medical Class I Updated 2021-08-04

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

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 08719992086016 Lot Numbers: 20021361 20202106 20202106 20018480 19854186 20019438 20018480 19854186 19854185 20202106 20019438 19854184 20202106 20018480 20202106 20018480 18687686
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