B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.

FDA device recall Z-1803-2026 · posted 2026-04-15 · Open, Classified

Recall details

Recalling firm

B Braun Medical Inc

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

FJK

Quantity affected

4,884 units

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Date initiated

2026-03-19

Date posted

2026-04-15

Location

Bethlehem, PA

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