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ICU Medical

ICU MEDICAL, INC. · Model B9756 · UDI-DI 00887709015166

FJK
1
510(k) clearances
8,011
Adverse events (307 deaths)
35
Recalls
63
Facilities

Description

132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave®, 4-Way Stopcock, Rotating Luer, 1 Ext

Recalls

DateFirmReason
2026-03-19B Braun Medical IncPotential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
2026-03-19B Braun Medical IncPotential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
2026-03-19B Braun Medical IncPotential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
2026-03-19B Braun Medical IncPotential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
2026-03-19B Braun Medical IncPotential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
2026-03-19B Braun Medical IncPotential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
2025-09-30B BRAUN MEDICAL INCThe potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
2024-08-15B Braun Medical IncIncomplete 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
2024-08-15B Braun Medical IncIncomplete 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
2024-08-15B Braun Medical IncIncomplete 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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Data 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.