BEUDAMED
    FDA Recall Terminated

    Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.

    Recall: Z-2869-2016 · Initiated August 22, 2016

    Recall

    Recall Number
    Z-2869-2016
    Event Number
    74989
    Firm
    Hologic, Inc
    FEI Number
    1000120743
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    August 22, 2016
    Posted
    September 21, 2016
    Terminated
    February 3, 2017
    Address
    250 Campus Dr, Marlborough, MA, 01752-3020

    Description

    Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.

    Reason

    Incorrect label on the Sertera Biopsy Kit

    Action

    Hologic notified customers in the United States through Certified letter on 8/22/16. The letter contains instructions of returning the product, provides contact information, and includes a postage-paid return card for the consignee to complete and return to Hologic. Contact technical support at 508-263-2900 or l-800-442:9892 Press Option 6 ).

    Distribution

    Nationwide.

    Quantity

    570 units