SOCLEAN 2 AUTOMATED SUPPLEMENTAL PAP MAINTENANCE DEVICE

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