Becton Dickinson Infusion Therapy Systems, Inc.
⚠️ High Risk
FEI: 1710034 • Sandy, UT • UNITED STATES
FEI Number
1710034
Location
Sandy, UT
Country
UNITED STATESAddress
9450 S State St, , Sandy, UT, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/4/2024 | 74DYBINTRODUCER, CATHETER | Division of Southeast Imports (DSEI) | |
| 10/29/2024 | 80FMFSYRINGE, PISTON | Division of Southeast Imports (DSEI) | |
| 1/11/2023 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 5/23/2022 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 9/9/2016 | 79GCBNEEDLE, CATHETER | Cincinnati District Office (CIN-DO) | |
| 3/13/2012 | 80FMFSYRINGE, PISTON | 118NOT LISTED | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Becton Dickinson Infusion Therapy Systems, Inc.'s FDA import refusal history?
Becton Dickinson Infusion Therapy Systems, Inc. (FEI: 1710034) has 16 FDA import refusal record(s) in our database, spanning from 3/13/2012 to 11/4/2024.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Becton Dickinson Infusion Therapy Systems, Inc.'s FEI number is 1710034.
What types of violations has Becton Dickinson Infusion Therapy Systems, Inc. received?
Becton Dickinson Infusion Therapy Systems, Inc. has been cited for 6 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Becton Dickinson Infusion Therapy Systems, Inc. come from?
All FDA import refusal data for Becton Dickinson Infusion Therapy Systems, Inc. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.