Imed EVA IV bags recalled for leaking during filling
The Metrix Company is recalling Imed EVA IV bags due to leakage discovered during the filling process. A limited number of bags were found to leak, potentially affecting the safety of intravenous therapy.
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 an FDA Class II medical device recall for a defect in a critical product used for intravenous administration. Although no illnesses or injuries are reported in the source text, the leakage defect poses inherent risk to patient safety, qualifying as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Metrix Company is recalling Imed EVA bags (1000 mL, 2-port, REF IM68055) distributed nationwide in the United States and Canada. These are single-use plastic pouches designed to contain fluids for intravenous administration.
A limited number of these IV bags have been found to leak during the filling process. Leaking bags could compromise the integrity of intravenous therapy and potentially pose a safety risk to patients.
The affected product (lot number 68055-A8362) was distributed to healthcare facilities in Texas, Illinois, Ohio, Pennsylvania, Washington, Maryland, Utah, California, Massachusetts, Michigan, Florida, and Puerto Rico, as well as Canada.
The recalled product
- Product
- Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
- Manufacturer
- The Metrix Company
- Hazard
- leakage
- device-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 (2)
- UDI/DI 00853155008427
- Lot Numbers: 68055-A8362
Distribution
Distributed nationwide across the United States.
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