Events

Recall of Device Recall Lithium Thionyl nonrechargeable disposable battery pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BRAEMAR, INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65423
  • Event Risk Class
    Class 2
  • Event Number
    Z-1645-2013
  • Event Initiated Date
    2011-05-02
  • Event Date Posted
    2013-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118870
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Transmitters and receivers, physiological signal, radiofrequency - Product Code DRG
  • 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.
  • 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.

Device

Device Recall Lithium Thionyl nonrechargeable disposable battery pack
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX.
  • Product Description
    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.

Manufacturer

BRAEMAR, INC.
  • Manufacturer Address
    BRAEMAR, INC., 1285 Corporate Center Dr, Eagan MN 55121-1267
  • Source
    USFDA