ICU Medical
⚠️ Moderate Risk
FEI: 1526863 • Dublin, OH • UNITED STATES
FEI Number
1526863
Location
Dublin, OH
Country
UNITED STATESAddress
6250 Shier Rings Rd, , Dublin, OH, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/11/2011 | 73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR) | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 2/23/2011 | 85KXQVIBRATOR FOR THERAPEUTIC USE, GENITAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/14/2009 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is ICU Medical's FDA import refusal history?
ICU Medical (FEI: 1526863) has 3 FDA import refusal record(s) in our database, spanning from 10/14/2009 to 7/11/2011.
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's FEI number is 1526863.
What types of violations has ICU Medical received?
ICU Medical has been cited for 2 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 come from?
All FDA import refusal data for ICU Medical 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.