The Recall Desk
HighFDA (Devices)·Z-1652-2021·Announced 2021-05-26

Bard Groshong NXT ClearVue Catheter Recalled for Connector Defects

Bard Access Systems is recalling specific lots of 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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where the defect could impede proper use, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Bard Access Systems Inc. is recalling the REF 7617400 Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm. The recall affects Lot No. redx4723 and REEU3251. These medical devices are designed for use when central venous catheterization is prescribed.

The recall was initiated due to two manufacturing issues: the inner diameter of the distal connector may be reduced, resulting in the inability to pass the catheter through the connector, and the catch slot on the distal connector may be deformed, resulting in the inability to properly lock. The agency has classified this as a Class II recall.

The affected products were distributed worldwide, including nationwide in the United States and in various countries such as Australia, Belgium, Canada, China, Japan, and others. Healthcare providers and facilities should stop using the affected lots and contact Bard Access Systems for further instructions.

The recalled product

Product
REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - 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. redx4723 and REEU3251

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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