Date Initiated by Firm |
October 25, 2005 |
Date Posted |
February 04, 2006 |
Recall Status1 |
Terminated 3 on November 28, 2007 |
Recall Number |
Z-0466-06 |
Recall Event ID |
33801 |
510(K)Number |
K983887
|
Product Classification |
Thermometer, Electronic, Clinical - Product Code FLL
|
Product |
Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN (Canada); an OTC device used to take an accurate patient temperature measurement in 4-6 seconds typically in the oral, rectal or under arm modes when the ambient temperature is between 50 degrees F and 93.2 degrees F; Distributed by: Omron Healthcare, Inc., 300 Lakeview Parkway, Vernon Hills, IL 60061, Made in Philippines; UPC 73796-43600 |
Code Information |
Model Numbers MC-600 (USA) and MC-600CAN (Canada) Lot numbers beginning with 1-32, 1-36, 1-37, 1-38. |
Recalling Firm/ Manufacturer |
Omron Healthcare, Inc. 1200 Lakeside Dr Bannockburn IL 60015-1243
|
For Additional Information Contact |
Ms. Mary Jean Maksudian 800-634-4350
|
Manufacturer Reason for Recall |
Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip.
|
FDA Determined Cause 2 |
Other |
Action |
Omron sent recall letters dated 10/21/05 to all of their direct accounts, informing them that the probe tip could overheat and possibly burn the person whose temperature is being taken. The accounts were instructed to check the lot number on their thermometers immediately to see if they fall within the range of affected thermometers (lots beginning with 01-32, 01-36, 01-37 and 01-38). The accounts were instructed to call Omron at 1-800-634-4350 if their unit is affected to get instructions on how to return the unit to Omron for a refund. Omron issued a press release on 10/24/05 to alert consumers who may have purchased the thermometer at a retail pharmacy, and has posted both the press release and the recall letter on their website at www.omronhealthcare.com. |
Quantity in Commerce |
Approximately 48,000 units |
Distribution |
Nationwide and internationally to Canada, Chile, Venezuela and Singapore |
Total Product Life Cycle |
TPLC Device Report
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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 = MEDISIM LTD.
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