Agency classClass IOur severity:Severe FDA (Devices)·Z-1386-2019·Announced 2019-07-03

Vyaire Medical Recalls enFlow Disposable Cartridges Due to Aluminum Elution

Vyaire Medical is recalling enFlow Disposable Cartridges with IV Extension Sets because testing showed aluminum elution during fluid warming.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming."

Plain-English summary

Vyaire Medical is recalling enFlow Disposable Cartridges with IV Extension Sets, which are 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 affected product is identified by Part Number 980202EU. The recall covers all units distributed through March 7, 2019. The total quantity of units involved is 5,782,820.

The product was distributed worldwide, including nationwide in the United States, as well as in Brazil, Canada, Chile, Colombia, Ecuador, Hong Kong, Hungary, Israel, India, Jordan, Korea, Kuwait, Kazakhstan, Lebanon, Macedonia, Mexico, Malaysia, Myanmar, Netherlands, New Zealand, Oman, Peru, Qatar, Russian Federation, Saudi Arabia, Thailand, Turkey, United Republic of Tanzania, South Africa, Panama, and Viet Nam. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units.

The recalled product

Product: enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
Manufacturer: Vyaire Medical
Category: Medical Device — IV Warming
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: 980202EU. 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