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Transonic Systems Inc recalls Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as
Recalled May 16, 2018 · FDA recall Z-1776-2018 · Transonic Systems
Hazard
The sterility of the device cannot be assured. There is a potential for an increased risk of infection. · FDA Class II
Units
6044
Sold at
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.
Description
The sterility of the device cannot be assured. There is a potential for an increased risk of infection.
Product
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.
Manufacturer(s)
Transonic Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →