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FDAFDA · Food and drugs·Recall number Z-0507-2025

V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

Published December 4, 2024 · Recall initiated: November 5, 2024

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

Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
KCI USA, INC.
Distributor
Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY O.U.S.(foreign) countries to: Australia, Estonia, Italy, Norway, Spain, Austria, Finland, Japan, Oman, Sweden, Bahrain, France, Jordan, Philippines, Switzerland, Brazil, Germany, Kuwait, Poland, Thailand, Canada, Greece, Malaysia, Qatar, Tunisia, Chile, Hong Kong, Malta, Romania, Turkey, China, India, Mexico, Saudi, Arabia, United Arab Emirates, Colombia, Indonesia, Morocco, Singapore, United Kingdom, Cyprus, Ireland, Netherlands, Slovenia, Czechia, Israel, New Zealand, South Africa, Vietnam, and Denmark
Lot
Model Number: CAPULTDEV01/BR.S UDI-DI codes: 00849554000636 00849554000636 00849554001084 Serial Numbers: GAAC06245 GAAC06246 GAAC06247 GAAC06248 GAAC06249 GAAC06250 GAAC06251 GAAC06252 GAAC06253 GAAC06254 GAAC06255 GAAC06256 GAAC06257 GAAC06258 GAAC06259 GAAC06260 GAAC06261 GAAC06262 GAAC06263 GAAC06264 GAAC06265 GAAC06266 GAAC06267 GAAC06268 GAAC06269 GAAC06270 GAAC06271 GAAC06272 GAAC06273 GAAC06274 GAAC06275 GAAC06276 GAAC06277 GAAC06278 GAAC06279 GAAC06280 GAAC06281 GAAC06282 GAAC06283 GAAC06284 GAAC06285 GAAC06286 GAAC06287 GAAC06288 GAAC06289 GAAC06290 GAAC06291 GAAC06292 GAAC06293 GAAC06294 GAAC06295 GAAC06296 GAAC06297 GAAC06298 GAAC06299 GAAC06300 GAAC06301 GAAC06302 GAAC06303 GAAC06304 GAAC06305 GAAC06306 GAAC06307 GAAC06308 GAAC06309 GAAC06310 GAAC06311 GAAC06312 GAAC06313 GAAC06314 GAAC06315 GAAC06316 GAAC06317 GAAC06318 GAAC06319 GAAC06320 GAAC06321 GAAC06322 GAAC06323 GAAC06324 GAAC06863 GAAC06864 GAAC06865 GAAC06866 GAAC06867 GAAC06868 GAAC06869 GAAC06870 GAAC06871 GAAC06872 GAAC06873 GAAC06874 GAAC06875 GAAC06876 GAAC06877 GAAC06878 GAAC06879 GAAC06880 GAAC06881 GAAC06882 GAAC06883 GAAC06884 GAAC06885 GAAC06886 GAAC06887 GAAC06888 GAAC06889 GAAC06890 GAAC06891 GAAC06892 GAAC06893 GAAC06894 GAAC06895 GAAC06896 GAAC06897 GAAC06898 GAAC06899 GAAC06900 GAAC06901 GAAC06902 GAAC06903 GAAC06904 GAAC06905 GAAC06906 GAAC06907 GAAC06908 GAAC06909 GAAC06910 GAAC06911 GAAC06912 GAAC06913 GAAC06914 GAAC06915 GAAC06916 GAAC06917 GAAC06918 GAAC06919 GAAC06920 GAAC06921 GAAC06922 GAAC06923 GAAC06924 GAAC06925 GAAC06926 GAAC06927 GAAC06928 GAAC06929 GAAC06930 GAAC06931 