Agency classClass IOur severity:Critical FDA (Devices)·Z-1385-2019·Announced 2019-07-03

Vyaire Medical Recalls enFlow Cartridges Due to Aluminum Elution

Vyaire Medical is recalling enFlow Disposable Cartridges because testing showed aluminum elution during fluid warming. The recall covers 5,782,820 units distributed worldwide.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states the agency classification is Class I. According to the rubric, FDA Class I recalls are assigned a severity score of 5 (Critical) regardless of other factors.

Plain-English summary

Vyaire Medical is recalling the enFlow Disposable Cartridge, a medical device used for intravenous warming therapy with fluid and blood solutions. The recall is being conducted because testing has demonstrated aluminum elution from the cartridge during the fluid warming process.

The recall involves 5,782,820 units of the enFlow Disposable Cartridge, identified by Part Number 980200EU. All affected units were distributed through March 7, 2019. The products were distributed worldwide, including in the United States, Brazil, Canada, and numerous other countries.

The U.S. Food and Drug Administration has classified this recall as Class I, which is the most serious type of recall. This classification indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death. Healthcare providers and consumers should stop using the affected cartridges and contact Vyaire Medical for further instructions.

The recalled product

Product: enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
Manufacturer: Vyaire Medical
Category: Medical Device — Intravenous Therapy
Hazard: aluminum-elution
Affected units: 5,782,820

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)

Part Number: 980200EU. All units distributed through March 7
2019.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Vyaire Medical 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 2 products in this recall →

Same manufacturer · Vyaire Medical

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Same hazard · aluminum elution