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Becton Dickinson Infusion Therapy Systems, Inc.
FDA Regulatory Profile
Becton Dickinson Infusion Therapy Systems, Inc. appears in FDA public data with 15 recalls, 36 510(k) clearances, 8 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2003-2025, Class II) was initiated on May 21, 2025. Its most recent 510(k) clearance was granted on April 2, 2026.
Summary
- Total Recalls
- 15
- 510(k) Clearances
- 36
- Inspections
- 8
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2003-2025 | Class II | REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 9 | May 21, 2025 |
| Z-2004-2025 | Class II | REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 m | May 21, 2025 |
| Z-2001-2025 | Class II | REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/mi | May 21, 2025 |
| Z-2002-2025 | Class II | REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILE | May 21, 2025 |
| Z-2007-2025 | Class II | REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, ST | May 21, 2025 |
| Z-2005-2025 | Class II | REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, ST | May 21, 2025 |
| Z-1999-2025 | Class II | REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERI | May 21, 2025 |
| Z-2000-2025 | Class II | REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA | May 21, 2025 |
| Z-2006-2025 | Class II | REF: 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-1808-2025 | Class II | BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena S | April 21, 2025 |
| Z-2458-2024 | Class II | BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.0 | June 26, 2024 |
| Z-0400-2024 | Class II | BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533 | October 4, 2023 |
| Z-0025-2024 | Class II | REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 | August 29, 2023 |
| Z-0174-2023 | Class II | BD 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-0306-2022 | Class II | BD 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-Number | Device | Date |
|---|
| K252137 | BD Insyte IV Catheter | April 2, 2026 |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter System | October 8, 2025 |
| K243403 | BD Nexiva Closed IV Catheter System | July 25, 2025 |
| K251155 | BD Cathena Safety IV Catheter | July 11, 2025 |
| K251654 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Ins | June 27, 2025 |
| K250682 | BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System | June 3, 2025 |
| K241586 | PIVO Pro Needle-free Blood Collection Device | February 27, 2025 |
| K233529 | BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector | December 1, 2023 |
| K230865 | PIVO Pro Needle-free Blood Collection Device | September 28, 2023 |
| K231239 | Nexiva Closed IV Catheter System with NearPort IV Access | September 22, 2023 |
| K220584 | BD Cathena Safety IV Catheter | March 31, 2022 |
| K201717 | BD Cathena Safety IV Catheter | September 22, 2020 |
| K192493 | BD Cathena (TM) Safety IV Catheter | January 24, 2020 |
| K183399 | BD Nexiva Closed IV Catheter System | March 20, 2019 |
| K173354 | BD Nexiva Diffusics Closed IV Catheter Systems | December 15, 2017 |
| K161777 | BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems | August 29, 2016 |
| K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter | July 27, 2015 |
| K143610 | BD INTIMA II CLOSED IV CATHETER | April 9, 2015 |
| K123734 | BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM | January 17, 2013 |
| K102520 | BD NEXIVA CLOSED IV CATHETER SYSTEM | January 6, 2011 |