FDA Announces The Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories

The U.S. Food and Drug Administration (FDA) is providing additional information about a product recall related to the use of SoClean2 and SoClean3 equipment used to clean, sanitize, or disinfect CPAP devices and accessories. The company’s recall consists of a 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.

On November 16, 2023, SoClean announced a voluntary recall to notify users of:

• a new version of the User Manual for SoClean2 and SoClean3, which includes: additional set-up, use, and cleaning instructions; and additional instructions for users regarding how to detect and deal with unexpected ozone exposure and
• the availability and use of a hose and mask adapter, which is intended to facilitate use of the SoClean2 and SoClean3 equipment without ozone entering the CPAP.

Recommendations for Consumers Using SoClean2 or SoClean3

• Do not use your SoClean2 or SoClean3 without the hose and mask adapter provided by the manufacturer.
• Never connect SoClean equipment to your CPAP device when the CPAP device is in use.
• Read the new version of the User Manual for SoClean2 and SoClean3 and carefully follow the instructions if you are using SoClean equipment.
• Follow the CPAP manufacturer’s cleaning instructions to clean your CPAP, including any instructions contraindicating the use of ozone gas or UV light to clean, sanitize or disinfect CPAP devices. The cleaning instructions provided by SoClean2 and SoClean3 are not intended to replace CPAP manufacturers’ cleaning instructions but rather are intended to be used to supplement cleaning procedures for CPAP masks and tubing.
• Review the recall notice from SoClean, which provides recommendations to users, and Unique Device Identifier (UDI) information. The UDI helps you identify affected products.
• 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.

Device Description

SoClean2 and SoClean3 equipment is intended to clean CPAP devices and accessories such as masks and hoses with ozone gas. CPAP machines are medical devices prescribed to people with obstructive sleep apnea to keep their airways open during sleep. Typically, CPAP manufacturers recommend regular cleaning of CPAP device accessories with mild soap and water.

Ozone, sometimes called “activated oxygen,” is a gas that can be used to kill harmful bacteria. However, for ozone to be effective in destroying harmful bacteria, it must be present at a concentration above levels considered safe for humans.

When used as directed, the SoClean hose and mask adapter and new User Manual are intended to help reduce the risk of patient exposure to ozone gas during use of the SoClean equipment or remaining in the mask or hose after cleaning.  Here’s how the adapter works per SoClean:

1. The adapter is placed between the SoClean ozone tubing and the ventilation hose. The adapter prevents ozone gas from entering the CPAP machine and/or its water reservoir. 
2. The mask remains attached to the ventilation hose at the other end. The SoClean’s ozone tubing is attached to the adapter’s port, the mask is placed in the SoClean chamber, and lid of the chamber is closed.
3. When the SoClean is turned on, ozone generated by the SoClean is then directed into the mask and hose through the ozone tubing.

Proper use of the adapter helps reduce the risk of patient exposure to ozone gas, by preventing ozone gas from entering the CPAP machine and/or its water reservoir. In addition,   the instructions for ozone aeration after cleaning will reduce the risk of exposure to ozone left in the mask or tubing (residual ozone).    

FDA Actions

The FDA continues to work with SoClean to bring the firm into compliance with FDA requirements.

The FDA will continue to monitor reports of adverse events associated with the use of SoClean equipment.

The FDA also continues to remind consumers that the FDA has not authorized for market any devices using ozone gas or UV light to clean, disinfect, or sanitize CPAP devices and accessories (for example, hoses, masks, tubing, and headgear). See the FDA’s CPAP Machine Cleaning: Ozone, UV Light Products Are Not FDA Approved for additional information.

The FDA will keep the public informed if significant new information becomes available.

Affected Products

Product information provided by the company, including Unique Device Identifier (UDI), is in the table below.

Unique Device Identifier (UDI)

The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. For more information on UDI, please visit Unique Device Identification System (UDI Systems).

• How do I recognize a UDI on a label?

Reporting Problems with Your Device

If you think you have a problem associated with the use of SoClean 2 and SoClean 3, or with any other medical device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Healthcare personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.

Source: FDA

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