Metrix SECURE 1000 mL IV Container Recall Due to Leaking
The Metrix Company is recalling SECURE 1000 mL empty IV containers because a limited number were found to leak during filling.
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: The recall involves a medical device with a defect (leaking) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
The Metrix Company is recalling SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports (REF 66055). These are empty, single-use plastic pouches intended to contain fluid for intravenous (IV) administration.
The recall was initiated because a limited number of the IV bags were found to leak during the filling process. The affected units are identified by UDI/DI 00812496011602 and Lot Numbers 66055-A8336 and 66055-A8483.
A total of 277 cases, containing 50 units each, were distributed. Distribution was worldwide, including US nationwide distribution in Texas, Illinois, Ohio, Pennsylvania, Washington, Maryland, Utah, California, Massachusetts, Michigan, Florida, Puerto Rico, and Canada. Consumers and healthcare facilities should stop using the affected products and contact the manufacturer for instructions.
The recalled product
- Product
- SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
- Manufacturer
- The Metrix Company
- Category
- Medical Device — IV Containers
- 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 (3)
- UDI/DI 00812496011602
- Lot Numbers: 66055-A8336
- 66055-A8483
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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