BEUDAMED
    FDA Enforcement Class II Terminated

    Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case

    Recall: Z-1777-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1777-2018
    Event ID
    79910
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Parker Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 16, 2018
    Initiation Date
    April 13, 2017
    Classification Date
    May 9, 2018
    Termination Date
    October 26, 2020
    Address
    286 Eldridge Rd, N/A, Fairfield, NJ, 07004-2509, United States

    Description

    Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case

    Reason

    There is a potential for the gel packets to have leaks in the packet seal.

    Code Info

    Lot numbers: L0117006, L0117007, L0217001, L0217002, L0217004, L0217006

    Distribution

    The products were distributed to the following US states: CA, FL, GA, IA, IL, OH, TN, and VA. The products were distributed to the following foreign countries: Canada, United Kingdom, and Malta.

    Quantity

    3275 cases/1310000 packets