| Class 2 Device Recall Wallach Loop Electrode 10mm x 10mm Square | |
Date Initiated by Firm | April 30, 2021 |
Create Date | June 10, 2021 |
Recall Status1 |
Terminated 3 on July 21, 2023 |
Recall Number | Z-1847-2021 |
Recall Event ID |
87920 |
510(K)Number | K020711 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product | CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures of the lower genital tract |
Code Information |
Lot 274420 |
Recalling Firm/ Manufacturer |
CooperSurgical, Inc. 95 Corporate Dr Trumbull CT 06611-1350
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For Additional Information Contact | Customer Service 203-601-9818 |
Manufacturer Reason for Recall | The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode. |
FDA Determined Cause 2 | Process control |
Action | On April 30, 2021, Cooper Surgical issued an Urgent Medical Device Removal notice to customers via letter notifying them Rounded Electrodes were sealed in packaging labeled as a Square Electrodes.
Customers were provided the following instructions:
Please inspect stock, quarantine, and discontinue use of all products subject to this recall, complete the attached Acknowledgement and Receipt Form, and return it to CooperSurgical. Once we receive the Acknowledgement Form, we will arrange for Product replacement(s) and return of affected Product(s). The replacement Product(s) will be charged at the same price as the original order and your account will be credited back once the affected Product(s) are returned to CooperSurgical. If you do not have affected Product in inventory, please use the same enclosed Form to indicate that and return it to CooperSurgical so that we may document receipt of this Recall Notice. |
Quantity in Commerce | 20 boxes of 5 each |
Distribution | US distribution to: CA, MD, MO, NJ, PA, and TX |
Total Product Life Cycle | TPLC Device Report |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = GEI
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