FDA Medical Device Recalls (openFDA)
Eight Medical International BV: 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 number
- Z-2005-2021
- Recalling firm
- Eight Medical International BV
- 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.
- Status
- Terminated
- Initiated
- 2021-06-04
- Posted
- not on file
- Terminated
- 2023-08-03
- Reason
- The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 22
- Distribution
- US Nationwide, Colombia, and Dubai.
- Lot, serial or model codes
- UDI: 08719992086016 Lot Numbers: 20021361 20202106 20202106 20018480 19854186 20019438 20018480 19854186 19854185 20202106 20019438 19854184 20202106 20018480 20202106 20018480 18687686
- 510(k) numbers
- ["K102900"]
- PMA numbers
- not on file
- Product code
- LGZ
- Firm FEI
- 3011831824
- Firm city
- Bergen Op Zoom
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28