BEUDAMED
    FDA Recall Terminated

    PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19

    Recall: Z-1238-2022 · Initiated April 21, 2022

    Recall

    Recall Number
    Z-1238-2022
    Event Number
    90172
    Firm
    Oakworks Inc
    FEI Number
    1000121370
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    April 21, 2022
    Terminated
    September 19, 2024
    Address
    923 E Wellspring Rd, New Freedom, PA, 17349-8408

    Description

    PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19

    Reason

    Product label was printed without the UDI number and warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.

    Action

    On April 21, 2022, the firm notified customers via mail and email of the field action. Customers should identify and locate all affected products. Distributors should quarantine the product and notify any customers who have received the product. For users, the product remains functional and can continue to be used. All customers should complete the included response form and return to Oakworks. Oakworks will set up a service visit to replace the labels on the affected beds. If you have any questions or concerns, please contact Oakworks Customer Service Department at 800-558-8850 or 717-235-6807 Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time.

    Distribution

    US Nationwide distribution in the states of MA, NJ, and PA.

    Quantity

    130