Drug recall
Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
FDA recall event 68244 · Class II · Terumo Cardiovascular Systems Corporation
Key facts
| Event ID | 68244 |
|---|---|
| Recall numbers | Z-2018-2014, Z-2019-2014 |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Product type | Devices |
| Products | Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS), Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items. |
| Initiation date | Jun 17, 2014 |
| Report date | Jul 16, 2014 |
| Termination date | Sep 22, 2014 |
| City | Ann Arbor |
| State | MI |
| Country | United States |
| FEI number | 1828100 |
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: