Data Foundry

Medical device recalls 2022

BD Nexiva Closed IV Catheter System — Class II medical device recall Z-0174-2023

Ongoing recall by Becton Dickinson Infusion Therapy Systems Inc., reported 2022-11-09, distributed in FL, GA, IL, MA, MD, ME, NC, NJ…. During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the

Recall numberZ-0174-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBecton Dickinson Infusion Therapy Systems Inc., Sandy, UT, United States
Recall initiated2022-10-12
Classified2022-11-03
Reported by FDA2022-11-09
DistributedFL, GA, IL, MA, MD, ME, NC, NJ, NY, PA, RI, SC, VA
Quantity56,080 units
UPC / GTIN / UDI-DI00382903835164
Lot numbers2168865
Model numbers383516, X1.0O

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 for recall

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).

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0174-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.