Recall Z-0695-2024 ยท QXQ Respiratory Accessory Microbial Reduction Device.
SoClean, Inc
SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
| Date | Jan 10, 2024 (initiated Nov 15, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling design |
| Action | An Urgent Medical Device Correction notice was issued November 16, 2023 advising customers: 1) Do not use your SoClean2 or SoClean3 without the hose and mask adapter provided by the manufacturer. 2) Review revised labeling and User Manuals for: additional warnings and set-up instructions to enable appropriate use; additional instructions for events in which a user is unable to smell residual ozone; additional clarity and consistency regarding that the SoClean2 and SoClean3 are not intended to replace CPAP manufacturers cleaning instructions but rather are to be used to supplement cleaning |
| Quantity | 2,339,352 |
| Distribution | Worldwide distribution - United States Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Egypt, El Salvador, England, France, Germany, Hong Kong, Isle of Man, Israel, Italy, Japan, Jordan, Korea, Lithuania, Mexico, New Zealand, Portugal, Russia, Saudi A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.