FDA recall Z-2394-2023

Product

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

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

Key facts

Status

Ongoing

Initiation date

2023-06-21

Report date

2023-08-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2394-2023