Recall Z-0334-2025
The Metrix Company · initiated October 9, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: UDI/DI 00812496011138, Lot Numbers: 64050-A8293, 64050-A8406, 64050-A8421, 64050-A8452, 64050-A8470
Reason for recall
A limited number of IV bags have been found to leak during filling.
FDA-determined cause: Under Investigation by firm
Action taken
The Metrix Company issued an URGENT: NOTICE OFMEDICAL DEVICE RECALL notice to it consignees on 10/09/2024 via email. The notice explained the issue and requested destruction of all affected product. Distributors were directed to notify their customers. For questions, contact: Demitrianna Soppe, Regulatory Affairs Specialist, The Metrix Company, 4400 Chavenelle Road, Dubuque, IA 52002; Telephone: 563-556-8800; E-mail: recall.coordinator@metrixco.com
Details
- Recall number
- Z-0334-2025
- Initiated
- October 9, 2024
- Posted by FDA
- November 8, 2024
- Product code
- KPE – Container, I.V.
- Quantity
- 1440 cases of 50 units
- Distribution
- Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
- Recalling firm
- The Metrix Company, Dubuque, IA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0330-2025 Class II | VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | 10/09/2024Open, Classified |
| Z-0331-2025 Class II | VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | 10/09/2024Open, Classified |
| Z-0332-2025 Class II | CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | 10/09/2024Open, Classified |
| Z-0333-2025 Class II | CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | 10/09/2024Open, Classified |
| Z-0335-2025 Class II | SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | 10/09/2024Open, Classified |
| Z-0336-2025 Class II | SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty…A limited number of IV bags have been found to leak during filling. | 10/09/2024Open, Classified |
| Z-0337-2025 Class II | SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made…A limited number of IV bags have been found to leak during filling. | 10/09/2024Open, Classified |
| Z-0338-2025 Class II | SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty…A limited number of IV bags have been found to leak during filling. | 10/09/2024Open, Classified |
| Z-0339-2025 Class II | SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | 10/09/2024Open, Classified |
| Z-0340-2025 Class II | SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | 10/09/2024Open, Classified |
| Z-0341-2025 Class II | SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | 10/09/2024Open, Classified |
| Z-0342-2025 Class II | Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made…A limited number of IV bags have been found to leak during filling. | 10/09/2024Open, Classified |
| Z-0343-2025 Class II | Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made…A limited number of IV bags have been found to leak during filling. | 10/09/2024Open, Classified |
| Z-0344-2025 Class II | Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made…A limited number of IV bags have been found to leak during filling. | 10/09/2024Open, Classified |
| Z-0345-2025 Class II | Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | 10/09/2024Open, Classified |