Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street, Sandy, UT, US
Registered product codes
8 product codes
Recent MDR events
12,182 on file
- Insyte AUTOGUARDJul 31, 2026Malfunction1710034-2026-00862
- Insyte AUTOGUARDJul 31, 2026Malfunction1710034-2026-00863
- Insyte AUTOGUARDJul 30, 2026Malfunction1710034-2026-00859
- Insyte AUTOGUARDJul 30, 2026Malfunction1710034-2026-00860
- ExT Extension SetJul 29, 2026Malfunction1710034-2026-00855
- Insyte AUTOGUARDJul 29, 2026Malfunction1710034-2026-00856
- Insyte AUTOGUARDJul 29, 2026Malfunction1710034-2026-00858
- Q-SyteJul 28, 2026Malfunction1710034-2026-00846
- Q-SyteJul 28, 2026Malfunction1710034-2026-00847
- Q-SyteJul 28, 2026Malfunction1710034-2026-00848
Recalls
15 on file
- Open, ClassifiedJun 23, 2025
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
View FDA record ↗ - Open, ClassifiedJun 23, 2025
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
View FDA record ↗ - Open, ClassifiedJun 23, 2025
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
View FDA record ↗ - Open, ClassifiedJun 23, 2025
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
View FDA record ↗ - Open, ClassifiedJun 23, 2025
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
View FDA record ↗ - Open, ClassifiedJun 23, 2025
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
View FDA record ↗ - Open, ClassifiedJun 23, 2025
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
View FDA record ↗ - Open, ClassifiedJun 23, 2025
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
View FDA record ↗ - Open, ClassifiedJun 23, 2025
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
View FDA record ↗ - Open, ClassifiedMay 21, 2025
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 blood exposure or the need for a second IV to be placed - which may result in therapy delay.
View FDA record ↗
Compliance history
Matched by FEI 1710034.
FDA inspections
2 on file
- No Action Indicated (NAI)May 21, 2024
Compliance: Devices
- No Action Indicated (NAI)May 21, 2024
Postmarket Assurance: Devices
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
2 on file
Top refusal reasons
Compare to industry ↗- Division of Southeast Imports (DSEI)Nov 4, 2024
74DYB \ INTRODUCER, CATHETER
- Division of Southeast Imports (DSEI)Oct 29, 2024
80FMF \ SYRINGE, PISTON