Recall record at a glance
| Official record | Z-2629-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | WOM World Of Medicine AG |
| Report date | Oct 4, 2023 |
| Recall initiation date | Jul 17, 2023 |
| Quantity | 1287 units |
| Location | Ludwigsstadt, N/A, Germany |
Official product description
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
Why the product was recalled
The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload
Distribution information
Nationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, UK, Kuwait, Qatar, Turkey, UAE
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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