FDA recall Z-1776-2018

Transonic Systems Inc · Class II · device

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.

Reason for recall

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

Distribution

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.

Key facts

Status
Terminated
Initiation date
2018-02-15
Report date
2018-05-16
Termination date
2019-04-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ithaca, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1776-2018