🔍 RecallPedia

Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001

Class I - Dangerous
🏥 Medical Devices Recalled: March 6, 2024 Outset Medical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 0850001011112 and 00850001011204. Serial Numbers: 400028, 400093, 400240, 400403, 400407, 400413, 400414, 400416, 400418, 400426, 400430, 400433, 400434, 400435, 400436, 400437, 400441, 400442, 400444, 400447, 400465, 400511, 400513, 400527, 400530, 400532, 400543, 400546, 400552, 400554, 400556, 400557, 400558, 400560, 400564, 400565, 400566, 400593, 400595, 400598, 400610, 400614, 400615, 400618, 400626, 400657, 400741, 400764, 400775, 400792, 400813, 400837, 400874, 400879, 400894, 400924, 400941, 400942, 400988, 401048, 401120, 401122, 600031, 600059, 600141, 600145, 600146, 600344, 600394, 600396, 600020M, 600021M, 600022M, 600023M, 600025M, 600030M, 600039M, 600095M, 600138M, 600143M, 600181M, 600259M, 600283M, 600285M, 600286M, 600354M, 600355M, 600357M, 600368M, 600373M, 600387M, 600388M, 600392M, 600447M, 600475M, 600481M, 600527M, 600537M, 600556M, 600582M, 600585M, 600587M, 600590M, 600652M, 600692M, 600720M, 600724M, 600727M, 600763M, 600849M, 600966M, 601032M, 601081M, 601095M, 601098M, 601099M, 601107M, 601108M, 601110M, 601114M, 601115M, 601116M, 601117M, 601181M, 601188M, 601301M, 601303M, 601306M, 601308M, 601309M, 601362M, 601376M, 601391M, 601415M, 601417M, 601420M, 601425M, 601428M, 601432M, 601443M, 601450M, 601457M, 601468M, 601469M, 601472M, 601524M, 601527M, 601528M, 601552M, 601554M, 601561M, 601603M, 601666M, 601675M, 601682M, 601699M, 601709M, 601713M, 601721M, 601723M, 601724M, 601726M, 601727M, 601728M, 601730M, 601731M, 601733M, 601735M, 601736M, 601738M, 601771M, 601772M, 601774M, 601775M, 601776M, 601778M, 601779M, 601787M, 601789M, 601791M, 601793M, 601799M, 601802M, 601809M, 601816M, 601819M, 601824M, 601825M, 601831M, 601832M, 601833M, 601834M, 601837M, 601840M, 601842M, 601845M, 601847M, 601849M, 601850M, 601851M, 601852M, 601856M, 601857M, 601858M, 601862M, 601863M, 601866M, 601868M, 601875M, 601877M, 601889M, 601896M, 601903M, 601936M, 601944M, 601945M, 601949M, 601950M, 601974M, 602056M, 602083M, 602111M, 602112M, 602113M, 602114M, 602122M, 602125M, 602130M, 602132M, 602135M, 602203M, 602244M, 602248M, 602316M, 602320M, 602323M, 602375M, 602382M, 602384M, 602387M, 602395M, 602400M, 602402M, 602403M, 602430M, 602440M, 602443M, 602452M, 602455M, 602459M, 602461M, 602464M, 602472M, 602477M, 602483M, 602484M, 602490M, 602492M, 602496M, 602498M, 602503M, 602517M, 602522M, 602531M, 602533M, 602535M, 602536M, 602539M, 602545M, 602558M, 602559M, 602566M, 602567M, 602575M, 602578M, 602580M, 602583M, 602585M, 602587M, 602588M, 602589M, 602590M, 602591M, 602593M, 602595M, 602598M, 602599M, 602600M, 602605M, 602607M, 602608M, 602634M, 602635M, 602655M, 602659M, 602660M, 602661M, 602684M, 602698M, 602708M, 602748M, 602752M, 602767M, 602769M, 602770M, 