The Recall Desk
HighFDA (Devices)·Z-1656-2021·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, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Bard Access Systems Inc. is recalling specific lots of REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm. The recall involves units distributed worldwide and across numerous US states, including AK, AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, and WI.

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, and the catch slot on the distal connector may be deformed, resulting in the inability to properly lock the device. The product is designed for use when central venous catheterization is prescribed.

Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to Bard Access Systems Inc. according to the firm's instructions.

The recalled product

Product
REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for use when central venous catheterization is prescribed.
Manufacturer
Bard Access Systems Inc.
Category
Medical Device — Catheter
Hazard

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.

See all →

Same hazard · functional defect

See all →