Z-0784-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 13, 2013
- Initiation Date
- August 14, 2012
- Termination Date
- March 8, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51,472 units
Product Description
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 for Recall
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.
Distribution Pattern
Nationwide Distribution, including the states of TX, CA, NJ, NY, SD, RI, WV, IL PA, NC and MN.
Code Information
Lot Numbers 100/12/01, 116/12/01, 108/12/01, 109/12/01, 149/12/01