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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0019-2025

Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.

Publicado el 9 de octubre de 2024 · Inicio del retiro: 1 de agosto 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

Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Outset Medical, Inc.
Distribuidor
US: CA, NY, IL, MO, KY, AZ, PA, FL, GA, AK, NM, VA, NC, SC, OK, AL, MA, OH, MI, WA, ID, TX, TN, WY, IA, LA, NE, IN, AR, NV, WV, CO, NJ, MD, KS, UT, CT, MN, MS, WI, HI, DE, VT, MT, OR, ND. OUS: UAE
Lote
UDI-DI: 00850001011112, 00850001011204. Serial Numbers: 400405, 602382M, 602384M, 602387M, 602400M, 602402M, 601124M, 601156M, 601102M, 601265M, 400109, 602248M, 602659M, 602670M, 602767M, 602769M, 602771M, 601356M, 602421M, 602403M, 400394, 601728M, 601730M, 601731M, 601733M, 601735M, 601736M, 601738M, 601771M, 601772M, 601774M, 600599M, 600614M, 600615M, 600620M, 600631M, 600641M, 600646M, 600648M, 600654M, 600659M, 601337M, 601357M, 601360M, 601361M, 601364M, 601368M, 601384M, 601395M, 601396M, 601422M, 601727M, 602748M, 600189, 601515M, 601513M, 601514M, 601517M, 601518M, 601838M, 601864M, 601870M, 601915M, 601924M, 601823M, 601854M, 601861M, 601887M, 601901M, 601908M, 601923M, 601903M, 601936M, 601945M, 601974M, 601799M, 600484M, 601876M, 601886M, 601938M, 601941M, 600488M, 601129M, 601146M, 601270M, 601298M, 601797M, 601805M, 601812M, 601814M, 601821M, 601855M, 601890M, 601897M, 601932M, 601934M, 600563M, 600569M, 600572M, 600574M, 601952M, 601954M, 601878M, 601899M, 601935M, 601942M, 601943M, 601947M, 601800M, 601811M, 601848M, 601874M, 601516M, 602354M, 600174M, 601955M, 602025M, 602035M, 601598M, 601620M, 601139M, 601149M, 601209M, 601210M, 601218M, 601842M, 602503M, 600261M, 602570M, 602626M, 602629M, 601857M, 601858M, 601862M, 601863M, 601866M, 601709M, 602185M, 602255M, 602257M, 602675M, 602744M, 602747M, 602750M, 602753M, 602754M, 602755M, 602756M, 602757M, 602759M, 601639M, 601640M, 601641M, 601642M, 601643M, 601648M, 602053M, 602075M, 602735M, 602784M, 602798M, 602807M, 602808M, 602817M, 602820M, 602833M, 602847M, 602435M, 602436M, 602438M, 602441M, 602444M, 602445M, 602447M, 602448M, 601655M, 602300M, 602301M, 602303M, 602304M, 602787M, 602801M, 602803M, 602809M, 602812M, 602740M, 602768M, 602778M, 602797M, 602813M, 602814M, 602848M, 600935M, 600946M, 600948M, 600715M, 600739M, 600753M, 600760M, 600767M, 601927M, 601928M, 601931M, 601933M, 601681M, 601796M, 601798M, 601801M, 600588M, 600616M, 600619M, 602701M, 602707M, 602709M, 602718M, 602723M, 602727M, 602734M, 602739M, 600609M, 601505M, 601573M, 601491M, 601494M, 601495M, 601722M, 601729M, 601732M, 601734M, 601737M, 601744M, 601752M, 401204, 600584M, 400087, 600399M, 602558M, 602559M, 600171M, 600460M, 600161M, 600162M, 600165M, 400063, 601301M, 601303M, 601306M, 601308M, 601309M, 600954M, 600955M, 600960M, 601171M, 601183M, 602520M, 602532M, 600618M, 600635M, 602485M, 601196M, 601207M, 601217M, 602309M, 602312M, 602571M, 602672M, 602743M, 602746M, 602758M, 601081M, 601247M, 600017, 600167M, 600051, 602525M, 600337, 600421M, 601484M, 600274, 601198M, 601199M, 602515M, 602521M, 602161M, 602163M, 602437M, 602475M, 602496M, 600229, 600235, 600236, 600468M, 600472M, 600473M, 600963M, 600994M, 602654M, 602656M, 600352M, 601348M, 600585M, 600704M, 600721M, 600790M, 600792M, 600794M, 600801M, 600030, 600164M, 600168M, 600277M, 600280M, 600281M, 600136M, 600137M, 600139M, 600157M, 600160M, 600267M, 600289M, 401168, 600300M, 600302M, 600340M, 600651M, 601358M, 602234M, 600369M, 600989M, 600806M, 600807M, 600811M, 600818M, 600967M, 600105M, 600106M, 600121M, 600141M, 600103M, 600104M, 600191M, 600193M, 601662M, 601668M, 601670M, 601716M, 601717M, 600795M, 600828M, 600867M, 600868M, 600875M, 600375M, 600895M, 600897M, 601083M, 601125M, 601041M, 602574M, 601806M, 601836M, 601869M, 601871M, 601872M, 601873M, 601880M, 602694M, 602696M, 602697M, 601882M, 601883M, 601884M, 601885M, 601810M, 601815M, 601817M, 601818M, 601822M, 601827M, 601853M, 602689M, 602693M, 400205, 401191, 600546M, 601953M, 600272M, 600284M, 600311, 600122M, 600305M, 600905M, 600916M, 600380M, 600381M, 600382M, 600383M, 600385M, 601001M, 601008M, 601020M, 601023M, 601031M, 600942M, 601057M, 601130M, 601131M, 600091M, 600393M, 602020M, 602021M, 602022M, 602023M, 602024M, 601940M, 601946M, 601957M, 601959M, 601961M, 601963M, 601980M, 601982M, 602168M, 602310M, 602236M, 602238M, 602267M, 602271M, 602637M, 602638M, 602247M, 602251M, 602252M, 602369M, 602370M, 602371M, 602373M, 602374M, 602340M, 602343M, 602
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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