FDA-Device2021-06-16Class II
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.
Hazard
The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.
Sold states
US distribution to: CA, MD, MO, NJ, PA, and TX
Affected count
20 boxes of 5 each
Manufactured in
95 Corporate Dr, N/A, Trumbull, CT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1847-2021Don't want to check this manually?
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