FDA Medical Device Recalls (openFDA)
B Braun Medical Inc: B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
- Recall number
- Z-1800-2026
- Recalling firm
- B Braun Medical Inc
- Product
- B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
- Status
- Open, Classified
- Initiated
- 2026-03-19
- Posted
- 2026-04-15
- Terminated
- not on file
- Reason
- 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
- 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
- 1,174,271 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot, serial or model codes
- Model Number: SL-2000M2095DA; UDI-DI Primary: 04046955776023; UDI-DI Unit: 04046955776016; All lots manufactured since 09JUN2025.
- 510(k) numbers
- ["K080807"]
- PMA numbers
- not on file
- Product code
- FJK
- Firm FEI
- 2521402
- Firm city
- Bethlehem
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28