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Health Canada Medical devices

SOCLEAN 2 AUTOMATED SUPPLEMENTAL PAP MAINTENANCE DEVICE

Issued May 16, 2022
Issue
Labelling changes were issued for the Soclean 2 such as 1) running the Soclean 2 for a 12-minute cycle time duration obtains a 99.9% reduction of microorganisms, 2) Soclean 2 is not an automated pap disinfecting system but rather an automated supplemental pap maintenance device, 3) users must follow the CPAP-manufacturer's instructions for cleaning their pap accessories and 4) the Soclean 2 is intended for use with single-user, personal at-home-use pap device accessories. Recall start date: Sept 7, 2021
Hazard description
Performance
Product
Product name
SOCLEAN 2 AUTOMATED SUPPLEMENTAL PAP MAINTENANCE DEVICE
Reference
ID
RA-64168