Drug recall
Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product…
FDA recall event 81430 · Class II · Stryker Sustainability Solutions
Key facts
| Event ID | 81430 |
|---|---|
| Recall numbers | Z-0498-2019 |
| Recalling firm | Stryker Sustainability Solutions |
| Product type | Devices |
| Products | Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain following the recall execution activities… |
| Initiation date | Jun 19, 2018 |
| Report date | Dec 5, 2018 |
| Termination date | Nov 15, 2024 |
| City | Tempe |
| State | AZ |
| Country | United States |
| FEI number | 3009350690 |
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: