Health product recall

SOCLEAN 2 AUTOMATED SUPPLEMENTAL PAP MAINTENANCE DEVICE

Brand(s)
Last updated

Summary

Product
SOCLEAN 2 AUTOMATED SUPPLEMENTAL PAP MAINTENANCE DEVICE
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Affected products

Affected products

Lot or Serial Number

Model or catalogue number

SOCLEAN 2 AUTOMATED SUPPLEMENTAL PAP MAINTENANCE DEVICE

All lots.

SC1200.CA

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

Additional information

Details
Original published date: 2022-05-19
Alert / recall type
Health product recall
Category
Health product - Medical device - General hospital and personal use
Companies

 

Soclean Inc.

12 Vose Farm Road, Peterborough, New Hampshire, United States, 03458

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-64168