Recall Z-2394-2023— Stryker Sustainability Solutions
Class II · Ongoing
Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2023-06-21. FDA's recall record names no specific 510(k) clearance for this event. Product: HoverMatt, 39" W x 78" L, REF: HM39SPU-B. 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..
- Recalling firm
- Stryker Sustainability Solutions
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-06-21
- Firm location
- Tempe, AZ, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.