Class 2 Device Recall SoClean

• Date Initiated by Firm: November 15, 2023
• Date Posted: January 10, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0694-2024
• Recall Event ID: 93570
• Product Classification: Ozone cleaning supplement for CPAP accessory - Product Code QXQ
• Product: SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
• Code Information: UDI: (01)00858242007147
• Recalling Firm/ Manufacturer: SoClean, Inc; 1 Vose Farm Rd; Peterborough NH 03458-2128
• For Additional Information Contact: Lisa Williams; 603-371-3242
• Manufacturer 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.
• FDA Determined 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 procedures for home use CPAP masks and tubing. 3) With each SoClean filter purchase, SoClean is supplying a complementary (no additional cost) Hose and Mask Adapter, which facilitates use of the SoClean2 and SoClean3 equipment without ozone entering the CPAP. Set-up Instructions for the Hose and Mask Adapter are included in the updated manuals. To obtain a no cost Hose and Mask Adapter, please contact our Customer Care team at 866-501-3705 or visit the SoClean website: https://www.soclean.com/field-correction. 4) As stated in the SoClean User Manual, patients with underlying lung diseases, such as asthma and chronic obstructive pulmonary disease (COPD, including emphysema and chronic bronchitis), and those with cardiovascular disease, may be sensitive to ozone and should consult with their health care provider before using a SoClean device. Customers are asked to confirm receipt of the recall notification online at the through the hyperlink embedded in the notice https://www.soclean.com/field-correction. Contact Customer Care at 866-501-3705 with questions.
• Quantity in Commerce: 40,075
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.