5008X
Fresenius Medical Care Renal Therapies Group, LLC · Model 03-5350-8 · UDI-DI 00840861102525
FJK
Prescription
1
510(k) clearances
8,011
Adverse events (307 deaths)
35
Recalls
63
Facilities
Description
5008X HD/HDF - with Twister Blood Tubing Set
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-19 | B Braun Medical Inc | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. |
| 2026-03-19 | B Braun Medical Inc | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. |
| 2026-03-19 | B Braun Medical Inc | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. |
| 2026-03-19 | B Braun Medical Inc | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. |
| 2026-03-19 | B Braun Medical Inc | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. |
| 2026-03-19 | B Braun Medical Inc | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. |
| 2025-09-30 | B BRAUN MEDICAL INC | The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors. |
| 2024-08-15 | B Braun Medical Inc | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rins |
| 2024-08-15 | B Braun Medical Inc | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rins |
| 2024-08-15 | B Braun Medical Inc | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rins |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.