BEUDAMED
    FDA Recall Open, Classified

    AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324

    Recall: Z-0187-2024 · Initiated August 24, 2023

    Recall

    Recall Number
    Z-0187-2024
    Event Number
    93147
    Firm
    MICROVENTION INC.
    FEI Number
    3013556777
    Product Code
    KRD
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 24, 2023
    Posted
    October 27, 2023
    Address
    35 Enterprise, Aliso Viejo, CA, 92656

    Description

    AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324

    Reason

    Peripheral coil system detachable has a potential of unsealed pouch packaging.

    Action

    On 8/22/23, recall notices were mailed to customers, who were asked to do the following: 1) Stop using, quarantine, and return affected devices to the firm. 2) Complete and return the customer acknowledgement form via email to [email protected]. Inquires can be directed to customer service at 800-990-8368

    Distribution

    US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.

    Quantity

    14