ICU Medical, Inc.
⚠️ Moderate Risk
FEI: 3013319212 • Lake Forest, IL • UNITED STATES
FEI Number
3013319212
Location
Lake Forest, IL
Country
UNITED STATESAddress
600 N Field Dr, , Lake Forest, IL, 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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
DE/RX KIT
The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is offered for import by other than the manufacturer, and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/1/2015 | 65FIK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/13/2014 | 62OCB24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/20/2012 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | Florida District Office (FLA-DO) |
| 11/20/2012 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | Florida District Office (FLA-DO) |
| 11/2/2012 | 55RP55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 64BCK24FUROSEMIDE (DIURETIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 65FIK99WATER N.E.C. (PHARMACEUTIC AID) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 61XCK18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 62OCK13VERAPAMIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 60CCK04EPINEPHRINE (ADRENERGIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 61TCK14PROCHLORPERAZINE (ANTI-EMETIC/NAUSEANT) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 61XCK18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 60CCK04EPINEPHRINE (ADRENERGIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 65RCK17RINGER'S INJECTION, LACTATED (REPLENISHER) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 65FIK99WATER N.E.C. (PHARMACEUTIC AID) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 65FIK99WATER N.E.C. (PHARMACEUTIC AID) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 65FIK99WATER N.E.C. (PHARMACEUTIC AID) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 62GCK94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 60CCK04EPINEPHRINE (ADRENERGIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 64BCK24FUROSEMIDE (DIURETIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 64BCK24FUROSEMIDE (DIURETIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 4/6/2012 | 60QDK79BUPIVACAINE HYDROCHLORIDE (ANESTHETIC) | Division of Southeast Imports (DSEI) | |
| 4/6/2012 | 62ODK44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 4/6/2012 | 61MDK11MAGNESIUM SULFATE (ANTI-CONVULSANT) | Division of Southeast Imports (DSEI) | |
| 4/28/2009 | 60QDK40LIDOCAINE HCL (ANESTHETIC) | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 12/4/2008 | 56KCP85VANCOMYCIN HYDROCHLORIDE | 16DIRECTIONS | Atlanta District Office (ATL-DO) |
| 8/4/2008 | 60QCP07LIDOCAINE | Chicago District Office (CHI-DO) | |
| 8/4/2008 | 60CCP04EPINEPHRINE (ADRENERGIC) | Chicago District Office (CHI-DO) | |
| 8/4/2008 | 60CCP04EPINEPHRINE (ADRENERGIC) | Chicago District Office (CHI-DO) | |
| 8/4/2008 | 55RG55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 8/4/2008 | 61LCP20ANTI-COAGULANT CITRATE DEXTROSE SOLUTION | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 6/24/2008 | 60QDK40LIDOCAINE HCL (ANESTHETIC) | 179AGR RX | Southwest Import District Office (SWI-DO) |
| 6/23/2008 | 61LCK22ANTI-COAGULANT HEPARIN SOL | 179AGR RX | Seattle District Office (SEA-DO) |
| 5/23/2008 | 55RG55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | Chicago District Office (CHI-DO) | |
| 5/23/2008 | 60QCP07LIDOCAINE | Chicago District Office (CHI-DO) | |
| 5/23/2008 | 60CCP04EPINEPHRINE (ADRENERGIC) | Chicago District Office (CHI-DO) | |
| 5/23/2008 | 61LCP20ANTI-COAGULANT CITRATE DEXTROSE SOLUTION | Chicago District Office (CHI-DO) | |
| 5/23/2008 | 60CCP04EPINEPHRINE (ADRENERGIC) | Chicago District Office (CHI-DO) | |
| 10/30/2007 | 60QCK40LIDOCAINE HCL (ANESTHETIC) | 179AGR RX | Southwest Import District Office (SWI-DO) |
| 6/18/2007 | 60QCK40LIDOCAINE HCL (ANESTHETIC) | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 2/6/2007 | 60QAP07LIDOCAINE | 179AGR RX | New Orleans District Office (NOL-DO) |
| 2/6/2007 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 1/31/2007 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 5/16/2006 | 60QCP40LIDOCAINE HCL (ANESTHETIC) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 5/16/2006 | 60QCP40LIDOCAINE HCL (ANESTHETIC) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 3/10/2006 | 65RCK14POTASSIUM CHLORIDE (REPLENISHER) | 179AGR RX | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is ICU Medical, Inc.'s FDA import refusal history?
ICU Medical, Inc. (FEI: 3013319212) has 46 FDA import refusal record(s) in our database, spanning from 3/10/2006 to 10/1/2015.
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, Inc.'s FEI number is 3013319212.
What types of violations has ICU Medical, Inc. received?
ICU Medical, Inc. has been cited for 5 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, Inc. come from?
All FDA import refusal data for ICU Medical, 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.