BEUDAMED
    FDA Recall Open, Classified

    Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F

    Recall: Z-2066-2026 · Initiated April 2, 2026

    Recall

    Recall Number
    Z-2066-2026
    Event Number
    98741
    Firm
    Windstone Medical Packaging, Inc.
    FEI Number
    1000125955
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    April 2, 2026
    Posted
    May 8, 2026
    Address
    1602 4th Ave N, Billings, MT, 59101-1521

    Description

    Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F

    Reason

    Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.

    Action

    Firm began notifying consignees via email on April 2, 2026. Notice was titled "URGENT: MEDICAL DEVICE RECALL." Consignees were instructed to check inventory and quarantine affected products. Firm instructed consignees to over-label affected products with a sticker which states that at the time the kit is opened, the affected Medline syringe should be identified and set aside, and that the affected syringe should be rendered unusable and disposed of. Firm will provide labels for any kits that need to be identified.

    Distribution

    US Nationwide distribution in the state of Arizona.

    Quantity

    150 kits (US only)