Covidien recalls HysteroLux Fluid Management System Control Units with serial numbers starting 1803CE... that freeze display at 32450 ml, risking fluid distention. Stop using immediately.
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.
Covidien is recalling specific HysteroLux Fluid Management System Control Units that may freeze their display when inflow reaches 32,450 ml, causing fluid to count backward and potentially distend soft tissues. This could lead to serious injury if the device is used as intended.
When the inflow volume reaches 32,450 ml, the device's display freezes. The outflow continues, causing accumulated fluid to count backward to zero. This can lead to fluid distention in soft tissues, potentially causing injury.
Women undergoing gynecological procedures who use the recalled HysteroLux Fluid Management System Control Units. Those with the specific serial numbers listed in the recall are most at risk.
Check the serial number on the control unit. The recalled units have serial numbers starting with 1803CE, 1804CE, 1805CE, 1806CE, 1807CE, 1808CE, 1809CE, or 1901CE, followed by specific digits as listed in the recall.
Discontinue use of the control unit if it has a serial number listed in the recall.
The HysteroLux Fluid Management System Control Unit with serial numbers starting with 1803CE, 1804CE, 1805CE, 1806CE, 1807CE, 1808CE, 1809CE, or 1901CE as listed in the recall.
When inflow volume reaches 32,450 ml, the display freezes while outflow continues, causing fluid to count backward and potentially distend soft tissues.
The recall does not mention a fix; the remedy is null.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2561-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2561-2021 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
