Drug recall
IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System…
FDA recall event 65245 · Class II · IDEV Technologies, Inc.
Key facts
| Event ID | 65245 |
|---|---|
| Recall numbers | Z-1550-2013 |
| Recalling firm | IDEV Technologies, Inc. |
| Product type | Devices |
| Products | IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There was an error on the outer labeling of this device. The inner label was correct. |
| Initiation date | May 29, 2012 |
| Report date | Jun 26, 2013 |
| Termination date | Jul 29, 2013 |
| City | Webster |
| State | TX |
| Country | United States |
| FEI number | 3005325609 |
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: