Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patie
Summary
The FDA issued a Class II for Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measure by Welch Allyn Inc. Reason: 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 potent.
Details
Source
Device Recall
External ID
Z-2482-2021
Action Date
2021-09-22
Status
Ongoing
Category
device
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
Lot/Code Info: 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.
Quantity Affected: 1,036,740 units
Reason for Recall
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-20
Company
Skaneateles Falls, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Welch Allyn Inc has 5 FDA actions in our database, including 1 recall and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Welch Allyn Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Welch Allyn Inc have FDA actions?
Welch Allyn Inc has 5 FDA actions in our database, including 1 recall and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2482-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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