BEUDAMED
    FDA Enforcement Class II Terminated

    Access Hi-Low Exam Tables, Model 6501-XX

    Recall: Z-2531-2018 · Reported August 1, 2018

    Enforcement

    Recall Number
    Z-2531-2018
    Event ID
    80164
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brewer Company, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 1, 2018
    Initiation Date
    March 29, 2018
    Classification Date
    July 24, 2018
    Termination Date
    August 29, 2019
    Address
    N88 W13901 Main St, N/A, Menomonee Falls, WI, 53051-2330, United States

    Description

    Access Hi-Low Exam Tables, Model 6501-XX

    Reason

    One lot, the wire harness was over-crimped on some of the connectors that go to the two vertical side switches on the exam table.

    Code Info

    Model 6501-XX, Lot/Serial No. HL018786, HL018787, HL018788, HL018789, HL018790, HL018791, HL018797, HL018805

    Distribution

    Devices distributed in WI, TX, MN and IL.

    Quantity

    7 devices