The Metrix Company
Dubuque, IA, US
THE METRIX COMPANY appears in FDA device records in Dubuque, IA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 33 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for The Metrix Company between 1977 and 2014. The busiest year on record is 1990, with 3. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1990 | 3 |
| 2003 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K132424 | METRIXCARE | KNT | Substantially Equivalent | |
| K030888 | EVA EMPTY SOLUTION CONTAINER | KPE | Substantially Equivalent | |
| K895922 | METRICARE EMPTY CONTAINER SYSTEMS | LHI | Substantially Equivalent | |
| K895924 | METRICARE DRUG RESERVOIRS | KPE | Substantially Equivalent | |
| K895923 | METRICARE ENTERAL FEEDING SYSTEM | FPD | Substantially Equivalent | |
| K761201 | ECHO-CARDIOTRACE, AUTOMATIC | HGM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1937141 | 1000117446 | THE METRIX COMPANY | 4400 Chavenelle Rd, DUBUQUE, IA 52002 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- LWEBone Marrow Collection/Transfusion Kit
- KPEContainer, I.V.
- FMHContainer, Specimen, Sterile
- KQTEvacuator, Gastro-Urology
- KZDInfusor, Pressure, For I.V. Bags
- LHISet, I.V. Fluid Transfer
- KYZSyringe, Irrigating (Non Dental)
- FMFSyringe, Piston
- HGMSystem, Monitoring, Perinatal
- MUUSystem, Suction, Lipoplasty
- FPDTube, Feeding
- KNTTubes, Gastrointestinal (And Accessories)
Recall records
Showing 25 of 33| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0345-2025 | Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | A limited number of IV bags have been found to leak during filling. | Class II | Open, Classified | |
| Z-0344-2025 | Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | A limited number of IV bags have been found to leak during filling. | Class II | Open, Classified | |
| Z-0343-2025 | Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | A limited number of IV bags have been found to leak during filling. | Class II | Open, Classified | |
| Z-0342-2025 | Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | A limited number of IV bags have been found to leak during filling. | Class II | Open, Classified | |
| Z-0341-2025 | SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | A limited number of IV bags have been found to leak during filling. | Class II | Open, Classified | |
| Z-0340-2025 | SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | A limited number of IV bags have been found to leak during filling. | Class II | Open, Classified | |
| Z-0339-2025 | SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | A limited number of IV bags have been found to leak during filling. | Class II | Open, Classified | |
| Z-0338-2025 | SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | A limited number of IV bags have been found to leak during filling. | Class II | Open, Classified | |
| Z-0337-2025 | SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | A limited number of IV bags have been found to leak during filling. | Class II | Open, Classified | |
| Z-0336-2025 | SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | A limited number of IV bags have been found to leak during filling. | Class II | Open, Classified | |
| Z-0335-2025 | SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | A limited number of IV bags have been found to leak during filling. | Class II | Open, Classified | |
| Z-0334-2025 | CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | A limited number of IV bags have been found to leak during filling. | Class II | Open, Classified | |
| Z-0333-2025 | CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | A limited number of IV bags have been found to leak during filling. | Class II | Open, Classified | |
| Z-0332-2025 | CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | A limited number of IV bags have been found to leak during filling. | Class II | Open, Classified | |
| Z-0331-2025 | VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | A limited number of IV bags have been found to leak during filling. | Class II | Open, Classified | |
| Z-0330-2025 | VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | A limited number of IV bags have been found to leak during filling. | Class II | Open, Classified | |
| Z-0008-2020 | ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures. | Potential for leaking product | Class II | Open, Classified | |
| Z-0007-2020 | ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures. | Potential for leaking product | Class II | Open, Classified | |
| Z-0006-2020 | SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures. | Potential for leaking product | Class II | Open, Classified | |
| Z-0005-2020 | SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures. | Potential for leaking product | Class II | Open, Classified | |
| Z-0004-2020 | SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures. | Potential for leaking product | Class II | Open, Classified | |
| Z-0003-2020 | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures. | Potential for leaking product | Class II | Open, Classified | |
| Z-0002-2020 | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures. | Potential for leaking product | Class II | Open, Classified | |
| Z-0001-2020 | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures. | Potential for leaking product | Class II | Open, Classified | |
| Z-3240-2017 | SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R, | The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets The Metrix Company edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain