Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN (Canada); an OTC device used to take an

FDA device recall Z-0466-06 · posted 2006-02-04 · Terminated

Recall details

Recalling firm

Omron Healthcare, Inc.

Reason for recall

Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip.

Action taken

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

Status

Terminated

Product code

FLL

Quantity affected

Approximately 48,000 units

Distribution

Nationwide and internationally to Canada, Chile, Venezuela and Singapore

Date initiated

2005-10-25

Date posted

2006-02-04

Date terminated

2007-11-28

Location

Bannockburn, IL

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