Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2664-2026·Announced 2026-07-08

PowerPICC Provena Catheters recalled for deficient manufacturing practices

Bard Access Systems is recalling PowerPICC Provena Catheters due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects 29,490 units distributed nationwide and in Belgium.

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. The source text describes deficient manufacturing practices in the lidocaine ampoules but does not report any illness, injury, or hospitalization cases. The hazard is precautionary rather than confirmed, placing this in the Moderate category.

Plain-English summary

Bard Access Systems, Inc. is recalling multiple models of PowerPICC Provena Catheters, including the PowerPICC Provena SOLO and PowerPICC Provena Catheter models in 3 Fr single-lumen and 4 Fr dual-lumen configurations. The recall is being issued because lidocaine ampoules included with these products were manufactured under deficient manufacturing practices by the ampoule manufacturer.

These catheters are indicated for short and long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and central venous pressure monitoring.

The recalled catheters have been distributed nationwide throughout the United States, including all 50 states, Puerto Rico, Washington DC, and to Belgium. A total of 29,490 units have been affected by this recall. Specific lot numbers for each model are available from the FDA.

Patients and healthcare providers should contact Bard Access Systems for instructions on managing affected catheters and for information on replacements or alternatives.

The recalled product

Product: CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188800 CK000884A PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741219177 CK001000…
Manufacturer: Bard Access Systems, Inc.
Category: Medical Device — Central Venous Catheter
Hazard: deficient-manufacturing
contamination-risk
Affected units: 29,490

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

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 →

Same manufacturer · Bard Access Systems, Inc.

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