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U.S. Department of Health and Human Services

Class 2 Device Recall Braun

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  Class 2 Device Recall Braun see related information
Date Initiated by Firm July 20, 2021
Create Date September 16, 2021
Recall Status1 Open3, Classified
Recall Number Z-2482-2021
Recall Event ID 88481
510(K)Number K152748  
Product Classification Thermometer, electronic, clinical - Product Code FLL
Product 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
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.
Recalling Firm/
Manufacturer		 Welch Allyn Inc
4341 State Street Rd
Skaneateles Falls NY 13153-5300
For Additional Information Contact Howard Karesh
312-237-6188
Manufacturer 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
FDA Determined
Cause 2		 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 Cleaning Guide for proper cleaning. 2. Do not use the device if the ring around the measurement button shows a green blinking or flashing light instead of a ready state (solid green light) and contact Hillrom Customer Service to report this issue. 3. Do not use the device if the device requires multiple power-ups prior to going to ready state (solid green light) and contact Hillrom Customer Service to report this issue. 4. If you experience an overheating probe tip, do not use the device and contact Hillrom Customer Service to report the issue. 5. Complete the attached response form and return to HillromSKF004@stericycle.com within one month. Actions to be taken by the distributor: Please share with end users and/or your accounts and complete the attached response form and return to HillromSKF004@stericycle.com within one month. Contact HillromSKF004@stericycle.com to receive an electronic copy of this notification, response form, and further instructions for notifying your accounts. Actions being taken by Hillrom: Hillrom is in the process of updating the Braun ThermoScan Pro 6000 Instructions for Use (IFU) to include additional fluid ingress warnings. The IFU and Cleaning Guide can be found on the Hillrom website, Hillrom.com, under the Education & Documentation section of the Braun ThermoScan PRO 6000 Products page. The updated IFU will be available on the website
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FLL and Original Applicant = KAZ USA, INC (A SUBSIDIARY OF HELEN OF TROY, INC)
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