FDAFDA · Food and drugs·Recall number Z-1652-2013
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.
Published July 10, 2013 · Recall initiated: February 24, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- BRAEMAR, INC.
- Distributor
- Nationwide Distribution including FL, IL, LMD, MA, MN, NY, OH, PA, TN, and TX.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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