distribution

    Worldwide Distribution - US Distribution to the states of AZ, AR, FL, MI, MN, MO, NY, TX, VA, WA and WI., and to the countries of Hungary and Spain.

    Quantity

    43