Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human bod...
FDA Device Recall #Z-2482-2021 — Class II — July 20, 2021
Recall Summary
| Recall Number | Z-2482-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 20, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Welch Allyn Inc |
| Location | Skaneateles Falls, NY |
| Product Type | Devices |
| Quantity | 1,036,740 units |
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
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 Pattern
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.
Lot / Code Information
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.
Other Recalls from Welch Allyn Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1672-2021 | Class II | GS777 Wall Transformer Model: 77710 ... | Apr 22, 2021 |
| Z-1673-2021 | Class II | ProBP 3400 Digital Blood Pressure Device ((hand... | Apr 22, 2021 |
| Z-1777-2017 | Class II | Welch Allyn ProBP 2400 Digital Blood Pressure D... | Feb 27, 2017 |
| Z-0169-2016 | Class II | Welch Allyn KleenSpec Corded Illumination Syste... | Oct 2, 2015 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.