Device recall
Z-1824-2013: EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest…
FDA device recall · Class II · Steritec Products Mfc. Co., Inc.
Key facts
| Recall number (Z-number) | Z-1824-2013 |
|---|---|
| Recall event | 65473 |
| Product | EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a… |
| Product code | FRC |
| Recalling firm | Steritec Products Mfc. Co., Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 19, 2013 |
| 510(k) numbers | K930682 |
| FEI number | 1000125215 |
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