602771M, 602777M, 602779M, 602781M, 602786M, 602791M, 602795M, 602796M, 602799M, 602800M, 602802M, 602804M, 602805M, 602806M, 602810M, 602811M, 602815M, 602816M, 602819M, 602821M, 602823M, 602824M, 602825M, 602826M, 602827M, 602829M, 602830M, 602831M, 602834M, 602835M, 602837M, 602839M, 602840M, 602841M, 602842M, 602844M, 602845M, 602846M, 602849M, 602850M, 602851M, 602852M, 602853M, 602854M, 602855M, 602856M, 602870M, 602881M, 602882M, 602897M, 602903M, 602913M, 602914M, 602916M, 602920M, 602921M, 602922M, 602925M, 602934M, 602935M, 602936M, 602939M, 602940M, 602942M, 602943M, 602944M, 602945M, 602946M, 602947M, 602948M, 602949M, 602950M, 602951M, 602952M, 602953M, 602954M, 602955M, 602956M, 602957M, 602958M, 602959M, 602960M, 602961M, 602962M, 602963M, 602964M, 602965M, 602966M, 602967M, 602968M, 602969M, 602970M, 602971M, 602972M, 602973M, 602975M, 602976M, 602977M, 602978M, 602979M, 602980M, 602981M, 603029M, 603030M, 603031M, 603032M, 603033M, 603034M, 603035M, 603036M, 603037M, 603038M, 603063M, 603064M, 603065M, 603066M, 603073M, 603075M, 603076M, 603078M, 603079M, 603080M, 603081M, 603082M, 603084M, 603085M, 603087M, 603088M, 603093M, 603114M, 603120M, 603124M, 603125M, 603127M, 603128M, 603136M, 603137M, 603138M, 603139M, 603143M, 603145M, 603146M, 603147M, 603148M, 603153M, 603154M, 603155M, 603156M, 603157M, 603158M, 603159M, 603160M, 603161M, 603162M, 603166M, 603167M, 603168M, 603169M, 603170M, 603171M, 603172M, 603174M, 603175M, 603176M, 603178M, 603179M, 603180M, 603181M, 603182M, 603183M, 603184M, 603185M, 603186M, 603190M, 603196M, 603200M, 603202M, 603203M, 603204M, 603205M, 603206M, 603207M, 603212M, 603225M, 603226M, 603227M, 603228M, 603230M, 603231M, 603232M, 603233M, 603234M, 603237M, 603240M, 603241M, 603242M, 603243M, 603244M, 603246M, 603247M, 603248M, 603249M, 603250M, 603253M, 603256M, 603260M, 603261M, 603262M, 603263M, 603264M, 603268M, 603274M, 603275M, 603277M, 603278M, 603281M, 603282M, 603283M, 603284M, 603285M, 603286M, 603290M, 603291M, 603292M, 603293M, 603294M, 603295M, 603296M, 603297M, 603298M, 603299M, 603300M, 603301M, 603302M, 603303M, 603304M, 603305M, 603306M, 603307M, 603308M, 603309M, 603310M, 603311M, 603312M, 603313M, 603314M, 603315M, 603317M, 603318M, 603319M, 603320M, 603321M, 603322M, 603323M, 603324M, 603325M, 603326M, 603327M, 603328M, 603329M, 603334M, 603340M, 603341M, 603342M, 603344M, 603345M, 603346M, 603347M, 603348M, 603349M, 603350M, 603351M, 603353M, 603356M, 603386M, 603402M, 603409M, 603410M, 603413M, 603416M, 603418M, 603419M, 603420M, 603421M, 603422M, 603423M, 603424M, 603425M, 603426M, 603427M, 603431M, 603432M, 603434M, 603437M, 603438M, 603439M, 603440M, 603441M, 603442M, 603447M, 603448M, 603450M, 603453M, 603455M, 603458M, 603463M, 603464M, 603470M, 603472M, 603475M, 603478M, 603481M, 603486M, 603487M, 603488M, 603490M, 603494M, 603496M, 603500M, 603518M, 603519M, 603520M, 603524M, 603526M, 603527M, 