CooperSurgical, Inc. Recall 87920
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
CooperSurgical, Inc. Recall 87920 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1847-2021 |
| Event ID | 87920 |
| Event 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 |
| Product Type | Devices |
| Distribution | US distribution to: CA, MD, MO, NJ, PA, and TX |
| Quantity | 20 boxes of 5 each |
| Recall Reason | The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode. |
| Device Classification | 20210616 |
| Device Code Info | Lot 274420 |
| Center Classification Date | 20210610 |
| Recall Initiation Date | 20210430 |
| Recalling Firm | CooperSurgical, Inc. |
| Initial Notification | Letter |
| Similar To |