Reported Apr 24, 2024 · Ongoing
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Outset Medical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Outset Medical, Inc. · 3052 Orchard Dr · San Jose, CA · 95134-2011
Is this the product you have?
- Tablo Hemodialysis System
- REF
PN-0003000PN-0006000 and PN-0007001
- Lot codes and dates
- UDI-DI0850001011112 and 00850001011204
- Serial Numbers
919 of 919 codes
400028400093400240400403400407400413400414400416400418400426400430400433400434400435400436400437400441400442400444400447400465400511400513400527400530400532400543400546400552400554400556400557400558400560400564400565400566400593400595400598400610400614400615400618400626400657400741400764400775400792400813400837400874400879400894400924400941400942400988401048
- Amount recalled
- 919
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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