Bard Access Systems Recalls Groshong NXT ClearVue Catheters Due to Connector Defects
Bard Access Systems is recalling specific Groshong NXT ClearVue Catheters because connector defects 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 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 recall is classified as FDA Class II. The source text describes mechanical defects that prevent device function but does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bard Access Systems Inc. is recalling the Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen. The recall affects Lot No. reep1720, which was distributed worldwide and in numerous US states. The product is designed for use when central venous catheterization is prescribed.
The recall was initiated due to two specific manufacturing issues. First, the inner diameter of the distal 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 catheters and contact Bard Access Systems for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035996 - Product Usage: is designed for use when central venous catheterization is prescribed.
- Manufacturer
- Bard Access Systems Inc.
- Category
- Medical Device — Catheters
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. reep1720
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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