BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A

    Recall: Z-0070-2026 · Initiated September 30, 2025

    Recall

    Recall Number
    Z-0070-2026
    Event Number
    97609
    Firm
    B BRAUN MEDICAL INC
    FEI Number
    3013764800
    Product Code
    FJK
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 30, 2025
    Posted
    October 22, 2025
    Address
    861 Marcon Blvd, Allentown, PA, 18109-9577

    Description

    Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A

    Reason

    The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.

    Action

    On September 29, 2025, "URGENT MEDICAL DEVICE CORRECTION" letters dated September 24, 2025, were sent to customers. Actions to be taken: 1. Ensure full adherence to the product Instructions for Use (IFU). In particular, the instructions for secure connection of patient connectors should be followed to reduce the probability of air ingress or leakage. 2. Increase visual inspection of the bloodlines during treatment. If air ingress or leakage is observed, re-secure or tighten connection using the product IFU. In some instances, the dialysis treatment should be stopped. 3. If re-securement or tightening connections does not resolve the concern, replace bloodline at earliest clinically feasible time. 4. If possible, avoid high flow during treatment if microbubbles are present. B. Braun Medical Inc. (BBMI) Customer/User: 1. Review this notice in its entirety. Ensure that all users in your organization of the above-mentioned products, and other concerned personnel are informed about this voluntary correction. Post this notification where the affected products are stored. Note: Product is not being returned as part of this correction notification. a. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The correction is to be extended to the consumer level. 2. Return the completed Urgent Medical Device Correction Acknowledgement Form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). If you have any questions, contact Director, Corporate Communications at 484-240-8373. ****Update 03/24/2026****On March 5, 2026, URGENT MEDICAL DEVICE CORRECTION letters were sent update letters out to notify of additional 15 lots impacted by the recall.

    Distribution

    Domestic: US Nationwide Distribution.

    Quantity

    1298454 units (1589674 - 3/5/26 Expansion)