The Recall Desk
ModerateFDA (Devices)·Z-1660-2021·Announced 2021-05-26

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.

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 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
Hazard

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

Distributed nationwide across the United States.

The notice also names 33 states specifically:

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.

See all 18 products in this recall →

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Same hazard · mechanical defect

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