Drug recall
Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for…
FDA recall event 79750 · Class II · Transonic Systems Inc
Key facts
| Event ID | 79750 |
|---|---|
| Recall numbers | Z-1776-2018 |
| Recalling firm | Transonic Systems Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The sterility of the device cannot be assured. There is a potential for an increased risk of infection. |
| Initiation date | Feb 15, 2018 |
| Report date | May 16, 2018 |
| Termination date | Apr 30, 2019 |
| City | Ithaca |
| State | NY |
| Country | United States |
| FEI number | 1319030 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: