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

FDA device recall Z-2394-2023 · posted 2023-08-11 · Open, Classified

Recall details

Recalling firm

Stryker Sustainability Solutions

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.

Action taken

On 6/21/23, recall notices were distributed to customers who were asked to do the following: 1) Return affected devices. 2) Complete and return the Business Reply form to SSSPFA@stryker.com 3) If any of the affected product have been forwarded to additional facilities (including but not limited to distribution warehouses), contact these facilities and communicate this recall to them and instruct them to complete and return the Business Reply Form. Adverse reactions or quality problems can be reported to the Complaint Hotline: +1-888-763-8803 or http://www.stryker.com/productexperience

Root cause

Packaging process control

Status

Open, Classified

Product code

FRZ

Quantity affected

340

Distribution

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

Date initiated

2023-06-21

Date posted

2023-08-11

Location

Tempe, AZ