603528M, 603529M, 603530M, 603531M, 603533M, 603534M, 603535M, 603536M, 603539M, 603540M, 603541M, 603544M, 603545M, 603546M, 603550M, 603552M, 603554M, 603556M, 603559M, 603560M, 603561M, 603562M, 603564M, 603567M, 603568M, 603569M, 603570M, 603571M, 603572M, 603573M, 603574M, 603578M, 603579M, 603580M, 603581M, 603583M, 603586M, 603587M, 603597M, 603601M, 603602M, 603603M, 603606M, 603607M, 603608M, 603609M, 603610M, 603615M, 603616M, 603617M, 603620M, 603622M, 603625M, 603626M, 603632M, 603633M, 603639M, 603640M, 603641M, 603644M, 603646M, 603647M, 603648M, 603649M, 603650M, 603651M, 603652M, 603653M, 603654M, 603655M, 603658M, 603659M, 603661M, 603663M, 603664M, 603665M, 603667M, 603668M, 603669M, 603670M, 603671M, 603672M, 603673M, 603674M, 603676M, 603677M, 603681M, 603684M, 603686M, 603688M, 603690M, 603692M, 603693M, 603694M, 603695M, 603696M, 603697M, 603699M, 603700M, 603701M, 603702M, 603703M, 603704M, 603705M, 603706M, 603707M, 603708M, 603709M, 603710M, 603711M, 603712M, 603713M, 603714M, 603715M, 603716M, 603717M, 603718M, 603719M, 603721M, 603722M, 603723M, 603724M, 603725M, 603726M, 603727M, 603728M, 603729M, 603730M, 603733M, 603734M, 603738M, 603742M, 603745M, 603746M, 603747M, 603748M, 603750M, 603751M, 603752M, 603754M, 603758M, 603761M, 603762M, 603763M, 603764M, 603767M, 603770M, 603772M, 603775M, 603776M, 603777M, 603778M, 603786M, 603787M, 603791M, 603793M, 603795M, 603796M, 603798M, 603800M, 603802M, 603803M, 603805M, 603806M, 603808M, 603809M, 603810M, 603814M, 603815M, 603816M, 603819M, 603820M, 603821M, 603822M, 603824M, 603825M, 603826M, 603828M, 603830M, 603831M, 603832M, 603833M, 603834M, 603835M, 603837M, 603838M, 603839M, 603840M, 603841M, 603842M, 603843M, 603844M, 603845M, 603846M, 603847M, 603848M, 603849M, 603850M, 603851M, 603852M, 603854M, 603855M, 603856M, 603857M, 603858M, 603859M, 603860M, 603862M, 603863M, 603864M, 603865M, 603866M, 603868M, 603869M, 603877M, 603878M, 603879M, 603881M, 603882M, 603883M, 603884M, 603885M, 603886M, 603887M, 603888M, 603889M, 603890M, 603892M, 603903M, 603905M, 603908M, 603916M, 603918M, 603923M, 603924M, 603926M, 603928M, 603929M, 603934M, 603936M, 603940M, 603941M, 603951M, 603954M, 603959M, 603963M, 603966M, 603969M, 603972M, 603974M, 603976M, 603977M, 603981M, 603984M, 603987M, 603988M, 603989M, 603990M, 603996M, 603999M, 604002M, 604004M, 604018M, 604019M, 604020M, 604028M, 604029M, 604037M, 604041M, 604043M, 604046M, 604048M, 604050M, 604051M, 604052M, 604054M, 604055M, 604056M, 604058M, 604062M, 604063M, 604064M, 604067M, 604070M, 604071M, 604074M, 604075M, 604079M, 604080M
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Outset Medical, Inc.
Reason for Recall:
Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PCBAs could cause: skin conditions, liver damage, impaired reproduction, development of certain kinds of cancer in humans.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001

Product Codes/Lot Numbers:

UDI-DI: 0850001011112 and 00850001011204. Serial Numbers: 400028, 400093, 400240, 400403, 400407, 400413, 400414, 400416, 400418, 400426, 400430, 400433, 400434, 400435, 400436, 400437, 400441, 400442, 400444, 400447, 400465, 400511, 400513, 400527, 400530, 400532, 400543, 400546, 400552, 400554, 400556, 400557, 400558, 400560, 400564, 400565, 400566, 400593, 400595, 400598, 400610, 400614, 400615, 400618, 400626, 400657, 400741, 400764, 400775, 400792, 400813, 400837, 400874, 400879, 400894, 400924, 400941, 400942, 400988, 401048, 401120, 401122, 600031, 600059, 600141, 600145, 600146, 600344, 600394, 600396, 600020M, 600021M, 600022M, 600023M, 600025M, 600030M, 600039M, 600095M, 600138M, 600143M, 600181M, 600259M, 600283M, 600285M, 600286M, 600354M, 600355M, 600357M, 600368M, 600373M, 600387M, 600388M, 600392M, 600447M, 600475M, 600481M, 600527M, 600537M, 600556M, 600582M, 600585M, 600587M, 600590M, 600652M, 600692M, 600720M, 600724M, 600727M, 600763M, 600849M, 600966M, 601032M, 601081M, 601095M, 601098M, 601099M, 601107M, 601108M, 601110M, 601114M, 601115M, 601116M, 601117M, 601181M, 601188M, 601301M, 601303M, 601306M, 601308M, 601309M, 601362M, 601376M, 601391M, 601415M, 601417M, 601420M, 601425M, 601428M, 601432M, 601443M, 601450M, 601457M, 601468M, 601469M, 601472M, 601524M, 601527M, 601528M, 601552M, 601554M, 601561M, 601603M, 601666M, 601675M, 601682M, 601699M, 601709M, 601713M, 601721M, 601723M, 601724M, 601726M, 601727M, 601728M, 601730M, 601731M, 601733M, 601735M, 601736M, 601738M, 601771M, 601772M, 601774M, 601775M, 601776M, 601778M, 601779M, 601787M, 601789M, 601791M, 601793M, 601799M, 601802M, 601809M, 601816M, 601819M, 601824M, 601825M, 601831M, 601832M, 601833M, 601834M, 601837M, 601840M, 601842M, 601845M, 601847M, 601849M, 601850M, 601851M, 601852M, 601856M, 601857M, 601858M, 601862M, 601863M, 601866M, 601868M, 601875M, 601877M, 601889M, 601896M, 601903M, 601936M, 601944M, 601945M, 601949M, 601950M, 601974M, 602056M, 602083M, 602111M, 602112M, 602113M, 602114M, 602122M, 602125M, 602130M, 602132M, 602135M, 602203M, 602244M, 602248M, 602316M, 602320M, 602323M, 602375M, 602382M, 602384M, 602387M, 602395M, 602400M, 602402M, 602403M, 602430M, 602440M, 602443M, 602452M, 602455M, 602459M, 602461M, 602464M, 602472M, 602477M, 602483M, 602484M, 602490M, 602492M, 602496M, 602498M, 602503M, 602517M, 602522M, 602531M, 602533M, 602535M, 602536M, 602539M, 602545M, 602558M, 602559M, 602566M, 602567M, 602575M, 602578M, 602580M, 602583M, 602585M, 602587M, 602588M, 602589M, 602590M, 602591M, 602593M, 602595M, 602598M, 602599M, 602600M, 602605M, 602607M, 602608M, 602634M, 602635M, 602655M, 602659M, 602660M, 602661M, 602684M, 602698M, 602708M, 602748M, 602752M, 602767M, 602769M, 602770M, 602771M, 602777M, 602779M, 602781M, 602786M, 602791M, 602795M, 602796M, 602799M, 602800M, 602802M, 602804M, 602805M, 602806M, 602810M, 602811M, 602815M, 602816M, 602819M, 602821M, 602823M, 602824M, 602825M, 602826M, 602827M, 602829M, 602830M, 602831M, 602834M, 602835M, 602837M, 602839M, 602840M, 602841M, 602842M, 602844M, 602845M, 602846M, 602849M, 602850M, 602851M, 602852M, 602853M, 602854M, 602855M, 