Recall Notice – Labelling Amendment
Dear Patient:
Re: SoClean 2 Labelling Amendment in Canada
Our records indicate that you have purchased a SoClean 2 Automated Supplemental PAP Maintenance Device in the past. 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 License No. 100197) in Canada.
These changes were approved by Health Canada in June 2021 and made known to ProResp by our SoClean distributor on May 19, 2022:
- 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 re-labelling 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.
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.
Thank you very much for your attention to this matter, and please do not hesitate to contact your local ProResp office with any questions or concerns.
Your ProResp Team