FDA Device

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).

Hazard

Product was marketed before its 510(k) application cleared.

What You Should Do

Remedy

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.

Products

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 8595700
Brand
Psi Health Solutions
UPC
all codes and devices manufactured between June 22 to December 20, 2006.

Units Affected

21000 units