Device product
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
Z-1847-2021
Product summary
- Event
- Event 87920
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 boxes of 5 each
- Official record key
device-enforcement:Z-1847-2021
Official wording
Reason: The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.
Code information: Lot 274420
Distribution pattern: US distribution to: CA, MD, MO, NJ, PA, and TX
Derived failure modes
-
Unknown
The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.