FDAFDA · Alimentos y medicamentos·N.º oficial Z-0516-2025
RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
Publicado el 4 de diciembre de 2024 · Inicio del retiro: 2 de octubre 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
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Smith & Nephew Medical, Ltd.
- Distribuidor
- U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: Canada
- Lote
- Model Numbers: 66803126, 66803126LRC UDI-DI codes: 05000223498634 Serial Numbers: PEAB230001 PEAE230422 PEAF230180 PEAG230269 PEAH230208 PEAH230859 PEAJ230484 PEAB230002 PEAE230423 PEAF230181 PEAG230271 PEAH230209 PEAH230861 PEAJ230490 PEAB230003 PEAE230427 PEAF230185 PEAG230272 PEAH230210 PEAH230862 PEAJ230491 PEAB230006 PEAE230428 PEAF230186 PEAG230273 PEAH230211 PEAH230863 PEAJ230492 PEAB230011 PEAE230429 PEAF230188 PEAG230275 PEAH230212 PEAH230865 PEAJ230493 PEAB230014 PEAE230432 PEAF230189 PEAG230277 PEAH230214 PEAH230867 PEAJ230497 PEAB230021 PEAE230433 PEAF230190 PEAG230279 PEAH230215 PEAH230868 PEAJ230499 PEAB230022 PEAE230434 PEAF230199 PEAG230280 PEAH230216 PEAH230871 PEAJ230502 PEAB230027 PEAE230436 PEAF230202 PEAG230282 PEAH230217 PEAH230872 PEAJ230505 PEAB230028 PEAE230437 PEAF230203 PEAG230283 PEAH230218 PEAH230874 PEAJ230512 PEAB230032 PEAE230438 PEAF230208 PEAG230285 PEAH230219 PEAH230875 PEAJ230513 PEAB230033 PEAE230439 PEAF230209 PEAG230287 PEAH230220 PEAH230876 PEAJ230515 PEAB230036 PEAE230440 PEAF230211 PEAG230288 PEAH230221 PEAH230877 PEAJ230525 PEAB230037 PEAE230441 PEAF230212 PEAG230289 PEAH230222 PEAH230879 PEAJ230526 PEAB230039 PEAE230442 PEAF230217 PEAG230292 PEAH230223 PEAH230882 PEAJ230527 PEAB230041 PEAE230443 PEAF230221 PEAG230294 PEAH230224 PEAH230883 PEAJ230530 PEAB230042 PEAE230448 PEAF230222 PEAG230295 PEAH230225 PEAH230884 PEAJ230532 PEAB230044 PEAE230450 PEAF230226 PEAG230301 PEAH230226 PEAH230885 PEAJ230538 PEAB230048 PEAE230452 PEAF230233 PEAG230303 PEAH230227 PEAH230886 PEAJ230541 PEAB230050 PEAE230454 PEAF230236 PEAG230305 PEAH230228 PEAH230888 PEAJ230542 PEAB230051 PEAE230455 PEAF230237 PEAG230306 PEAH230229 PEAH230889 PEAJ230545 PEAB230052 PEAE230456 PEAF230239 PEAG230307 PEAH230230 PEAH230892 PEAJ230558 PEAB230053 PEAE230458 PEAF230243 PEAG230308 PEAH230231 PEAH230893 PEAJ230563 PEAB230054 PEAE230459 PEAF230247 PEAG230309 PEAH230234 PEAH230896 PEAJ230564 PEAB230057 PEAE230461 PEAF230249 PEAG230313 PEAH230235 PEAH230897 PEAJ230565 PEAB230059 PEAE230462 PEAF230250 PEAG230315 PEAH230237 PEAH230899 PEAJ230578 PEAB230060 PEAE230463 PEAF230254 PEAG230322 PEAH230239 PEAH230903 PEAJ230580 PEAB230061 PEAE230464 PEAF230255 PEAG230326 PEAH230240 PEAH230904 PEAJ230588 PEAB230063 PEAE230466 PEAF230258 PEAG230327 PEAH230241 PEAH230905 PEAJ230591 PEAB230064 PEAE230467 PEAF230267 PEAG230329 PEAH230243 PEAH230906 PEAJ230604 PEAB230065 PEAE230468 PEAF230269 PEAG230335 PEAH230244 PEAH230907 PEAJ230605 PEAB230066 PEAE230470 PEAF230273 PEAG230337 PEAH230245 PEAH230908 PEAJ230610 PEAB230069 PEAE230471 PEAF230277 PEAG230340 PEAH230246 PEAH230909 PEAJ230611 PEAB230070 PEAE230473 PEAF230280 PEAG230342 PEAH230248 PEAH230911 PEAJ230613 PEAB230072 PEAE230474 PEAF230281 PEAG230344 PEAH230249 PEAH230912 PEAJ230614 PEAB230074 PEAE230476 PEAF230284 PEAG230346 PEAH230250 PEAH230914 PEAJ230615 PEAB230080 PEAE230480 PEAF230285 PEAG230347 PEAH230252 PEAH230915 PEAJ230619 PEAB230080 PEAE230481 PEAF230287 PEAG230348 PEAH230253 PEAH230916 PEAJ230620 PEAC230081 PEAE230483 PEAF230288 PEAG230349 PEAH230256 PEAH230917 PEAJ230622 PEAC230083 PEAE230484 PEAF230289 PEAG230350 PEAH230258 PEAH230918 PEAJ230628 PEAC230087 PEAE230487 PEAF230290 PEAG230351 PEAH230259 PEAH230922 PEAJ230630 PEAC230088 PEAE230489 PEAF230291 PEAG230353 PEAH230260 PEAH230923 PEAJ230634 PEAC230089 PEAE230491 PEAF230292 PEAG230354 PEAH230262 PEAH230925 PEAJ230642 PEAC230090 PEAE230493 PEAF230293 PEAG230355 PEAH230263 PEAH230927 PEAJ230643 PEAC230091 PEAE230494 PEAF230294 PEAG230357 PEAH230264 PEAH230928 PEAJ230645 PEAC230092 PEAE230496 PEAF230295 PEAG230358 PEAH230265 PEAH230930 PEAJ230646 PEAC230093 PEAE230498 PEAF230296 PEAG230359 PEAH230266 PEAH230931 PEAJ230649 PEAC230095 PEAE230500 PEAF230300 PEAG230364 PEAH230267 PEAH230932 PEAJ230652 PEAC230096 PEAE230502 PEAF230301 PEAG230365 PEAH230268 PEAH230933 PEAJ230653 PEAC230097 PEAE230503 PEAF230302 PEAG230366 PEAH230269 PEAH230935 PEAJ230654 PEAC230098 PEAE230505 PEAF230305 PEAG230368 PEAH230270 PEAH230935 PE
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United Kingdom
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