BEUDAMED
    FDA Enforcement Class II Ongoing

    B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606108-02

    Recall: Z-2643-2023 · Reported October 4, 2023

    Enforcement

    Recall Number
    Z-2643-2023
    Event ID
    92910
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 4, 2023
    Initiation Date
    August 7, 2023
    Classification Date
    September 27, 2023
    Address
    901 Marcon Blvd, N/A, Allentown, PA, 18109-9512, United States

    Description

    B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606108-02

    Reason

    The sterile blister packaging may be damaged, and sterility may be compromised

    Code Info

    UDI-DI: 04046955597031 Lot Numbers: 22M28C8, 23A09C8

    Distribution

    US Nationwide distribution in the state of VA.

    Quantity

    534,000 units