The Recall Desk
ModerateFDA (Devices)·Z-1659-2021·Announced 2021-05-26

Bard Groshong NXT ClearVue Catheter Recalled for Connector Defects

Bard Access Systems is recalling specific Groshong NXT ClearVue catheters due to defects in the distal connector that may prevent proper catheter passage or locking.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The defects described are mechanical failures that prevent the device from functioning as intended, but the source text does not report any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity score.

Plain-English summary

Bard Access Systems Inc. is recalling the Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen (REF 9617405). The recall affects Lot No. reeu1838. These medical devices are designed for use when central venous catheterization is prescribed.

The recall is due to two 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 affected products were distributed worldwide, including in the United States and various international markets. Healthcare providers and facilities should check their inventory for this specific lot number and discontinue use of the affected units.

The recalled product

Product
REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035989 - 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. reeu1838

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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