Recall Z-1847-2021 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
CooperSurgical, Inc.
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
| Date | Apr 30, 2021 |
| Status | Terminated |
| Reason | The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode. |
| Root cause | 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 |
| Quantity | 20 boxes of 5 each |
| Distribution | US distribution to: CA, MD, MO, NJ, PA, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020711 | WALLACH LOOP ELECTRODE Wallach Surgical Devices, Inc., Jun 3, 2002 |