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Product Notices and Recalls

Look here for future information on product recalls, product notices, etc.

Notice Type	Date	Product Notice
Field Notification	11/16/2023	Medical Device Field Correction
Recall Notice	7/25/2023	Portable Outlet Backup Battery/UPS V2 Recall

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Contraindications for Use: Persons with underlying lung diseases, such as asthma and chronic obstructive pulmonary disease (also known as COPD, which includes emphysema and chronic bronchitis), and those with cardiovascular disease may be sensitive to ozone and should consult with their health care professional before using this product. Safety in pregnant or breastfeeding women and children under the age of 22 have not been established. Consult with your health care professional before using this product.

Any mention of the term "bacteria" references the disclaimer * and any mention of the terms, "accessory" or "hose and mask" references the disclaimer **.

^*The SoClean 3+ device is intended to be used as an adjunct to reduce bacterial populations on certain compatible home use CPAP mask and ventilation hoses after cleaning. An in vitro 3-log (99.9%) bacterial reduction by SoClean 3+ has been demonstrated for the following bacteria: Staphylococcus aureus (ATCC 6538), Klebsiella aerogenes (ATCC 13048), Staphylococcus haemolyticus (ATCC 29970), Escherichia coli (ATCC 11229), Staphylococcus hominis (ATCC 27844), Klebsiella pneumoniae (ATCC 4352), Pseudomonas aeruginosa (ATCC 15442), and Streptococcus pyogenes (ATCC 14289) after a complete processing cycle. Any correlation between in vitro results and clinical outcome has not been established.

^**The SoClean 3+ bacterial reduction device is an over-the-counter device for single patient home use. This device must not be used to replace the cleaning procedures as recommended by the CPAP mask and hose manufacturers. SoClean 3+ has been tested for use with ResMed Mirage FX (nasal mask), ResMed ClimateLine Air (tubing), and SlimLine (tubing) for ResMed AirSense 10 CPAP device. The safe use of SoClean 3+ with any other respiratory devices or accessories has not been established.

^***Free standard shipping on most orders over $50. An additional surcharge may apply to some items due to their size and/or weight. The surcharge, if applicable, will be noted on the product page as well as the shipping subtotal of your order. 2-year warranty and 30-day risk free trial applicable to the SoClean 3, SoClean O3 Smarthome Cleaning System^™, and SoClean Air Purifier+ only.

^****SoClean is an independent company not affiliated with ResMed Inc. Names and associated trademarks are solely owned by the respective companies and manufacturers. Depictions of brand logos are for informational and educational purposes only and are used for customer equipment recognition.

^†FDA-Cleared

© SoClean® is a registered trademark owned by SoClean Inc. All Rights Reserved.

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