GAAC06932 GAAC06933 GAAC06934 GAAC06935 GAAC06936 GAAC06937 GAAC06938 GAAC06939 GAAC06940 GAAC06941 GAAC06942 GAAC06943 GAAC06944 GAAC06945 GAAC06946 GAAC06947 GAAC06948 GAAC06949 GAAC06950 GAAC06951 GAAC06952 GAAC06953 GAAC06954 GAAC06955 GAAC06956 GAAC06957 GAAC06958 GAAC11856 GAAC11857 GAAC11858 GAAC11859 GAAC11860 GAAC11861 GAAC11862 GAAC11863 GAAC11864 GAAC11865 GAAC11866 GAAC11867 GAAC11868 GAAC11869 GAAC11870 GAAC11871 GAAC11872 GAAC11873 GAAC11874 GAAC11875 GAAC11876 GAAC11877 GAAC11878 GAAC11879 GAAC11880 GAAC11881 GAAC11882 GAAC11883 GAAC11884 GAAC11885 GAAC11886 GAAC11887 GAAC11888 GAAC11889 GAAC11890 GAAC11891 GAAC11892 GAAC11893 GAAC11894 GAAC11895 GAAC11904 GAAC11905 GAAC11906 GAAC11907 GAAC11908 GAAC11909 GAAC11910 GAAC11911 GAAC11912 GAAC11913 GAAC11914 GAAC11915 GAAC11916 GAAC11917 GAAC11918 GAAC11919 GAAC11920 GAAC11921 GAAC11922 GAAC11923 GAAC11924 GAAC11925 GAAC11926 GAAC11927 GAAC11928 GAAC11929 GAAC11930 GAAC11931 GAAC11932 GAAC11933 GAAC11934 GAAC11935 GAAC11936 GAAC11937 GAAC11938 GAAC11939 GAAC11940 GAAC11941 GAAC11942 GAAC11943 GAAC11944 GAAC11945 GAAC11946 GAAC11947 GAAC11948 GAAC11949 GAAC11950 GAAC11951 GAAC11952 GAAC11953 GAAC11954 GAAC11955 GAAC11956 GAAC11957 GAAC11958 GAAC11959 GAAC11960 GAAC11961 GAAC11962 GAAC11963 GAAC11964 GAAC11965 GAAC11966 GAAC11967 GAAC11968 GAAC11969 GAAC11970 GAAC11971 GAAC11972 GAAC11973 GAAC11974 GAAC11975 GAAC11976 GAAC11977 GAAC11978 GAAC11979 GAAC11980 GAAC11981 GAAC11982 GAAC11983 GAAC11984 GAAC11985 GAAC11986 GAAC11987 GAAC11988 GAAC11989 GAAC11990 GAAC11991 GAAC11992 GAAC11993 GAAC11994 GAAC11995 GAAC11996 GAAC11997 GAAC11998 GAAC11999 GAAC12000 GAAC12001 GAAC12002 GAAC12003 GAAC12004 GAAC12005 GAAC12006 GAAC12007 GAAC12008 GAAC12009 GAAC12010 GAAC12011 GAAC12012 GAAC12013 GAAC12014 GAAC12015 GAAC12016 GAAC12017 GAAC12018 GAAC12019 GAAC12020 GAAC12021 GAAC12022 GAAC12023 GAAC14304 GAAC14305 GAAC14306 GAAC14307 GAAC14308 GAAC14309 GAAC14310 GAAC14311 GAAC14312 GAAC14313 GAAC14314 GAAC14315 GAAC14316 GAAC14317 GAAC14318 GAAC14319 GAAC14320 GAAC14321 GAAC14322 GAAC14323 GAAC14324 GAAC14325 GAAC14326 GAAC14327 GAAC14328 GAAC14329 GAAC14330 GAAC14331 GAAC14332 GAAC14333 GAAC14334 GAAC14335 GAAC14336 GAAC14337 GAAC14338 GAAC14339 GAAC14340 GAAC14341 GAAC14342 GAAC14343 GAAC14344 GAAC14345 GAAC14346 GAAC14347 GAAC14348 GAAC14349 GAAC14350 GAAC14351 GAAC14352 GAAC14353 GAAC14354 GAAC14355 GAAC14356 GAA
Risk classification
Class II
Area (FDA)
device
Country
United States

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