Drug recall
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with…
FDA recall event 83712 · Class II · WOM World of Medicine AG
Key facts
| Event ID | 83712 |
|---|---|
| Recall numbers | Z-2767-2019 |
| Recalling firm | WOM World of Medicine AG |
| Product type | Devices |
| Products | Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk. |
| Initiation date | Aug 14, 2019 |
| Report date | Oct 9, 2019 |
| Termination date | May 20, 2020 |
| City | Berlin |
| Country | Germany |
| FEI number | 3001556604 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: