Agency classClass IIOur severity:High FDA (Devices)·Z-0335-2025·Announced 2024-11-20

IV Fluid Container Bags Recalled for Leaking Defect

The Metrix Company is recalling SECURE 100 mL empty EVA containers for IV use due to leaking discovered during filling. Approximately 2,229 cases were distributed to healthcare facilities in the US and Canada.

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 3/5 (High).

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 an FDA Class II medical device recall for a product defect (leaking) in a critical medical device. While no illnesses or injuries have been reported, leaking IV containers pose a risk of harm through potential fluid contamination and improper delivery. The rubric permits High (3) for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The Metrix Company is recalling SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (REF 66040), an empty single-use plastic pouch designed to hold fluid for intravenous (IV) administration. The recall was initiated after a limited number of IV bags were found to leak during the filling process.

The recall affects 2,229 cases of 50 units each. Distribution includes locations throughout the United States (Texas, Illinois, Ohio, Pennsylvania, Washington, Maryland, Utah, California, Massachusetts, Michigan, Florida, and Puerto Rico) and Canada. Affected lot numbers are 66040-A8314, 66040-A8368, 66040-A8417, and 66040-A8482.

A leaking IV container could compromise the sterility of intravenous fluid and pose a risk of improper administration. Healthcare facilities and medical professionals with these products should verify they do not have affected lot numbers and inspect containers for damage or leaking before clinical use.

The recalled product

Product: SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Manufacturer: The Metrix Company
Category: Medical Device — Intravenous Infusion Equipment
Hazard: leaking
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 (5)

UDI/DI 00812496011541
Lot Numbers: 66040-A8314
66040-A8368
66040-A8417
66040-A8482

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

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 →

Same manufacturer · The Metrix Company

See all →

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Same hazard · leaking