BEUDAMED
    FDA Recall Terminated

    AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Nada CI Q90 Sound Processor (CI-5280), Nada CI Q70 Sound Processor (CI-5245) and Nada CI Q30 Sound Processor (CI-5260) for cochlear implant.

    Recall: Z-0486-2021 · Initiated September 26, 2020

    Recall

    Recall Number
    Z-0486-2021
    Event Number
    86536
    Firm
    Advanced Bionics, LLC
    FEI Number
    1000220815
    Product Code
    MCM
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 26, 2020
    Posted
    November 25, 2020
    Terminated
    May 4, 2023
    Address
    28515 Westinghouse Pl, Valencia, CA, 91355-1398

    Description

    AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Nada CI Q90 Sound Processor (CI-5280), Nada CI Q70 Sound Processor (CI-5245) and Nada CI Q30 Sound Processor (CI-5260) for cochlear implant.

    Reason

    Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

    Action

    On 9/26/2020 Advanced Bionics sent a "Field Correction Notification" to affected customers informing them about the mislabeled PowerCel Batteries. On October 5, 2020, Advanced Bionics sent a follow-up email to affected consignees. In addition, to informing consignees about the recall, the firm provided each affected consignee with the correct battery.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of NY, IL, MA, NE, CA, HI, LA, MS, AL, FL, SC, OH and the countries of Belgium, Germany, Italy Netherlands, Spain, Colombia, Czech Republic, Iran, Kuwait, Panama, Peru, Taiwan, Italy.

    Quantity

    53 units