BEUDAMED
    FDA Recall Terminated

    LiquaSonic Ultrasound Gel 250mL, Model No. 001205

    Recall: Z-2391-2021 · Initiated August 20, 2021

    Recall

    Recall Number
    Z-2391-2021
    Event Number
    88540
    Firm
    Athena Medical Products Inc
    FEI Number
    3012175629
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 20, 2021
    Posted
    September 9, 2021
    Terminated
    February 2, 2023
    Address
    11270 Groome Rd St, # B, Cincinnati, OH, 45242

    Description

    LiquaSonic Ultrasound Gel 250mL, Model No. 001205

    Reason

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

    Action

    On August 20, 2021, the firm issued an Urgent Medical Device Recall letter to its only customer, who is a distributor. The letter explained the product issue and asked that the distributor identify their customers and notify them at once of the product recall. ALL lots of product should be returned or destroyed. Athena will no longer purchase or distribute products manufactured by Eco-Med. If you or your customers have any questions you can call the Recall Coordinator at 888-216-7307 or email [email protected].

    Distribution

    Distributed to one distributor within the US.

    Quantity

    12,240 cases of 12