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FDA (Device enforcement)Recalled 2015-11-20closedclass ii

Bigwall Enterprises: 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 rel

Is my product affected?

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

  • UPC 31191717008

Check against the official notice below — it lists the full affected range.

What happened

Bigwall Enterprises is recalling 87,503 units of the WARM STEAM Personal Steam Inhaler with adjustable steam flow control and soft touch facial and nasal masks nationwide, including Washington DC, U.S. Virgin Islands, and Puerto Rico. The recall was issued out of an abundance of caution following one or more consumer complaints that were independently investigated. No causal connection has been determined between the complaints and the product's proper use as instructed.

The recalled units include Model PJ1011 (Item 366596, UPC 31191717008) with the following lot numbers and quantities: Lot No. 08/14 (45,228 units), Lot No. 12/14 (21,096 units), Lot No. 01/15 (14,220 units), and Lot No. 03/15 (20,040 units). The source document does not specify what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

"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."

Details from the source

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." Distribution: Nationwide Distribution including Washington, DC, U.S. Virgin Islands, and Puerto Rico. Quantity: 87503 Lot/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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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