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U.S. Department of Health and Human Services

Class 2 Device Recall Braun Thermoscan PRO 6000 Ear Thermometer

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 Class 2 Device Recall Braun Thermoscan PRO 6000 Ear Thermometersee related information
Date Initiated by FirmJune 13, 2024
Date PostedJuly 11, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2339-2024
Recall Event ID 94825
510(K)NumberK152748 
Product Classification Thermometer, electronic, clinical - Product Code FLL
ProductBraun Thermoscan PRO 6000 Ear Thermometer
Code Information UDI: 00732094309003 (product code 06000-200) and 00732094309027 (product code 06000-300); All serial numbers.
FEI Number 1417572
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall		The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
FDA Determined
Cause 2		Process control
ActionA communication was sent to affected customers via U.S.P.S., first class mail on 06/13/2024. Baxter is asking customers to: 1. Clinicians may continue to use the PRO 6000 ear thermometers according to the current IFU (CD material Number 421032). Please discard all versions of the outdated IFU (material number 419450). The material number is printed on the CD. 2. Acknowledge the receipt of this notification by completing a reply form on the customer portal. UPDATE PER EMAIL DATED 7/24/2024: The firm issued a follow-up letter dated 7/24/2024 via USPS first class mail. The follow-up letter flagged Urgent Medical Device Correction provides the following additional actions to be taken by the customer as a result of the firm expanding the scope of the recall strategy and actions to be taken by the customer: (The content of the other numbered actions remains the same as the initial letter dated 6/13/2024.) 2. Please share this communication with all potential users in your organization and instruct them to follow cleaning instructions in the IFU Maintenance and Service section for proper cleaning. For convenience, the cleaning instructions are summarized in the enclosed Cleaning Guide. 3. 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). Contact Baxter Technical Support to report this issue. 4. Do not use the device if the device requires multiple power-ups prior to going to ready state (solid green light). Contact Baxter Technical Support to report this issue. 5. If you experience an overheating probe tip, do not use the device. Contact Baxter Technical Support to report the issue. A Cleaning Guide was enclosed with the letter as well as another response form.
Quantity in Commerce265,647 units
DistributionDistributed to United States, Canada, Australia, Malaysia, New Zealand, Philippines, Austria, Belgium, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, and United Kingdom. UPDATED PER EMAIL DATED 7/24/2024: United States (including Puerto Rico and Guam), Canada, Australia, Brunei, Hong Kong, India, Korea, Malaysia, Maldives, Myanmar, New Zealand, Philippines, Singapore, Taiwan, Thailand, Vietnam, Afghanistan, Austria, Bahrain, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Jordan, Kuwait, Luxemburg, Namibia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Yemen, Bahamas, Bolivia, Chile, Colombia, Ecuador, Guatemala, Mexico, and Panama.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FLL
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