Reported Aug 4, 2021 · Terminated
Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion…
Eight Medical International BV
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Eight Medical International BV · Laan Van Hildernisse-Noord 2a · Bergen Op Zoom, N/A · N/A
Is this the product you have?
- Recirculator 8.0s Disposable Lavage Kit (product code number 8100)
- GTIN08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature
- Lot codes and dates
- UDI08719992086016
- Lot Numbers
2002136120202106202021062001848019854186200194382001848019854186198541852020210620019438198541842020210620018480202021062001848018687686
- Amount recalled
- 22
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Using this product could cause serious injury, illness or death — stop using it now.
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