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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Product Detail

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.
Recall Number Z-1645-2013
Classification Class II
Code Info n/a
Product Distributed Qty 10,785 packs
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.

Event Detail

Event Id 65423
Product Type Devices
Status Ongoing
Recalling Firm BRAEMAR, INC.
City Eagan
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-05-02
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Nationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX.
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