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BRAEMAR, INC. recalls Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Even
Recalled July 10, 2013 · FDA recall Z-1652-2013 · BRAEMAR
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. · FDA Class II
Units
3286 packs
Sold at
Nationwide Distribution including FL, IL, LMD, MA, MN, NY, OH, PA, TN, and TX.
Description
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.
Product
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.
Manufacturer(s)
BRAEMAR, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →