Recall Z-0694-2024— SoClean, Inc
Class II · Ongoing
Class II FDA medical device recall by SoClean, Inc, initiated 2023-11-15. FDA's recall record names no specific 510(k) clearance for this event. Product: SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System. Reason: New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas after the use of a SoClean device..
- Recalling firm
- SoClean, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-15
- Firm location
- Peterborough, NH, United States
Product description
SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
Reason for recall
New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas after the use of a SoClean device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.