Home / Recalls / BRAEMAR, INC. / Z-1652-2013

Z-1652-2013 Class II Terminated

Recalled by BRAEMAR, INC. — Eagan, MN

Recall Details

Product Type: Devices
Report Date: July 10, 2013
Initiation Date: February 24, 2012
Termination Date: July 15, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3286 packs

Product Description

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.

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 result in any patient related injury or present any clinical impact.

Distribution Pattern

Nationwide Distribution including FL, IL, LMD, MA, MN, NY, OH, PA, TN, and TX.

Code Information

n/a