ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009
Check against the official notice below — it lists the full affected range.
Stryker Corporation is recalling ComfortGel pressure injury prevention and treatment devices (Model 2850) because the products were distributed to residential customers for home use, despite being intended for use only in healthcare facilities. The product labeling correctly identifies the proper use environment, but home users may not be aware of or fully understand the instructions that were designed for healthcare professionals. A total of 3 units have been affected, with distribution occurring worldwide including throughout the US and in Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand.
The recall involves specific units identified by Serial Numbers 20170928500311838 and UDI codes 07613327277852 and 07613327277937. According to the recall record provided, no specific remedy or action is specified for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand. Quantity: 3 units Lot/code info: Serial Numbers: 20170928500311838 UDI: 07613327277852 07613327277937
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.