Bigwall Enterprises recalls WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks" Product…

Recall date

November 20, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0698-2016

FDA classification

Class II

Brand / firm

Bigwall Enterprises

Sold / distributed

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

Why it was recalled

"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."

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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