Device recall
Z-2701-2017: The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for…
FDA device recall · Class II · Natus Medical Incorporated
Key facts
| Recall number (Z-number) | Z-2701-2017 |
|---|---|
| Recall event | 76427 |
| Product | The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment by killing vegetative bacteria and viruses, in a hot water bath at ~160 - ~170 F for 30 minutes. Catalog Number/Description: 007168 PM3500… |
| Product code | MEC |
| Recalling firm | Natus Medical Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 3, 2019 |
| 510(k) numbers | K081094 |
| FEI number | 3018859 |
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