IV Fluid Container Bags Recalled for Potential Leaks During Filling
The Metrix Company is recalling SECURE 250 mL IV fluid containers due to leaks found during filling. Affected units 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: FDA Class II recall with no reported illnesses or injuries. The hazard is a product-integrity defect (leaks during filling) that poses a risk of harm if not caught during use, but no actual injury has been reported. This meets the High severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Metrix Company is recalling SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports (REF 66045) due to leaks discovered during the filling process.
The recalled IV bags are intended for containing fluids for intravenous administration. A limited number of units from the affected lots have been found to leak when being filled.
The recall affects 2,921 cases containing 50 units each. The recalled lot numbers are 66045-A8308, 66045-A8334, 66045-A8360, 66045-A8382, and 66045-A8419. Distribution was nationwide across multiple U.S. states (Texas, Illinois, Ohio, Pennsylvania, Washington, Maryland, Utah, California, Massachusetts, Michigan, Florida, and Puerto Rico) and Canada.
Healthcare facilities and consumers who have received these IV bags should inspect them before use. Any bags showing signs of leaks or damage should not be used. For questions or to report adverse events, contact the manufacturer or the FDA.
The recalled product
- Product
- SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
- Manufacturer
- The Metrix Company
- Hazard
- leak
- product-integrity
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 00812496011589
- Lot Numbers: 66045-A8308
- 66045-A8334
- 66045-A8360
- 66045-A8382
- 66045-A8419
Distribution
Distributed nationwide across the United States.
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