Events

Recall of Ace Heat Therapy

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Company.

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
    49086
  • Event Risk Class
    Class 2
  • Event Number
    Z-2431-2008
  • Event Initiated Date
    2008-04-25
  • Event Date Posted
    2008-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72726
  • 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
    Disposable Hot Pack - Product Code IMD
  • Reason
    Potential for skin irritation and burns associated with the use of this product.
  • Action
    Important: Product Recall Letters were sent by UPS second day air with tracking on April 25, 2008 to all customers asking them to please contact Customer Service at 866-228-7265 to have a Return Goods Authorization issued. The letter also states that neither customers nor a third party should destroy product.

Device

Ace Heat Therapy
  • Model / Serial
    All lots  Catalog Numbers: 207569, 207570, 207535, 207541, 207542, 207543, 207544, 207545, 207549, 207550, 207557, 207565, 207582, 207583, and 207586.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Ace Heat Therapy, A BD Product || Up to 10 hours of Soothing Heat; Heat therapy for muscle and joint pain. || Apply Directly to Skin, Instant, Air-Activated Heat Patches || Distributed by: BD Medical, Franklin Lakes, NJ 07417 || Catalog Numbers: 207569, 207570, 207535, 207541, 207542, 207543, 207544, 207545, 207549, 207550, 207557, 207565, 207582, 207583, and 207586.
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Manufacturer Address
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA