Recall record at a glance
| Official record | Z-0694-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | SoClean, Inc. |
| Report date | Jan 17, 2024 |
| Recall initiation date | Nov 15, 2023 |
| Quantity | 40,075 |
| Location | Peterborough, NH, United States |
Official product description
SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
Why the product was recalled
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.
Distribution information
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 Arabia, Seoul, Singapore, Spain, Sri Lanka, Switzerland, Thailand, Netherlands, Turkey, United Arab Emirates, and United Kingdom.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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