ICU Medical Costa Rica Ltd.
⚠️ High Risk
FEI: 3002999813 • Heredia, Heredia • COSTA RICA
FEI Number
3002999813
Location
Heredia, Heredia
Country
COSTA RICAAddress
La Aurora De Heredia,1 Km Noreste Del Centro Comercial, Real Cariari, ZONA FRANCA GLOBAL Park De Entrada 300, Heredia, Heredia, Costa Rica
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.
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C 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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/6/2025 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/11/2022 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/11/2022 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/11/2022 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/11/2022 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/11/2022 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/11/2022 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/11/2022 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/11/2022 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/11/2022 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/11/2022 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/14/2022 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | Division of Southeast Imports (DSEI) | |
| 3/14/2022 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | Division of Southeast Imports (DSEI) | |
| 1/15/2022 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/15/2022 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/15/2022 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/30/2021 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/30/2021 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/27/2021 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/21/2020 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/25/2020 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/24/2020 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/21/2020 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/21/2020 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/27/2020 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | Division of Southeast Imports (DSEI) | |
| 7/27/2020 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | Division of Southeast Imports (DSEI) | |
| 8/30/2018 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/30/2018 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/30/2018 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/30/2018 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/30/2018 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/10/2018 | 80KZHINTRODUCER, SYRINGE NEEDLE | Division of Southeast Imports (DSEI) | |
| 8/24/2016 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | Atlanta District Office (ATL-DO) | |
| 6/20/2013 | 80FRNPUMP, INFUSION | 2780DEVICEGMPS | San Francisco District Office (SAN-DO) |
| 3/29/2013 | 80FRNPUMP, INFUSION | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 4/6/2012 | 80FRNPUMP, INFUSION | Florida District Office (FLA-DO) | |
| 4/6/2012 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | Division of Southeast Imports (DSEI) | |
| 4/6/2012 | 80FRNPUMP, INFUSION | Division of Southeast Imports (DSEI) | |
| 3/29/2005 | 74KRBPROBE, THERMODILUTION | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 3/29/2005 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is ICU Medical Costa Rica Ltd.'s FDA import refusal history?
ICU Medical Costa Rica Ltd. (FEI: 3002999813) has 40 FDA import refusal record(s) in our database, spanning from 3/29/2005 to 8/6/2025.
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. ICU Medical Costa Rica Ltd.'s FEI number is 3002999813.
What types of violations has ICU Medical Costa Rica Ltd. received?
ICU Medical Costa Rica Ltd. 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 ICU Medical Costa Rica Ltd. come from?
All FDA import refusal data for ICU Medical Costa Rica Ltd. 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.