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Hemodialysis Bloodlines recallZ-1799-2026 · B Braun Medical Inc · initiated Mar 19, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from B Braun Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

FDA root cause category: Device Design

What the company is doing

B. Braun notified consignees on about 03/19/2026 via letter titled URGENT MEDICAL DEVICE CORRECTION. Consignees were instructed to use alternative dialysis equipment and disposables, if possible. If not, BBMI recommends the following actions that can help mitigate potential harm should you need to use sets impacted by this field action on patients: 1. Ensure full adherence to both the bloodline and dialysis machine Instructions for Use (IFU). a. Streamline bloodlines - strict adherence to the priming process as outlined in the IFU, with special emphasis on Step 26. b. B3 bloodlines - strict adherence to the priming process as outlined in the IFU, with special emphasis on Step 12. 2. If possible, avoid high flow during treatment if small air bubbles are present. 3. Avoid retrograde rinseback if small air bubbles are present. 4. Be alert for a follow-up communication indicating the issue is resolved. Consignees were also instructed to review the customer notification its entirety, ensure all affected personnel are notified and aware of the issue, post the notification where the affected products are stored, and complete and return the response form. For distributors, they were instructed to forward the notification to all consignees as this recall extends to the consumer level. B. Braun will provide a follow up communication to users when lots with corrective actions are available, and users may resume high flow treatment and use of retrograde rinseback where indicated.

Recall details

Recall number
Z-1799-2026
Status
Open, Classified
Initiated by the company
Mar 19, 2026
Posted by the FDA
Apr 15, 2026
Recalling firm
B Braun Medical Inc
Quantity
2,653,711 units
Product code
FJK
FDA submissions
K080807
Distribution
Worldwide distribution - US Nationwide and the country of Canada.

Product description

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096

Code information (models, lots, serial numbers)

Model Number: SL-2010M2096; UDI-DI Primary: 04046964367786; UDI-DI Unit: 04046964367779; All lots manufactured since 25MAY2025.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 98552).

Sources and updates

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