VYGON 100 mL IV Container Pouch Recalled for Potential Leakage
The Metrix Company is recalling a limited number of VYGON 100 mL empty IV containers (Lot Numbers 62040-A8375 and 62040-A8432) due to leakage found during the filling process. The affected containers are distributed in multiple U.S. states and Canada.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device with a manufacturing defect (leakage during filling) that prevents proper containment of intravenous fluids. IV administration is a critical medical function, making this a risk-of-harm product where injury has not yet been reported. The functional defect in a device used for patient care warrants a high severity rating.
Plain-English summary
The Metrix Company is recalling a limited number of VYGON 100 mL empty EVA containers with 2 ports (reference number CMS-9601) due to leakage that has been found to occur during the filling process. The product is a single-use plastic pouch designed to contain intravenous (IV) fluids for patient administration.
The affected containers have lot numbers 62040-A8375 and 62040-A8432, totaling 288 cases of 50 units. These containers have been distributed worldwide, including to healthcare facilities in Texas, Illinois, Ohio, Pennsylvania, Washington, Maryland, Utah, California, Massachusetts, Michigan, Florida, Puerto Rico, and Canada.
The recalled product
- Product
- 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.
- Manufacturer
- The Metrix Company
- Hazard
- container-leak
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI 00812496011008
- Lot Numbers: 62040-A8375
- 62040-A8432
Distribution
Distributed nationwide across the United States.
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