Outset Medical, Inc.: Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001

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.

Details from the source

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. Distribution: 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 Quantity: 919 Lot/code info: 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,

UPC codes

0850001011112, 00850001011204

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.