Eight Medical International BV Laan Van Hildernisse-Noord 2a Bergen Op Zoom Netherlands 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Eight Medical International BV Laan Van Hildernisse-Noord 2a Bergen Op Zoom Netherlands
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI: 08719992086016 Lot Numbers: 20021361 20202106 20202106 20018480 19854186 20019438 20018480 19854186 19854185 20202106 20019438 19854184 20202106 20018480 20202106 20018480 18687686
Eight Medical International BV Laan Van Hildernisse-Noord 2a Bergen Op Zoom Netherlands is recalling Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperth due to The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Recommended Action
Per FDA guidance
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 hurtt.tracy@eightmedical.com (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, hurtt.tracy@eightmedical.com 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026