602856M, 602870M, 602881M, 602882M, 602897M, 602903M, 602913M, 602914M, 602916M, 602920M, 602921M, 602922M, 602925M, 602934M, 602935M, 602936M, 602939M, 602940M, 602942M, 602943M, 602944M, 602945M, 602946M, 602947M, 602948M, 602949M, 602950M, 602951M, 602952M, 602953M, 602954M, 602955M, 602956M, 602957M, 602958M, 602959M, 602960M, 602961M, 602962M, 602963M, 602964M, 602965M, 602966M, 602967M, 602968M, 602969M, 602970M, 602971M, 602972M, 602973M, 602975M, 602976M, 602977M, 602978M, 602979M, 602980M, 602981M, 603029M, 603030M, 603031M, 603032M, 603033M, 603034M, 603035M, 603036M, 603037M, 603038M, 603063M, 603064M, 603065M, 603066M, 603073M, 603075M, 603076M, 603078M, 603079M, 603080M, 603081M, 603082M, 603084M, 603085M, 603087M, 603088M, 603093M, 603114M, 603120M, 603124M, 603125M, 603127M, 603128M, 603136M, 603137M, 603138M, 603139M, 603143M, 603145M, 603146M, 603147M, 603148M, 603153M, 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603326M, 603327M, 603328M, 603329M, 603334M, 603340M, 603341M, 603342M, 603344M, 603345M, 603346M, 603347M, 603348M, 603349M, 603350M, 603351M, 603353M, 603356M, 603386M, 603402M, 603409M, 603410M, 603413M, 603416M, 603418M, 603419M, 603420M, 603421M, 603422M, 603423M, 603424M, 603425M, 603426M, 603427M, 603431M, 603432M, 603434M, 603437M, 603438M, 603439M, 603440M, 603441M, 603442M, 603447M, 603448M, 603450M, 603453M, 603455M, 603458M, 603463M, 603464M, 603470M, 603472M, 603475M, 603478M, 603481M, 603486M, 603487M, 603488M, 603490M, 603494M, 603496M, 603500M, 603518M, 603519M, 603520M, 603524M, 603526M, 603527M, 603528M, 603529M, 603530M, 603531M, 603533M, 603534M, 603535M, 603536M, 603539M, 603540M, 603541M, 603544M, 603545M, 603546M, 603550M, 603552M, 603554M, 603556M, 603559M, 603560M, 603561M, 603562M, 603564M, 603567M, 603568M, 603569M, 603570M, 603571M, 603572M, 603573M, 603574M, 603578M, 603579M, 603580M, 603581M, 603583M, 603586M, 603587M, 603597M, 603601M, 603602M, 603603M, 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604020M, 604028M, 604029M, 604037M, 604041M, 604043M, 604046M, 604048M, 604050M, 604051M, 604052M, 604054M, 604055M, 604056M, 604058M, 604062M, 604063M, 604064M, 604067M, 604070M, 604071M, 604074M, 604075M, 604079M, 604080M

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1485-2024

Related Recalls

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.

Outset Medical

Class I - Dangerous

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.

Aug 1, 2024 Other Medical Devices Nationwide View Details →

TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodialysis System.

Outset Medical

Class I - Dangerous

A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat, sparks, smoke, melting or charring (thermal event) of the female connector or the associated connector power entry module, which may lead to transient delay in treatment or blistering to the user.

Apr 30, 2024 Infusion Pumps Nationwide View Details →

Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility.

Outset Medical

Class I - Dangerous

An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.

Jan 24, 2023 Other Medical Devices Nationwide View Details →