BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1604-2024 · Initiated March 22, 2024

    Recall

    Recall Number
    Z-1604-2024
    Event Number
    94303
    Firm
    Parker Laboratories, Inc.
    FEI Number
    2212018
    Product Code
    GYB
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    March 22, 2024
    Posted
    April 19, 2024
    Address
    286 Eldridge Rd, Fairfield, NJ, 07004-2509

    Description

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

    Reason

    Product demonstrates low viscosity.

    Action

    An URGENT MEDICAL DEVICE RECALL notification, dated 3/19/24, was emailed to consignees notifying them of this recall. Consignees were asked to examine their inventory for affected devices, quarantine devices identified as part of this recall and discontinue use, and return the email acknowledgement and Recall Stock Response Form to the firm. If product was further distributed, consignees are to conduct their own sub-recalls of affected devices. Consignees with any questions can contact Parker Laboratories by email at [email protected] or by phone at 973-276-9500x7107 from Monday through Thursday, from 8:30 AM to 5:00 PM, or Friday from 8:30 AM to 1:00 PM.

    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)