Z-1385-2019 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2019
- Initiation Date
- March 13, 2019
- Termination Date
- September 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,782,820 units total
Product Description
enFlow Disposable Cartridge, 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 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.
Code Information
Part Number: 980200EU. All units distributed through March 7, 2019.