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.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is FDA Class I, which is defined as unlikely to cause adverse health consequences, corresponding to a Low severity score.
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
- 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.
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Same hazard · aluminum elution
See all →- CriticalVyaire Medical Recalls enFlow Cartridges Due to Aluminum Elution
FDA (Devices) · 2019-07-03