FDAClass IIJuly 10, 2013

Lithium Thionyl non-rechargeable disposable battery recall

Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable…

Why was Lithium Thionyl non-rechargeable disposable battery recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

n/a

Product
Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable…
Recalling firm
BRAEMAR, INC.
Quantity
10,785 packs
Distribution
Nationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX.
Recall date
July 10, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls