Container, I.v.
General Hospital · 21 CFR 880.5025
Recent MDR events
6,755 adverse event reports on file
- INTRAVIAJul 30, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02506
- INTRAVIAJul 29, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02479
- INTRAVIAJul 29, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02477
- INTRAVIAJul 29, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02476
- BAG DECANTERJul 29, 2026MalfunctionValmed Srl3009128476-2026-00105
- INTRAVIAJul 27, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02414
- INTRAVIAJul 22, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02401
- INTRAVIAJul 22, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02402
- INTRAVIAJul 22, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02403
- INTRAVIAJul 22, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02405
Event type breakdown
Recalls
62 recall events for this product code
- The Metrix CompanyOpen, ClassifiedNov 8, 2024
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) administ
A limited number of IV bags have been found to leak during filling.
Z-0330-2025 · View FDA record ↗ - The Metrix CompanyOpen, ClassifiedNov 8, 2024
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) administ
A limited number of IV bags have been found to leak during filling.
Z-0331-2025 · View FDA record ↗ - The Metrix CompanyOpen, ClassifiedNov 8, 2024
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) administ
A limited number of IV bags have been found to leak during filling.
Z-0332-2025 · View FDA record ↗ - The Metrix CompanyOpen, ClassifiedNov 8, 2024
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) administ
A limited number of IV bags have been found to leak during filling.
Z-0333-2025 · View FDA record ↗ - The Metrix CompanyOpen, ClassifiedNov 8, 2024
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) administ
A limited number of IV bags have been found to leak during filling.
Z-0334-2025 · View FDA record ↗ - The Metrix CompanyOpen, ClassifiedNov 8, 2024
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) administra
A limited number of IV bags have been found to leak during filling.
Z-0335-2025 · View FDA record ↗ - The Metrix CompanyOpen, ClassifiedNov 8, 2024
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 (
A limited number of IV bags have been found to leak during filling.
Z-0336-2025 · View FDA record ↗ - The Metrix CompanyOpen, ClassifiedNov 8, 2024
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) administrat
A limited number of IV bags have been found to leak during filling.
Z-0337-2025 · View FDA record ↗ - The Metrix CompanyOpen, ClassifiedNov 8, 2024
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 (
A limited number of IV bags have been found to leak during filling.
Z-0338-2025 · View FDA record ↗ - The Metrix CompanyOpen, ClassifiedNov 8, 2024
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) administra
A limited number of IV bags have been found to leak during filling.
Z-0339-2025 · View FDA record ↗
Registered firms
153 firms currently registered for this product code
Microtek Medical Llc
Northfield, IL, US
Sterigenics Us Llc
Fort Worth, TX, US
Baxter Healthcare Corporation
ROUND LAKE, IL, US
Worldwide Supplies Limited
Hong Kong, HK
Cbr Enterprise Limited
Hong Kong, HK
Sterigenics Us Llc
Gurnee, IL, US
Km Medical
North York Ontario, CA
Epic International (thailand) Co., Ltd.
Amphur Pluakdaeng Rayong, TH
Medtronic Perfusion Systems
Minneapolis, MN, US
Baxter Healthcare, S.a.
Haina San Cristobal, DO
Sterigenics U.s., Llc
Atlanta, GA, US
B. Braun Medical Inc.
BETHLEHEM, PA, US
Orta Medical Ltd
TZUR YIGAL Central, IL
Ming Fai Industrial (shenzhen) Co. Ltd.
SHENZHEN Guangdong, CN
Shipserve New Zealand Limited
Ellerslie Auckland, NZ
Microtek Medical Llc
Eagan, MN, US
B. Braun Avitum Italy S.p.a.
MIRANDOLA Modena, IT
Gvs Spa
Borgocarbonara Mantova, IT
B. Braun Medical Inc.
Allentown, PA, US
Sterigenics U.s., Llc
Haw River, NC, US
510(k) clearances
117 clearances for this product code
- Beijing L&Z Medical Technology Development Co., Ltd.Apr 2, 2026
K252079 · Disposable Infusion Bag for Parenteral Nutrition
- Icu Medical, Inc.Mar 20, 2026
K251980 · ClaveQS Bag
- Fresenius Kabi AGJan 9, 2026
K251139 · KabiHelp® Uno; KabiHelp® Advance plus
- Epic Medical Pte. , Ltd.Aug 1, 2025
K252094 · eZSURE Empty Fluid Container
- Technoflex Sas.Apr 18, 2025
K250459 · DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution
- Epic Medical Pte. , Ltd.Jun 21, 2024
K241442 · eZSURE Empty Fluid Container with ProSeal Injection Site
- Epic Medical Pte. , Ltd.Sep 1, 2023
K223674 · eZSURE Empty Fluid Container (models 426030, 426040, 426110)
- Beijing L&Z Medical Technology Development Co., Ltd.Feb 16, 2023
K222622 · Disposable Infusion Bag for Parenteral Nutrition