Device recall
Z-2350-2008: Steris Small Renaissance Eagle 3000 -- Remanufactured Gravity Models 3011 and…
FDA device recall · Class II · Steris Corp
Key facts
| Recall number (Z-number) | Z-2350-2008 |
|---|---|
| Recall event | 48999 |
| Product | Steris Small Renaissance Eagle 3000 -- Remanufactured Gravity Models 3011 and 3021 and Prevacuum Models 3013 and 3023. Products are designed for efficient sterilization of non-porous and porous, heat and moisture-stable materials used in healthcare facilities. |
| Product code | FLE |
| Recalling firm | Steris Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 28, 2010 |
| 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