Recall Z-2339-2024— Baxter Healthcare Corporation

Name: FDA recall Z-2339-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-13

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2024-06-13. It names one FDA 510(k) clearance: K152748. Product: Braun Thermoscan¿ PRO 6000 Ear Thermometer. Reason: The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU)..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-06-13
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K152748 — Braun Thermoscan PRO 6000 Ear ThermometerKaz USA, Inc (A Subsidiary of Helen of Troy, Inc)·cleared 2016-03-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).

Data sourced from openFDA. This site is unofficial and independent of the FDA.