BEUDAMED
    FDA Enforcement Class II Ongoing

    Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A

    Recall: Z-3079-2024 · Reported September 18, 2024

    Enforcement

    Recall Number
    Z-3079-2024
    Event ID
    94968
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Sol-Millennium Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2024
    Initiation Date
    May 9, 2024
    Classification Date
    September 6, 2024
    Address
    311 S Wacker Dr, Chicago, IL, 60606-6604, United States

    Description

    Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A

    Reason

    Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

    Code Info

    1) Model No. STCB01, UPC N/A, LOT NUMBERS: 4201063, 4209005, 4307016, 4308061, 4311036; 2) Model No. STCB02, UPC N/A, LOT NUMBERS: 4201064; 3) Model No. 110101150020, UPC N/A LOT NUMBERS: EXPIRED 4) Model No. STCT01, UPC: Sole in Canada only, LOT NUMBERS: 4301023, 4308072, 4308073, 4309043, 4310029, 04311037, 4312011, 4312093, 4402006

    Distribution

    US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia, Netherland, France, Switzerland, Latvia, UK, Spain, Germany, Philippines, Australia, Malaysia, Jamaica, Slovenia, Brazil, Taiwan, Denmark, Sweden, Singapore, Romania, Poland, Barbados, Mexico, Guatemala, Chile, Ireland, Italy, Panama