Transonic Systems Inc recalls Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as pa…

Recall date

February 15, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1776-2018

FDA classification

Class II

Brand / firm

Transonic Systems Inc

Sold / distributed

Worldwide Distribution - USA (nationwide) Distribution and to the states of : NJ, NY, OH, PA, and TX., and to the countries of : Canada, South Korea, Thailand, Australia and Taiwan.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 hemodialysis treatment.