Berlin, N/A, Germany
WOM World of Medicine AG recalls
5 recalls recorded since 2018, most recently on 24 May 2024. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)3
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 24 May 2024
- Reason
- Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2243-2024
- WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01
Ongoing Class II Medical devices
- Recall started
- 17 July 2023
- 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
- Distribution
- Nationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, UK, Kuwait, Qatar, Turkey, UAE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2629-2023
- 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 t
Ongoing Class II Medical devices
- Recall started
- 18 June 2021
- Reason
- 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.
- Distribution
- US Nationwide distribution in the state of CT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2561-2021
- Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
Terminated Class II Medical devices
- Recall started
- 14 August 2019
- Terminated
- 20 May 2020
- Reason
- The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2767-2019
- Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
Terminated Class II Medical devices
- Recall started
- 22 October 2018
- Terminated
- 6 May 2021
- Reason
- It is possible that the packaging of the product can be damaged by the prongs on the tube set.
- Distribution
- Worldwide Distribution - US in the state of California and country of Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0508-2019
- PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMO
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.