Device recall
Z-1104-2017: ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains…
FDA device recall · Class II · Mesa Laboratories Inc
Key facts
| Recall number (Z-number) | Z-1104-2017 |
|---|---|
| Recall event | 76101 |
| Product | ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products… |
| Product code | FRC |
| Recalling firm | Mesa Laboratories Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 26, 2017 |
| 510(k) numbers | K971432 |
| 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