Recall Z-0203-2024— Coapt LLC

Name: FDA recall Z-0203-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-02

Class II · Ongoing

Class II FDA medical device recall by Coapt LLC, initiated 2023-10-02. It names one FDA 510(k) clearance: K190416. Product: Coapt Dome Electrode, Gen2 system, cutaneous electrode. Reason: Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged..

Recalling firm: Coapt LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-10-02
Firm location: Chicago, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K190416 — Dome ElectrodeCoapt, LLC·cleared 2019-04-04

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

Coapt Dome Electrode, Gen2 system, cutaneous electrode

Reason for recall

Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.

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