FDA recall record

Stryker Sustainability Solutions HoverMatt, 39" W x 78" L, REF: HM39SPU-B recall — FDA Z-2394-2023

39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a decreased surface area available to distribute…

Class IIclassification
Z-2394-2023official record ID
Aug 16, 2023report date

Recall record at a glance

Official recordZ-2394-2023
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmStryker Sustainability Solutions
Report dateAug 16, 2023
Recall initiation dateJun 21, 2023
Quantity340
LocationTempe, AZ, United States

Official product description

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

Why the product was recalled

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 information

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

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

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