BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1007-2018 · Initiated October 14, 2017

    Recall

    Recall Number
    Z-1007-2018
    Event Number
    79319
    Firm
    Medtronic Minimally Invasive Therapies Group
    FEI Number
    1282497
    Product Code
    MPB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 14, 2017
    Terminated
    June 15, 2018
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    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.

    Action

    Medtronic began notifying customers via telephone on October 14, 2017, and all consignees were notified via Federal Express or certified mail on October 17, 2017. The letter informs customers that they were shipped devices that were not sterile. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice.

    Distribution

    U.S.