Events

Recall of Device Recall HeaterBaum Foot & Ankle Heating Pad

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ergoactives, Llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74078
  • Event Risk Class
    Class 2
  • Event Number
    Z-2137-2016
  • Event Initiated Date
    2016-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146226
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pad, heating, powered - Product Code IRT
  • Reason
    Products are marketed without a cleared 510k.
  • 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.

Device

Device Recall HeaterBaum Foot & Ankle Heating Pad
  • Model / Serial
    All lots; UPC: 862821000030.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
  • Manufacturer
    Ergoactives, Llc

Manufacturer

Ergoactives, Llc
  • Manufacturer Address
    Ergoactives, Llc, 20725 NE 16th Ave Ste A26, Miami FL 33179-2132
  • Manufacturer Parent Company (2017)
    Ergoactives Llc
  • Source
    USFDA