BEUDAMED
    FDA Enforcement Class II Terminated

    MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.

    Recall: Z-1007-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-1007-2018
    Event ID
    79319
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Minimally Invasive Therapies Group
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    March 21, 2018
    Initiation Date
    October 14, 2017
    Classification Date
    March 14, 2018
    Termination Date
    June 15, 2018
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113, United States

    Description

    MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.

    Reason

    Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays, Lot 1717900160, following notification from our supplier that one production lot of MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays was inadvertently shipped to Medtronic and distributed without being sterilized.

    Code Info

    UDI: 10884521126473/20884521126470 Lot: 1717900160.

    Distribution

    U.S.