Recall Z-2581-2023— Baxter Healthcare Corporation

Name: FDA recall Z-2581-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-10

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2023-08-10. It names one FDA 510(k) clearance: K142356. Product: Welch Allyn Connex Spot Monitor. Reason: Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-08-10
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K142356 — Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.·cleared 2014-12-19

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

Welch Allyn Connex Spot Monitor

Reason for recall

Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.

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