Drug recall
lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by…
FDA recall event 65289 · Class II · Invatec Llc
Key facts
| Event ID | 65289 |
|---|---|
| Recall numbers | Z-1517-2013 |
| Recalling firm | Invatec Llc |
| Product type | Devices |
| Products | lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified. |
| Initiation date | Mar 4, 2009 |
| Report date | Jun 12, 2013 |
| Termination date | Jun 10, 2013 |
| City | Bethlehem |
| State | PA |
| Country | United States |
| FEI number | 3006466080 |
At a glance
- 1–9 Products in this recall
- None 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: