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U.S. Department of Health and Human Services

Class 1 Device Recall HoMedics Thera P heating pad

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  Class 1 Device Recall HoMedics Thera P heating pad see related information
Date Initiated by Firm February 09, 2007
Date Posted March 21, 2007
Recall Status1 Terminated 3 on January 04, 2010
Recall Number Z-0623-2007
Recall Event ID 37106
Product Classification Heating Pad - Product Code IRT
Product HoMedics Thera-P Standard size Moist/Dry Heating Pad, Model No. HP-150 (UPC 031262003638) and sold as Walgreens by Homedics model number 802857 (UPC 04922149892).
Code Information All units with a four digit date code ending in ''01'' (this code is located on the hand control and on the bottom panel of the heat pad box).
Recalling Firm/
Manufacturer		 HoMedics, Inc.
3000 N Pontiac Trail
Commerce Township MI 48390-2720
For Additional Information Contact John Wettlaufer
249-863-3000 Ext. 1168
Manufacturer Reason
for Recall		 Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
FDA Determined
Cause 2		 Other
Action Press release issued on 2/9/07 instructing consumers to return the product to store of purchase or Homedics. Retail stores notified via recall letter issued on 2/9/07. Retail stores are being instructed to accept returns and to post placards to notify customers of the recall.
Quantity in Commerce 292,108 of all models
Distribution Nationwide and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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