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Device Correction – SoClean

By January 24, 2024Recalls

About the Recall:

SoClean has received approximately 7,417 complaints resulting from improper set-up, unauthorized device modifications, and use by individuals for whom the device is not recommended as indicated in the user manual. Common complaints include the customer not being able to set up or turn to the device, mildew smell in the hose, excessive ozone smell, cough, and exacerbation of preexisting conditions.

Products(s) numbers/models that are affected:

SoClean2 / UPC 187293000860
SoClean3 / UDI (01) 00858242007147

Manufacturer Notice/Web Site:

www.soclean.com/field-correction

Actions to be taken by customer/Patient:

This voluntary field action does not require you to stop using or return your SoClean unit. Please download a new version of the User Manual by visiting: www.soclean.com/field-correction. To obtain a paper copy of the new version of the User Manual, simply contact Customer Care at 866-501-3705.