Z-1645-2013Class II

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

Name: Z-1645-2013 Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series...
Creator: Braemar, Inc.
Published: 2011-05-02
License: https://open.fda.gov/license/

Braemar Manufacturing, LLC / initiated 2011-05-02 / Terminated / root cause: manufacturing process

FDA source

BRAEMAR, INC. began a recall of Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable... on 2011-05-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1645-2013
Classification: Class II
Status: Terminated
Initiated: 2011-05-02
Posted: 2013-07-02
Terminated: 2013-07-15
Recalling firm: Braemar Manufacturing, LLC
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.
Product code: DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 10,785 packs
Distribution: Nationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX.
Product codes and lots: n/a

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1645-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1645-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01

Product code DRG

K072008Class IIBraemar Er900 Wireless Series Arrhythmia Event RecorderBraemar, Inc. / cleared 2007-10-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)