Device recall
Z-1868-2013: Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use…
FDA device recall · Class II · Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Key facts
| Recall number (Z-number) | Z-1868-2013 |
|---|---|
| Recall event | 65544 |
| Product | Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes. |
| Product code | FRC |
| Recalling firm | Mesa Laboratories, Inc., Bozeman Manufacturing Facility |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 22, 2013 |
| 510(k) numbers | K093794 |
| FEI number | 3013667284 |
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