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
    65410
  • Event Risk Class
    Class 2
  • Event Number
    Z-1652-2013
  • Event Initiated Date
    2012-02-24
  • 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=118792
  • 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 has recently became aware of a battery related incident that occurred with ewt battery packs that are used in a braemer er920w wireless event monitor and fusion device. the event did not result in any patient related injury or present any clinical impact.
  • Action
    Braemar began notifying customers by telephone on 2/24/2012. Braemar issued Advisory Notice letter P/N 600-066201 RevA on 3/02/2012. The letter described the product, the problem, and the action to be taken by the customer. Customers were requested to only use TESTED batteries that they have receivewd fromBraemar starting on February 23, 2012. Complete and return the attached Verification Form. If customers have any untested product in their inventory, they were instructed to segregate those battery packs and await further instruction from Braemar to coordinate the return of those untested units. Upon receipt of the attached verification form, Braemar will continue to send replacement battery packs that have passed the additional testing protocol. Customers were instructed to contact their Braemar sales representative if they have any questions regarding the notice. 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