Recall Z-0698-2016 ยท KFZ Humidifier, Non-Direct Patient Interface (Home-Use)
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 relieve symptoms of stuffy nasal passages, congestion or scratchy throats due to cold, flu or allergies
| Date | Nov 20, 2015 |
| Status | Terminated |
| 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." |
| Root cause | 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 | 87503 |
| Distribution | Nationwide Distribution including Washington, DC, U.S. Virgin Islands, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.