Recall Z-1645-2013— BRAEMAR, INC.
Class II · Terminated
Class II FDA medical device recall by BRAEMAR, INC., initiated 2011-05-02, terminated 2013-07-15. It names one FDA 510(k) clearance: K072008. Product: 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: 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.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-05-02
- Terminated
- 2013-07-15
- Firm location
- Eagan, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.