Drug recall
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
FDA recall event 82019 · Class II · Terumo Cardiovascular Systems Corporation
Key facts
| Event ID | 82019 |
|---|---|
| Recall numbers | Z-0966-2019 |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Product type | Devices |
| Products | Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of natural rubber latex is not declared in the label |
| Initiation date | Dec 20, 2018 |
| Report date | Mar 6, 2019 |
| Termination date | Aug 20, 2019 |
| City | Elkton |
| State | MD |
| Country | United States |
| FEI number | 3000204839 |
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: