FDA Announces Recall of Omron 3-Way Thermometers for Overheating Risk Caused by Electrical Problem

Omron Healthcare Inc. has initiated a voluntary recall of certain Omron® 3-Way Instant Thermometers model numbers MC-600 and MC-600CAN. The tip of the device may overheat causing 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.

The voluntary recall was initiated following receipt of a limited number of consumer complaints. 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

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