# FDA recall Z-1385-2019

> **Vyaire Medical** · Class I · device recall initiated 2019-03-13.

## Product

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

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

- **Recall number:** Z-1385-2019
- **Recalling firm:** Vyaire Medical
- **Classification:** Class I
- **Product type:** device
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1385-2019

## Citation

> AI Analytics. FDA recall Z-1385-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1385-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*