Device recall
Z-0059-2021: 1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage…
FDA device recall · Class II · AB ULAX
Key facts
| Recall number (Z-number) | Z-0059-2021 |
|---|---|
| Recall event | 86417 |
| Product | 1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia. |
| Product code | BYD |
| Recalling firm | AB ULAX |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 10, 2023 |
| FEI number | 3004030908 |
At a glance
- None 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