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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Event Detail

Event ID 65410
Product Type Devices
Status Ongoing
Recalling Firm BRAEMAR, INC.
City Eagan
State MN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-02-24
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including FL, IL, LMD, MA, MN, NY, OH, PA, TN, and TX.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. n/a Class II 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. 3286 packs Z-1652-2013