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U.S. Department of Health and Human Services

Class 2 Device Recall Skin Temperature Sensor

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  Class 2 Device Recall Skin Temperature Sensor see related information
Date Initiated by Firm March 08, 2006
Date Posted April 18, 2006
Recall Status1 Terminated 3 on May 30, 2012
Recall Number Z-0767-06
Recall Event ID 34844
510(K)Number K864195  
Product Classification Thermometer, Electronic, Clinical - Product Code FLL
Product STS-400 Level1¿ Skin Temperature Sensor with 400 Series Thermistor
Code Information Lot Number: 3141
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 2¿C higher than the actual temperature
FDA Determined
Cause 2		 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 and Original Applicant = RESPIRATORY SUPPORT PRODUCTS, INC.
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