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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 Recall
Brookstone Heated Body Bean
see related information
Date Posted December 27, 2012
Recall Status1 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
Recalling Firm/
Manufacturer
Brookstone Company, Inc.
1 Innovation Way
Merrimack, New Hampshire 03054-4873
Manufacturer Reason
for Recall
Additional Warning Statement to prevent burns to the skin
FDA Determined
Cause 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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