FDA-Device2013-07-10Class II
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.
BRAEMAR, INC.
Hazard
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 result in any patient related injury or present any clinical impact.
Sold states
Nationwide Distribution including FL, IL, LMD, MA, MN, NY, OH, PA, TN, and TX.
Affected count
3286 packs
Manufactured in
1285 Corporate Center Dr, N/A, Eagan, MN, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1652-2013Don't want to check this manually?
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