PowerPICC Catheters recalled for deficient manufacturing practices
Bard Access Systems, Inc. is recalling multiple PowerPICC catheter models due to lidocaine ampoules being 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: FDA Class II recall. The source states deficient manufacturing practices but does not report any adverse events, illnesses, or injuries, making this a precautionary recall based on manufacturing quality issues rather than demonstrated harm.
Plain-English summary
Bard Access Systems, Inc. is recalling multiple PowerPICC catheter models, including PowerPICC Catheter, PowerPICC SOLO Catheter, PowerPICC SOLO FT Catheter, PowerPICC HF Catheter, and PowerPICC Provena Catheter in various configurations and sizes. The recall is due to lidocaine ampoules being manufactured under deficient manufacturing practices by the supplier.
Approximately 39,245 units have been distributed nationwide throughout the United States, including Alaska, Hawaii, and Puerto Rico, as well as to Belgium.
Patients and healthcare providers who have these catheters in stock should contact Bard Access Systems, Inc. for further instructions regarding the recalled products. Healthcare facilities should check their inventory against the provided lot numbers to identify affected units.
The recalled product
- Product
- 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1174108D4 PowerPICC Catheter 4 Fr…
- Manufacturer
- Bard Access Systems, Inc.
- Affected units
- 39,245
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.
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