Recall Z-2394-2023 ยท FRZ Device, Patient Transfer, Powered
Stryker Sustainability Solutions
HoverMatt, 39" W x 78" L, REF: HM39SPU-B
| Date | Aug 11, 2023 (initiated Jun 21, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Packaging process control |
| Action | 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 |
| Quantity | 340 |
| Distribution | US: WI, ID, CA, FL, HI, MD, RI, AZ, MA, GA, IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.