BEUDAMED
    FDA Enforcement Class II Ongoing

    BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

    Recall: Z-1982-2026 · Reported May 6, 2026

    Enforcement

    Recall Number
    Z-1982-2026
    Event ID
    98657
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2026
    Initiation Date
    April 7, 2026
    Classification Date
    April 29, 2026
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212, United States

    Description

    BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

    Reason

    BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.

    Code Info

    Catalog Nunber: 260684; UDI-DI: 30382902606841; Lot Numbers: 5303157, 5329857, 5329860.

    Distribution

    Worldwide distribution - US Nationwide and the country of Hong Kong.

    Quantity

    25,760 units