BEUDAMED
    FDA Enforcement Class II 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 · Reported March 2, 2016

    Enforcement

    Recall Number
    Z-0698-2016
    Event ID
    72837
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bigwall Enterprises
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 2, 2016
    Initiation Date
    November 20, 2015
    Classification Date
    February 24, 2016
    Termination Date
    March 6, 2018
    Address
    125 55th St Ste 200, N/A, Clarendon Hills, IL, 60514-6307, United States

    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."

    Code Info

    Model: PJ1011 Item: 366596 UPC code: 31191717008 Lot No. 08/14: 45228pcs Lot No. 12/14: 21096pcs Lot No. 01/15: 14220pcs Lot No. 03/15: 20040pcs

    Distribution

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

    Quantity

    87503