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FDA (Device enforcement)Recalled 2023-06-21class ii

Stryker Sustainability Solutions: HoverMatt, 39" W x 78" L, REF: HM39SPU-B

Hazard

39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a decreased surface area available to distribute the patient's weight across, which may increase the effort exerted by staff for a lateral patient transfer, and there may be increased friction and shearing forces when the patient is moved resulting in skin tear injury.

Details from the source

Reason for recall: 39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a decreased surface area available to distribute the patient's weight across, which may increase the effort exerted by staff for a lateral patient transfer, and there may be increased friction and shearing forces when the patient is moved resulting in skin tear injury. Distribution: US: WI, ID, CA, FL, HI, MD, RI, AZ, MA, GA, IL Quantity: 340 Lot/code info: UDI-DI: 07613327487718, Lot: 0000185127, Distribution Dates: 11/28/2022-12/08/2022

UPC codes

07613327487718

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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