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Stryker Medical Division of Stryker Corporation recalls Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (incl
Recalled August 18, 2021 · FDA recall Z-2215-2021 · Stryker Medical Division of Stryker
Hazard
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 · FDA Class II
Units
1 unit
Sold at
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Description
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
Product
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
Manufacturer(s)
Stryker Medical Division of Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →