Eight Medical International BV recalls Recirculator 8.0s Disposable Lavage Kit (product code number
Recalled 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.
Hazard / Issue
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Issued by
FDA
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