Recall Z-2137-2016
Ergoactives, Llc · initiated January 19, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
Codes / lots: All lots; UPC: 862821000030.
Reason for recall
Products are marketed without a cleared 510k.
FDA-determined cause: No Marketing Application
Action taken
Customers were notified by phone on 01/19/2016. Two follow-up notifications were sent to customers via e-mail. Customers were asked to immediately examine their inventory for the affected product; and, to notify and identify any customers they may have further distributed to. Ergoactives LLC requests that all Heaterbaum products be sent back to their headquarters: 20725 NE 16th Avenue, Suite A-26, Miami, FL 33179, along with the order number and note of where the product was purchased. The enclosed response form should be completed and returned as well. If customers have any questions, they can call Ergoactives LLC at (305)359-5031. Customers will receive a full refund for the return of their Heaterbaum products.
Details
- Recall number
- Z-2137-2016
- Initiated
- January 19, 2016
- Terminated
- October 13, 2017
- Product code
- IRT – Pad, Heating, Powered
- Quantity
- 278 units
- Distribution
- 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.
- Recalling firm
- Ergoactives, Llc, Miami, FL