PowerPICC SV Catheters recalled due to deficient lidocaine manufacturing
Bard Access Systems is recalling PowerPICC SV Catheters because lidocaine ampoules supplied with the product were manufactured under deficient practices.
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 no reported illnesses or injuries. The source text identifies a manufacturing deficiency without specifying the nature of the hazard or reporting any adverse health consequences, making this a precautionary recall that meets the Moderate severity threshold.
Plain-English summary
Bard Access Systems, Inc. is recalling PowerPICC SV Catheters, including the 4 Fr Dual-Lumen model (code 1274108D, lot REKW2449) and the 3 Fr Single-Lumen model (code 3173108D, lot REKV2227). These catheters are used for short or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
The recall is due to lidocaine ampoules being manufactured under deficient manufacturing practices by the supplier. A total of 624 units have been distributed.
The affected products were distributed nationwide throughout the United States (including Alaska, Hawaii, and Puerto Rico) and to Belgium. Patients currently using these catheters or healthcare providers in possession of recalled units should contact Bard Access Systems, Inc. for further instructions regarding replacement or proper handling.
The recalled product
- Product
- 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536 The PowerPlCC SV catheters are intended for short or long term peripheral access to the central venous system for intravenous…
- Manufacturer
- Bard Access Systems, Inc.
- Affected units
- 624
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
Similar recalls
- HighBard Access Systems Recalls PowerPICC Provena Catheters Due to Possible Leaks
FDA (Devices) · 2018-02-14
- LowBard Access Systems Recalls PowerPICC Solo Catheter Kits for Labeling Errors
FDA (Devices) · 2015-07-15
- HighPowerPICC Catheter Kits Recalled for Incorrect Micro-Introducer Components
FDA (Devices) · 2021-07-07
- LowBard Access Systems Recalls PowerPICC Solo Catheters for Labeling Errors
FDA (Devices) · 2015-07-15
- SevereBD 4 Fr Single-Lumen PowerPICC Catheters Recall Risk of Leaks
FDA (Devices) · 2025-04-23
- ModerateBard Access Systems Recalls MRI Low Profile Ports with Undersized Catheters
FDA (Devices) · 2014-01-29