# FDA recall Z-1665-2021

> **Bard Access Systems Inc.** · Class II · device recall initiated 2021-04-07.

## Product

REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107822 - Product Usage: is designed for use when central venous catheterization is prescribed.

## Reason for recall

Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector  and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock

## Distribution

Worldwide distribution - US Nationwide distribution in the states of 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, WI and the countries of Australia, Belgium, Canada, China, Japan, Taiwan, Hong Kong, Malaysia, Chile, Bangladesh, Korea, Brazil, India, Singapore, Thailand.

## Key facts

- **Recall number:** Z-1665-2021
- **Recalling firm:** Bard Access Systems Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-07
- **Report date:** 2021-05-26
- **Termination date:** 2023-06-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salt Lake City, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1665-2021

## Citation

> AI Analytics. FDA recall Z-1665-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1665-2021. Source: US FDA. Licensed CC0.

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