Drug recall
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to…
FDA recall event 69049 · Class II · Volcano Corporation
Key facts
| Event ID | 69049 |
|---|---|
| Recall numbers | Z-2636-2014 |
| Recalling firm | Volcano Corporation |
| Product type | Devices |
| Products | Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product. |
| Initiation date | Aug 13, 2014 |
| Report date | Sep 24, 2014 |
| Termination date | Jun 30, 2015 |
| City | Rancho Cordova |
| State | CA |
| Country | United States |
| FEI number | 2939520 |
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: