PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 16, 2021 Initiated: April 30, 2021 #Z-1847-2021

Product 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

Reason for Recall

The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.

Details

Recalling Firm
CooperSurgical, Inc.
Units Affected
20 boxes of 5 each
Distribution
US distribution to: CA, MD, MO, NJ, PA, and TX
Location
Trumbull, CT

Frequently Asked Questions

What product was recalled?
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. Recalled by CooperSurgical, Inc.. Units affected: 20 boxes of 5 each.
Why was this product recalled?
The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 16, 2021. Severity: Moderate. Recall number: Z-1847-2021.