# FDA recall Z-0384-2019

> **Becton Dickinson & Company** · Class II · device recall initiated 2018-08-23.

## Product

BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539    Product Usage:  BD Nexiva  Closed IV Catheter System Dual Port (hereafter referred to as BD Nexiva device or catheter) (see Figure below) incorporates a passive needle shielding mechanism that is activated as part of the usual insertion procedure when the needle is withdrawn from the catheter. BD Nexiva device is designed to protect the clinician from accidental needle stick injuries and minimize exposure to blood during the insertion process. The needle shield is designed to not release from the catheter adapter until the needle tip is protected and cannot be rearmed once activated. The BD Nexiva device is intended for use in the peripheral vascular system to provide access for the administration of fluids, medication, blood and blood products, and for the withdrawal of blood samples. This catheter may be used for any patient population with consideration given to patient size, ap

## Reason for recall

One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated needlestick injury.

## Distribution

Worldwide Distribution -US Nationwide in the states of:  CA, CO, FL, GA, IL, LA, MI, ND, NE, NY, OH, PA, RI, SC, VA, WA and WV.    The products were distributed to the following foreign countries:  Argentina, Australia, Belgium, Brazil, Canada, Colombia, Costa Rica, Mexico and New Zealand.

## Key facts

- **Recall number:** Z-0384-2019
- **Recalling firm:** Becton Dickinson & Company
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-23
- **Report date:** 2018-11-14
- **Termination date:** 2020-02-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Franklin Lakes, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0384-2019

## Citation

> AI Analytics. FDA recall Z-0384-2019. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-0384-2019. Source: US FDA. Licensed CC0.

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