FDA-Device2026-07-08Class IIPROCESSING DEFECT
Bard Access Systems Power-Trialysis dialysis catheters recalled for deficient lidocaine ampoule manufacturing
What this means
Bard Access Systems is recalling multiple lots of Power-Trialysis short-term dialysis catheters because the lidocaine ampoules included with them were manufactured under deficient manufacturing practices. The affected catheters come in straight, curved extension, and Alphacurve styles with model numbers 5605150, 5605240, 5605300, 5615120, 5615200, and 5655120.
- Check if your facility has any of the affected lot numbers: REKX1755, REKW0663, REKY2472, REKZ0393, REKQ1130, REKX3745, REKY2418, or REKY2420.
- Contact Bard Access Systems or your medical device supplier for instructions on handling and replacement of affected catheters.
- Do not use affected catheters until you receive guidance from Bard or your supplier.
The agency's original wording
Hazard
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
8,795
Manufactured in
605 N 5600 W, N/A, Salt Lake City, UT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2660-2026More Bard Access Systems, Inc. recalls
- FDA-Device2026-07-08Bard Access Systems PowerPICC catheters recalled for deficient lidocaine manufacturing
- FDA-Device2026-07-08Bard Access Systems soft tissue biopsy trays recalled for defective lidocaine ampoules
- FDA-Device2026-07-08Bard Access Systems PowerMidline Catheter recalled for deficient lidocaine ampoule manufacturing
- FDA-Device2026-07-08Bard Groshong NXT ClearVue Catheter recalled for deficient lidocaine ampoule manufacturing
- FDA-Device2026-07-08Bard Access Systems thoracentesis and paracentesis trays recalled for deficient lidocaine manufacturing
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