Recall Z-0384-2019— Becton Dickinson & Company

Name: FDA recall Z-0384-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-23

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2018-08-23, terminated 2020-02-28. It names one FDA 510(k) clearance: K032843. 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a passive needle shielding mechanism that is activated as part of the usual insertion procedure when the needle is withdrawn from the catheter.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, appropriateness for solutions being infused and duration of therapy.. Reason: 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..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2018-08-23
Terminated: 2020-02-28
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K032843 — NEXIVA CLOSED IV CATHETER SYSTEMBecton Dickinson Infusion Therapy Systems, Inc.·cleared 2004-02-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.