Z-2339-2024 Class II Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
July 17, 2024
Initiation Date
June 13, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
265,647 units

Product Description

Braun Thermoscan¿ PRO 6000 Ear Thermometer

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The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).

Distribution Pattern

Distributed 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.

Code Information

UDI: 00732094309003 (product code 06000-200) and 00732094309027 (product code 06000-300); All serial numbers.