Braun Thermoscan PRO 6000 Recall: Outdated Instructions on Included CD
Braun Thermoscan PRO 6000 ear thermometers may have been shipped with outdated Instructions for Use on an included CD. Approximately 265,647 units were distributed globally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class II recall, indicating moderate risk. No injuries or illnesses have been reported, and the hazard is instructional rather than a physical device defect. Per the rubric, documented labeling or documentation errors with no reported harm score as Moderate.
Plain-English summary
The Braun Thermoscan PRO 6000 is an ear thermometer. The FDA has issued a recall because units may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use.
Approximately 265,647 units have been distributed to the United States (including Puerto Rico and Guam), Canada, Australia, and numerous countries in Europe, Asia, the Middle East, Africa, Latin America, and the Caribbean. The affected units are identified by UDI codes 00732094309003 and 00732094309027, and all serial numbers are included.
The concern is that users who follow the outdated instructions may not be using the device correctly. No injuries or illnesses have been reported related to this issue.
If you own this device, verify that you have access to the current Instructions for Use before using it. Contact Baxter Healthcare Corporation for updated documentation or consult the FDA website for more information.
The recalled product
- Product
- Braun Thermoscan¿ PRO 6000 Ear Thermometer
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device
- Hazard
- Affected units
- 265,647
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers.
Distribution
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