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FDAJanuary 20, 2022device

Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.

What to do

FDA enforcement status: Ongoing

Brands named

outset medicaloutset

UPCs

0085000101111200850001011204

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000 — Recall Details · AllClear