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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.
Recall Number Z-0176-2014
Classification Class II
Code Info ALL LOTS
Product Distributed Qty 28,994 units (Mini and Micro)
Reason For Recall Failure to submit a premarket submission and gain approval of a medical device.

Event Detail

Event Id 66191
Product Type Devices
Status Ongoing
Recalling Firm Pinook-Usa
City Orlando
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-23
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the states of AZ, CA, CO, FL, IL, MA, MD, MO, MT, NC, ND, NJ, NV, NY, TX, VA, and WA and the country of Canada.