Recall MonitorHealth Products
Soclean 2
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: Soclean 2
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: General public, Healthcare, Industry
Recall class: Type II
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