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
FDA Recall Z-0466-06 · Posted 2006-02-04
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Recalling FirmOmron Healthcare, Inc.
Recall StatusTerminated
Product CodeFLL
Date Initiated2005-10-25
Date Terminated2007-11-28
Product QuantityApproximately 48,000 units
Reason for Recall
Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide and internationally to Canada, Chile, Venezuela and Singapore
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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