Z-2137-2016 Class II Terminated
FDA device recall Z-2137-2016 was initiated by Ergoactives, Llc on January 19, 2016 and is designated Class II. Reason for recall: Products are marketed without a cleared 510k. The recall status is terminated (terminated October 13, 2017). Affected quantity: 278 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 13, 2016
- Initiation Date
- January 19, 2016
- Termination Date
- October 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 278 units
Product Description
HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
Reason for Recall
Products are marketed without a cleared 510k.
Distribution Pattern
Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, KS, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA, and WA; and, the countries of Ecuador & Venezuela.
Code Information
All lots; UPC: 862821000030.