FDA Device recall Z-2661-2026
5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialy…
- FDA Device
- Class II
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class II recall of 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialy… by Bard Access Systems, citing due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2661-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-21 |
| Published | 2026-07-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Bard Access Systems |
| Distribution | US |
Product
5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 5865120 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107191 5865200 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI_DI Code: 00801741107214 5865240 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107221 The Power-Trialysis Slim-Cath Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
Reason
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Identifiers
| code_info | 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177…5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 Lot Number: REKY2412 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 Lot Number: REKY1364 5865120 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107191 Lot Number: RELN0881 5865200 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI_DI Code: 00801741107214 Lot Number: REKY1381 5865240 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107221 Lot Number: REJZ0927 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2661-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.