Chrysalis Intelligence · Sponsors · Becton Dickinson Infusion Therapy Systems, Inc.

Becton Dickinson Infusion Therapy Systems, Inc.

Sandy, UT, US · 13 510(k) clearances · 15 recalls

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Total clearances

13

2020-01-24 → 2026-04-02

Last 12 months

2

Product codes

2

Most recent

2026-04-02

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	Class II	General Hospital	11	2026-04-02
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Class II	Clinical Chemistry	2	2025-02-27

Safety

Recalls (15)

Class I (serious)

0

Risk of injury / death

Total recalls

15

Currently ongoing

15

Most recent

2025-05-21

Date	Severity	Status	Recall #	Product	Code	Reason
2025-05-21	Class II	Ongoing	Z-2007-2025	REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly	—	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-05-21	Class II	Ongoing	Z-2006-2025	REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOn…	—	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-05-21	Class II	Ongoing	Z-2005-2025	REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly	—	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-05-21	Class II	Ongoing	Z-2004-2025	REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERIL…	—	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-05-21	Class II	Ongoing	Z-2003-2025	REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO,…	—	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-05-21	Class II	Ongoing	Z-2002-2025	REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly	—	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-05-21	Class II	Ongoing	Z-2001-2025	REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly	—	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-05-21	Class II	Ongoing	Z-2000-2025	REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 m…	—	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-05-21	Class II	Ongoing	Z-1999-2025	REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY	—	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-04-21	Class II	Ongoing	Z-1808-2025	BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20…	—	Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blo…
2024-06-26	Class II	Ongoing	Z-2458-2024	BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 …	—	Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
2023-10-04	Class II	Ongoing	Z-0400-2024	BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533	—	Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, b…
2023-08-29	Class II	Ongoing	Z-0025-2024	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx On…	—	There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the nee…
2022-10-12	Class II	Ongoing	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)	—	During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (lea…
2021-09-08	Class II	Ongoing	Z-0306-2022	BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/h…	—	There is a breach in the product packaging that renders the product non-sterile.

Filings

All 510(k) clearances (13)

Date	K-number	Device	Code	Class	Specialty
2026-04-02	K252137	BD Insyte IV Catheter	FOZ	Class II	General Hospital
2025-10-08	K251422	BD Saf-T-Intima Subcutaneous Catheter System	FOZ	Class II	General Hospital
2025-07-25	K243403	BD Nexiva Closed IV Catheter System	FOZ	Class II	General Hospital
2025-07-11	K251155	BD Cathena Safety IV Catheter	FOZ	Class II	General Hospital
2025-06-27	K251654	BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter	FOZ	Class II	General Hospital
2025-06-03	K250682	BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector	FOZ	Class II	General Hospital
2025-02-27	K241586	PIVO Pro Needle-free Blood Collection Device	JKA	Class II	Clinical Chemistry
2023-12-01	K233529	BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector	FOZ	Class II	General Hospital
2023-09-28	K230865	PIVO Pro Needle-free Blood Collection Device	JKA	Class II	Clinical Chemistry
2023-09-22	K231239	Nexiva Closed IV Catheter System with NearPort IV Access	FOZ	Class II	General Hospital
2022-03-31	K220584	BD Cathena Safety IV Catheter	FOZ	Class II	General Hospital
2020-09-22	K201717	BD Cathena Safety IV Catheter	FOZ	Class II	General Hospital
2020-01-24	K192493	BD Cathena (TM) Safety IV Catheter	FOZ	Class II	General Hospital