Reported Sep 22, 2021 · Ongoing
Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for…
Welch Allyn Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Welch Allyn Inc · 4341 State Street Rd · Skaneateles Falls, NY · 13153-5300
Is this the product you have?
- 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
- Model6000
- Lot codes and dates
- All Devices in distribution
- UDI00732094309027 DDDYYKXXXXX DDD = 3 DIGIT JULIAN DAY (EXAMPLE - 234). YY = LAST 2 DIGITS OF JULIAN YEAR (EXAMPLE - 13) K = KEYTRONIC XXXXX = 5 DIGIT BASE 10 SERIALIZED NUMBER
- Amount recalled
- 1,036,740 units
Where it was sold
- Nationwide
- PR
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
This product could cause temporary or reversible health problems — stop using it.
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