Z-1801-2026Class I

B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L

Name: Z-1801-2026 B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L
Creator: B Braun Medical Inc
Published: 2026-03-19
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2026-03-19 / Open, Classified / root cause: design

FDA source

B Braun Medical Inc began a recall of B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L on 2026-03-19. FDA classified it as Class I and gives the reason as "Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1801-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-03-19
Posted: 2026-04-15
Recalling firm: B Braun Medical Inc
Product: B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
Product code: FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 328,640 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: Model Number: SL-2000M2095L; UDI-DI Primary: 04046955348909; UDI-DI Unit: 04046955348893; All lots manufactured since 29JUN2025.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1801-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1798-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-15
Z-1799-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-15
Z-1800-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-15
Z-1801-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-15
Z-1802-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-15
Z-1803-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-15

Product code FJK

K080807Class IIBlood Tubing Sets (Sterile Fluid Path)Nxstage Medical, Inc. / cleared 2008-07-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)