IV Fluid Bags Recalled Due to Leakage During Filling
The Metrix Company is recalling SECURE 50 mL empty IV containers due to leakage found during filling. A limited number of affected bags have been distributed nationwide.
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 involving intravenous fluid containers with a leakage defect. No illnesses or injuries have been reported, but the defect presents a risk of product contamination; as a risk-of-harm product without reported injury, it is scored as High severity.
Plain-English summary
The Metrix Company is recalling SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66043, a single-use plastic pouch designed to hold intravenous (IV) fluids for patient administration.
A limited number of these IV bags have been found to leak during filling. This defect can compromise the integrity of the product and affect its intended use.
The recalled products were distributed nationwide in Texas, Illinois, Ohio, Pennsylvania, Washington, Maryland, Utah, California, Massachusetts, Michigan, Florida, Puerto Rico, and Canada. Lot number 66043-A8298 is affected, with 83 cases of 50 units recalled.
Customers and patients should discontinue use of affected units. Healthcare providers and patients with questions should contact The Metrix Company.
The recalled product
- Product
- SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
- Manufacturer
- The Metrix Company
- Hazard
- leakage
- contamination-risk
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 50812496011577
- Lot Numbers: 66043-A8298
Distribution
Distributed nationwide across the United States.
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