Drug recall
Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series…
FDA recall event 65423 · Class II · BRAEMAR, INC.
Key facts
| Event ID | 65423 |
|---|---|
| Recall numbers | Z-1645-2013 |
| Recalling firm | BRAEMAR, INC. |
| Product type | Devices |
| Products | Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 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 Inc., became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor. The event did not result in any patient related… |
| Initiation date | May 2, 2011 |
| 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: