BEUDAMED
    FDA Recall Open, Classified

    Pink Luminous Breast, Breast transilluminator

    Recall: Z-2269-2024 · Initiated May 20, 2024

    Recall

    Recall Number
    Z-2269-2024
    Event Number
    94539
    Firm
    Silkprousa LLC
    FEI Number
    3013213867
    Product Code
    LEK
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    May 20, 2024
    Posted
    July 5, 2024
    Address
    3257 Nw 7th Avenue Cir, Miami, FL, 33127-3313

    Description

    Pink Luminous Breast, Breast transilluminator

    Reason

    Firm is marketing and distributing the Pink Luminous Breast device without premarket approval

    Action

    SilkProUSA issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 05/16/2024 via FedEx air. The notice explained the issue, the potential risk to health, and requested the consignee quarantine all inventory and notify those to whom they distributed the product. The firm is seeking the return of the affected product.

    Distribution

    US Nationwide distribution in the states of WA, RI.

    Quantity

    2000 devices