BEUDAMED
    FDA Recall Terminated

    SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound

    Recall: Z-0655-2017 · Initiated October 28, 2016

    Recall

    Recall Number
    Z-0655-2017
    Event Number
    75558
    Firm
    Hologic, Inc
    FEI Number
    1000120743
    Product Code
    HHM
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    October 28, 2016
    Posted
    November 22, 2016
    Terminated
    August 18, 2017
    Address
    250 Campus Dr, Marlborough, MA, 01752-3020

    Description

    SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound

    Reason

    Breach in sterile barrier compromising product sterility

    Action

    Hologic notified customers in the United States through Certified letter on 10/28/16. The letter contains instructions with the option of returning or destroying the product, provides contact information, and includes a postage paid return card for the consignee to complete and return to Hologic.Questions or require clarification of the response process please contact 1- 800-442-9892 and selection option 6 and then option 2 for surgical product technical support. For questions regarding this recall call 508-263-8920.

    Distribution

    Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria.

    Quantity

    600 units (US) ; 24 units (OUS)