BEUDAMED
    FDA Recall Terminated

    Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N

    Recall: Z-1913-2021 · Initiated April 29, 2021

    Recall

    Recall Number
    Z-1913-2021
    Event Number
    87958
    Firm
    Exact Medical Manufacturing, Inc.
    FEI Number
    3008011779
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    April 29, 2021
    Terminated
    May 26, 2022
    Address
    4917 William St, Ste C, Lancaster, NY, 14086-3200

    Description

    Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N

    Reason

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

    Action

    Exact Medical issued Correction Notification via email on 4/29/21. Letter states: Exact Medical Manufacturing Ultrasonic Transducer Cover can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not to be used in a natural or surgical opening to the body. The Exact Medical Manufacturing Ultrasonic Transducer Cover are also sold as bulk non-sterile, single use items, to repackers/relabelers establishments for further packaging and ethylene oxide sterilization. These are the boundaries and limitations of use for existing Probe/Transducer cover products in any existing stock from Exact Medical Manufacturing, Inc Further instructions will be given at a future date and we encourage you to reach out with any questions or concerns regarding this issue.

    Distribution

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

    Quantity

    5621 units