Events

Recall of Device Recall FARInfrared Heat Home Sauna, 2 person

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Therasage, 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
    70737
  • Event Risk Class
    Class 2
  • Event Number
    Z-1539-2015
  • Event Initiated Date
    2014-12-23
  • Event Date Posted
    2015-04-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134581
  • 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
    unknown device name - Product Code N/A
  • Reason
    Product distributed without 510(k) approval.
  • Action
    On January 20, 2015 Therasage sent a notification to its consignees asking them to discard any of the labeling materials that state the following: 1) Use of the sauna allows one to "naturally detoxify." 2) Use of the sauna expels toxins from the body 3) Any reference to an exact amount of calories one uses in an hour when enjoying the benefits of this product 4) Although this product is enhanced with a negative ion environment, we cannot say that the product is enhanced with negative ion therapy 5) Any reference to the maximum infrared absorption available cannot be explicitly stated, as it may vary for each individual person. Customers with questions were instructed to call 888-416-4441 or email info@therasage.com. For questions regarding this recall call 561-416-9300.

Device

Device Recall FARInfrared Heat Home Sauna, 2 person
  • Model / Serial
    TS4544
  • Distribution
    Nationwide Distribution including SD, IL, TX, OR, NY, WI, GA, and CA.
  • Product Description
    FAR-Infrared Heat Home Sauna, 2 person || Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
  • Manufacturer
    Therasage, LLC.

Manufacturer

Therasage, LLC.
  • Manufacturer Address
    Therasage, LLC., 21000 Boca Rio Rd Ste A21c, Boca Raton FL 33433-1504
  • Manufacturer Parent Company (2017)
    Therasage Llc
  • Source
    USFDA