IV Fluid Bags Recalled Due to Leaking During Filling
The FDA is recalling Imed EVA BAG IV bags after a limited number were found to leak during filling. The affected bags were distributed nationwide and in 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 FDA Class II recall involves a structural defect (leaking) in medical devices for IV administration. The hazard is a risk-of-harm scenario where the product's integrity is compromised, and no adverse events have been reported, fitting the rubric criterion for Score 3.
Plain-English summary
The FDA is recalling Imed Products Imed EVA BAG (150 mL, 2-PORTS, REF IM38040) manufactured by The Metrix Company. A limited number of these IV bags have been found to leak during filling. The product is a single-use plastic pouch intended to contain fluid for intravenous administration.
A total of 768 units are affected. The recalled lot numbers are 68040-A8318, 68040-A8408, 68040-A8441, and 68040-A8474. The bags have been distributed nationwide in the following states: Texas, Illinois, Ohio, Pennsylvania, Washington, Maryland, Utah, California, Massachusetts, Michigan, Florida, and Puerto Rico, as well as in Canada.
Leaking bags may compromise the integrity of the fluid being administered. Patients and healthcare providers who have received or used these bags should contact The Metrix Company or the FDA if they have questions or concerns.
The recalled product
- Product
- Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
- Manufacturer
- The Metrix Company
- Hazard
- leakage
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 00812496011305
- Lot Numbers: 68040-A8318
- 68040-A8408
- 68040-A8441
- 68040-A8474
Distribution
Distributed nationwide across the United States.
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