FDA DevicesClass I
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number:...
Published: April 22, 2026Recall ID: Z-1800-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Product Description & Identification
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
Additional Source Details
| Field | Value |
|---|---|
| City | Bethlehem |
| State | PA |
| Event id | 98552 |
| Address 1 | 824 12th Ave |
| Address 2 | N/A |
| Code info | Model Number: SL-2000M2095DA; UDI-DI Primary: 04046955776023; UDI-DI Unit: 04046955776016; All lots manufactured since 09JUN2025. |
| Postal code | 18018-3524 |
| Report date | 20260422 |
| Product type | Devices |
| Product quantity | 1,174,271 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260319 |
| Initial firm notification | Letter |
| Center classification date | 20260415 |
Overview
- Recalling FirmB Braun Medical Inc
- StatusOngoing
- Risk LevelClass I
- DistributionWorldwide distribution - US Nationwide and the country of Canada.