Metrix Secure EVA Dual Chamber IV Bags Recalled for Leaking Risk
The Metrix Company is recalling 1,596 Secure EVA dual chamber IV bags due to a potential for leaking. The affected bags were distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Metrix Company is recalling 1,596 units of the SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615. The recall is being conducted because of a potential for the product to leak. These containers are intended for use in intravenous admixture programs for the storage and delivery of parenteral admixtures.
The affected products are identified by Lot Numbers 66615-A3539 and 66615-A5098. The recall covers a US Nationwide distribution, including the states of Pennsylvania, Massachusetts, Illinois, and California.
Healthcare facilities and pharmacies should stop using the affected lots and contact The Metrix Company for further instructions on how to return or dispose of the product.
The recalled product
- Product
- SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of…
- Manufacturer
- The Metrix Company
- Hazard
- Affected units
- 1,596
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 (2)
- Lot Numbers: 66615-A3539
- 66615-A5098
Distribution
Part of a larger recall action
This product is one of 8 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.
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