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U.S. Department of Health and Human Services

Class 2 Device Recall Wallach Loop Electrode 10mm x 10mm Square

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  Class 2 Device Recall Wallach Loop Electrode 10mm x 10mm Square see related information
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
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
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
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.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = WALLACH SURGICAL DEVICES, INC.
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