IV Bag Containers Recalled Due to Leaking During Filling
The FDA has recalled CORMIX 250 mL empty IV bags made by The Metrix Company due to leaking during the filling process. Approximately 3,456 cases were distributed across the US and 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: This FDA Class II recall involves a documented defect in a high-risk medical device used for intravenous administration. Although no illnesses or injuries have been reported, the leaking defect presents a potential risk of harm to patients. Per the severity rubric, products that present risk of harm without reported injuries score at most High (3).
Plain-English summary
The Metrix Company is recalling CORMIX 250 mL EMPTY EVA CONTAINER with 2 ports (REF MS64045), an empty plastic pouch designed to hold intravenous (IV) fluid for patient administration. A total of 3,456 cases containing 50 units each have been distributed.
The company discovered that a limited number of these IV bags leak during the filling process. This defect could potentially compromise the integrity of the intravenous fluid being prepared for patient use.
The recalled products were distributed nationwide across Texas, Illinois, Ohio, Pennsylvania, Washington, Maryland, Utah, California, Massachusetts, Michigan, Florida, and Puerto Rico, as well as Canada. The affected lot numbers are: 64045-A8305, 64045-A8341, 64045-A8366, 64045-A8377, 64045-A8405, 64045-A8411, 64045-A8447, 64045-A8469, and 64045-A8485.
Healthcare facilities and providers who have received these products should stop using them immediately. Affected units can be identified by the lot numbers listed above or the UDI/DI 00812496011121. Contact The Metrix Company for instructions on returning the recalled items.
The recalled product
- Product
- CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
- Manufacturer
- The Metrix Company
- Hazard
- container-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 (10)
- UDI/DI 00812496011121
- Lot Numbers: 64045-A8305
- 64045-A8341
- 64045-A8366
- 64045-A8377
- 64045-A8405
- 64045-A8411
- 64045-A8447
- 64045-A8469
- 64045-A8485
Distribution
Distributed nationwide across the United States.
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