Drug recall
Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for…
FDA recall event 81042 · Class II · Surge Medical Sales, LLC (DBA Surge Cardiovascular)
Key facts
| Event ID | 81042 |
|---|---|
| Recall numbers | Z-0068-2019 |
| Recalling firm | Surge Medical Sales, LLC (DBA Surge Cardiovascular) |
| Product type | Devices |
| Products | Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device was built with the rigid insertion stylet instead of the flexible stylet. |
| Initiation date | Jul 18, 2018 |
| Report date | Oct 10, 2018 |
| Termination date | Apr 4, 2019 |
| City | Grand Rapids |
| State | MI |
| Country | United States |
| FEI number | 3004986960 |
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: