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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles. ALL LOTS Class II Failure to submit a premarket submission and gain approval of a medical device. 28,994 units (Micro and Mini) Z-0177-2014
Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles. ALL LOTS Class II Failure to submit a premarket submission and gain approval of a medical device. 28,994 units (Mini and Micro) Z-0176-2014
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