The Recall Desk
HighFDA (Devices)·Z-1662-2021·Announced 2021-05-26

Bard Access Systems Recalls Groshong NXT ClearVue Catheters Due to 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 involves a medical device with functional defects that could prevent proper use or locking, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

Bard Access Systems Inc. is recalling specific lots of REF 9617408D Groshong NXT ClearVue Catheters with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, Single-Lumen. The affected lots are reen4697 and reep0632. These medical devices are designed for use when central venous catheterization is prescribed.

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

The recalled product

Product
REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036016 - 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. reen4697 and reep0632

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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