Provena Midline Catheters recalled due to deficient manufacturing practices
Bard Access Systems is recalling Provena Midline Catheters because lidocaine ampoules used in manufacturing were produced under deficient manufacturing practices by a 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: The recall is classified as FDA Class II. No illnesses, injuries, or deaths are reported in the source text, and the hazard (deficient manufacturing practices affecting lidocaine ampoules) is stated without indication of confirmed adverse health consequences. This meets the Moderate criterion for low-risk or precautionary recalls with no reported harm.
Plain-English summary
Bard Access Systems, Inc. is recalling Provena Midline Catheters in multiple configurations (3 Fr and 4 Fr, single-lumen and dual-lumen models). The catheters are intended for short-term peripheral intravenous access for selected therapies, blood sampling, and power injection of contrast media.
The recall is due to lidocaine ampoules being manufactured under deficient manufacturing practices by a supplier. Approximately 24,348 units have been distributed.
The affected products have been distributed nationwide throughout the United States and to Belgium. Affected lot numbers and UDI-DI codes are identified in the FDA notice. Consumers and healthcare providers should immediately stop using affected catheters and contact Bard Access Systems for instructions on return or replacement.
The recalled product
- Product
- CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 S4153108BP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153990 S4153108D Provena…
- Manufacturer
- Bard Access Systems, Inc.
- Affected units
- 24,348
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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