The Recall Desk
HighFDA (Devices)·Z-1666-2021·Announced 2021-05-26

Bard Groshong NXT ClearVue Catheter Recall for 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

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 functional defects that could prevent proper use or locking, posing a risk of harm, but no specific injuries or illnesses are reported in the source text.

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 specific lots identified as redx1384, reep4143, and reeq1238. 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 device.

The affected products were distributed worldwide, including nationwide in the United States and in various international markets. Healthcare providers and facilities should stop using the affected lots and contact Bard Access Systems for further instructions on replacement or return.

The recalled product

Product
REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, CE 2797, UDI: (01)10801741102704 - Product Usage: is designed for use when central venous catheterization is prescribed.

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. redx1384 reep4143 reeq1238

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 →

Same manufacturer · Bard Access Systems Inc.

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