Home › Device types › FJK
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
FDA product code FJK · Class 2 · Gastroenterology, Urology
194
Registered devices
8,171
Adverse events
36
Recalls
77
510(k) clearances
Devices with this code
VITAL — VITAL HEALTHCARE SDN. BHD.NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET — NIPRO MEDICAL CORPORATIONPlasma Exchange Tubeset — ASAHI KASEI MEDICAL AMERICA INC.Tablo(R) Cartridge — Outset Medical, Inc.SUNDER — SUNDER BIOMEDICAL TECH. CO., LTD.B.BRAUN — B. BRAUN MEDICAL INC.Streamline Airless System Set with Locksite Needleless Access Sites — NXSTAGE MEDICAL, INC.Moda-flx Hemodialysis System — Diality IncTablo(R) Cartridge — Outset Medical, Inc.ICU Medical — ICU MEDICAL, INC.NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET — NIPRO MEDICAL CORPORATION5008X — Fresenius Medical Care Renal Therapies Group, LLCNA — GAMBRO DASCO SPADiapact® — B. BRAUN MEDICAL INC.Tablo(R) Cartridge — Outset Medical, Inc.CombiSet — Fresenius Medical Care Holdings, Inc.ICU Medical — ICU MEDICAL, INC.SLIMLINE™ BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET — NIPRO MEDICAL CORPORATIONICU Medical — ICU MEDICAL, INC.NovaLine — Bain Medical Equipment (Guangzhou) Co., Ltd.Recirculation Adapter/Priming Connector — Gambro Renal Products, S.A. de C.V.NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET — NIPRO MEDICAL CORPORATIONLifemed 60 inch Monitor Line — LIFEMED OF CALIFORNIAFresenius HemaClip — Fresenius Medical Care Holdings, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-29 | Fresenius Medical Care Renal Therapies Group, LLC | Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed. |
| 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 |
| 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 |
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