Recall Z-2482-2021 · FLL Continuous Measurement Thermometer
Welch Allyn Inc
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
| Date | Jul 20, 2021 |
| Status | Open, Classified |
| 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 potentially causing a burn to the user or the ear canal of the patient |
| Root cause | Labeling design |
| Action | Welch Allen (a Hill Rom company) issued Urgent Medical Device Correction Letter (FA-2021-05-001-SKF-004) on 7/30/21 to: Chief Executive; Facility Administrator; Facility Engineer; Vigilance Manager; Biomedical Engineering; Medical Device Liaison Officer; Distributor mailed (with signature service) to all first-level consignees by Sedgwick (third party recall company). The letter states reason for the Field Action, risk mitigations, and Actions to be taken by the User: 1. Please share this communication with all potential users in your organization and instruct them to follow the provided Cle |
| 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 (Iv |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152748 | Braun Thermoscan PRO 6000 Ear Thermometer Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc), Mar 1, 2016 |