# FDA recall Z-2066-2019

> **Medline Industries Inc** · Class I · device recall initiated 2019-05-03.

## Product

Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled Vyaire enFlow Disposable Cartridge, which is the subject of this recall, and the recalled BD Alaris Pump Infusion Set (RES#82951)     Product Usage:  The Vyaire enFlow Disposable Cartridges contain a heating element that is used to help raise or maintain a patient's body temperature.

## Reason for recall

The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum levels to elute into the infusate. The Use of the BD Alaris Pump Infusion Set may lead to serious adverse events for patients due to the incomplete occlusion caused by variation in tubing wall thickness.

## Distribution

One distributor located in Illinois.

## Key facts

- **Recall number:** Z-2066-2019
- **Recalling firm:** Medline Industries Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-03
- **Report date:** 2019-08-21
- **Termination date:** 2021-03-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2066-2019

## Citation

> AI Analytics. FDA recall Z-2066-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2066-2019. Source: US FDA. Licensed CC0.

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