FDA Device recall 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 extracorpor…
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorpor… by Transonic Systems, citing the sterility of the device cannot be assured. There is a potential for an increased risk of infection.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1776-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-15 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Transonic Systems |
| Distribution | US |
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.
Identifiers
| code_info | Lots B151130E2 and B161115E0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1776-2018%22
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