Recall Z-1821-2008 ยท MVV Device, Acupressure
Psi Health Solutions
Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (UPC 859570001029), Color Play (UPC 859570001043) and Cherry Blossom (UPC 859570001012).
| Date | Sep 2, 2008 (initiated Apr 26, 2007) |
| Status | Terminated |
| Reason | Product was marketed before its 510(k) application cleared. |
| Root cause | PMA |
| Action | Recall imitated 04/26/07. Retailers were informed via phone and email and mail. The product was marketed prior to the firm receiving clearance to market from the FDA. Contact Carla Falcone at 831-373-7712 if you have questions. |
| Quantity | 21000 units |
| Distribution | Product was distributed to approximately 21,000 consumers and retailers throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070766 | PSI BANDS Psi Health Solutions, Inc., Jul 26, 2007 |