FDA-Device2024-04-24Class I
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Outset Medical, Inc.
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.
Sold states
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
Affected count
919
Manufactured in
3052 Orchard Dr, San Jose, CA, United States
Products
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1485-2024Don't want to check this manually?
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