SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
Summary
The FDA issued a Class II for SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System by SoClean, Inc. Reason: New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intende.
Details
Source
Device Recall
External ID
Z-0694-2024
Action Date
2024-01-17
Status
Ongoing
Category
device
Product Description
SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
Lot/Code Info: UDI: (01)00858242007147
Quantity Affected: 40,075
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.
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 Arabia, Seoul, Singapore, Spain, Sri Lanka, Switzerland, Thailand, Netherlands, Turkey, United Arab Emirates, and United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-15
Company
Peterborough, NH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SoClean, Inc has 4 FDA actions in our database, including 2 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SoClean, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SoClean, Inc have FDA actions?
SoClean, Inc has 4 FDA actions in our database, including 2 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0694-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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