Recall Z-2629-2023— WOM World Of Medicine AG
Class II · Ongoing
Class II FDA medical device recall by WOM World Of Medicine AG, initiated 2023-07-17. It names one FDA 510(k) clearance: K172040. 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. Reason: 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.
- Recalling firm
- WOM World Of Medicine AG
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-17
- Firm location
- Ludwigsstadt, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.