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Power-Trialysis catheter
Bard Access Systems, Inc. · Model 5618240 · UDI-DI 00801741042003
NIE
Prescription
10
510(k) clearances
825
Adverse events (26 deaths)
38
Recalls
20
Facilities
Description
13Fr Trialysis PC 24cm Kit
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 supplier. |
| 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 supplier. |
| 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 issues and limited repo |
| 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 coats the catheter t |
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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.