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
Recall
- Recall Number
- Z-1847-2021
- Event Number
- 87920
- Firm
- CooperSurgical, Inc.
- FEI Number
- 1216677
- Product Code
- GEI
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- April 30, 2021
- Terminated
- July 21, 2023
- Address
- 95 Corporate Dr, Trumbull, CT, 06611-1350
Description
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
The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.
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.
US distribution to: CA, MD, MO, NJ, PA, and TX
20 boxes of 5 each