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U.S. Department of Health and Human Services

Class 2 Device Recall Brookstone Heated Body Bean

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  Class 2 Device Recall Brookstone Heated Body Bean see related information
Date Initiated by Firm November 02, 2012
Date Posted December 27, 2012
Recall Status1 Terminated 3 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
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 2		 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.
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