BEUDAMED
    FDA Recall Terminated

    PediaLift Access Device, Device Identifier: B751PDLFT0

    Recall: Z-0931-2020 · Initiated July 3, 2019

    Recall

    Recall Number
    Z-0931-2020
    Event Number
    84591
    Firm
    PediaLift LLC
    FEI Number
    3012103974
    Product Code
    FMS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 3, 2019
    Terminated
    May 15, 2020
    Address
    181 Illinois Ave S, Mansfield, OH, 44905-2825

    Description

    PediaLift Access Device, Device Identifier: B751PDLFT0

    Reason

    The firm was unsuccessful in obtaining a satisfactory Certificate of Conformance from the original vendor of the mattress showing that they are in compliance with labeling requirements.

    Action

    Customers were contacted via email on 7/3/19. Customers were instructed to respond to the email so that replacement mattresses could be shipped. Letters dated 11/26/19 accompanied the replacement mattresses sent to customers. The letter instructed customers to please be advised that you must immediately dispose of the old mattress and utilize this replacement mattress. If you have any questions regarding this matter, feel free to contact us. Thank you, Jillena Atchison [email protected] 724-417-9180

    Distribution

    The products were distributed to the following US states: IN, NJ, NY, OH, and PA

    Quantity

    11