Device recall
Z-0508-2019: PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube…
FDA device recall · Class II · WOM World of Medicine AG
Key facts
| Recall number (Z-number) | Z-0508-2019 |
|---|---|
| Recall event | 81480 |
| Product | PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic… |
| Product code | HIF |
| Recalling firm | WOM World of Medicine AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 6, 2021 |
| 510(k) numbers | K170784 |
| FEI number | 3001556604 |
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