Device recall
Z-2629-2023: Aquilex Fluid Control System-Intended to provide fluid distension of the uterus…
FDA device recall · Class II · WOM World Of Medicine AG
Key facts
| Recall number (Z-number) | Z-2629-2023 |
|---|---|
| Recall event | 92938 |
| Product | Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P |
| Product code | HIG |
| Recalling firm | WOM World Of Medicine AG |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K172040 |
| FEI number | 3002914049 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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