Eight Medical International BV Recall 87406
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.
Eight Medical International BV Recall 87406 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2005-2021 |
| Event ID | 87406 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide, Colombia, and Dubai. |
| Quantity | 22 |
| Recall Reason | The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions. |
| Device Classification | 20210804 |
| Device Code Info | UDI: 08719992086016 Lot Numbers: 20021361 20202106 20202106 20018480 19854186 20019438 20018480 19854186 19854185 20202106 20019438 19854184 20202106 20018480 20202106 20018480 18687686 |
| Center Classification Date | 20210723 |
| Recall Initiation Date | 20210604 |
| Recalling Firm | Eight Medical International BV |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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