BEUDAMED
    FDA Enforcement Class II Terminated

    PediaLift Access Device, Device Identifier: B751PDLFT0

    Recall: Z-0931-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-0931-2020
    Event ID
    84591
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PediaLift LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 12, 2020
    Initiation Date
    July 3, 2019
    Classification Date
    February 1, 2020
    Termination Date
    May 15, 2020
    Address
    181 Illinois Ave S, N/A, Mansfield, OH, 44905-2825, United States

    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.

    Code Info

    Serial Numbers: PCL-HDPE-DL-1, PCL-HDPE-DL-2, PCL-HDPE-DL-3, PCL-HDPE-DL-4, PCL-HDPE-DL-5, PCL-HDPE-DL-6, PCL-HDPE-DL-7, PCL-HDPE-DL-8, PCL-HDPE-DL-9, PCL-HDPE-DL-10, PCL-HDPE-DL-11, PCL-HDPE-DL-12

    Distribution

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

    Quantity

    11