Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2665-2026·Announced 2026-07-08

Groshong NXT ClearVue Catheter Recalled Due to Manufacturing Deficiency

Bard Access Systems is recalling Groshong NXT ClearVue Catheters (4 Fr Single-Lumen) due to lidocaine ampoules manufactured under deficient practices. The product is distributed nationwide and internationally.

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 source indicates an FDA Class II recall. The hazard is a manufacturing deficiency in supplied ampoules with no reported illnesses or injuries documented in the source text, making this a precautionary recall.

Plain-English summary

Bard Access Systems, Inc. is recalling the Groshong NXT ClearVue Catheter 4 Fr Single-Lumen (UDI-DI Code: 00801741035258, Lot Number: REKY1686). The Groshong NXT PICC is used to provide short-term (less than 30 days) or long-term (greater than 30 days) peripheral access to the central venous system for intravenous therapy or blood sampling.

The recall has been issued because lidocaine ampoules supplied with the catheter were manufactured under deficient manufacturing practices. Approximately 120 units have been distributed nationwide across all U.S. states and territories, as well as to Belgium.

Patients and healthcare providers currently using or holding this product should contact Bard Access Systems, Inc. for further instructions regarding return or replacement of affected units.

The recalled product

Product: 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.
Manufacturer: Bard Access Systems, Inc.
Category: Medical Device — Catheter / PICC Line
Hazard: manufacturing-defect
ampoule-deficiency
Affected units: 120

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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