Welch Allyn product recalled over fire hazard

Recall date

July 20, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Welch Allyn Inc recalls Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for pati…

Recall number

Z-2482-2021

FDA classification

Class II

Brand / firm

Welch Allyn Inc

Sold / distributed

Worldwide distribution - US Nationwide distribution and the countries of Afghanistan, Andorra, Australia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Canada, Chile, China, Colombia, Congo, Costa Rica, C¿te D'ivoire (Ivo…

Why it was recalled

If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 6000