Device recall
Z-2005-2021: Recirculator 8.0s Disposable Lavage Kit (product code number 8100), GTIN…
FDA device recall · Class I · Eight Medical International BV
Key facts
| Recall number (Z-number) | Z-2005-2021 |
|---|---|
| Recall event | 87406 |
| 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 |
| Recalling firm | Eight Medical International BV |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 3, 2023 |
| 510(k) numbers | K102900 |
| FEI number | 3011831824 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database