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Recall Observatory FDA recall evidence

Device 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

Z-0698-2016

November 20, 2015

Class II

Product summary

Firm
Bigwall Enterprises
Event
Event 72837
Status
Terminated
Classification
Class II
Quantity
87503
Official record key
device-enforcement:Z-0698-2016

Official wording

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 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    "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."