ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009

Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Code information: Serial Numbers: 20170928500311838 UDI: 07613327277852 07613327277937

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.