IV Fluid Containers Recalled for Leakage Risk During Filling
The Metrix Company is recalling CORMIX 150 mL empty IV fluid containers due to leakage found during filling, which could compromise the integrity of intravenous fluids.
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: FDA Class II medical device with a confirmed product defect (leakage) in a critical application (intravenous fluid administration). No reported illnesses or injuries have been documented, but the defect poses a risk of harm through potential fluid contamination.
Plain-English summary
The Metrix Company is recalling CORMIX 150 mL empty EVA containers (IV bags) with 2 ports, Reference MS64040. These are single-use plastic pouches designed to hold intravenous fluids for patient administration.
A limited number of IV bags have been found to leak during the filling process. Leakage could compromise the sterility and integrity of intravenous fluids.
The recall affects 1920 cases of 50 units each, distributed nationwide in the United States and Canada, including Texas, Illinois, Ohio, Pennsylvania, Washington, Maryland, Utah, California, Massachusetts, Michigan, Florida, and Puerto Rico.
The affected products have lot numbers 64040-A8313, 64040-A8340, 64040-A8365, and 64040-A8437, identified by UDI/DI 00812496011114.
The recalled product
- Product
- 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.
- Manufacturer
- The Metrix Company
- Hazard
- leakage
- contamination
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 (5)
- UDI/DI 00812496011114
- Lot Numbers: 64040-A8313
- 64040-A8340
- 64040-A8365
- 64040-A8437
Distribution
Distributed nationwide across the United States.
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