Bard Groshong NXT ClearVue Catheter Recalled for Connector Defects
Bard Access Systems is recalling Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.
What this means for you
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, but the source text does not report any injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Bard Access Systems Inc. is recalling the REF 7655405J Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm. The recall involves specific lot numbers distributed worldwide and across numerous US states. The product is designed for use when central venous catheterization is prescribed.
The recall was initiated due to two manufacturing issues with the 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 facilities and distributors should stop using the affected lots and contact Bard Access Systems for instructions on return or replacement. The source text does not report any specific injuries or illnesses associated with these defects.
The recalled product
- Product
- REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - 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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