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WOM World of Medicine AG Recall 88426

Description: Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000

WOM World of Medicine AG Recall 88426 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2561-2021
Event ID88426
Event DescriptionCovidien HysteroLux Fluid Management System Control Unit, REF: 72205000
Product TypeDevices
DistributionUS Nationwide distribution in the state of CT.
Recall ReasonWhen 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.
Device Classification20211006
Device Code InfoSerial Numbers: 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 1805CE0367 1805CE0368 1805CE0369 1805CE0370 1805CE0371 1805CE0805 1805CE0806 1805CE0807 1805CE0808 1805CE0809 1805CE0810 1805CE0811 1805CE0812 1805CE0813 1805CE0814 1806CE0013 1806CE0014 1806CE0015 1806CE0016 1806CE0017 1806CE0018 1806CE0019 1806CE0020 1806CE0021 1806CE0022 1806CE0318 1806CE0319 1806CE0320 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Center Classification Date20210924
Recall Initiation Date20210618
Recalling FirmWOM World of Medicine AG
Initial Notification E-Mail
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