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Eight Medical International BV recalls Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion Syst
Recalled August 4, 2021 · FDA recall Z-2005-2021 · Eight Medical International BV
Hazard
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions. · FDA Class I
Units
22
Sold at
US Nationwide, Colombia, and Dubai.
Description
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
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.
Manufacturer(s)
Eight Medical International BV
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →