Bard Access Systems Recalls Groshong NXT ClearVue Catheter Kits
Bard Access Systems is recalling specific Groshong NXT ClearVue Catheter Basic Kits because the distal connector may be defective, preventing proper catheter passage or locking.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could prevent proper use or locking, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Bard Access Systems Inc. is recalling the REF 7617405 Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm. The product is designed for use when central venous catheterization is prescribed. The recall covers specific lot numbers distributed worldwide and across numerous US states and countries.
The recall was initiated due to two manufacturing issues with the catheter's distal connector. First, the inner diameter of the connector may be reduced, which can result in the inability to pass the catheter through the connector. Second, the catch slot on the distal connector may be deformed, resulting in the inability to properly lock the device.
Healthcare providers and facilities that have received these specific lot numbers should stop using the affected catheters and contact Bard Access Systems for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741086998 - Product Usage: is designed for use when central venous catheterization is prescribed.
- Manufacturer
- Bard Access Systems Inc.
- Category
- Medical Device — Catheter
Distribution
Part of a larger recall action
This product is one of 18 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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