FDAFebruary 15, 2018device

Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hem...

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

The hazard

The sterility of the device cannot be assured. There is a potential for an increased risk of infection.

What to do

FDA enforcement status: Terminated

Brands named

transonic systemstransonic

Recall history

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

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