The Recall Desk
HighFDA (Devices)·Z-1654-2021·Announced 2021-05-26

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.

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 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
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. REDY1755

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 →

Related recalls

Same manufacturer · Bard Access Systems Inc.

See all →

Same hazard · device defect

See all →