Becton Dickinson & Company: Medical Device Recall in 2018 - (Recall #: Z-0384-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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a passive needle shielding mechanism that is activated as part of the usual insertion procedure when the needle is withdrawn from the catheter.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, appropriateness for solutions being infused and duration of therapy.

Product Classification:

Class II

Date Initiated: August 23, 2018

Date Posted: November 14, 2018

Recall Number: Z-0384-2019

Event ID: 81040

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.

Status: Terminated

Product Quantity: 133,230 units

Code Information:

Lot 8087800, UDI (01)30382903835394

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated