enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
Reported: July 3, 2019 Initiated: March 13, 2019 #Z-1385-2019
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.
Details
- Recalling Firm
- Vyaire Medical
- Units Affected
- 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.
- Location
- Mettawa, IL
Frequently Asked Questions
What product was recalled? ▼
enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.. Recalled by Vyaire Medical. Units affected: 5,782,820 units total.
Why was this product recalled? ▼
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 3, 2019. Severity: Critical. Recall number: Z-1385-2019.
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