Class 1 Medical Device Recall – HoMedics® Thera-P® Heating Pads

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 color box. ONLY 4-DIGIT DATE CODES ENDING IN "01" ARE SUBJECT TO THIS VOLUNTARY RECALL.

In order to accurately identify the date code, consumers should refer to the diagram included in this release.

HoMedics® received complaints of user burns and fires to bedding, clothing and houses that were started by the heating pads. The FDA learned about these complaints during an FDA inspection of HoMedics®. The inspection also revealed quality system deficiencies related to design controls, complaint handling, and corrective and preventative actions. Complaints were reviewed during an FDA inspection and the firm elected to recall products after discussions with the FDA.

HoMedics® received eight reports of minor or first degree burns associated with the use of the heating pads and five additional reports of minor or first degree burns possibly related to the use of the heating pads as well as reports of property damage. If burned, the consumer should seek medical attention if appropriate.

Approximately 292,108 heating pads are being recalled which were produced in 2001 and shipped to retailers in 2001 and 2002. These heating pads were sold in the United States to Walgreens as well as to drug stores, discount stores and department stores.

Consumers who have any of these specific heating pads should discontinue the use of the product immediately and return it to the retailer of purchase for a full refund. HoMedics® is currently contacting the retailers of these heating pads to communicate return instructions. Further information can be obtained by going to the company’s press release at: For more information about this recall, please see the company’s press release at: http://www.homedics.com/MediaCenter/PressRelease.aspx?id=90&cat=prp

Consumers with questions may contact the company at 1-800-466-3342 or email the company at cservice@homedics.com.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that, should this particular malfunction occur, use of the affected product may cause serious injury or death if the problem is not corrected.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at:
  www.fda.gov/MedWatch/getforms.htm.
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD
  20852-9787
• FAX: 1-800-FDA-0178