United StatesWhat's being recalled
ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.
Recalling firm: Becton, Dickinson and Company, Irvine, CA, United States.
How to identify it
Catalog/Model Number: HEMFSM10 UDI-DI code: 00690103210927 Part Number: 10026986001 Serial Numbers: 1907004 1907003 Part Number: 10026986002 Serial Numbers: 1941066 1941067 1924040 1925006 1925003 1925004 1924039 1938085 1923033 1928009 Part Number: 10026986003 Serial Numbers: 1944199 1950029 2008008 2008010 2008042 2008046 2008043 2008047 2008045 2008049 1942006 2008009 1928057 1938088 Part Number: 10034992001 Serial Numbers: 21101894 21101342 21101444 Part Number: 10034992003 Serial Numbers: 21103817 21103821 21103822 21103690 21103691 21103689 21103594 21103621 21103632 21103633 21103634 21103635 21103997 21103870 21103871 21103920 21103814 21103815 21103679 21103985 21103982 21103990 21104261 21104269 21103850 21103851 21104131 21104136 21104180 21104183 21104186 21104026 21104020 21104043 21104044 21104019 21104023 21104030 21103766 21103767 21103772 21103626 21103654 21104438 21103643 21103808 21103810 21104454 21103768 21103811 21103986 21103809 21103867 21103868 21103869 21104172 21104173 21103680 21103682 21103685 21103677 21103684 21103686 21103687 21103839 21103846 21103842 21103843 21103857 21103835 21103840 21103860 21104018 21103957 21103975 21103978 21103737 21103743 21103744 21103748 21103760 21104445 21104446 21103620 21103623 21103619 21104260 21103543 21103597 21103780 21103873 21103968 21103966 21103969 21103967 21103972 21103970 21103979 21103847 21103906 21103908 21104451 21103813 21103600 21103602 21103606 21103607 21103608 21103609 21103696 21103697 21103738 21104118 21104359 21103707 21103708 21103709 21103705 21103706 21103536 21103535 21103537 21103539 21103882 21103998 21104021 21104022 21104024 21104025 21103728 21103729 21103730 21103731 21103734 21103735 21103736 21103519 21103501 21103506 21103508 21103509 21103510 21103514 21103516 21103518 21103503 21103504 21103507 21103512 21103513 21103515 21103520 21103521 21103502 21103927 21103928 21105044 21104036 21104037 21104040 21104042 21103951 21103958 21103976 21103983 21104300…
The hazard
Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - U.S Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Grand Cayman.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)