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.
What this means for you
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.
- Hazard
- manufacturing-defect
- ampoule-deficiency
Distribution
Distributed nationwide across the United States.
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