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U.S. Department of Health and Human Services

Class 2 Device Recall HeaterBaum Foot & Ankle Heating Pad

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 Class 2 Device Recall HeaterBaum Foot & Ankle Heating Padsee related information
Date Initiated by FirmJanuary 19, 2016
Create DateJuly 07, 2016
Recall Status1 Terminated 3 on October 13, 2017
Recall NumberZ-2137-2016
Recall Event ID 74078
Product Classification Pad, heating, powered - Product Code IRT
ProductHeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
Code Information All lots; UPC: 862821000030.
FEI Number 3007084179
Recalling Firm/
Manufacturer		 Ergoactives, Llc
20725 NE 16th Ave Ste A26
Miami FL 33179-2132
For Additional Information ContactHarry Birnbaum
305-359-5031
Manufacturer Reason
for Recall		Products are marketed without a cleared 510k.
FDA Determined
Cause 2		No Marketing Application
ActionCustomers 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.
Quantity in Commerce278 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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