Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unstageable and Deep Tissue Pressure Injury, Model Number: 2972, Part # 2972000000
Check against the official notice below — it lists the full affected range.
Stryker Corporation's Isolibrium Support Surface, a device designed to help prevent and treat pressure injuries, was distributed to residential customers even though it was intended for use only in healthcare facilities. The device's labeling correctly states its intended use environment, but home users may not be aware of or fully understand the instructions written for healthcare professionals. The affected device has Serial Number 219009000417 and was distributed worldwide, including throughout the United States and in Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand.
The recall involves one unit of the product. According to the recall record provided, no specific remedy or consumer action is specified.
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: 1 unit Lot/code info: Serial Numbers: 219009000417 UDI: 07613327278453
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.