Bard Groshong NXT ClearVue Catheter Recalled for Connector Defects
Bard Access Systems is recalling Groshong NXT ClearVue Catheters due to defects in the distal connector that may prevent 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.
Plain-English summary
Bard Access Systems Inc. is recalling the Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm (REF 7617408, Lot No. REDY1755). The product is designed for use when central venous catheterization is prescribed. The recall covers units distributed worldwide, including nationwide distribution in the United States and in various international markets.
The recall is due to two specific manufacturing issues with the distal connector. First, the inner diameter of the connector may be reduced, which could 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.
The source text does not report any illnesses, injuries, or deaths associated with this recall. Consumers and healthcare providers should stop using the affected product and contact Bard Access Systems for further instructions or replacement.
The recalled product
- Product
- REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035255 - Product Usage: is designed for use when central venous catheterization is prescribed.
- Manufacturer
- Bard Access Systems Inc.
- Category
- Medical Device — Catheter
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot No. REDY1755
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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