KEGO Corporation issues recall for SoClean 2
Since its inception, Renaissance Respiratory has sought to raise the bar of excellence. Because of that, we are following through with a recall issued by KEGO Corporation for the SoClean 2.
The letter we received from KEGO Corporation reads as follows:
Recall Notice – Labelling Amendment
May 19, 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 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. 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.
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 email (asommers@kegocorp.com) or by fax (1-866-294-5346).
Thank you very much for your attention to this matter. As KEGO no longer distributes the SoClean 2, any further questions may be directed to SoClean directly at (800) 916-4577 or info@soclean.com.
Sincerely,
Amie Sommers
HR/Quality Manager, Customer Care Manager
KEGO Corporation
asommers@kegocorp.com 866-862-7328 ext. 215Mailing: 1064 Hargrieve Road, Unit C, London, ON N6E 1P5 | Warehouse: 4350 Castleton Road, Unit 3/4, London, ON N6N 0A3
Tel: 866.862.7328 Fax: 866.294.5346 www.kegocorp.com