NOTICE: FDA Announces Voluntary Recall of SoClean Ozone Cleaners

[Sleeprider]

Issued November 21, 2023 FDA Announcement Link

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.  SoClean Recall Link

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.
  

Editorial Comments:
I consistently recommend against the use of  SoClean and and other ozone based cleaning and disinfecting equipment.The SoClean "Voluntary Field Correction" consists of revised instructions for use of the machine and an adapter that prevents the ozone from entering the actual CPAP. This approach does not help customers that may have damaged CPAP equipment, masks or tubing related to ozone exposure, and dismisses health impacts as "improper set-up, unauthorized device modifications, and use by individuals for whom the device is not recommended as indicated in the user manual".  This will not remedy invalidation of CPAP manufacturer's warranties by machine already affected, and continues to promote the use of ozone for cleaning patient equipment.  It is recommended that CPAP patients not use any ozone cleaning devices, including the modified instructions and mask adapter, and to follow manufacturer cleaning recommendations that is included in all owner's manuals, to use soap and water on the mask, tubing and humidifier chamber. The SoClean super-thread is here: https://www.apneaboard.com/forums/Thread...g-machines

[The opinions expressed in this notice are the author's and may not represent Apnea Board policy]

[SuperSleeper]

So, this sounds like it's not really a "recall" of the actual machines, correct?  But rather a "recall" so that current owners of SoClean devices can get a copy of the "new user manual", which has additional information in it-- does that sound correct?

Is the suggested "hose and mask adapter" something that already comes with a SoClean unit?  Or is that something that is going to be sent out to owners?  If so, it's strange because their form doesn't ask for a shipping address at all-- just an name & email address.

In other words, neither FDA or SoClean is asking that owners turn in their machines for repair or replacement.  And, they're saying that their device should only be used for cleaning hose & mask, but not the CPAP machine itself.    If correct, that goes against all their prior marketing, which seems to indicate that SoClean is for both CPAP machines AND the mask/hose stuff.

Am I missing something, or is this correct?

[Sleeprider]

Your summary seems correct to me except that it appears SoClean is making a more clear warning of who should avoid ozone exposure, and is promoting the use of Ozone filters. "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." The SoClean recall instructs:

Hose and Mask Adapter:
If you recently purchased a SoClean filter and only want 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

I have no idea what the adapter consists of, but it appears the objective is now to keep ozone from entering the CPAP machine. This is the weakest possible action on the part of the FDA and leaves a product known to cause harm to medical devices and sensitive patient populations on the market. SoClean has aggressively marketed this product through retail sales and DMEs and it's hard to know if patients are adequately warned of the known adverse effects and health effects prior to purchase, or that the purchase is optional and not recommended by the CPAP manufacturers.

[OpalRose]

It's not a recall of the actual SoClean machines, but a recall to obtain a new version of the user manual, and the Hose and Mask Adapter.

Maybe the Thread Title should be changed.

Directions for download of the manual are in this link:  https://www.soclean.com/field-correction

Scroll down to "Actions to be Taken by You".  There is also a phone number to call if you wish to receive the Hose and Mask Adapter.

[Sleeprider]

The thread title follows the same language used by the FDA announcement:
Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication