| Class 1 Device Recall Mighty Bliss Electric Heating Pad | |
Date Initiated by Firm | October 24, 2022 |
Date Posted | November 23, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0238-2023 |
Recall Event ID |
90977 |
Product Classification |
Pad, heating, powered - Product Code IRT
|
Product | Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating
Pad, PE-MtyBls-HeatPad-12x24-Gry-V2 |
Code Information |
No UDI
Lots:
220103 |
Recalling Firm/ Manufacturer |
Whele LLC DBA Perch 222 Berkeley St Fl 8 Boston MA 02116-3748
|
For Additional Information Contact | Sedgwick Claims Management Services 866-918-8768 |
Manufacturer Reason for Recall | The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation. |
FDA Determined Cause 2 | Device Design |
Action | On October 24, 2022, the firm notified retailers Amazon.com and Walmart of the recall.
These internet retailers were instructed to notify users of the product about the recall using their customer information. Whele LLC will also have a website for the public that will include instructions for the recall as well as customer support for the recall. The website can be found at https://www.mightyblissheatingpadrecall.expertinquiry.com/
Users are asked to immediately cease use of the product and safely destroy the product by cutting the cord (after ensuring the product is unplugged.) Users are asked to take a photo of the destroyed product and upload it to the firm's recall website to verify that the product can no longer be used.
Firm also issued press release: https://www.prnewswire.com/news-releases/whele-llc-announces-national-voluntary-recall-of-mighty-bliss-electric-heating-pad-due-to-product-safety-concerns-301656419.html |
Quantity in Commerce | 4,034 |
Distribution | US Nationwide through Amazon.com and Walmart. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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