Imed EVA IV Fluid Bags Recalled Due to Leakage During Filling
The Metrix Company is recalling Imed EVA IV fluid bags that may leak during filling. A limited number of units have been found defective across 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: FDA Class II device recall for IV bags confirmed to leak during filling. While no illnesses or injuries have been reported, this defect poses a direct risk to patient safety during intravenous therapy, meeting the criterion for a risk-of-harm product without documented adverse events.
Plain-English summary
The Metrix Company is recalling Imed Products Imed EVA BAG, 250 mL, 2-PORTS (Model IM68045), an empty single-use plastic pouch designed to hold intravenous (IV) fluids. The recall affects 1,056 cases containing 50 units each.
A limited number of these IV bags have been found to leak during the filling process.
The affected products were distributed across multiple U.S. states including Texas, Illinois, Ohio, Pennsylvania, Washington, Maryland, Utah, California, Massachusetts, Michigan, and Florida, as well as Puerto Rico and Canada. The following lot numbers are involved: 68045-A8289, 68045-A8319, 68045-A8347, 68045-A8390, and 68045-A8434 (UDI/DI 00812496011312).
The recalled product
- Product
- Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; 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 (6)
- UDI/DI 00812496011312
- Lot Numbers: 68045-A8289
- 68045-A8319
- 68045-A8347
- 68045-A8390
- 68045-A8434
Distribution
Distributed nationwide across the United States.
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