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.

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

An Urgent: Medical Device Recall notification letter dated 6/7/21 was emailed and mailed to customers. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: Inspect inventory and quarantine impacted product. Remove and destroy the instruction for use (IFU) (Rev F) upon opening the kit during the treatment Replace with the IFU (Rev G) attached to this letter Attach the laminated card provided with this letter on the fluid warmer device itself, not on the disposable kit. Until we are able to provide kits with the corrected IFU (Rev G), please continue to use the attached Rev G. Complete and return response form FM-018-02 via email to [email protected] (the document is attached) TYPE OF ACTION BY THE COMPANY: EIGHT MEDICAL INTERNATIONAL B.V. is working towards an updated design solution and will notify customers in order to replace products, when available. OTHER INFORMATION: If you need any further information or support concerning this issue, please contact Tracy Hurtt, [email protected] For calls +1 (812) 212-2198 - Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. For Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.