Reported Oct 6, 2021 · Ongoing

Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000

WOM World of Medicine AG

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: WOM World of Medicine AG · Salzufer 8 · Berlin, N/A · N/A

Is this the product you have?

  • Covidien HysteroLux Fluid Management System Control Unit
  • REF72205000
Lot codes and dates
  • Serial Numbers

    1,100 of 1,100 codes

    • 1709VG0832
    • 1803CE0680
    • 1803CE0681
    • 1803CE0682
    • 1803CE0683
    • 1803CE0684
    • 1803CE0685
    • 1803CE0686
    • 1803CE0687
    • 1803CE0688
    • 1803CE0689
    • 1803CE1024
    • 1803CE1025
    • 1803CE1026
    • 1803CE1027
    • 1803CE1028
    • 1803CE1029
    • 1803CE1030
    • 1803CE1031
    • 1803CE1032
    • 1803CE1033
    • 1803CE1084
    • 1803CE1085
    • 1803CE1086
    • 1803CE1087
    • 1804CE0171
    • 1804CE0172
    • 1804CE0173
    • 1804CE0174
    • 1804CE0175
    • 1804CE0176
    • 1804CE0177
    • 1804CE0178
    • 1804CE0179
    • 1804CE0180
    • 1804CE0292
    • 1804CE0293
    • 1804CE0294
    • 1804CE0295
    • 1804CE0296
    • 1804CE0297
    • 1804CE0298
    • 1804CE0299
    • 1804CE0300
    • 1804CE0301
    • 1805CE0298
    • 1805CE0299
    • 1805CE0300
    • 1805CE0301
    • 1805CE0302
    • 1805CE0303
    • 1805CE0304
    • 1805CE0305
    • 1805CE0306
    • 1805CE0307
    • 1805CE0362
    • 1805CE0363
    • 1805CE0364
    • 1805CE0365
    • 1805CE0366
Amount recalled
1100

Where it was sold

  • Nationwide
  • CT

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new WOM World recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.