FDAFDA · Alimentos y medicamentos·N.º oficial Z-1826-2024
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VTT
Publicado el 22 de mayo de 2024 · Inicio del retiro: 9 de abril de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error involving perforation of the inner channel of the catheter during stylet insertion.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- Sophysa S.A.
- Distribuidor
- Worldwide - US Nationwide distribution in the states of AZ, NY, TX and the countries of ARGENTINA, CHINA, CZECH REPUBLIC, FRANCE, GREECE, HUNGARY, JAPAN, PAKISTAN, Portugal, ROMANIA, SOUTH AFRICA, SWEDEN, VIETNAM.
- Lote
- UDI-DI: 3760124132922 US Serial Numbers: 22D06059 22D06060 22D06745 22D06747 22D06749 22D07240 22D07242 22D07243 22D07246 22D07249 22D07250 22D07251 22D07257 22D08435 22D08436 22D08438 22D08511 22D08512 22D08522 22D08525 22D08526 22D08527 22D08528 22D08529 22D12007 22D12009 22D12012 22D12013 22D12014 22D12016 22D12017 22D12018 22D12019 22D12020 22D12021 22D12022 22D12023 22D12024 22D12025 22D12027 22D12032 OUS S/N: 22D04871 22D04873 22D04875 22D04877 22D04881 22D04907 22D04908 22D04909 22D05006 22D05021 22D09368 22D09376 22D09377 22D09378 22D09379 22D09380 22D09381 22D09382 22D09383 22D09384 22D52761 22D52764 21D20346 21D20353 21D20355 21D20361 21D20367 21D42206 21D42212 21D42215 21D42240 22D00060 22D00064 22D00065 22D00066 22D00067 22D00068 22D00069 22D00070 22D00071 22D00072 22D00074 22D00075 22D00076 22D00077 22D00084 22D00124 22D00240 22D00241 22D00242 22D00244 22D00245 22D00247 22D00248 22D00253 22D00256 22D00258 22D00259 22D00262 22D00263 22D00264 22D00265 22D00267 22D00269 22D00271 22D00276 22D00277 22D00278 22D00279 22D00286 22D00290 22D00292 22D00297 22D00298 22D00299 22D00301 22D00302 22D00304 22D00307 22D00310 22D00313 22D00315 22D00616 22D00621 22D00622 22D00636 22D00637 22D00638 22D00640 22D00643 22D00645 22D00649 22D00650 22D00661 22D00665 22D00666 22D00667 22D00668 22D00670 22D00671 22D00672 22D00673 22D00674 22D00675 22D00676 22D00677 22D00678 22D00679 22D00680 22D00681 22D00682 22D00683 22D00684 22D00685 22D00686 22D00687 22D00690 22D00691 22D00692 22D00736 22D00746 22D00770 22D00771 22D00772 22D00773 22D00775 22D00776 22D00777 22D00778 22D00780 22D00781 22D00782 22D00783 22D00841 22D00844 22D00845 22D00847 22D00848 22D00850 22D00851 22D00853 22D00854 22D00855 22D00857 22D00858 22D00861 22D00865 22D00866 22D00867 22D00873 22D00875 22D00876 22D00940 22D00952 22D00953 22D00954 22D00955 22D00956 22D00957 22D00959 22D00960 22D00961 22D00962 22D00963 22D00964 22D00965 22D00966 22D00967 22D00968 22D00969 22D00970 22D00971 22D00973 22D00978 22D00979 22D00985 22D00986 22D01353 22D01354 22D01360 22D01361 22D01363 22D01366 22D01367 22D01368 22D01373 22D01377 22D01385 22D01387 22D01388 22D01389 22D01390 22D01391 22D01392 22D01395 22D01410 22D01413 22D01416 22D01418 22D01422 22D01423 22D01424 22D01426 22D01427 22D01428 22D01429 22D01437 22D01454 22D01455 22D01456 22D01457 22D01459 22D01460 22D01471 22D01472 22D01479 22D01508 22D01510 22D01512 22D01515 22D01516 22D01520 22D01521 22D01534 22D01535 22D01536 22D01538 22D01539 22D01540 22D01541 22D01542 22D01543 22D01544 22D01545 22D01546 22D01547 22D01549 22D01550 22D01551 22D01552 22D01553 22D01557 22D01559 22D01560 22D01561 22D01562 22D01616 22D01617 22D01618 22D01619 22D01620 22D01707 22D01708 22D01709 22D01711 22D01712 22D01713 22D01714 22D01715 22D01716 22D01717 22D01719 22D01724 22D01726 22D01737 22D01738 22D01963 22D01964 22D01965 22D01966 22D01967 22D01969 22D01970 22D01971 22D01972 22D01973 22D01974 22D01975 22D01976 22D02014 22D02015 22D02016 22D02019 22D02020 22D02021 22D02022 22D02023 22D02024 22D02025 22D02026 22D02027 22D02028 22D02029 22D02030 22D02032 22D02033 22D02034 22D02035 22D02036 22D02037 22D02038 22D02039 22D02041 22D02042 22D02043 22D02044 22D02045 22D02046 22D02047 22D02048 22D02049 22D02050 22D02051 22D02053 22D02054 22D02055 22D02057 22D02058 22D02059 22D02060 22D02061 22D02062 22D02064 22D02065 22D02066 22D02067 22D02074 22D02075 22D02076 22D02077 22D02078 22D02079 22D02080 22D02081 22D02133 22D02134 22D02135 22D02137 22D02140 22D02141 22D02143 22D02148 22D02149 22D02150 22D02151 22D02153 22D02154 22D02155 22D02157 22D02158 22D02161 22D02162 22D02163 22D02165 22D02193 22D02194 22D02197 22D02247 22D02249 22D02250 22D02251 22D02252 22D02253 22D02254 22D02257 22D02259 22D02260 22D02261 22D02262 22D02263 22D02267 22D02269 22D02270 22D02272 22D02273 22D02274 22D02275 22D02276 22D02277 22D02278 22D02279 22D02280 22D02281 22D02282 22D02284 22D02285 22D02286 22D02288 22D02289 22D02291 22D02292 22D02293 22D02295 22D02296 22D02297 22D02298 22D02628 22D026
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- France
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.