IV Fluid Bags Found to Leak During Filling; Manufacturer Recalls Affected Units
The Metrix Company is recalling 2549 cases of SECURE 100 mL empty IV fluid bags because a limited number were found to leak during filling, which could result in contamination during fluid administration.
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 a risk-of-harm medical device where leaking has been identified, creating potential for fluid contamination and sterility compromise. Although no illnesses or injuries have been reported, the hazard involves IV administration where contamination could cause serious harm, meeting the threshold for High severity without reported adverse events.
Plain-English summary
The Metrix Company is recalling SECURE 100 mL EMPTY EVA CONTAINER units (REF 66041), empty single-use plastic pouches intended to hold intravenous fluids. The recall affects 2549 cases of 50 units each, distributed nationwide and internationally.
A limited number of these IV bags have been found to leak during the filling process. If a leaking container is not detected before fluid administration, contaminated or compromised fluid could be administered to patients, potentially causing harm.
The affected lot numbers are 66041-A8296, 66041-A8343, 66041-A8386, 66041-A8418, and 66041-A8433. The product was distributed to healthcare facilities in Texas, Illinois, Ohio, Pennsylvania, Washington, Maryland, Utah, California, Massachusetts, Michigan, Florida, Puerto Rico, and Canada.
Healthcare providers who have received these products should stop using the affected lot numbers and contact The Metrix Company or the FDA with questions.
The recalled product
- Product
- SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
- Manufacturer
- The Metrix Company
- Hazard
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 50812496011553
- Lot Numbers: 66041-A8296
- 66041-A8343
- 66041-A8386
- 66041-A8418
- 66041-A8433
Distribution
Part of a larger recall action
This product is one of 16 recalled by The Metrix Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 16 products in this recall →Related recalls
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