Recall Z-2339-2024 ยท FLL Continuous Measurement Thermometer
Baxter Healthcare Corporation
Braun Thermoscan PRO 6000 Ear Thermometer
| Date | Jul 11, 2024 (initiated Jun 13, 2024) |
| Status | Open, Classified |
| Reason | The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU). |
| Root cause | Process control |
| Action | A 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 Please discard all versions of the outdated IFU (material number 419450).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 fla |
| Quantity | 265,647 units |
| Distribution | 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 |
| 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 |