enFlow Disposable Cartridge with IV Extension Set recall
enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
Why was enFlow Disposable Cartridge with IV Extension Set recalled?
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: 980202EU. All units distributed through March 7, 2019.
- Product
- enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
- Recalling firm
- Vyaire Medical
- Quantity
- 5,782,820 units total
- Distribution
- Worldwide Distribution. US nationwide, 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.
- Recall date
- July 3, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)