Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096

FDA device recall Z-0070-2026 · posted 2025-10-22 · Open, Classified

Recall details

Recalling firm

B BRAUN MEDICAL INC

Reason for recall

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

Action taken

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 recalls@bbraunusa.com 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.

Root cause

Process control

Status

Open, Classified

Product code

FJK

Quantity affected

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

Distribution

Domestic: US Nationwide Distribution.

Date initiated

2025-09-30

Date posted

2025-10-22

Location

Allentown, PA

Related 510(k) clearances