Class II — Transonic Systems Inc
| Recalling firm | TRANSONIC SYSTEMS, INC. |
|---|---|
| Registered facility | TRANSONIC SYSTEMS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The sterility of the device cannot be assured. There is a potential for an increased risk of infection. |
| 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. |
| Quantity | 6044 |
| 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 | 2018-02-15 |
| Classified | 2018-05-09 |
| Terminated | 2019-04-30 |
| Recall number | Z-1776-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Transonic Systems Inc (Z-1776-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79750/
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