BEUDAMED
    FDA Recall Open, Classified

    Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B

    Recall: Z-2606-2026 · Initiated May 28, 2026

    Recall

    Recall Number
    Z-2606-2026
    Event Number
    99209
    FEI Number
    1417592
    Product Code
    OES
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    May 28, 2026
    Posted
    June 26, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B

    Reason

    Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.

    Action

    On May 28, 2026, the firm notified customers via letters titled "URGENT MEDICAL DEVICE CORRECTION." Customers were referred to BD's recall notice, which provides advice for users and instructions to mitigate hub breakage issues. Product return is not required. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

    Distribution

    US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.

    Quantity

    9,272 kits