Drug recall
Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020…
FDA recall event 65654 · Class II · Stryker Neurovascular
Key facts
| Event ID | 65654 |
|---|---|
| Recall numbers | Z-1808-2013 |
| Recalling firm | Stryker Neurovascular |
| Product type | Devices |
| Products | Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. The Model Number on the… |
| Initiation date | Jun 24, 2013 |
| Report date | Jul 31, 2013 |
| Termination date | Sep 30, 2013 |
| City | Fremont |
| State | CA |
| Country | United States |
| FEI number | 3008853977 |
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: