Drug recall
Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series…
FDA recall event 65410 · Class II · BRAEMAR, INC.
Key facts
| Event ID | 65410 |
|---|---|
| Recall numbers | Z-1652-2013 |
| Recalling firm | BRAEMAR, INC. |
| Product type | Devices |
| Products | Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device. The event did not… |
| Initiation date | Feb 24, 2012 |
| Report date | Jul 10, 2013 |
| Termination date | Jul 15, 2013 |
| City | Eagan |
| State | MN |
| Country | United States |
| FEI number | 1000520785 |
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: