IV Fluid Container Leak During Filling — SECURE 500 mL EVA Container Recall
The Metrix Company is recalling SECURE 500 mL EVA containers (REF 66050) used for intravenous administration because a limited number have been found to leak during filling. Affected lots 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 of IV administration containers with potential for patient harm due to leakage. No illnesses or injuries have been reported. Per the severity rubric, Class II recalls without documented hospitalization or reported illness are classified as High (3).
Plain-English summary
The Metrix Company is recalling SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports (REF 66050), single-use plastic pouches intended to contain intravenous (IV) fluids. A limited number of units from the affected lots have been found to leak during the filling process.
This recall affects 1020 cases of 50 units each. The affected lot numbers are 66050-A8335, 66050-A8409, and 66050-A8460. Distribution was nationwide to the following states: Texas, Illinois, Ohio, Pennsylvania, Washington, Maryland, Utah, California, Massachusetts, Michigan, Florida, and Puerto Rico, as well as Canada.
Healthcare facilities that have received affected units should not use them for IV administration. Leaking containers could compromise sterility or affect proper medication delivery. Contact The Metrix Company for instructions on replacement or return of affected units.
The recalled product
- Product
- SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; 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 (4)
- UDI/DI 00812496011596
- Lot Numbers: 66050-A8335
- 66050-A8409
- 66050-A8460
Distribution
Distributed nationwide across the United States.
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