Class 2 Device Recall Brookstone Heated Body Bean

• Date Initiated by Firm: November 02, 2012
• Date Posted: December 27, 2012
• Recall Status: Terminated on June 13, 2013
• Recall Number: Z-0616-2013
• Recall Event ID: 63497
• Product: Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue), 734864 (Plum), 734865 (Red). Brookstone 3 in 1 wrap ,SKU734397 (Brown). The Products are liquid filled bean shaped pouches that are electrically heated and then detached from the charger prior to use.
• Code Information: All lot codes
• FEI Number: 1221298
• Recalling Firm/ Manufacturer: Brookstone Company, Inc.; 1 Innovation Way; Merrimack NH 03054-4873
• For Additional Information Contact: 603-880-9500
• Manufacturer Reason for Recall: Additional Warning Statement to prevent burns to the skin
• FDA Determined Cause: Labeling design
• Action: Brookstone sent a "MEDICAL DEVICE CORRECTION" letter dated December 10, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Recall Information is on the website link from the homepage, www. Brookstone.com. Recall posted: http://www.brookstone.com/recall-information. Questions call Brookstone Customer Care at 800.846.3000 or visit any Brookstone Store.
• Quantity in Commerce: 109,956 units
• Distribution: Nationwide Distribution.

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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.