Z-2660-2026Class II

5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953...

Name: Z-2660-2026 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953...
Creator: Bard Access Systems, Inc.
Published: 2026-05-21
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2026-05-21 / Open, Classified / root cause: manufacturing process

FDA source

Bard Access Systems, Inc. began a recall of 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-Term Straight... on 2026-05-21. FDA classified it as Class II and gives the reason as "Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2660-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-21
Posted: 2026-07-02
Recalling firm: Bard Access Systems, Inc.
Product: 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 5605300 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086984 5615120 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075087 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5655120 Power-Trialysis Short-Term Alphacurve Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741066054 The Power-Trialysis" 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.
Product code: NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Reason for recall: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 05/21/2026, the firm FedEx'd an "URGENT: Medical Device Recall" letter informing customers/distributed that BD has become aware that the FDA has placed Lidocaine manufactured by Huons Co., Ltd. on import alert #66-40 - Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs. BD is recalling products that contain the affected lidocaine ampules. Customers are instructed to: 1. Not to use the affected Lidocaine ampules. 2. Secure an alternative local Lidocaine drug prior to entering the procedural environment. 3. Upon opening the kit, remove and destroy the drug product from the BD convenience kits/procedure trays at the point of use, within a controlled and sterile environment to maintain the sterility of the remaining components within the kit. All other kit/tray components are safe to use. 4. If affected Lidocaine ampule was previously used without issue, no additional treatment or clinical follow up is required. 5. If affected Lidocaine ampule was previously used with issue, report the incident per institutional guidelines and take any necessary actions. Additional actions to take: 1. Circulate this notice to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. 2. Post this notice on all inventory storage locations and any location where the product may be used. 3. Label affected kits/trays using the template provided in Appendix 2 to facilitate easy identification of products containing the affected ampules. The label can be printed using Avery template 5160. a. Apply the labels to the product without covering or obscuring any regulatory or traceability information. b. Apply to the top web of the kit/tray pressing firmly to ensure adhesion, while taking care not to damage or compromise the sterile barrier. For Questions - Contact North American Regional Complaint Center at 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompt
Quantity in commerce: 8,795
Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
Product codes and lots: 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 Lot Number: REKX1755 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 Lot Number: REKW0663 5605300 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086984 Lot Number: REKY2472 5615120 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075087 Lot Number: REKZ0393 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 Lot Number: REKQ1130 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 Lot Number: REKX3745 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 Lot Number: REKY2418 5655120 Power-Trialysis Short-Term Alphacurve Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741066054 Lot Number: REKY2420

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2660-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2655-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2656-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2657-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2658-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2659-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2660-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2661-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2662-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2663-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2664-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2665-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2666-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2667-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2668-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02

Product code NIE

K133456Class IIPower-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. / cleared 2014-09-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)