Braun ThermoScan PRO 6000 Ear Thermometer-indicated for recall
Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from…
Why was Braun ThermoScan PRO 6000 Ear Thermometer-indicated for 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Devices in distribution. UDI: 00732094309027 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.
- Product
- Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from…
- Recalling firm
- Welch Allyn Inc
- Quantity
- 1,036,740 units
- Distribution
- 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 (Ivory Coast), Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep., Ecuador, Estonia, Finland, France, Frenc.Polynesia, French, Guiana, Germany, Greece, Guadeloupe, Guam, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, Lesotho, Libya, Luxembourg, Malaysia, Maldives, Malta, Martinique, Mexico, Monaco, Myanmar, N.Mariana Islnd, Netherlands (the), New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion Romania, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Ukraine, United Kingdom, Utd.Arab Emir., Vietnam, Zimbabwe.
- Recall date
- September 22, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)