Device recall
Z-1808-2020: ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical…
FDA device recall · Class II · Uromedica Inc.
Key facts
| Recall number (Z-number) | Z-1808-2020 |
|---|---|
| Recall event | 85486 |
| Product | ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced. |
| Product code | KOA |
| Recalling firm | Uromedica Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 18, 2020 |
| PMA numbers | P130018 |
| FEI number | 3003477176 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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