Z-2005-2021Class I

Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic...

Name: Z-2005-2021 Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic...
Creator: Eight Medical International BV
Published: 2021-06-04
License: https://open.fda.gov/license/

Eight Medical International BV / initiated 2021-06-04 / Terminated / root cause: design

FDA source

Eight Medical International BV began a recall of Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of... on 2021-06-04. FDA classified it as Class I and gives the reason as "The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2005-2021
Classification: Class I
Status: Terminated
Initiated: 2021-06-04
Posted: 2021-07-23
Terminated: 2023-08-03
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.
Product code: LGZ Warmer, Thermal, Infusion Fluid
Reason for recall: The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Root cause tag: design
FDA 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 [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.
Quantity in commerce: 22
Distribution: US Nationwide, Colombia, and Dubai.
Product codes and lots: UDI: 08719992086016 Lot Numbers: 20021361 20202106 20202106 20018480 19854186 20019438 20018480 19854186 19854185 20202106 20019438 19854184 20202106 20018480 20202106 20018480 18687686

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2005-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2005-2021	Class I	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-23

Product code LGZ

K102900Class IIHeiter 3000 Hyperthermic Perfusion SystemHei, Inc. / cleared 2012-03-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)