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Recall Observatory FDA recall evidence

Device product

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

Z-2394-2023

June 21, 2023

Class II

Product summary

Firm
Stryker Sustainability Solutions
Event
Event 92655
Status
Ongoing
Classification
Class II
Quantity
340
Official record key
device-enforcement:Z-2394-2023

Official wording

Reason: 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.

Code information: UDI-DI: 07613327487718, Lot: 0000185127, Distribution Dates: 11/28/2022-12/08/2022

Distribution pattern: US: WI, ID, CA, FL, HI, MD, RI, AZ, MA, GA, IL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.