Drug recall
SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and…
FDA recall event 73595 · Class II · Stryker Instruments Div. of Stryker Corporation
Key facts
| Event ID | 73595 |
|---|---|
| Recall numbers | Z-1379-2016 |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Product type | Devices |
| Products | SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: The SurgiCount Safety Sponge System is indicated for use in counting and… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2). Also, the… |
| Initiation date | Mar 21, 2016 |
| Report date | Apr 20, 2016 |
| Termination date | Sep 6, 2016 |
| City | Portage |
| State | MI |
| Country | United States |
| FEI number | 1811755 |
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: