BEUDAMED
    FDA Enforcement Class II Terminated

    Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA

    Recall: Z-1907-2021 · Reported June 30, 2021

    Enforcement

    Recall Number
    Z-1907-2021
    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 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA

    Reason

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

    Code Info

    Lot Numbers: 1907E366 1908E436 1910E101 1910E444 1912E463 2003E605 2005E438 2008E091 2012E096 2012E103

    Distribution

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

    Quantity

    8800 units