Braun Thermoscan PRO 6000 Ear Thermometer recallZ-2339-2024 · Baxter Healthcare Corporation · initiated Jun 13, 2024

Why it was recalled

The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).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

What the company is doing

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 Please discard all versions of the outdated IFU (material number 419450).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 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.

Recall details

Recall number

Z-2339-2024

Status

Open, Classified

Initiated by the company

Jun 13, 2024

Posted by the FDA

Jul 11, 2024

Recalling firm

Baxter Healthcare Corporation

Quantity

265,647 units

Product code

FLL

FDA submissions

K152748

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 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.

Product description

Braun Thermoscan PRO 6000 Ear Thermometer

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• Welch Allyn, Inc. 901054

  Welch Allyn, Inc. · Thermometer, electronic, clinical
  1 recall221 reports
• Welch Allyn, Inc. 901054

  Welch Allyn, Inc. · Thermometer, electronic, clinical
  2 recalls13 reports