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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1825-2024

The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VT

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: 03760124131482 OUS Serial Numbers: 22C02558 22C02582 22C07751 22C07753 22C09753 22C09757 22C09772 22C09780 22C09781 22C09783 22C09850 22C11644 22C13089 22C14035 22C14036 22C14151 22C14152 22C14153 22C14154 22C14156 22C14158 22C14159 22C14165 22C14166 22C14167 22C14171 22C14172 22C14173 22C14174 22C14178 23C02554 23C03278 23C03279 23C03280 23C03281 23C03282 23C03283 23C03284 23C03285 23C03286 23C03287 23C03288 23C03289 23C03290 23C03291 23C03295 23C03302 23C03308 23C03310 23C03314 23C03315 23C03316 23C03317 23C07704 23C07710 23C07718 23C60201 23C60202 23C60203 23C60209 23C60210 23C60211 23C60212 23C60227 23C60232 23C60233 23C60240 23C60270 23C60271 23C60273 23C60275 23C60276 23C60277 23C60278 23C60282 23C60283 23C60284 22C22761 22C33393 22C33394 22C33395 22C33396 22C33397 22C33398 22C33642 22C41544 22C41545 22C41546 22C41547 22C41548 22C41553 22C41554 22C41557 22C41558 22C41560 22C41810 22C41811 22C41812 22C41813 22C41814 22C41815 22C41817 22C41818 22C41820 22C41821 22C41822 22C41824 22C42031 22C42032 22C42033 22C42034 22C42038 22C42040 22C42041 22C57405 22C57408 22C57409 22C57411 22C57412 22C57413 22C58468 22C58469 22C58470 22C58471 22C58472 22C58473 22C58474 22C58477 22C00882 22C00883 22C01603 22C01604 22C01605 22C01606 22C01607 22C02085 22C04231 22C05404 22C05407 22C05492 22C05494 22C05598 22C05599 22C05600 22C59630 22C59631 22C01874 22C05601 22C04267 22C05603 22C59632 22C05403 22C05602 22C05604 22C05405 22C05400 22C59633 22C02888 22C02891 22C03378 22C03380 22C03381 22C03387 22C03388 22C03389 22C03390 22C03391 22C03458 22C03461 22C03464 22C03467 22C03468 22C03469 22C03470 22C03471 22C03472 22C03473 22C03474 22C03475 22C03476 22C03477 22C03478 22C03485 22C08732 22C08733 22C08735 22C08736 22C08737 22C08738 22C08739 22C08740 22C08741 22C08742 22C08745 22C10279 22C10280 22C10283 22C10285 22C10628 22C10632 22C10633 22C10907 22C10909 22C10910 22C10911 22C11574 22C11577 22C11584 22C11589 22C11590 22C11595 23C60204 23C60205 23C60206 23C60213 23C60215 23C60217 23C60219 23C60220 22C02667 22C02668 22C02674 22C02675 22C02676 22C02697 22C02698 22C02704 22C02705 22C02726 22C02729 22C02730 22C02732 22C02889 22C02890 22C02894 22C02902 22C02903 22C02907 22C03035 22C03108 22C03115 22C03117 22C03119 22C03121 22C03122 22C03123 22C03124 22C03127 22C03133 22C03182 22C03245 22C03249 22C03251 22C03254 22C03255 22C03258 22C03260 22C03262 22C03357 22C03358 22C04546 22C04975 22C04983 22C05517 22C05523 22C05524 22C05629 22C06680 22C06688 22C06695 22C06699 22C06703 22C06705 22C06727 22C06728 22C06729 22C07412 22C07421 22C07436 22C07461 22C07464 22C07468 22C07484 22C07500 22C07508 22C07509 22C07510 22C07511 22C07604 22C07606 22C07611 22C07613 22C07614 22C07617 22C08711 22C08715 22C08725 22C08924 22C08925 22C08926 22C08927 22C08928 22C08938 22C08939 22C08940 22C08941 22C08948 22C08949 22C08950 22C08952 22C08953 22C08955 22C57027 22C57028 22C57035 22C57041 22C57043 22C57047 22C57048 22C57050 22C57054 22C57207 22C57214 22C57218 22C57301 22C57304 22C57305 22C57308 22C57316 22C57317 22C57318 22C57325 22C57326 22C57327 22C57362 22C57364 22C57365 22C57368 22C57374 22C57375 22C57378 22C57379 22C57388 22C57389 22C57390 22C57391 22C57392 22C57393 22C57394 22C57395 22C57398 22C57400 22C57401 22C57402 22C57403 22C57404 22C57420 22C57421 22C57423 22C57444 22C57446 22C57451 22C57452 22C57455 22C57456 22C57457 22C57464 22C57465 22C57470 22C57471 22C57472 22C57473 22C57474 22C58442 22C58443 22C58447 22C58456 22C58458 22C58459 22C58460 22C58461 22C58463 22C58464 22C58466 22C02892 22C03010 22C03019 22C03023 22C03134 22C03135 22C03174 22C03178 22C03183 22C03186 22C03351 22C03375 22C03376 22C03377 22C04955 22C04957 22C04959 22C04984 22C05751 22C07369 22C07370 22C07379 22C07380 22C07381 22C08724 22C08726 22C08727 22C08728 22C08730 22C08919 22C08920 22C08922 22C08923 22C08942 22C08943 22C08945 22C08946 22C08947 22C10257 22C10604 22C10613 22C10614 22C10616 22C10619 22C10892 22C10893 22C10894 22C10895 22C10896 22C10897 22C10899 22C10900 22C10901 22C10902 22C10903 22C109
Clasificación de riesgo
Class II
Área (FDA)
device
País
France

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