Recall Z-2661-2026— Bard Access Systems, Inc.

Name: FDA recall Z-2661-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-21

Class II · Ongoing

Class II FDA medical device recall by Bard Access Systems, Inc., initiated 2026-05-21. It names one FDA 510(k) clearance: K141531. 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..

Recalling firm: Bard Access Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-05-21
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K141531 — POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETERC.R. Bard, Inc.·cleared 2015-06-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Data sourced from openFDA. This site is unofficial and independent of the FDA.