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U.S. Department of Health and Human Services

Class 2 Device Recall Well at Walgreens Warm Steam Personal Steam Inhaler

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  Class 2 Device Recall Well at Walgreens Warm Steam Personal Steam Inhaler see related information
Date Initiated by Firm November 20, 2015
Create Date February 25, 2016
Recall Status1 Terminated 3 on March 06, 2018
Recall Number Z-0698-2016
Recall Event ID 72837
Product Classification Humidifier, non-direct patient interface (home-use) - Product Code KFZ
Product 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
Code Information 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 
Recalling Firm/
Manufacturer		 Bigwall Enterprises
125 55th St Ste 200
Clarendon Hills IL 60514-6307
For Additional Information Contact Consumer Services
877-365-6274
Manufacturer Reason
for Recall		 "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."
FDA Determined
Cause 2		 Unknown/Undetermined by firm
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."
Quantity in Commerce 87503
Distribution Nationwide Distribution including Washington, DC, U.S. Virgin Islands, and Puerto Rico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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