FDA Medical Device Recalls (openFDA)
BRAEMAR, INC.: 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.
- Recall number
- Z-1645-2013
- Recalling firm
- BRAEMAR, INC.
- 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.
- Status
- Terminated
- Initiated
- 2011-05-02
- Posted
- 2013-07-02
- Terminated
- 2013-07-15
- 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.
- Root cause
- Process control
- Action
- Braemar began notifying customers by telephone on 5/2/2011. Braemar issued Advisory Notice letter P/N 600-0662-00 RevA dated May 16, 2011. The letter was sent by UPS to all consignees.The letter described the problem and the product involved in the recall. Consignees were advised not to use the battery pack in the Braemar ER920W or Braemar Fusion device and requested consignees to complete and return the Verification Form. For questions regarding this recall call 651-286-8620.
- Quantity
- 10,785 packs
- Distribution
- Nationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX.
- Lot, serial or model codes
- n/a
- 510(k) numbers
- ["K072008"]
- PMA numbers
- not on file
- Product code
- DRG
- Firm FEI
- 1000520785
- Firm city
- Eagan
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28