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Terminated

HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.

FDA Recall Z-2137-2016 · Posted None

Recalling FirmErgoactives, Llc
Recall StatusTerminated
Product CodeIRT
Date Initiated2016-01-19
Date Terminated2017-10-13
Product Quantity278 units

Reason for Recall

Products are marketed without a cleared 510k.

Firm Action

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.

Root Cause

No Marketing Application

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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