| Date Initiated by Firm | October 02, 2023 |
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| 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 |
| FEI Number |
3010605876
|
Recalling Firm/
Manufacturer |
Coapt LLC
303 W Institute Pl Ste 200
Chicago IL 60610-3080
|
| For Additional Information Contact |
844-262-7800 |
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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. |
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FDA Determined
Cause 2 | Process design |
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| 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. |
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| 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
|
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