BEUDAMED
    FDA Enforcement Class II Ongoing

    Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.

    Recall: Z-1604-2024 · Reported May 1, 2024

    Enforcement

    Recall Number
    Z-1604-2024
    Event ID
    94303
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Parker Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 1, 2024
    Initiation Date
    March 22, 2024
    Classification Date
    April 19, 2024
    Address
    286 Eldridge Rd, N/A, Fairfield, NJ, 07004-2509, United States

    Description

    Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.

    Reason

    Product demonstrates low viscosity.

    Code Info

    Product No. 66-04; UDI: 20855683006399 (Master), 10855683006392 (Inner Box), 00855683006395 (Each); Lot No. (Expiration Date): A1122010 (11/29/25) and A0523002 (5/12/26).

    Distribution

    Worldwide distribution - US Nationwide in the states of CA, CO, FL, GA, IL, MD, MI, MN, NC, NE, NY, OH, PA, SC, & TX. The countries of AU, CA, OM, & SA.

    Quantity

    217 cases (1,085 Inner Boxes; 10,850 Eaches)