Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
Reported: October 6, 2021 Initiated: June 18, 2021 #Z-2561-2021
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.
Details
- Recalling Firm
- WOM World of Medicine AG
- Units Affected
- 1100
- Distribution
- US Nationwide distribution in the state of CT.
- Location
- Berlin, N/A
Frequently Asked Questions
What product was recalled? ▼
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000. Recalled by WOM World of Medicine AG. Units affected: 1100.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 6, 2021. Severity: Moderate. Recall number: Z-2561-2021.
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