BEUDAMED
    FDA Enforcement Class II Terminated

    Cordis PRECISE (R) RX Nitinol Stent System (Biliary)

    Recall: Z-1947-2016 · Reported June 22, 2016

    Enforcement

    Recall Number
    Z-1947-2016
    Event ID
    74097
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cordis Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 22, 2016
    Initiation Date
    May 4, 2016
    Classification Date
    June 10, 2016
    Termination Date
    July 26, 2019
    Address
    14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802, United States

    Description

    Cordis PRECISE (R) RX Nitinol Stent System (Biliary)

    Reason

    Inability to deploy the stent or partial stent deployment.

    Code Info

    Catalog Number: P05030RXB, Lot Number: 17241836; Catalog Number: P09030RXB, Lot Number: 17241838; Catalog Number: P07030RXB, Lot Number : 17291878; Catalog Number: P07040RXB, Lot Number: 17291879; Catalog Number: P06040RXB, Lot Number: 17415243.

    Distribution

    NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.

    Quantity

    4,400 units in US; 3,100 units to Foreign Countries