UPDATE: May 27, 2022
SoClean Recall Notice- Labelling Amendment
Please see the notice from SoClean below:
Recall Notice – Labelling Amendment
May 6, 2022
Dear Sir/Madame:
Re: SoClean 2 Labelling Amendment in Canada
We are writing to notify you of a recent important change to the label and instructions for use applicable to the SoClean 2 device (Medical Device Licence No. 100197) in Canada.
We are notifying SoClean 2 users of the following labelling changes, which were approved by Health
Canada in June 2021:
• Running the SoClean 2 for a 12-minute cycle time duration obtains a 99.9% reduction of
microorganisms. Independent lab testing with SoClean 2 demonstrates that, when set at the 12-
minute cycle time duration, it kills 99.9% of the following microorganisms comprised of the following
bacteria: Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus epidermidis, and
yeast: Candida albicans. Previous labelling did not specify to run SoClean for a 12-minute cycle.
• SoClean 2 is not an Automated PAP disinfecting system but rather an Automated Supplemental PAP
Maintenance Device.
• Users must follow the CPAP-manufacturer’s instructions for cleaning their PAP accessories. The
SoClean 2 is intended for use as a supplement to that cleaning.
• The SoClean 2 is intended for use with single-user, personal at-home-use PAP device accessories.
This labeling amendment was made in consultation with Health Canada. Health Canada considers the relabelling to be a recall, so we are writing to you today to notify you of the action taken and to provide you with the following link to the updated label and instructions for use for the SoClean 2: SoClean2 CA IFU. This notice applies only to Canada.
No action is required in connection with the SoClean 2 device itself and it can continue to be used safely
and effectively in accordance with the updated label and instructions for use linked above. All new orders and/or new customers will be provided with the new label/instructions for use.
If you have sold or otherwise distributed the SoClean 2 device, please forward this communication to your customers with instructions that they do the same. In addition, please acknowledge your receipt of
this notice by reply email (SC2CanadianRecall5-2022@soclean.com), fax (1-603-446-6845) or by
contacting the undersigned.
Thank you very much for your attention to this matter, and please do not hesitate to contact us with any
questions or concerns. We appreciate your support and thank you for your business. Rest assured that
SoClean continues to stand behind the SoClean product.
COVID-19 UPDATE: July 15, 2021
RESUMPTION OF REGULAR HOURS
Door Locked
In order to manage the flow and limit the number of clients in our clinic at any given time, our office doors will be locked - we are not closed! If you have a pre-scheduled appointment, please knock. If you do not have an appointment, please call us from your vehicle (667-7120- ext 1) OR self-screen and then knock. If possible, please call prior to visiting our office so that we can best serve you.
Safety and Pre-screening
Pre-screening will be required prior to entering our office for any pre-scheduled appointments.
Symptoms? Please reschedule
If you are experiencing any COVID-19 symptoms, please reschedule your in-person appointment to another day, or to a phone call appointment.
Vaccinated?
Our current COVID-19 practices apply to all clients, fully vaccinated or not.
Traveled?
Please note that we will continue to screen any travelers, fully vaccinated or not, and request that if you have traveled, to avoid coming into our clinic until 14 days have passed from your return.
Masks:
We continue to ask that anyone entering the clinic wear a mask, unless medically unable. If you do not have a mask of your own, reusable masks are available for purchase.
Available Services
We are available for phone inquiries and support, curbside equipment pick-up and pre-scheduled, pre-screened in-office appointments.
Office Hours
Monday-Thursday 8:30am-4:30pm, Friday 9:00am-4:00pm. Closed from 11:30am-12:30pm for lunch.
To get in touch
Please call our office or send an email to info@truenorthrespiratory.com prior to visiting so that we can best serve you.
Do not visit if
- You, or someone you have been in contact with have traveled within the last 14 days
- You, or a member of your household are under self-isolation
- You are experiencing any of the symptoms of COVID-19: fever +/- chills, cough, shortness of breath
If you have specific questions not addressed here, please reach out to us!
- Your Team at TrueNorth Respiratory 😊