BEUDAMED
    FDA Recall Terminated

    WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks" Product labeling reads in part: "Well at Walgreens***WARM Helps relieve symptoms of stuffy nasal passages, congestion or scratchy throats due to cold, flu or allergies

    Recall: Z-0698-2016 · Initiated November 20, 2015

    Recall

    Recall Number
    Z-0698-2016
    Event Number
    72837
    Firm
    Bigwall Enterprises
    FEI Number
    3008651658
    Product Code
    KFZ
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    November 20, 2015
    Terminated
    March 6, 2018
    Address
    125 55th St, Ste 200, Clarendon Hills, IL, 60514-6307

    Description

    WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks" Product labeling reads in part: "Well at Walgreens***WARM Helps relieve symptoms of stuffy nasal passages, congestion or scratchy throats due to cold, flu or allergies

    Reason

    "The public reason for the recall is that the product is being recalled out of an abundance of caution due to one or more consumer complaints, which have been independently investigated and remain unconfirmed. No causal connection between the complaints and the producta"s proper use as instructed have been determined."

    Action

    The firm has only sold the product to Walgreens. Walgreens has notified all of its distribution centers and stores. According to the firm: "Walgreens has issued a stop sale at the store level. Units removed from store shelves and in stock will be sent back to the Walgreens distribution center Valparaiso, Indiana. As units are received from all store locations they will be sent to Bigwall Enterprises."

    Distribution

    Nationwide Distribution including Washington, DC, U.S. Virgin Islands, and Puerto Rico.

    Quantity

    87503