FDAFDA · Food and drugs·Recall number Z-2561-2021
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
Published October 6, 2021 · Recall initiated: June 18, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- WOM World of Medicine AG
- Distributor
- US Nationwide distribution in the state of CT.
- Lot
- Serial 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 1806CE0321 1806CE0322 1806CE0323 1806CE0324 1806CE0325 1806CE0326 1806CE0327 1806CE0328 1806CE0329 1806CE0330 1806CE0331 1806CE0332 1806CE0333 1806CE0334 1806CE0335 1806CE0336 1806CE0337 1807CE0343 1807CE0344 1807CE0345 1807CE0346 1807CE0347 1807CE0348 1807CE0349 1807CE0350 1807CE0351 1807CE0425 1807CE0426 1807CE0427 1807CE0428 1807CE0429 1807CE0430 1807CE0431 1807CE0432 1807CE0433 1807CE0434 1807CE0467 1807CE0468 1807CE0469 1807CE0470 1807CE0471 1807CE0472 1807CE0473 1807CE0474 1807CE0475 1807CE0476 1807CE0551 1807CE0552 1807CE0553 1807CE0554 1807CE0555 1807CE0556 1807CE0557 1807CE0558 1807CE0559 1807CE0560 1807CE0601 1807CE0602 1807CE0603 1807CE0604 1807CE0605 1807CE0606 1807CE0607 1807CE0608 1807CE0609 1807CE0610 1807CE0658 1807CE0659 1807CE0660 1807CE0661 1807CE0662 1807CE0663 1807CE0664 1807CE0665 1807CE0666 1807CE0667 1807CE0825 1807CE0826 1807CE0827 1807CE0828 1807CE0829 1807CE0830 1807CE0831 1807CE0832 1807CE0833 1807CE0834 1807CE0915 1807CE0916 1807CE0917 1807CE0918 1807CE0919 1807CE0920 1807CE0921 1807CE0922 1807CE0923 1807CE0924 1808CE0001 1808CE0002 1808CE0003 1808CE0004 1808CE0005 1808CE0006 1808CE0007 1808CE0008 1808CE0009 1808CE0010 1808CE0047 1808CE0048 1808CE0049 1808CE0050 1808CE0051 1808CE0052 1808CE0053 1808CE0054 1808CE0055 1808CE0056 1808CE0089 1808CE0090 1808CE0091 1808CE0092 1808CE0093 1808CE0094 1808CE0095 1808CE0096 1808CE0097 1808CE0098 1808CE0176 1808CE0177 1808CE0178 1808CE0179 1808CE0180 1808CE0181 1808CE0182 1808CE0183 1808CE0184 1808CE0185 1808CE0294 1808CE0295 1808CE0296 1808CE0297 1808CE0298 1808CE0299 1808CE0300 1808CE0301 1808CE0302 1808CE0303 1808CE0324 1808CE0325 1808CE0326 1808CE0327 1808CE0328 1808CE0329 1808CE0330 1808CE0331 1808CE0332 1808CE0333 1808CE0736 1808CE0737 1808CE0738 1808CE0739 1808CE0740 1808CE0741 1808CE0742 1808CE0743 1808CE0744 1808CE0745 1808CE0766 1808CE0767 1808CE0768 1808CE0769 1808CE0770 1808CE0771 1808CE0772 1808CE0773 1808CE0774 1808CE0775 1808CE0797 1808CE0798 1808CE0799 1808CE0800 1808CE0801 1808CE0802 1808CE0803 1808CE0804 1808CE0805 1808CE0806 1808CE0859 1808CE0860 1808CE0861 1808CE0862 1808CE0863 1808CE0864 1808CE0865 1808CE0866 1808CE0867 1808CE0868 1808CE0890 1808CE0891 1808CE0892 1808CE0893 1808CE0894 1808CE0895 1808CE0896 1808CE0897 1808CE0898 1808CE0899 1808CE0972 1808CE0973 1808CE0974 1808CE0975 1808CE0976 1808CE0977 1808CE0978 1808CE0979 1808CE0980 1808CE0981 1809CE0094 1809CE0095 1809CE0096 1809CE0097 1809CE0098 1809CE0099 1809CE0100 1809CE0101 1809CE0102 1809CE0103 1809CE0134 1809CE0135 1809CE0136 1809CE0137 1809CE0138 1809CE0139 1809CE0140 1809CE0141 1809CE0142 1809CE0143 1809CE0461 1809CE0462 1809CE0463 1809CE0464 1809CE0465 1809CE0466 1809CE0467 1809CE0468 1809CE0469 1809CE0470 1809CE0471 1809CE0472 1809CE0504 1809CE0505 1809CE0506 1809CE0507 1809CE0508 1809CE0509 1809CE0510 1809CE0511 1809CE0512 1809CE0513 1809CE0631 1809CE0632 1809CE0633 1809CE0634 1809CE0635 1809CE0636 1809CE0637 1809CE0638 1809CE0639 1809CE0640 1809CE0735 1809CE0736 1809CE0737 1809CE0738 1809CE0739 1809CE0740 18
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.