Becton Dickinson Infusion Therapy Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
15
510(k) Clearances
35
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2002-2025Class IIREF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEMay 21, 2025
Z-2004-2025Class IIREF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mMay 21, 2025
Z-2007-2025Class IIREF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STMay 21, 2025
Z-2005-2025Class IIREF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STMay 21, 2025
Z-1999-2025Class IIREF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERIMay 21, 2025
Z-2006-2025Class IIREF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/May 21, 2025
Z-2003-2025Class IIREF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 9May 21, 2025
Z-2000-2025Class IIREF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GAMay 21, 2025
Z-2001-2025Class IIREF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/miMay 21, 2025
Z-1808-2025Class IIBD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena SApril 21, 2025
Z-2458-2024Class IIBD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.0June 26, 2024
Z-0400-2024Class IIBD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533October 4, 2023
Z-0025-2024Class IIREF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 August 29, 2023
Z-0174-2023Class IIBD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min October 12, 2022
Z-0306-2022Class IIBD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -September 8, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K251422BD Saf-T-Intima™ Subcutaneous Catheter SystemOctober 8, 2025
K243403BD Nexiva™ Closed IV Catheter SystemJuly 25, 2025
K251155BD Cathena™ Safety IV CatheterJuly 11, 2025
K251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD InsJune 27, 2025
K250682BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System June 3, 2025
K241586PIVO™ Pro Needle-free Blood Collection DeviceFebruary 27, 2025
K233529BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free ConnectorDecember 1, 2023
K230865PIVO™ Pro Needle-free Blood Collection DeviceSeptember 28, 2023
K231239Nexiva™ Closed IV Catheter System with NearPort™ IV AccessSeptember 22, 2023
K220584BD Cathena Safety IV CatheterMarch 31, 2022
K201717BD Cathena Safety IV CatheterSeptember 22, 2020
K192493BD Cathena (TM) Safety IV CatheterJanuary 24, 2020
K183399BD Nexiva Closed IV Catheter SystemMarch 20, 2019
K173354BD Nexiva Diffusics Closed IV Catheter SystemsDecember 15, 2017
K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsAugust 29, 2016
K151698BD Angiocath IV Catheter, BD Insyte IV CatheterJuly 27, 2015
K143610BD INTIMA II CLOSED IV CATHETERApril 9, 2015
K123734BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEMJanuary 17, 2013
K102520BD NEXIVA CLOSED IV CATHETER SYSTEMJanuary 6, 2011
K100775BD INTIMA II CLOSED IV CATHETERJune 3, 2010