RecallRadar

FDA Device recall Z-0174-2023

BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr)

On 2022-11-09 the FDA classified a Class II recall of BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr) by Becton Dickinson Infusion Therapy Systems, citing during needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0174-2023
ClassificationClass II
Statusongoing
Initiated2022-10-12
Published2022-11-09
Last updated2026-09-13 11:56 UTC
CompanyBecton Dickinson Infusion Therapy Systems
DistributionFL, GA, IL, MA, MD, ME, NC, NJ, NY, PA, RI, SC, VA

Product

BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr)

Reason

During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).

Identifiers

code_infoCatalog Number: 383516 UDI-DI Code: (01)00382903835164 Lot Number: 2168865

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0174-2023%22

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