Drug recall
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain…
FDA recall event 81321 · Class II · Stryker Sustainability Solutions
Key facts
| Event ID | 81321 |
|---|---|
| Recall numbers | Z-0467-2019 |
| Recalling firm | Stryker Sustainability Solutions |
| Product type | Devices |
| Products | Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing. |
| Initiation date | Aug 23, 2018 |
| Report date | Nov 21, 2018 |
| Termination date | Feb 4, 2021 |
| 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: