Vyaire Medical: Medical Device Recall in 2019 - (Recall #: Z-1386-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: March 13, 2019

Date Posted: July 3, 2019

Recall Number: Z-1386-2019

Event ID: 82393

Reason for Recall:

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

Status: Terminated

Product Quantity: 5,782,820 units total

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.

Voluntary or Mandated:

Voluntary: Firm initiated