Recall record at a glance
| Official record | Z-2482-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Welch Allyn Inc. |
| Report date | Sep 22, 2021 |
| Recall initiation date | Jul 20, 2021 |
| Quantity | 1,036,740 units |
| Location | Skaneateles Falls, NY, United States |
Official product description
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
Why the product 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
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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