Recirculator 8.0s Disposable Lavage Kit (product code… recallZ-2005-2021 · Eight Medical International BV · initiated Jun 4, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Eight Medical International BV or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2005-2021
- Status
- Terminated
- Initiated by the company
- Jun 4, 2021
- Recalling firm
- Eight Medical International BV
- Quantity
- 22
- Product code
- LGZ
- FDA submissions
- K102900
- Distribution
- US Nationwide, Colombia, and Dubai.
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.
Code information (models, lots, serial numbers)
UDI: 08719992086016 Lot Numbers: 20021361 20202106 20202106 20018480 19854186 20019438 20018480 19854186 19854185 20202106 20019438 19854184 20202106 20018480 20202106 20018480 18687686
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Lavage Procedure Kit 1Eight Medical International B.V. · Warmer, Thermal, Infusion Fluid1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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