Device recall
Z-1561-2015: AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small…
FDA device recall · Class II · Steris Corporation
Key facts
| Recall number (Z-number) | Z-1561-2015 |
|---|---|
| Recall event | 70938 |
| Product | AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in healthcare facilities. |
| Product code | FLE |
| Recalling firm | Steris Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 20, 2016 |
| 510(k) numbers | K111223, K112055 |
| 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