BEUDAMED
    FDA Enforcement Class II 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 · Reported November 30, 2016

    Enforcement

    Recall Number
    Z-0655-2017
    Event ID
    75558
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hologic, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 30, 2016
    Initiation Date
    October 28, 2016
    Classification Date
    November 22, 2016
    Termination Date
    August 18, 2017
    Address
    250 Campus Dr, N/A, Marlborough, MA, 01752-3020, United States

    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

    Code Info

    Lot Code US: 16E25RC 16E25RD 16F16R Lot Code OUS: 16E25RB

    Distribution

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

    Quantity

    600 units (US) ; 24 units (OUS)