FDA Device Intelligence
Home › NIPRO MEDICAL CORPORATION › NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET

NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET

NIPRO MEDICAL CORPORATION · Model A223D/V809D · UDI-DI 00383790004176

FJK Prescription
10
510(k) clearances
8,114
Adverse events (307 deaths)
36
Recalls
62
Facilities

Description

PUMP SEGMENT 8.0 mm PRIMING VOLUME 141 ML EQUIPMENT FRESENIUS 2008

Recalls

DateFirmReason
2026-07-29Fresenius Medical Care Renal Therapies Group, LLCCommunication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.