FDA recall Z-1386-2019

Product

enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.

Reason for recall

Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.

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.

Key facts

Status

Terminated

Initiation date

2019-03-13

Report date

2019-07-03

Termination date

2020-09-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mettawa, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1386-2019