Voluntary Advisory Notice – Labelling Amendment
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July 30, 2025
Re: SoClean 2 (SC1200.CA) Supplemental PAP Hose and Mask Maintenance Device
SoClean is issuing this voluntary Advisory Notice to advise you that it has updated the user manual for all SoClean 2 units. This voluntary Advisory Notice does not require you to stop using or return your SoClean unit.
As stated in the SoClean 2 user manual, people with underlying lung diseases, such as asthma and chronic obstructive pulmonary disease (also known as COPD, which includes emphysema and chronic bronchitis), and those with cardiovascular disease, may be sensitive to ozone and should consult with their health care professional before using a SoClean 2.
SoClean has revised its user manual for the SoClean 2 to incorporate: (i) additional warnings and contraindications; and (ii) proper and consistent device set-up instructions including instructions with respect to the use of a hose and mask adapter.
Actions Taken by SoClean
SoClean revised the previous user manual for the SoClean 2 to clarify instructions as follows:
- Incorporated additional warnings and set-up instructions to better facilitate appropriate use.
- Additional instructions for events in which a user is unable to smell residual ozone.
- Additional clarity and consistency confirming that the SoClean 2 is not intended to replace CPAP manufacturers’ cleaning instructions but rather is to be used to supplement cleaning procedures for home use CPAP masks and tubing.
- Provide that SoClean is supplying a complementary (no additional cost) Hose and Mask Adapter with each SoClean filter. Set-up Instructions for the Hose and Mask Adapter are included in the updated manuals.
How to recognize if the device is not properly set up
Note that improper set-up of your SoClean can be detected by the machine not turning on and/or the smell of ozone. As noted above, the updated user manual contains instructions for users that are unable to smell ozone.
Actions to be Taken by You
- User Manuals: Download new version of User Manual using the following link: SoClean 2 Support
To obtain a paper copy of the new version of user manual, simply contact Customer Care at 800-916-4577.
As noted above, this voluntary Advisory Notice does not require you to stop using or return your SoClean unit. Hose and Mask Adapter:
If you recently purchased a SoClean filter and only want to obtain a no cost Hose and Mask Adapter, please contact our Customer Care team at 800-916-4577 or visit the SoClean website:
https://www.soclean.com/en-ca/field-correction
This amendment to the SoClean 2 user manual was made in consultation with Health Canada. We are writing to you today to notify you of the actions taken and to provide you with the following link to the updated label and instructions for use for the SoClean 2: SoClean2 CA IFU and information regarding accessing the Hose and Mask Adapter. This notice applies only to Canada.
No action is required by you in connection with the SoClean 2 device itself and it can continue to be used safely and effectively in accordance with the updated user manual linked above, which will also be included with all new SoClean 2 devices.
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 (SC2CanadianRecall7-2025@soclean.com), fax (1-603-446-6845) or by contacting the undersigned.
We truly appreciate your loyalty as a SoClean customer.
Sincerely,
George Peters
VP, Quality Assurance &
Regulatory Affairs