Recalls / —

—#44817

Product

TTS-400J Level1 Tympanic Temperature Sensor with 400 Series Thermistor

FDA product code

FLL — Continuous Measurement Thermometer

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K864195

Affected lot / code info

Lot Number: 3080

Why it was recalled

Product temperature readings may be 2C higher than the actual temperature

Root cause (FDA determination)

Other

Action the firm took

Smiths Medical notified consignees by letter dated 3/8/05. Customers are instructed to complete customer reply notices and return affected products for replacement.

Recalling firm

Firm

Smiths Medical ASD, Inc.

Address

160 Weymouth St, Rockland, Massachusetts 02370-1136

Distribution

Distribution pattern

Nationwide, Canada, France, Japan, Netherlands

Timeline

Recall initiated

2006-03-08

Posted by FDA

2006-04-18

Terminated

2012-05-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #44817. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.