Drug recall
RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only…
FDA recall event 72810 · Class II · RenovoRx, Inc.
Key facts
| Event ID | 72810 |
|---|---|
| Recall numbers | Z-0565-2016 |
| Recalling firm | RenovoRx, Inc. |
| Product type | Devices |
| Products | RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: The RenovoCath RC120 Catheter is intended for the isolation of blood flow and… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrect version of Instructions for Use were shipped to two US customers. |
| Initiation date | Nov 25, 2015 |
| Report date | Jan 6, 2016 |
| Termination date | Feb 29, 2016 |
| City | Los Altos |
| State | CA |
| Country | United States |
| FEI number | 3011279674 |
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: