Class 2 Device Recall Skin Temperature Sensor

• Date Initiated by Firm: March 08, 2006
• Date Posted: April 18, 2006
• Recall Status: Terminated on May 30, 2012
• Recall Number: Z-0767-06
• Recall Event ID: 34844
• 510(K)Number: K864195
• Product Classification: Continuous Measurement Thermometer - Product Code FLL
• Product: STS-400 Level1 Skin Temperature Sensor with 400 Series Thermistor
• Code Information: Lot Number: 3141
• FEI Number: 1221261
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc.; 160 Weymouth St; Rockland MA 02370-1136
• For Additional Information Contact: Christine Lloyd; 781-878-8011 Ext. 7904
• Manufacturer Reason for Recall: Product temperature readings may be 2C higher than the actual temperature
• FDA Determined Cause: Other
• Action: Smiths Medical notified consignees by letter dated 3/8/05. Customers are instructed to complete customer reply notices and return affected products for replacement.
• Quantity in Commerce: 20,000
• Distribution: Nationwide, Canada, France, Japan, Netherlands
• 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.

• 510(K) Database: 510(K)s with Product Code = FLL