Drug recall
RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to…
FDA recall event 71232 · Class III · Acclarent, Inc.
Key facts
| Event ID | 71232 |
|---|---|
| Recall numbers | Z-1740-2015 |
| Recalling firm | Acclarent, Inc. |
| Product type | Devices |
| Products | RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. . |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date. |
| Initiation date | Apr 28, 2015 |
| Report date | Jun 17, 2015 |
| Termination date | Jun 10, 2015 |
| City | Menlo Park |
| State | CA |
| Country | United States |
| FEI number | 3005172759 |
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: