FDAJune 4, 2021device
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
What to do
FDA enforcement status: Terminated
Brands named
eight medical international bveighteight medical
UPCs
08719992086016
Recall history
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