BEUDAMED
    FDA Recall Open, Classified

    Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ

    Recall: Z-1981-2026 · Initiated March 19, 2026

    Recall

    Recall Number
    Z-1981-2026
    Event Number
    98720
    Firm
    American Contract Systems Inc
    FEI Number
    3008492337
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 19, 2026
    Posted
    May 6, 2026
    Address
    85 Shaffer Park Dr, Tiffin, OH, 44883-9290

    Description

    Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ

    Reason

    Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.

    Action

    Firm notified distributors with an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" dated March 19, 2026, via email. Distributors were instructed to notify end-users. An updated letter with additional kits was sent to the customer on 3/20/26. Customers should quarantine all affected product. Customers may add warning labels to affected ACS kits to ensure all users are aware of prescribed actions that were identified in the Medline recall notice. The warning labels state, "Per Medline, due to the risk of serious injury or death, customers are directed to remove and destroy all Namic RA Syringes. If use is unavoidable because failure to proceed would result in patient harm, the Namic RA syringe must be used with extreme caution and vigilance, including manual stabilization of syringe-to-manifold connections and continuous, 100% monitoring during setup and throughout the entire procedure." Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. If you have any questions, contact the Regulatory Affairs Manager, by email: [email protected] or at 419-455-2090.

    Distribution

    US distribution to MN. No OUS distribution.

    Quantity

    7,311 kits