Transonic ADT1018 Flow QC Clear Advantage Tubing — Class II medical device recall Z-1776-2018
Terminated recall by Transonic Systems Inc, reported 2018-05-16, distributed nationwide. The sterility of the device cannot be assured. There is a potential for an increased risk of infection.
| Recall number | Z-1776-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Transonic Systems Inc, Ithaca, NY, United States |
| Recall initiated | 2018-02-15 |
| Classified | 2018-05-09 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2019-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, KR, TH, TW |
| Quantity | 6,044 |
| Reason classes | sterility |
| Lot numbers | B151130E2, B161115E0 |
| Model numbers | ADT1018, ADT1018-40 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1776-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.