Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless...
FDA Recall #Z-1645-2013 — Class II — May 2, 2011
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.
Recalling Firm
BRAEMAR, INC. — Eagan, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
10,785 packs
Distribution
Nationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX.
Code Information
n/a
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated