Device product
enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
Z-1386-2019
Product summary
- Firm
- Vyaire Medical
- Event
- Event 82393
- Status
- Terminated
- Classification
- Class I
- Quantity
- 5,782,820 units total
- Official record key
device-enforcement:Z-1386-2019
Official wording
Reason: Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
Code information: Part Number: 980202EU. All units distributed through March 7, 2019.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.