Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Recirculator 8.0s Disposable Lavage Kit (product code number 8100) Recalled by Eight Medical International BV Due to The patient may be exposed to potential aluminum...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Eight Medical International BV directly.
Affected 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.
Quantity: 22
Why Was This Recalled?
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Eight Medical International BV
Eight Medical International BV has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report