FDAFDA · Food and drugs·Recall number Z-1485-2024
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Published April 24, 2024 · Recall initiated: March 6, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Outset Medical, Inc.
- Distributor
- US: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
- Lot
- 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, 60314
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.