Recall Z-2005-2021 ยท LGZ Warmer, Thermal, Infusion Fluid
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.
| Date | Jun 4, 2021 |
| Status | Terminated |
| 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 r |
| Quantity | 22 |
| Distribution | US Nationwide, Colombia, and Dubai. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102900 | HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM Hei, Inc., Mar 21, 2012 |