Recall Z-0698-2016— Bigwall Enterprises
Class II · Terminated
Class II FDA medical device recall by Bigwall Enterprises, initiated 2015-11-20, terminated 2018-03-06. FDA's recall record names no specific 510(k) clearance for this event. 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. 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.".
- Recalling firm
- Bigwall Enterprises
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-20
- Terminated
- 2018-03-06
- Firm location
- Clarendon Hills, IL, United States
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
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."
Data sourced from openFDA. This site is unofficial and independent of the FDA.