Advice for Patients: Possible Burns or Fires from Heating Pads Manufactured by HoMedics, Inc.

Issued: July 11, 2007

Background

On February 9, 2007, HoMedics, Inc. recalled their TheraP model heating pads after receiving complaints from users that these products had caused fires and burns. For a complete list of the recalled pads, see below.

The source of the problem may be a loose connection in the heating pad which could cause a short circuit. This may pose a risk of burns, fire, and damage to materials in close contact to the heating pad, such as bedding, furniture, or clothing.

The voluntary recall includes approximately 292,108 heating pads produced in 2001 and shipped to retailers in 2001 and 2002. These heating pads were sold in the U.S. to Walgreens and other retail drug and department stores.

Advice for Patients

• Check the models below to see if you have one of the affected heating pads:
  • Walgreen’s by Homedics® Model 802857 Standard Size Moist/Dry Heating Pad
  • HoMedics® Thera-P® Model HP-100 Standard Size Dry Heating Pad
  • HoMedics® Thera-P® Model HP-150 Standard Size Moist/Dry Heating Pad
  • HoMedics® Thera-P® Model HP-200 Standard Size Moist/Dry Heating Pad with Auto Shut-off
  • HoMedics® Thera-P® Model HP-300 King Size Moist/Dry Heating Pad
  • HoMedics® Thera-P® Model HP-500 King Size Moist/Dry Heating Pad with Auto Shut-off

Each HoMedics® heating pad is marked with a unique 4-digit date code located both on the back of the hand control as well as on the bottom panel of the packaging. ONLY 4-DIGIT DATE CODES ENDING IN "01" ARE SUBJECT TO THIS VOLUNTARY RECALL.

• If you have one of the recalled pads, stop using it immediately and return it to the retailer for a full refund.
   
• Report to the FDA's MedWatch Adverse Event Reporting program (see below).

For More Information about the Homedics Heating Pad recall, check:

• the FDA Recall Notice at:
  http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm062696.htm

• Homedics press release at: http://www.homedics.com/products/recall for more information about this recall
   
• Questions and Answers on HoMedics®, Inc. Heating Pads and General Heating Pad Safety

For more about general heating pad safety, check:

• The FDA/CPSC Public Health Advisory: Hazards Associated with the Use of Electric Heating Pads at http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/UCM062624.pdf. Although this Advisory was released in 1995, the recommendations are still valid.

Consumers with questions may contact:

• HoMedics, Inc . at 1-800-466-3342, John Wettlaufer at 1-249-863-3000 ext. 1168, or email cservice@homedics.com.

MedWatch Reporting

Consumers who have experienced adverse reactions or quality problems with the use of this product are also encouraged to report to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online: MedWatch
• By phone: 1-800-FDA-1088
• Regular Mail: use postage-paid FDA form 3500
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178  

Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health
Food and Drug Administration