Braemar Recalls Lithium Thionyl Battery Packs for ER920 Wireless Event Recorders
Braemar, Inc. is recalling 3,286 non-rechargeable lithium thionyl battery packs used with ER920 Wireless Series Arrhythmia Event Recorders due to a battery-related incident.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device battery with a reported incident, but the source explicitly states no patient injury or clinical impact occurred. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Braemar, Inc. is recalling 3,286 non-rechargeable lithium thionyl disposable battery packs (P/N 350-0294-01) used with the ER920 Wireless Series Arrhythmia Event Recorder. The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-1652-2013.
The recall was initiated after Braemar became aware of a battery-related incident involving EWT battery packs used in the Braemar ER920W wireless event monitor and Fusion device. The source text explicitly states that the event did not result in any patient-related injury or present any clinical impact.
The affected battery packs were distributed nationwide, including in Florida, Illinois, Louisiana, Maryland, Massachusetts, Minnesota, New York, Ohio, Pennsylvania, Tennessee, and Texas. Consumers and healthcare providers should stop using the affected battery packs and contact Braemar, Inc. for further instructions.
The recalled product
- Product
- Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
- Manufacturer
- BRAEMAR, INC.
- Category
- Medical Device — Battery Pack
- Hazard
- Affected units
- 3,286
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- n/a
Distribution
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