Recall Z-0616-2013— Brookstone Company, Inc.
Class II · Terminated
Class II FDA medical device recall by Brookstone Company, Inc., initiated 2012-11-02, terminated 2013-06-13. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Additional Warning Statement to prevent burns to the skin.
- Recalling firm
- Brookstone Company, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-02
- Terminated
- 2013-06-13
- Firm location
- Merrimack, NH, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.