Device recall
Z-0604-2020: Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000…
FDA device recall · Class II · Steris Corporation
Key facts
| Recall number (Z-number) | Z-0604-2020 |
|---|---|
| Recall event | 84185 |
| Product | Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used in healthcare facilities, and are available in two configurations: Gravity designed for sterilization of non-porous, heat- and moisture stabile goods… |
| Product code | FLE |
| Recalling firm | Steris Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 6, 2020 |
| 510(k) numbers | K964332 |
| FEI number | 1527821 |
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