Drug recall
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been…
FDA recall event 76603 · Class II · Devicor Medical Products Inc
Key facts
| Event ID | 76603 |
|---|---|
| Recall numbers | Z-1512-2017 |
| Recalling firm | Devicor Medical Products Inc |
| Product type | Devices |
| Products | Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number. |
| Initiation date | Feb 28, 2017 |
| Report date | Mar 29, 2017 |
| Termination date | Aug 3, 2017 |
| City | Cincinnati |
| State | OH |
| Country | United States |
| FEI number | 3008492462 |
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: