Agency classClass IIOur severity:High FDA (Devices)·Z-0331-2025·Announced 2024-11-20

VYGON 250 mL IV Fluid Containers Recalled for Leaks During Filling

The Metrix Company is recalling VYGON 250 mL IV fluid containers that have been found to leak during filling. Leaking containers cannot properly contain intravenous fluid.

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 a FDA Class II medical device recall involving high-risk intravenous equipment with no reported illnesses or injuries. The leak defect poses a potential risk to patient safety by compromising the container's ability to properly hold intravenous fluid.

Plain-English summary

The Metrix Company is recalling VYGON 250 mL Empty EVA Containers (REF CMS-9602) used for intravenous (IV) fluid administration. These are empty single-use plastic pouches intended to contain fluids for IV administration. The recall affects 384 cases containing 50 units each.

A limited number of these IV containers have been found to leak during the filling process. Leaking containers cannot properly contain the intravenous fluid, potentially compromising product integrity.

The affected units were distributed nationwide in the following U.S. states: Texas, Illinois, Ohio, Pennsylvania, Washington, Maryland, Utah, California, Massachusetts, Michigan, Florida, and Puerto Rico, as well as Canada. The recalled lot numbers are 62045-A8339, 62045-A8376, and 62045-A8467.

Healthcare facilities and patients who may have received these IV containers should verify their inventory using the provided lot numbers. If affected units are identified, they should be removed from service and not used. Any adverse events should be reported to The Metrix Company or the FDA.

The recalled product

Product: VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; 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 Equipment
Hazard: leak
device-defect

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 (4)

UDI/DI 00812496011022
Lot Numbers: 62045-A8339
62045-A8376
62045-A8467

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 · leak