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
Reported: October 4, 2023 Initiated: July 17, 2023 #Z-2629-2023
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
Reason for Recall
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
Details
- Recalling Firm
- WOM World Of Medicine AG
- Units Affected
- 1287 units
- Distribution
- Nationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, UK, Kuwait, Qatar, Turkey, UAE
- Location
- Ludwigsstadt, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by WOM World Of Medicine AG. Units affected: 1287 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 4, 2023. Severity: Moderate. Recall number: Z-2629-2023.
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