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

Starting date:

December 18, 2015

Posting date:

December 18, 2015

Type of communication:

Advisory

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Important Safety Information, Unauthorized products

Audience:

General Public

Identification number:

RA-56382

• Issue
• What you should do
• Who is affected
• Media enquiries
• Public enquiries
• What Health Canada is doing

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".

What you 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.

Who is affected

Any Canadian who uses Cryosaunas.

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709

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.

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