Device 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.
Z-2005-2021
Product summary
- Event
- Event 87406
- Status
- Terminated
- Classification
- Class I
- Quantity
- 22
- Official record key
device-enforcement:Z-2005-2021
Official wording
Reason: The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Code information: UDI: 08719992086016 Lot Numbers: 20021361 20202106 20202106 20018480 19854186 20019438 20018480 19854186 19854185 20202106 20019438 19854184 20202106 20018480 20202106 20018480 18687686
Distribution pattern: US Nationwide, Colombia, and Dubai.
Derived failure modes
-
Unknown
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.