510(k) K030888 ยท KPE Container, I.V.
EVA EMPTY SOLUTION CONTAINER
| Applicant | Metrix Co., Dubuque IA, US |
| Decision | Substantially Equivalent, Apr 2, 2003 |
| Received | Mar 21, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030888
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2024 | The Metrix Company 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. Open, Classified |
KPE | None listed |
| Nov 8, 2024 | The Metrix Company 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. Open, Classified |
KPE | None listed |
| Nov 8, 2024 | The Metrix Company 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. Open, Classified |
KPE | None listed |
| Nov 8, 2024 | The Metrix Company 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. Open, Classified |
KPE | None listed |
| Nov 8, 2024 | The Metrix Company 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. Open, Classified |
KPE | None listed |
| Nov 8, 2024 | The Metrix Company 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. Open, Classified |
KPE | None listed |
| Nov 8, 2024 | The Metrix Company 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. Open, Classified |
KPE | None listed |
| Nov 8, 2024 | The Metrix Company 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. Open, Classified |
KPE | None listed |
| Nov 8, 2024 | The Metrix Company 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. Open, Classified |
KPE | None listed |
| Nov 8, 2024 | The Metrix Company 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. Open, Classified |
KPE | None listed |
| Nov 8, 2024 | The Metrix Company 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. Open, Classified |
KPE | None listed |
| Nov 8, 2024 | The Metrix Company 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. Open, Classified |
KPE | None listed |
| Nov 8, 2024 | The Metrix Company 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. Open, Classified |
KPE | None listed |
| Nov 8, 2024 | The Metrix Company 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. Open, Classified |
KPE | None listed |
| Nov 8, 2024 | The Metrix Company 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. Open, Classified |
KPE | None listed |
| Nov 8, 2024 | The Metrix Company 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. Open, Classified |
KPE | None listed |
| Jun 23, 2016 | The Metrix Company Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL. Terminated |
NEP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.