FDA-Device2026-07-08Class IIPROCESSING DEFECT
Bard PowerPICC SOLO HF Catheter recalled due to defective lidocaine ampoules
What this means
Bard Access Systems is recalling PowerPICC SOLO HF Catheters (5 Fr Triple-Lumen) because the lidocaine ampoules included with the kit were manufactured under deficient manufacturing practices. The affected lot (REKT1554) was distributed nationwide and internationally.
- Check if you have lot number REKT1554 of the PowerPICC SOLO HF Catheter
- Contact Bard Access Systems for instructions on returning or replacing the affected catheter kits
- Do not use catheters from the affected lot until you receive guidance from Bard
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
66
Manufactured in
605 N 5600 W, N/A, Salt Lake City, UT, United States
Products
CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2658-2026More Bard Access Systems, Inc. recalls
- FDA-Device2026-07-08Bard Access Systems Power-Trialysis dialysis catheters recalled for deficient lidocaine ampoule manufacturing
- 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
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