Device recall
Z-2411-2018: FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN…
FDA device recall · Class II · Fort Defiance Industries, LLC
Key facts
| Recall number (Z-number) | Z-2411-2018 |
|---|---|
| Recall event | 80293 |
| Product | FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments… |
| Product code | FLE |
| Recalling firm | Fort Defiance Industries, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 27, 2023 |
| 510(k) numbers | K141009 |
| FEI number | 3011421558 |
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