Product Wiki · Recalls · Health Canada — Medical Devices

SOCLEAN 2 AUTOMATED SUPPLEMENTAL PAP MAINTENANCE DEVICE — recall 64168

Health Canada — Medical Devices · Canada · 2022-05-16 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
64168
Date of alert
2022-05-16
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
General hospital and personal use
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/soclean-2-automated-supplement

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