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Recall Observatory FDA recall evidence

Device 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.

Z-0616-2013

November 02, 2012

Class II

Product summary

Firm
Brookstone Company, Inc.
Event
Event 63497
Status
Terminated
Classification
Class II
Quantity
109,956 units
Official record key
device-enforcement:Z-0616-2013

Official wording

Reason: Additional Warning Statement to prevent burns to the skin

Code information: All lot codes

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Additional Warning Statement to prevent burns to the skin