The Metrix Company

FDA Regulatory Profile

Summary

Total Recalls
33
510(k) Clearances
6
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0336-2025Class IISECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch mOctober 9, 2024
Z-0337-2025Class IISECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic October 9, 2024
Z-0339-2025Class IISECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plasticOctober 9, 2024
Z-0338-2025Class IISECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch mOctober 9, 2024
Z-0331-2025Class IIVYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastOctober 9, 2024
Z-0342-2025Class IIImed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic October 9, 2024
Z-0335-2025Class IISECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plasticOctober 9, 2024
Z-0334-2025Class IICORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastOctober 9, 2024
Z-0345-2025Class IIImed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plasticOctober 9, 2024
Z-0341-2025Class IISECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastiOctober 9, 2024
Z-0333-2025Class IICORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastOctober 9, 2024
Z-0332-2025Class IICORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastOctober 9, 2024
Z-0340-2025Class IISECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plasticOctober 9, 2024
Z-0330-2025Class IIVYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastOctober 9, 2024
Z-0343-2025Class IIImed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic October 9, 2024
Z-0344-2025Class IIImed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic October 9, 2024
Z-0001-2020Class IISECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product UsaSeptember 21, 2018
Z-0003-2020Class IISECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product UsaSeptember 21, 2018
Z-0006-2020Class IISECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - ProduSeptember 21, 2018
Z-0002-2020Class IISECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product UsaSeptember 21, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K132424METRIXCAREFebruary 12, 2014
K030888EVA EMPTY SOLUTION CONTAINERApril 2, 2003
K895922METRICARE EMPTY CONTAINER SYSTEMSAugust 22, 1990
K895924METRICARE DRUG RESERVOIRSJuly 26, 1990
K895923METRICARE ENTERAL FEEDING SYSTEMJuly 19, 1990
K761201ECHO-CARDIOTRACE, AUTOMATICJanuary 12, 1977