Eight Medical International BV recalls Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion Syste…
- Recall date
- June 4, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2005-2021
- FDA classification
- Class I
- Brand / firm
- Eight Medical International BV
- Sold / distributed
- US Nationwide, Colombia, and Dubai.
Why it was recalled
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
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.
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