THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.

Reason: The Spanish translation on the Instructions for Use (IFU) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat.

Code information: Lot Numbers 100/12/01, 116/12/01, 108/12/01, 109/12/01, 149/12/01

Distribution pattern: Nationwide Distribution, including the states of TX, CA, NJ, NY, SD, RI, WV, IL PA, NC and MN.