Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1485-2024 — Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001

U.S. FDA — Device Enforcement · United States · 2024-03-06 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1485-2024
Date of alert
2024-03-06
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Outset Medical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0850001011112
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.