IV Fluid Pouches Found to Leak During Filling
The Metrix Company is recalling SECURE 50 mL EVA containers used for intravenous fluid administration because a limited number of pouches have been found to leak during filling. Affected products were distributed nationwide and to 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 functional defect in a FDA Class II medical device used for critical intravenous administration. While no illnesses or injuries have been reported, leaking IV bags present a genuine risk of harm to patients, meeting the rubric criterion of a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Metrix Company is recalling SECURE 50 mL EMPTY EVA CONTAINER with 2 Ports (REF 66042). This medical device is a single-use plastic pouch designed to contain fluids for intravenous (IV) administration.
A limited number of pouches from the affected lots have been found to leak during the filling process. The defect affects pouches in the following lot numbers: 66042-A8297, 66042-A8422, and 66042-A8459.
The affected products comprise 1,013 cases (50 units per case) and were distributed nationwide to healthcare facilities in Texas, Illinois, Ohio, Pennsylvania, Washington, Maryland, Utah, California, Massachusetts, Michigan, Florida, Puerto Rico, and Canada.
Consumers and healthcare facilities with affected products should discontinue use and contact The Metrix Company for instructions on returns or disposal.
The recalled product
- Product
- 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.
- Manufacturer
- The Metrix Company
- Hazard
- leak
- malfunction
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 (4)
- UDI/DI 00812496011565
- Lot Numbers: 66042-A8297
- 66042-A8422
- 66042-A8459
Distribution
Distributed nationwide across the United States.
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