Events

Recall of Device Recall Well at Walgreens Warm Steam Personal Steam Inhaler

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bigwall Enterprises.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72837
  • Event Risk Class
    Class 2
  • Event Number
    Z-0698-2016
  • Event Initiated Date
    2015-11-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142338
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Humidifier, non-direct patient interface (home-use) - Product Code KFZ
  • 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."

Device

Device Recall Well at Walgreens Warm Steam Personal Steam Inhaler
  • Model / Serial
    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
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including Washington, DC, U.S. Virgin Islands, and Puerto Rico.
  • Product 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
  • Manufacturer
    Bigwall Enterprises

Manufacturer

Bigwall Enterprises
  • Manufacturer Address
    Bigwall Enterprises, 125 55th St Ste 200, Clarendon Hills IL 60514-6307
  • Manufacturer Parent Company (2017)
    Bigwall Enterprises Inc.
  • Source
    USFDA