BEUDAMED
    FDA Recall Open, Classified

    Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.

    Recall: Z-0928-2026 · Initiated November 14, 2025

    Recall

    Recall Number
    Z-0928-2026
    Event Number
    98045
    Firm
    AVID Medical, Inc.
    FEI Number
    1047429
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 14, 2025
    Posted
    December 15, 2025
    Address
    9000 Westmont Dr, Toano, VA, 23168-9351

    Description

    Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.

    Reason

    Potential for incomplete seal on header bag.

    Action

    AVID Medical notified consignees on 11/14/2025 via emailed letter. Consignees were instructed to identify, segregate and quarantine all impacted product on hand, discontinue use of all affected units, and discard them. Distributors were instructed to notify customers if any of the affected kits were further distributed. Additionally, consignees were requested to complete and return the Recall Response Form.

    Distribution

    US distribution to GA, IL, NE, MD.

    Quantity

    300 units