Home / Recalls / Eight Medical International BV / Z-2005-2021

Z-2005-2021 Class I Terminated

Recalled by Eight Medical International BV — Bergen Op Zoom, N/A

Recall Details

Product Type: Devices
Report Date: August 4, 2021
Initiation Date: June 4, 2021
Termination Date: August 3, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 22

Product Description

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.

Reason for Recall

The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.

Distribution Pattern

US Nationwide, Colombia, and Dubai.

Code Information

UDI: 08719992086016 Lot Numbers: 20021361 20202106 20202106 20018480 19854186 20019438 20018480 19854186 19854185 20202106 20019438 19854184 20202106 20018480 20202106 20018480 18687686