IV Bag Containers Recalled for Leaking During Filling Process
The Metrix Company is recalling CORMIX 500 mL IV bag containers that may leak during the filling process. These plastic pouches are intended for intravenous 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: FDA Class II medical device with a concrete leak hazard affecting IV bags. No illnesses or injuries have been reported. As a risk-of-harm product where injury has not yet been reported, it warrants a High severity rating.
Plain-English summary
The Metrix Company has recalled CORMIX 500 mL empty EVA containers (plastic pouches) intended for intravenous fluid administration. The product comes with two ports for IV connections and carries reference number MS64050.
A limited number of these IV bags have been found to leak during the filling process. Leaking bags could compromise the integrity of the infusion and pose a risk of contamination.
The recall affects approximately 1,440 cases containing 50 units each, distributed nationwide in the United States (Texas, Illinois, Ohio, Pennsylvania, Washington, Maryland, Utah, California, Massachusetts, Michigan, Florida, and Puerto Rico) as well as Canada. The affected lot numbers are 64050-A8293, 64050-A8406, 64050-A8421, 64050-A8452, and 64050-A8470.
Anyone with these products should stop using them and contact The Metrix Company for additional guidance.
The recalled product
- Product
- CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
- Manufacturer
- The Metrix Company
- Hazard
- leak
- contamination
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 00812496011138
- Lot Numbers: 64050-A8293
- 64050-A8406
- 64050-A8421
- 64050-A8452
- 64050-A8470
Distribution
Distributed nationwide across the United States.
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