Drug recall
Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by…
FDA recall event 70647 · Class II · Transonic Systems Inc
Key facts
| Event ID | 70647 |
|---|---|
| Recall numbers | Z-1295-2015 |
| Recalling firm | Transonic Systems Inc |
| Product type | Devices |
| Products | Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. The user saw a zero or a very low flow value displayed on HD03 and/or… |
| Initiation date | Feb 17, 2015 |
| Report date | Mar 25, 2015 |
| Termination date | May 31, 2016 |
| 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: