BEUDAMED
    FDA Enforcement Class II Ongoing

    Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations

    Recall: Z-1658-2025 · Reported April 30, 2025

    Enforcement

    Recall Number
    Z-1658-2025
    Event ID
    96497
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Edge Biologicals Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 30, 2025
    Initiation Date
    October 2, 2023
    Classification Date
    April 23, 2025
    Address
    598 N 2nd St, N/A, Memphis, TN, 38105-1634, United States

    Description

    Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations

    Reason

    Due to product outer packaging incorrectly labeled.

    Code Info

    Product Number: T-0780 UDI-DI code: B645T-07803012232023012320240123100E Lot Numbers: 01223

    Distribution

    U.S. Nationwide distribution in the state of PA.

    Quantity

    660 units