FDA-Device2013-07-10Class II
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.
BRAEMAR, INC.
Hazard
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.
Sold states
Nationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX.
Affected count
10,785 packs
Manufactured in
1285 Corporate Center Dr, N/A, Eagan, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1645-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief