Recall Z-2561-2021— WOM World of Medicine AG
Class II · Ongoing
Class II FDA medical device recall by WOM World of Medicine AG, initiated 2021-06-18. It names one FDA 510(k) clearance: K173489. Product: Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000. 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..
- Recalling firm
- WOM World of Medicine AG
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-06-18
- Firm location
- Berlin, 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
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.