Braemar Recalls Lithium Thionyl Battery Packs for ER920W Event Recorders
Braemar Inc. is recalling 10,785 lithium thionyl battery packs used with ER920W wireless event monitors following a battery incident that caused no patient injury.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source explicitly states that the incident did not result in any patient-related injury or clinical impact, fitting the criteria for a moderate severity recall without reported harm.
Plain-English summary
Braemar Inc. is recalling 10,785 non-rechargeable disposable lithium thionyl battery packs (P/N 350-0294-00) used with the ER920 Wireless Series Arrhythmia Event Recorder. The recall was initiated after the company became aware of a battery-related incident involving an Able battery pack used in a Braemar ER920W wireless event monitor.
The incident did not result in any patient-related injury or present any clinical impact. The affected battery packs were distributed nationwide, including in Florida, Illinois, Maryland, Minnesota, New York, Ohio, Pennsylvania, South Carolina, Tennessee, and Texas.
Consumers and healthcare providers should stop using the affected battery packs and contact Braemar Inc. for further instructions or a replacement.
The recalled product
- 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.
- Manufacturer
- BRAEMAR, INC.
- Category
- Medical Device — Battery Pack
- Hazard
- Affected units
- 10,785
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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