Device recall
Z-0605-2014: VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS…
FDA device recall · Class II · Steris Corporation
Key facts
| Recall number (Z-number) | Z-0605-2014 |
|---|---|
| Recall event | 67036 |
| Product | VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes. |
| Product code | FRC |
| Recalling firm | Steris Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 14, 2014 |
| 510(k) numbers | K083665, K854631, K854902 |
| 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