BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1982-2026 · Initiated April 7, 2026

    Recall

    Recall Number
    Z-1982-2026
    Event Number
    98657
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    KZJ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 7, 2026
    Posted
    April 29, 2026
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    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.

    Action

    On 04/07/2026, BD sent URGENT: Medical Device Correction letters to customers and distributors. Consignees were instructed that there are no recommendations for retrospective chart review or repeat patient testing. They are to verify incubation atmospheres by incorporating the use of appropriate gas indicators as part of routine laboratory quality control practices. Each BD GasPak EZ Gas Generating Pouch System should be tested periodically for its ability to provide adequate conditions for the growth of target organisms. For CO2 incubation, laboratories may use BD CO2 Indicators (Catalog No. 271055), along with the impacted catalog 260684, to verify sufficient CO2 presence in the environment. If conditions are not confirmed or are suspected to be out of specification, laboratories should repeat incubation using alternative validated methods or established laboratory procedures to ensure organism recovery. Additionally, consignees were instructed to ensure the contents of the notification are read and understood, share this notification with the facility network and forward it to any customers to whom product may have been distributed, and complete and return the Customer Response Form. Distributors were instructed to ensure the notification is read and understood, identify all customers that purchased any affected product, and provide a copy of the attached customer letter to all customers who received the affected lots to advise them of this Product Advisory on BD's behalf. BD is investigating the root cause and will implement appropriate corrective actions to prevent recurrence of this issue. BD GasPak catalog numbers 260684 and 260685 are currently on backorder due to seal integrity challenges identified in some batches following a recent overhaul of supplier manufacturing equipment. BD anticipates resumption of product shipments by the end of March 2026, with full recovery expected by June 2026.

    Distribution

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

    Quantity

    25,760 units