Home › Device types › NIE
Catheter, Hemodialysis, Triple Lumen, Non-Implanted
FDA product code NIE · Class 2 · Gastroenterology, Urology
373
Registered devices
825
Adverse events
38
Recalls
12
510(k) clearances
Devices with this code
PowerTrialysis — Bard Access Systems, Inc.MAHURKAR — Mozarc Medical US LLCARROW — TELEFLEX INCORPORATEDARROW — TELEFLEX INCORPORATEDTRIO-CT® — Medical Components, Inc.TRIO-CT® — Medical Components, Inc.MAHURKAR Elite — Mozarc Medical US LLCMAHURKAR — Mozarc Medical US LLCT-3T-3 — Medical Components, Inc.T-3 Triple Lumen CT — Medical Components, Inc.Power-Trialysis catheter — Bard Access Systems, Inc.T-3 Triple Lumen CT — Medical Components, Inc.ARROW — TELEFLEX INCORPORATEDARROW — TELEFLEX INCORPORATEDMAHURKAR — Mozarc Medical US LLCMAHURKAR — Mozarc Medical US LLCTRIO-CT® — Medical Components, Inc.T-3 TRIPLE LUMEN CT — Medical Components, Inc.T-3 TRIPLE LUMEN — Medical Components, Inc.PowerTrialysis — Bard Access Systems, Inc.T-3 TRIPLE LUMEN CT — Medical Components, Inc.TRIO-CT — Medical Components, Inc.12F TRI-FLOW TRIPLE LUMEN CATHETER12F TRI-FLOW TRIPLE LUMEN CATHETER — Medical Components, Inc.MAHURKAR — Mozarc Medical US LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-21 | Bard Access Systems, Inc. | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplie |
| 2026-05-21 | Bard Access Systems, Inc. | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplie |
| 2026-04-21 | ARROW INTERNATIONAL, LLC | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality iss |
| 2025-10-17 | Mozarc Medical US LLC | A potential issue with the seal integrity of header bag packaging. |
| 2025-10-17 | Mozarc Medical US LLC | A potential issue with the seal integrity of header bag packaging. |
| 2025-10-17 | Mozarc Medical US LLC | A potential issue with the seal integrity of header bag packaging. |
| 2025-10-17 | Mozarc Medical US LLC | A potential issue with the seal integrity of header bag packaging. |
| 2025-10-17 | Mozarc Medical US LLC | A potential issue with the seal integrity of header bag packaging. |
| 2025-10-17 | Mozarc Medical US LLC | A potential issue with the seal integrity of header bag packaging. |
| 2023-06-28 | Covidien LP | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which |
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