Z-0616-2013 Class II Terminated
FDA device recall Z-0616-2013 was initiated by Brookstone Company, Inc. on November 2, 2012 and is designated Class II. Reason for recall: Additional Warning Statement to prevent burns to the skin The recall status is terminated (terminated June 13, 2013). Affected quantity: 109,956 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 2, 2013
- Initiation Date
- November 2, 2012
- Termination Date
- June 13, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 109,956 units
Product Description
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.
Reason for Recall
Additional Warning Statement to prevent burns to the skin
Distribution Pattern
Nationwide Distribution.
Code Information
All lot codes