BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1777-2018 · Initiated April 13, 2017

    Recall

    Recall Number
    Z-1777-2018
    Event Number
    79910
    Firm
    Parker Laboratories, Inc.
    FEI Number
    2212018
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 13, 2017
    Terminated
    October 26, 2020
    Address
    286 Eldridge Rd, Fairfield, NJ, 07004-2509

    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.

    Action

    Notification letters distributed 4/13/17 instructed customers to perform the following: We request that you quarantine any affected product in your inventory and contact Parker to discuss options for disposition of the recalled products in question. Should you identify any customers to whom the affected product may have already been distributed, we would be happy to provide you with a customer letter that can be transcribed onto your own company letterhead for the purposes of notifying them of this quality issue. Please completed the attached response form as soon as possible and return it to us at the email or fax number listed on the form, so that further arrangements can be made.

    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