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Outset Medical, Inc. Recall 94224

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

Outset Medical, Inc. Recall 94224 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1485-2024
Event ID94224
Event DescriptionTablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Product TypeDevices
DistributionUS:FL, CA, NM, SC, AZ, TN, NC, TX, IL, MD, IN, DE, AL, MI, AK, KY, LA, ID, OK, IA, VA, GA, MA, NE, KS, WI, PA, OH, WA, MT, RI, MN, MO, AR, NY, CO, WV, SD, OR, UT, WY, DC. OUS: AE
Recall ReasonHemodialysis 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.
Device Classification20240424
Device Code InfoUDI-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, 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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
Center Classification Date20240412
Recall Initiation Date20240306
Recalling FirmOutset Medical, Inc.
Initial Notification Letter
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