BEUDAMED
    FDA Enforcement Class II Terminated

    Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)

    Recall: Z-0792-2020 · Reported January 15, 2020

    Enforcement

    Recall Number
    Z-0792-2020
    Event ID
    83970
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cochlear Americas Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 15, 2020
    Initiation Date
    December 18, 2018
    Classification Date
    January 9, 2020
    Termination Date
    January 28, 2021
    Address
    13059 E Peakview Ave, N/A, Centennial, CO, 80111-6511, United States

    Description

    Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)

    Reason

    Product was packaged with the Incorrect tamper proof battery door.

    Code Info

    Part Number: P1129017 UDI Number: 09321502041096 Lot Number: COH1253733

    Distribution

    Domestic: CA, FL, IL, IN, MA, MO, NY, SD, TN, and TX OUS Regions; Asia Pacific (APAC), and Europe, The Middle East and Africa (EMEA)

    Quantity

    50 units