Device recall
Z-0191-2020: Irrisept Wound Debridement and Cleansing System. 12 units per case.
FDA device recall · Class II · IrriMAX Corporation
Key facts
| Recall number (Z-number) | Z-0191-2020 |
|---|---|
| Recall event | 83599 |
| Product | Irrisept Wound Debridement and Cleansing System. 12 units per case. |
| Product code | FQH |
| Recalling firm | IrriMAX Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 25, 2020 |
| 510(k) numbers | K080779 |
| FEI number | 3005706359 |
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