Drug recall
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The…
FDA recall event 64329 · Class II · Medrad Inc
Key facts
| Event ID | 64329 |
|---|---|
| Recall numbers | Z-0870-2013 |
| Recalling firm | Medrad Inc |
| Product type | Devices |
| Products | MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory. |
| Initiation date | Nov 5, 2012 |
| Report date | Feb 27, 2013 |
| Termination date | Mar 10, 2015 |
| City | Warrendale |
| State | PA |
| Country | United States |
| FEI number | 3006316319 |
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: