medical Class II Updated 2021-08-18

Stryker Medical Division of Stryker Corporation recalls Isolibrium Support Surface - support surface assists in the

Recalled 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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 219009000417 UDI: 07613327278453
View official government recall

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