FDA-Device2021-08-04Class I
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.
Eight Medical International BV
Hazard
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Sold states
US Nationwide, Colombia, and Dubai.
Affected count
22
Manufactured in
Laan Van Hildernisse-Noord 2a, N/A, Bergen Op Zoom, N/A, Netherlands
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2005-2021Don't want to check this manually?
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