The Recall Desk
HighFDA (Devices)·Z-1653-2021·Announced 2021-05-26

Bard Groshong NXT ClearVue Catheter Recall 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 or locking, representing a risk of harm where specific injury reports are not detailed in the source text.

Plain-English summary

Bard Access Systems Inc. is recalling the Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm (REF 7617405J). The recall is 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, or the catch slot on the distal connector may be deformed, resulting in the inability to properly lock the device.

The affected products were distributed worldwide, including nationwide in the United States and in specific countries such as Australia, Canada, China, and Japan. Specific lot numbers are listed in the agency's recall record.

Healthcare providers and patients should stop using the affected catheters and contact Bard Access Systems for further instructions or replacement.

The recalled product

Product
REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - 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 (20)

  • Lot No. reds3422
  • redt4228
  • redu0707
  • redu1364
  • redv1255
  • redv2161
  • redv2786
  • redv4057
  • redw0433
  • redw1225
  • redw2664
  • redw3833
  • redx2372
  • redx4194
  • redy0664
  • redy1758
  • redz0057
  • redz0666
  • redz1930
  • reen1132

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.

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Same hazard · device defect

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