Recall Z-0176-2014 ยท NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Pinook-Usa
Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.
| Date | Nov 7, 2013 (initiated May 23, 2013) |
| Status | Terminated |
| Reason | Failure to submit a premarket submission and gain approval of a medical device. |
| Root cause | No Marketing Application |
| Action | On October 18, 2013 the firm sent the following notification to their customers: This is to inform you of a product recall involving: Pinooks Mini-massager and Pinooks Micro Massager model number PT-11 See enclosed product label (for ease in identifying the product at retail/user level). This recall has been initiated due to failure to submit a premarket submission and gain approval. We began shipping this product on 11/27/2012. Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify you |
| Quantity | 28,994 units (Mini and Micro) |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.