Advisory - Unlicensed medical devices "Cryosaunas" illegally imported to Canada and possibly linked to a death in the U.S.

OTTAWA, Dec. 18, 2015 /CNW/ -

The issue:

Health Canada is advising Canadians that several clinics in Ontario and at least one in Québec are currently using illegally imported medical devices, Cryosaunas, which are potentially linked to a death in the US. Cryosaunas use liquid nitrogen to expose users to cold air (at or below -200-300°F) for several minutes for the purpose of "whole body therapy".

Who is affected:

Any Canadian who uses Cryosaunas.

What consumers should do:

  • Consult your health care provider if you have used this device.
  • Report any adverse events to Health Canada.
  • Report complaints about health products to Health Canada by calling toll-free to 1-800-267-9675, or complete an online complaint form.

What Health Canada is doing:

Health Canada has requested that the manufacturer stop the sale and immediately recall the unlicensed Class III devices. Health Canada has informed clinics who are currently using this device to advise them of the serious potential health risk.

Health Canada is also working with the Canadian Border Services Agency to help prevent further illegal importation of Cryosaunas.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

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SOURCE Health Canada

For further information: Media Enquiries: Health Canada, (613) 957-2983; Public Enquiries: (613) 957-2991, 1-866 225-0709

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