Outset Medical recalls Tablo Hemodialysis Systems with specific part numbers due to potential PCBAs in tubing that could cause skin conditions, liver damage, and cancer risks. Affected units have serial numbers listed in the 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.
Outset Medical is recalling certain Tablo Hemodialysis Systems because the tubing may contain PCBAs (non-dioxin-like polychlorinated biphenyl acids) that can cause skin conditions, liver damage, impaired reproduction, and certain cancers. These risks are linked to tubing used less than 336 hours.
The tubing in these systems may contain PCBAs that have not been fully flushed out over time. Exposure to PCBAs can lead to skin conditions, liver damage, impaired reproductive health, and certain types of cancer in humans.
People using the recalled Tablo Hemodialysis Systems with specific part numbers and serial numbers listed in the recall are at risk. Hemodialysis patients and caregivers are most affected.
Check the product's part numbers (PN-0003000, PN-0006000, PN-0007001) or serial numbers listed in the recall. The system uses less than 336 hours of operation before the recall applies.
Identify your Tablo Hemodialysis System's part numbers or serial numbers to see if they match the recalled units.
Outset Medical is recalling Tablo Hemodialysis Systems with specific part numbers and serial numbers due to potential PCBAs in the tubing that could cause health issues.
Check your system's part numbers (PN-0003000, PN-0006000, PN-0007001) or serial numbers listed in the recall. The system must have been used less than 336 hours.
Exposure to PCBAs in the tubing could cause skin conditions, liver damage, impaired reproduction, and certain types of cancer in humans.
We’ve drafted a message you can send Outset Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1485-2024 — Outset Medical Outset Medical Hello, I own a Outset Medical that is covered by recall Z-1485-2024 from Outset Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
