Eight Medical International BV: Medical Device Recall in 2021 - (Recall #: Z-2005-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: June 4, 2021

Date Posted: August 4, 2021

Recall Number: Z-2005-2021

Event ID: 87406

Reason for Recall:

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

Status: Terminated

Product Quantity: 22

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.

Voluntary or Mandated:

Voluntary: Firm initiated