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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Omron 3-Way Instant Thermometers Recalled for Possible Safety Risk

Contact:
Mary Jean Maksudian
(847) 247-5638

FOR IMMEDIATE RELEASE -- BANNOCKBURN, ILL. -- October 24, 2005 -- Omron Healthcare Inc. today initiated a voluntary recall of certain Omron® 3-Way Instant Thermometers -- model numbers MC-600 and MC-600CAN -- due to a potential issue that may cause the tip of the device to overheat.

The voluntary recall was initiated following receipt of a limited number of consumer complaints indicating discomfort during and following use of the subject thermometers. Consumers who continue using the affected thermometers are at risk of discomfort during use, potentially resulting in redness or even a blister on the skin. Very young children using this device are at an increased risk due to the inability to express themselves and their difficulty in pulling away from the device held by an adult.

The battery-operated, digital thermometers were sold in the United States and Canada between Sept. 19, 2001, and October 21, 2005. Available through drug stores, the pharmacy sections of food stores and mass merchandise chains, and internet retailers, the potentially affected products have Lot Numbers beginning with 01-32, 01-36, 01-37 and 01-38. (Lot numbers are located inside the battery compartments of the thermometers.) It should be noted that no lot numbers begin with 01-33, 01-34 or 01-35. Omron determined that the overheating was a result of a change in the manufacturing process of the MC-600 and MC-600CAN thermometers by Medisim Ltd., the third-party manufacturer from whom Omron purchased the devices.

While none of the reports have involved serious injury, Omron is requesting consumers to immediately discontinue use of any affected device and call 800.634.4350 for information on how to return and receive a refund or exchange for a different thermometer model. Information is also available on the company website: www.omronhealthcare.com.

Consumers who have questions about the recall are encouraged to call Omron Healthcare at 800.634.4350.

For further information on Omron Healthcare Inc. visit the company's Web site at www.omronhealthcare.com.

"We have enjoyed a long history of providing consumers with safe, accurate and technologically-advanced devices that allow for healthier living," stated Kaz Saito, Chairman & CEO. "As part of our ongoing commitment to the consumers who rely on our products, we are working to rapidly and efficiently recover these devices of concern."

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