Date Initiated by Firm |
October 02, 2023 |
Date Posted |
October 31, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0204-2024 |
Recall Event ID |
93138 |
510(K)Number |
K223605
|
Product Classification |
Electrode, cutaneous - Product Code GXY
|
Product |
Coapt ControlSeal Electrode, cutaneous EMG Electrode |
Code Information |
UDI/DI: +B618P1/$+202210P1603, All serial numbers |
Recalling Firm/ Manufacturer |
Coapt LLC 303 W Institute Pl Ste 200 Chicago IL 60610-3080
|
For Additional Information Contact |
844-262-7800
|
Manufacturer 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.
|
FDA Determined Cause 2 |
Process design |
Action |
Coapt, LLC issued a Medical Device Correction notice to its consignees on 10/02/2023 via email. The notice explained the problem, risk, and urged users to take precautions as described in the most recent handbook: https://coaptengineering.com/clinicians. The handbook is under "Downloadable product handbooks." |
Quantity in Commerce |
109 devices |
Distribution |
Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Sweden. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = GXY and Original Applicant = Coapt
|