Home / Recalls / BRAEMAR, INC. / Z-1645-2013

Z-1645-2013 Class II Terminated

Recalled by BRAEMAR, INC. — Eagan, MN

Recall Details

Product Type: Devices
Report Date: July 10, 2013
Initiation Date: May 2, 2011
Termination Date: July 15, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10,785 packs

Product Description

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.

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 injury or present any clinical impact.

Distribution Pattern

Nationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX.

Code Information

n/a