BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2394-2023 · Initiated June 21, 2023

    Recall

    Recall Number
    Z-2394-2023
    Event Number
    92655
    Firm
    Stryker Sustainability Solutions
    FEI Number
    3009350690
    Product Code
    FRZ
    Status
    Open, Classified
    Root Cause
    Packaging process control
    Initiated
    June 21, 2023
    Posted
    August 11, 2023
    Address
    1810 W Drake Dr, Tempe, AZ, 85283-4327

    Description

    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.

    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 [email protected] 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

    Distribution

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

    Quantity

    340