BEUDAMED
    FDA Enforcement Class II Terminated

    Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N

    Recall: Z-1917-2021 · Reported June 30, 2021

    Enforcement

    Recall Number
    Z-1917-2021
    Event ID
    87958
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Exact Medical Manufacturing, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 30, 2021
    Initiation Date
    April 29, 2021
    Classification Date
    June 21, 2021
    Termination Date
    May 26, 2022
    Address
    4917 William St Ste C, N/A, Lancaster, NY, 14086-3200, United States

    Description

    Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N

    Reason

    No 510k for the product to be used in a natural or surgical opening to the body

    Code Info

    Lot Numbers: 1906E310 1908E208 1908E561 1910E032 1910E350 1911E262 1912E540 2003E308 2002E135 2003E324 2004E513 2009E129 2009E408 2101E069 2011E404

    Distribution

    US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico

    Quantity

    51300 units