Drug recall
Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use…
FDA recall event 63079 · Class II · Terumo Cardiovascular Systems Corporation
Key facts
| Event ID | 63079 |
|---|---|
| Recall numbers | Z-0049-2013, Z-0050-2013 |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Product type | Devices |
| Products | Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only., Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly… |
| Initiation date | Sep 25, 2012 |
| Report date | Oct 17, 2012 |
| Termination date | Jan 15, 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: