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07-13-2013, 09:17 AM #1
- Join Date
- Aug 2012
- Merced, CA 95348-1422
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Recall: Able battery pack for a Braemar ER920W wireless event monitor
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 Id 65423
Product Type Devices
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.