Soclean 2
Brand(s)
Last updated
Summary
Product
Soclean 2
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| SoClean 2 Supplemental PAP Hose And Mask Maintenance Device | All lots. | SC1200.CA |
| SoClean 2 Automated Supplemental PAP Maintenance Device | All lots. | SC1200 |
| SoClean 2 Automated Supplemental PAP Maintenance Device | All lots. | SC1200.CA |
Issue
The SoClean 2 label and IFU are being updated to address mitigation of risk in relation to the safety of ozone, and to instruct users to use the provided hose and mask adapter (which was added to the device licence by way of amendment) to keep ozone out of the pap machine.
Recall start date: July 18, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Soclean Inc.
1 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-77890
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