Lithium Thionyl non-rechargeable disposable battery pack P/N… — Class II medical device recall Z-1645-2013
Terminated recall by BRAEMAR, INC., reported 2013-07-10, distributed nationwide. Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack being used in
| Recall number | Z-1645-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BRAEMAR, INC., Eagan, MN, United States |
| Recall initiated | 2011-05-02 |
| Classified | 2013-07-01 |
| Reported by FDA | 2013-07-10 |
| Terminated | 2013-07-15 |
| Distributed | Nationwide (US) |
| Quantity | 10,785 packages |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1645-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.