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WOM World Of Medicine AG Recalls
5 recalls on record · December 5, 2018 to July 10, 2024 · Medical Devices
Recalls by year
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24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 10, 2024Medical DevicesFDA
WOM World Of Medicine AG recalls WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries.
Hazard: Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
October 4, 2023Medical DevicesFDA
WOM World Of Medicine AG recalls Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteros
Hazard: 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
October 6, 2021Medical DevicesFDA
WOM World of Medicine AG recalls Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
Hazard: When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system.
October 9, 2019Medical DevicesFDA
WOM World of Medicine AG recalls Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid du
Hazard: The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
December 5, 2018Medical DevicesFDA
WOM World of Medicine AG recalls PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set
Hazard: It is possible that the packaging of the product can be damaged by the prongs on the tube set.