Recall Z-1776-2018— Transonic Systems Inc
Class II · Terminated
Class II FDA medical device recall by Transonic Systems Inc, initiated 2018-02-15, terminated 2019-04-30. It names one FDA 510(k) clearance: K021571. 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: The sterility of the device cannot be assured. There is a potential for an increased risk of infection..
- Recalling firm
- Transonic Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-15
- Terminated
- 2019-04-30
- Firm location
- Ithaca, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.