PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen Medical Device Recall
Bard Access Systems, Inc. is recalling PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen devices due to lidocaine ampoules manufactured under deficient manufacturing practices by the supplier.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with a manufacturing-practices deficiency in a supplied component (lidocaine ampoules). The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is manufacturing-based rather than an identified patient risk.
Plain-English summary
Bard Access Systems, Inc. is recalling the PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen (Model CK000662, UDI-DI Code: 00801741129674, Lot Number: REKT1554). The recall was initiated because lidocaine ampoules supplied with these catheters were manufactured under deficient manufacturing practices.
Approximately 66 units were distributed nationwide across the United States, including all 50 states plus Washington D.C., Puerto Rico, and Belgium.
Patients or healthcare providers who have received this product should contact Bard Access Systems, Inc. for instructions on whether their specific unit is affected and what steps should be taken.
The recalled product
- Product
- CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.
- Manufacturer
- Bard Access Systems, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 66
Distribution
Part of a larger recall action
This product is one of 14 recalled by Bard Access Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
Same manufacturer · Bard Access Systems, Inc.
See all →- SevereBard Access Systems Recalls Power-Trialysis Dialysis Catheters
FDA (Devices) · 2026-09-23
- SevereBard Access Systems Recalls DuoGlide Short-Term Dialysis Catheters
FDA (Devices) · 2026-09-23
- SevereBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- ModeratePowerPICC Provena Catheters recalled for deficient manufacturing practices
FDA (Devices) · 2026-07-08
- ModeratePoly Midline Catheters recalled due to manufacturing defects
FDA (Devices) · 2026-07-08
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighPowerPICC Catheter Kits Recalled for Incorrect Micro-Introducer Components
FDA (Devices) · 2021-07-07
- LowBard Access Systems Recalls PowerPICC Solo Catheter Kits for Labeling Errors
FDA (Devices) · 2015-07-15
- SevereBD 4 Fr Single-Lumen PowerPICC Catheters Recall Risk of Leaks
FDA (Devices) · 2025-04-23
- LowBard Access Systems Recalls PowerPICC Solo Catheters for Labeling Errors
FDA (Devices) · 2015-07-15
- HighBard Access Systems Recalls PowerPICC Provena Catheters Due to Possible Leaks
FDA (Devices) · 2018-02-14
- ModerateBard Access Systems Recalls PowerPICC Catheter Marketing Brochures
FDA (Devices) · 2015-09-30