FDA Device recall Z-2005-2021
Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016
- FDA Device
- Class I
- terminated
- Published 2021-08-04
On 2021-08-04 the FDA classified a Class I recall of Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016 by Eight Medical International Bv, citing the patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2005-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-06-04 |
| Published | 2021-08-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Eight Medical International Bv |
| Distribution | US |
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.
Reason
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Identifiers
| code_info | UDI: 08719992086016 Lot Numbers: 20021361 20202106 20202106 20018480 19854186 20019438 20018480 19854186 198…UDI: 08719992086016 Lot Numbers: 20021361 20202106 20202106 20018480 19854186 20019438 20018480 19854186 19854185 20202106 20019438 19854184 20202106 20018480 20202106 20018480 18687686 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2005-2021%22
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