Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (U
FDA device recall Z-1821-2008 · posted 2008-09-02 · Terminated
Recall details
- Recalling firm
- Psi Health Solutions
- Reason for recall
- Product was marketed before its 510(k) application cleared.
- Action taken
- 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.
- Root cause
- PMA
- Status
- Terminated
- Product code
- MVV
- Quantity affected
- 21000 units
- Distribution
- Product was distributed to approximately 21,000 consumers and retailers throughout the US.
- Date initiated
- 2007-04-26
- Date posted
- 2008-09-02
- Date terminated
- 2008-12-18
- Location
- Pacific Grove, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PSI BANDS (K070766) | Psi Health Solutions, Inc. | 2007-07-26 |