# FDA recall Z-2005-2021

> **Eight Medical International BV** · Class I · device recall initiated 2021-06-04.

## Product

Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016.   Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.

## Reason for recall

The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.

## Distribution

US Nationwide,  Colombia, and Dubai.

## Key facts

- **Recall number:** Z-2005-2021
- **Recalling firm:** Eight Medical International BV
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-04
- **Report date:** 2021-08-04
- **Termination date:** 2023-08-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bergen Op Zoom, N/A, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2005-2021

## Citation

> AI Analytics. FDA recall Z-2005-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2005-2021. Source: US FDA. Licensed CC0.

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