Container, I.V.
FDA adverse event reports and recall history for container, i.v. (product code KPE), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 6,755
- Deaths
- 8
- Injuries
- 80
- Malfunctions
- 6,533
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2024-11-08Open, ClassifiedUnder Investigation by firm
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.
- 2024-11-08Open, ClassifiedUnder Investigation by firm
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.
- 2024-11-08Open, ClassifiedUnder Investigation by firm
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.
- 2024-11-08Open, ClassifiedUnder Investigation by firm
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.
- 2024-11-08Open, ClassifiedUnder Investigation by firm
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.
- 2024-11-08Open, ClassifiedUnder Investigation by firm
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.
- 2024-11-08Open, ClassifiedUnder Investigation by firm
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.
- 2024-11-08Open, ClassifiedUnder Investigation by firm
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.
- 2024-11-08Open, ClassifiedUnder Investigation by firm
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.
- 2024-11-08Open, ClassifiedUnder Investigation by firm
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.
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