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Stryker Medical Division of Stryker Corporation recalls IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, P
Recalled August 18, 2021 · FDA recall Z-2213-2021 · 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
3 units
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
IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
Manufacturer(s)
Stryker Medical Division of Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →