| Class 2 Device Recall | |
Date Initiated by Firm | August 01, 2024 |
Date Posted | October 03, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0019-2025 |
Recall Event ID |
95294 |
510(K)Number | K233335 |
Product Classification |
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
|
Product | 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. |
Code Information |
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, 602344M, 602345M, 602346M, 600107M, 600198M, 602148M, 600374M, 600377M, 600451M, 600452M, 600784M, 601126M, 601195M, 601201M, 601325M, 601174M, 601177M, 602150M, 601070M, 601072M, 601073M, 601564M, 601565M, 601569M, 601571M, 601578M, 601579M, 601680M, 601685M, 601687M, 602225M, 602063M, 602065M, 602067M, 602069M, 601499M, 601501M, 601611M, 601612M, 601614M, 602679M, 602681M, 602683M, 601581M, 601588M, 601590M, 601593M, 601595M, 601599M, 602214M, 602216M, 602182M, 602183M, 602187M, 601059M, 601079M, 601092M, 601096M, 601101M, 600440M, 602128M, 602291M, 602292M, 602293M, 602294M, 602295M, 602357M, 602358M, 602462M, 602526M, 602632M, 601027M, 601045M, 601055M, 601065M, 601067M, 602146M, 602147M, 601545M, 601546M, 601549M, 600542M, 602560M, 602562M, 602569M, 601703M, 601705M, 601708M, 601710M, 602352M, 602356M, 602359M, 602362M, 602368M, 600617M, 600621M, 601028M, 601042M, 601088M, 602296M, 602297M, 602298M, 602299M, 601526M, 601531M, 601054M, 601172M, 602213M, 600438M, 600448M, 600449M, 600549M, 601715M, 601718M, 601719M, 601132M, 601192M, 602031M, 601594M, 602167M, 602169M, 602172M, 602173M, 602175M, 601502M, 601506M, 601507M, 601511M, 601512M, 601600M, 601601M, 601602M, 601604M, 602245M, 602261M, 602262M, 602264M, 600406M, 600417M, 600398M, 600787M, 601085M, 601090M, 601094M, 601097M, 600997M, 601145M, 601152M, 601580M, 602381M, 602287M, 602332M, 602333M, 602334M, 602338M, 600529M, 600545M, 600788M, 600789M, 602129M, 602134M, 602184M, 602224M, 601868M, 602192M, 602222M, 602226M, 601615M, 601617M, 602219M, 601622M, 601624M, 601625M, 602229M, 602026M, 602220M, 602221M, 601652M, 601653M, 602230M, 602231M, 602232M, 600274M, 600287M, 602160M, 602342M, 602466M, 602486M, 602643M, 602142M, 602360M, 602361M, 602365M, 600435M, 600441M, 600450M, 602561M, 601702M, 602625M, 602647M, 602648M, 602651M, 602493M, 602579M, 602582M, 601626M, 601628M, 601712M, 601713M, 601714M, 601645M, 601988M, 601134M, 602115M, 602120M, 602123M, 601007M, 601019M, 601026M, 600184M, 602404M, 602411M, 600926M, 600927M, 600928M, 600188M, 600194M, 600196M, 600197M, 600200M, 600649M, 601465M, 601480M, 600555M, 600558M, 600559M, 600560M, 600562M, 600912M, 600913M, 600914M, 600915M, 600230, 600046M, 600493M, 600509M, 600299M, 600307M, 600325M, 600326M, 600328M, 600990M, 601492M, 601500M, 601503M, 601504M, 600780M, 600820M, 600821M, 600847M, 600850M, 600854M, 600866M, 602452M, 602492M, 602531M, 602533M, 602799M, 600575M, 600579M, 600580M, 600694M, 600700M, 600730M, 600962M, 601014M, 600673M, 600677M, 600680M, 600693M, 600741M, 601004M, 601012M, 600731M, 600887M, 600917M, 600918M, 600919M, 600175M, 600096M, 600301M, 600987M, 601646M, 601647M, 601649M, 601659M, 401118, 600798M, 600838M, 600840M, 600841M, 600331M, 600332M, 400222, 400227, 600294M, 601251M, 601260M, 601262M, 600306M, 600315M, 600317M, 600981M, 600985M, 601290M, 601291M, 601299M, 601404M, 601449M, 600413M, 600561M, 600565M, 600924M, 600416M, 600429M, 600459M, 600573M, 600576M, 600939M, 600281, 600391, 600012M, 600961M, 600233, 600392M, 400463, 601929M, 601937M, 601939M, 600181M, 600283M, 600286M, 601017M, 601589M, 602288M, 602290M, 602098M, 602099M, 602101M, 600357M, 600652M, 400487, 600507M, 600508M, 600512M, 600513M, 600521M, 600522M, 600524M, 600525M, 601374M, 601378M, 601379M, 601380M, 601381M, 601373M, 601388M, 601390M, 601394M, 601399M, 600528M, 600532M, 600964M, 601743M, 601745M, 601754M, 601765M, 601773M, 602494M, 602499M, 401082, 600922M, 600923M, 600024M, 600026M, 600031M, 600040M, 600042M, 401194, 601122M, 601271M, 600610M, 600870M, 600872M, 600903M, 600908M, 600911M, 602014M, 602015M, 602016M, 602017M, 600598M, 600602M, 600603M, 600802M, 600803M, 600804M, 600805M, 601977M, 600195M, 601121M, 400141, 600446M, 600458M, 600408M, 600410M, 600321M, 600892M, 600898M, 601637M, 602838M, 601849M, 601852M, 600707M, 600713M, 601850M, 601851M, 601856M, 600206, 600252M, 600257M, 600258M, 600686M, 600793M, 600890M, 600404M, 600418M, 600430M, 600975M, 600979M, 600991M, 600100M, 601048M, 601112M, 601113M, 600742M, 601053M, 601056M, 601060M, 601100M, 601665M, 400849, 601990M, 601993M, 600204M, 600894M, 601280M, 601323M, 601339M, 602392M, 601193M, 602097M, 602241M, 602394M, 601185M, 601587M, 600734M, 600752M, 601162M, 601525M, 600736M, 602136M, 600800M, 601605M, 602088M, 602383M, 400058, 400082, 400317, 600237M, 600403M, 601914M, 601917M, 601918M, 601919M, 601920M, 601921M, 601922M, 601925M, 601926M, 600032M, 600564M, 600570M, 600329, 600880M, 600901M, 601118M, 601119M, 600309M, 600310M, 600312M, 600316M, 600318M, 600113M, 600313M, 600891M, 601095M, 601098M, 601099M, 601107M, 601108M, 600298M, 600304M, 600327M, 601080M, 601084M, 601086M, 601089M, 601091M, 400048, 600394M, 600395M, 601071M, 601078M, 601246M, 601269M, 601297M, 602348M, 602385M, 602388M, 602401M, 602406M, 602408M, 602410M, 602412M, 602414M, 602415M, 602509M, 602510M, 602527M, 602528M, 602534M, 600070M, 600074M, 600076M, 600077M, 600083M, 600085M, 600893M, 600965M, 600969M, 600971M, 602165M, 602170M, 602186M, 602189M, 602190M, 601542M, 601592M, 601204M, 601219M, 601232M, 601233M, 600876M, 600877M, 600595M, 600596M, 600612M, 601782M, 601784M, 601788M, 601792M, 602790M, 601025M, 601678M, 601683M, 601684M, 601686M, 601242M, 601245M, 601248M, 601249M, 601263M, 400440, 600149M, 600159M, 600697M, 601487M, 601488M, 600192M, 600427M, 600951M, 600166M, 600333M, 600953M, 600134M, 600145M, 600150M, 602446M, 600203M, 600433M, 600068M, 602512M, 602516M, 602518M, 602519M, 602523M, 602524M, 602529M, 602530M, 602541M, 602563M, 600714M, 600756M, 600762M, 600765M, 600690M, 602578M, 602698M, 602580M, 602635M, 602634M, 602684M, 602103M, 602106M, 602102M, 602597M, 602614M, 602691M, 602692M, 602695M, 602704M, 602706M, 602711M, 602712M, 602713M, 601740M, 601741M, 601742M, 600485M, 600643M, 600084, 602449M, 602450M, 602504M, 602546M, 602577M, 601274M, 601281M, 601286M, 600293M, 600295M, 600320M, 600322M, 600323M, 602633M, 602636M, 602640M, 602641M, 602642M, 602644M, 601034M, 601038M, 601981M, 601983M, 602564M, 602604M, 602639M, 602652M, 602657M, 602667M, 602671M, 602673M, 602535M, 602539M, 600869M, 600907M, 602581M, 602592M, 602606M, 602611M, 602393M, 602389M, 602396M, 602596M, 601244M, 601283M, 601324M, 601780M, 600653M, 600655M, 600656M, 600657M, 600661M, 600021M, 600025M, 600023M, 600022M, 601340M, 601351M, 601355M, 601397M, 601452M, 601453M, 601454M, 600434M, 600519M, 600520M, 600523M, 600540M, 600936M, 600947M, 601707M, 400288, 600526M, 601464M, 601470M, 601477M, 601609M, 601619M, 601621M, 600592M, 600593M, 600594M, 600604M, 600030M, 600039M, 600902M, 600904M, 600591M, 601047M, 601128M, 601762M, 601763M, 600600M, 601024M, 601044M, 601755M, 601760M, 601761M, 602668M, 600060M, 600533M, 600534M, 602032M, 602033M, 601691M, 601692M, 601693M, 601694M, 602575M, 602576M, 600454M, 601137M, 601328M, 601329M, 601330M, 601331M, 601332M, 600178M, 600431M, 600874M, 600199, 600465M, 600478M, 601419M, 602087M, 602089M, 601524M, 601527M, 601528M, 602275M, 602277M, 602278M, 602194M, 602195M, 602197M, 602198M, 601537M, 601538M, 601540M, 602080M, 602139M, 602157M, 601063M, 601064M, 601066M, 602584M, 602603M, 602619M, 602630M, 600796M, 601441M, 601447M, 601479M, 601485M, 601497M, 602325M, 602327M, 602329M, 602330M, 602336M, 602337M, 601493M, 601520M, 601523M, 600605M, 600626M, 600639M, 601673M, 601674M, 601746M, 602083M, 401144, 600132M, 600342M, 600343M, 600241M, 600242M, 600243M, 602131M, 600253M, 600197, 600268M, 600273M, 600245M, 600247M, 600250M, 600266M, 600351M, 600265M, 600356M, 600358M, 600341M, 600347M, 600349M, 600214M, 600290M, 601000M, 601003M, 600035M, 600041M, 600977M, 600980M, 601808M, 601828M, 601829M, 601830M, 601843M, 600825M, 601958M, 601804M, 601956M, 601960M, 601973M, 601979M, 601907M, 601909M, 601910M, 601912M, 601913M, 601916M, 601720M, 602118M, 602121M, 602124M, 600636M, 600637M, 600642M, 600650M, 601859M, 601867M, 600645M, 600647M, 600658M, 600660M, 600664M, 601239M, 601860M, 601865M, 601965M, 601966M, 601967M, 601968M, 601969M, 602649M, 602650M, 602363M, 602376M, 602377M, 602379M, 602390M.602391M, 602397M, 602398M, 602133M, 602335M, 602471M, 602537M, 602538M, 602540M, 600185M, 600187M, 600133, 601320M, 600550M, 601962M, 601976M, 601978M, 601987M, 602710M, 601991M, 601992M, 601994M, 601995M, 601996M, 600701M, 601279M, 602056M, 600776M, 600777M, 600778M, 601721M, 601723M, 601724M, 601726M, 600718M, 600726M, 600729M, 600786M, 600791M, 601574M, 600929M, 600930M, 600931M, 601010M, 601021M, 601043M, 601314M, 601315M, 601318M, 601319M, 600212, 600535M, 600958M, 600255M, 600910M, 600943M, 601790M, 400347, 600401M, 601664M, 602316M, 602320M, 602323M, 602322M, 600696M, 601253M, 601231M, 600684M, 600759M, 601230M, 602331M, 600264M, 600414M, 601671M, 601748M, 602328M, 602699M, 602700M, 602702M, 602703M, 602705M, 601893M, 601895M, 601898M, 601900M, 601902M, 601906M, 602349M, 602353M, 602355M, 602364M, 600319M, 400412, 600335M, 600337M, 600334M, 600339M, 600345M, 600361M, 601176M, 400432, 601123M, 601178M, 600303M, 601482M, 600344M, 601170M, 600360M, 601163M, 601165M, 601182M, 600510M, 600543M, 600577M, 602777M, 602788M, 602776M, 600553M, 601407M, 602779M, 602786M, 602796M, 600353M, 600483M, 602627M, 600471M, 601429M, 601430M, 602474M, 602479M, 602617M, 600470M, 600492M, 601417M, 601187M, 601434M, 602454M, 600495M, 600502M, 601433M, 600469M, 602623M, 601405M, 601408M, 602622M, 601459M, 601461M, 601398M, 600475M, 601423M, 600515M, 600531M, 602481M, 600477M, 602470M, 602476M, 602468M, 601406M, 600489M, 600834M, 601455M, 601457M, 601353M, 601456M, 602781M, 601438M, 601416M, 602464M, 602465M, 602773M, 601347M, 600503M, 602783M, 601444M, 600779M, 600547M, 601354M, 601414M, 601432M, 602660M, 600538M, 601402M, 601426M, 600504M, 600506M, 602456M, 601190M, 600530M, 600548M, 601424M, 601462M, 601427M, 602451M, 602244M, 600499M, 601466M, 600158M, 600986M, 601425M, 601450M, 600476M, 601350M, 602253M, 602272M, 602276M, 601186M, 601409M, 602616M, 601440M, 601442M, 601370M, 600988M, 602281M, 602283M, 602284M, 601051M, 601106M, 600527M, 602319M, 601532M, 601535M, 601536M, 601256M, 601257M, 601258M, 601278M, 601285M, 602315M, 602318M, 602156M, 602164M, 400916, 602250M, 601948M, 601951M, 600354M, 600355M, 600368M, 600373M, 600387M, 600388M, 602553M, 602556M, 602557M, 602741M, 602742M, 602714M, 602716M, 602717M, 602730M, 602731M, 602732M, 601011M, 601016M, 600624M, 600855M, 601386M, 602805M, 602824M, 602399M, 602405M, 602407M, 602413M, 602416M, 601544M, 601550M, 601551M, 601552M, 601554M, 601561M, 601562M, 601022M, 401177, 600764M, 600769M, 601567M, 601534M, 601539M, 601553M, 601557M, 601293M, 601294M, 601296M, 601203M, 601205M, 601243M, 600225, 600228, 601168M, 600336M, 400981, 600096, 601739M, 601068M, 601077M, 601200M, 601208M, 601215M, 601216M, 601572M, 601576M, 601577M, 601582M, 601585M, 601586M, 601591M, 602542M, 602543M, 602544M, 602547M, 602548M, 602549M, 600155M, 600537M, 600582M, 600587M, 600589M, 600590M, 601437M, 600819M, 601667M, 600029M, 600251M, 600259M, 600750M, 600761M, 600772M, 600775M, 600827M, 600672M, 600674M, 600675M, 600678M, 600681M, 600682M, 600683M, 601153M, 601333M, 601334M, 601335M, 601336M, 602037M, 602111M, 602112M, 602113M, 602114M, 602122M, 602125M, 602130M, 602132M, 602135M, 601191M, 601241M, 601255M, 601268M, 401141, 600376M, 600391M, 600670M, 600845M, 600846M, 600758M, 601490M, 600133M, 600153M, 600630M, 600151M, 600627M, 601758M, 601769M, 602078M, 600706M, 600708M, 600709M, 600783M, 601575M, 601583M, 601888M, 601894M, 601904M, 601911M, 600115M, 600118M, 600878M, 600883M, 601781M, 601785M, 601807M, 601839M, 602480M, 602487M, 602497M, 602501M, 602505M, 602491M, 602495M, 602502M, 602506M, 600082M, 600900M, 600608M, 602280M, 602282M, 602285M, 602286M, 600244, 601794M, 601795M, 602341M, 602347M, 602350M, 602453M, 602457M, 600842M, 600844M, 602550M, 602551M, 602552M, 602555M, 602568M, 602645M, 602658M, 602669M, 602674M, 602676M, 602678M, 602653M, 602666M, 602554M, 602565M, 602205M, 602203M, 602196M, 602200M, 602204M, 600685M, 600692M, 600711M, 600720M, 600722M, 601161M, 601623M, 601287M, 601288M, 601289M, 600748M, 600751M, 601375M, 601167M, 601304M, 602488M, 602489M, 601984M, 601985M, 601986M, 602588M, 602593M, 602517M, 602589M, 602591M, 601634M, 602208M, 601275M, 601365M, 601382M, 601519M, 601635M, 602079M, 601387M, 601147M, 601541M, 602587M, 602048M, 602085M, 600984M, 602246M, 601046M, 602042M, 602044M, 602090M, 602158M, 602621M, 602598M, 602258M, 600481M, 601472M, 602536M, 601327M, 601483M, 602223M, 602484M, 601343M, 601618M, 601682M, 602662M, 601127M, 601179M, 601627M, 602235M, 602339M, 600324, 600397M, 600464M, 600544M, 600972M, 600973M, 600978M, 601029M, 601154M, 601638M, 601803M, 602061M, 602066M, 602074M, 602152M, 602176M, 602460M, 600463M, 601002M, 601568M, 601725M, 602091M, 602054M, 601087M, 602791M, 601431M, 601630M, 602143M, 602178M, 600607M, 601548M, 601556M, 602151M, 602154M, 602179M, 602233M, 602240M, 602126M, 601421M, 602409M, 602193M, 601143M, 601481M, 600346M, 600995M, 601144M, 601158M, 601160M, 602039M, 602046M, 602047M, 602051M, 601711M, 601222M, 601254M, 602180M, 601661M, 602498M, 602041M, 602055M, 601135M, 602034M, 602057M, 602440M, 600814M, 600862M, 602109M, 602595M, 600338M, 602473M, 601469M, 602269M, 601277M, 602174M, 600348M, 600365M, 600428M, 600455M, 600993M, 601212M, 602059M, 602086M, 602140M, 602149M, 602469M, 602478M, 602482M, 602077M, 601656M, 602100M, 601675M, 602522M, 601654M, 602110M, 602395M, 602455M, 602443M, 601559M, 602770M, 601467M, 600364M, 602600M, 602137M, 602367M, 600396M, 600426M, 601238M, 601264M, 602144M, 602153M, 602249M, 602259M, 601607M, 602585M, 602458M, 601751M, 602095M, 602206M, 600514M, 600494M, 600500M, 600556M, 602459M, 600271M, 600516M, 600613M, 601140M, 601142M, 601292M, 601322M, 602094M, 602096M, 602104M, 600269M, 600270M, 601136M, 602062M, 601663M, 600482M, 602064M, 602171M, 600992M, 602076M, 602463M, 601757M, 600480M, 601560M, 601610M, 602145M, 601468M, 601629M, 600457M, 600996M, 601173M, 601180M, 601597M, 601631M, 601632M, 601669M, 602260M, 602372M, 601603M, 600474M, 601155M, 600486M, 601636M, 602049M, 602052M, 602058M, 602084M, 602239M, 602045M, 602256M, 601666M, 602227M, 602093M, 602155M, 602254M, 601443M, 601473M, 600551M, 600632M, 600668M, 600439M, 601362M, 602036M, 602043M, 602050M, 602119M, 600491M, 601150M, 602081M, 601341M, 601633M, 601415M, 602138M, 600622M, 602289M, 602780M, 601813M, 601543M, 602607M, 601366M, 601376M, 602586M, 602583M, 600461M, 602273M, 600447M, 600467M, 602628M, 602483M, 602545M, 602127M, 602107M, 601342M, 602599M, 601344M, 602177M, 602461M, 600859M, 400424, 400425, 401243, 400995, 602265M, 602268M, 602270M, 601521M, 601522M, 401262, 602162M, 602181M, 602266M, 602378M, 602380M, 602215M, 602228M, 602263M, 602116M, 602117M, 600865M, 600873M, 600889M, 600716M, 600717M, 600719M, 600625M, 600628M, 602601M, 601471M, 601474M, 601475M, 601478M, 601391M, 601392M, 602794M, 601428M, 602655M, 600501M, 600982M, 601352M, 602302M, 602366M, 600583M, 600983M, 602313M, 602375M, 601411M, 601420M, 602752M, 602661M, 601410M, 602646M, 602467M, 602602M, 600667M, 601445M, 601446M, 601463M, 601476M, 601194M, 601197M, 601236M, 601237M, 601252M, 601302M, 601311M, 600108M, 600109M, 600119M, 600123M, 600629M, 600633M, 600634M, 600638M, 600665M, 601229M, 601316M, 601372M, 601412M, 601439M, 601448M, 601451M, 601458M, 601460M, 600871M, 600879M, 601766M, 601768M, 601770M, 600405M, 600407M, 600415M, 600420M, 600424M, 600932M, 600933M, 600938M, 600945M, 600735M, 600755M, 601061M, 601062M, 601184M, 601188M, 601189M, 602004M, 602005M, 602615M |
Recalling Firm/ Manufacturer |
Outset Medical, Inc. 3052 Orchard Dr San Jose CA 95134-2011
|
For Additional Information Contact | 669-231-8200 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | On 8/1/24, field action notices were sent to customers who were asked to do the following:
Component replacement will be performed with routine maintenance and/or service to affected devices. To support component replacement, the device software may be upgraded, as needed. A firm's Field Service Engineer will coordinate this service with your staff to minimize device downtime.
Disseminate this information to appropriate personnel within your facility for processing and distribution. This notice should be shared with any organization where the potentially affected devices have been transferred.
Identify and notify your home patients with affected devices of this component replacement.
Accounts that have completed the firm's biomedical engineering training program and service their systems will receive additional information.
Complete and return the response form via email to FieldActionAdvisory@OutsetMedical.com
If you have any questions regarding this notification contact the firm's Technical Support team (844-698-2256 or support@outsetmedical.com). |
Quantity in Commerce | 2,422 |
Distribution | 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 |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database | 510(K)s with Product Code = KDI
|
|
|
|