Drug recall
HEMO-10 Hemospray Endoscopic Hemostat
FDA recall event 84822 · Class II · Wilson-Cook Medical Inc.
Key facts
| Event ID | 84822 |
|---|---|
| Recall numbers | Z-1745-2020, Z-1746-2020 |
| Recalling firm | Wilson-Cook Medical Inc. |
| Product type | Devices |
| Products | HEMO-10 Hemospray Endoscopic Hemostat, HEMO-7 Hemospray Endoscopic Hemostat |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the… |
| Initiation date | Feb 4, 2020 |
| Report date | Apr 29, 2020 |
| Termination date | Jan 15, 2021 |
| City | Winston Salem |
| State | NC |
| Country | United States |
| FEI number | 1037905 |
At a glance
- 1–9 Products in this recall
- 10–99 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: