Ithaca, NY, United States
Transonic Systems Inc recalls
1 recall recorded since 2018, most recently on 15 February 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 15 February 2018
- Terminated
- 30 April 2019
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1776-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.